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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): 18.0-999.0, Eye Cancer Participant must be 18 years of age or over 2. Possible or suspicious sebaceous gland carcinoma of the eyelid. 3. A CXR (chest x-ray), liver enzymes, and a head and neck CT or magnetic resonance imaging (MRI) and an ultrasound negative for clinical evidence of metastasis. 4. Patient provided written informed consent. In the event that non-English speaking participants are eligible for this study, a short form (if applicable) or an ICD in their language, will be utilized and completed in accordance with the MDACC policy for Consenting Non-English Speaking Participants Pregnant or nursing females | 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, Brain Tumors and/or Solid Tumors Including Brain Stem Glioma High Grade CNS Tumors Ependymoma Medulloblastoma Craniopharyngioma Low Grade CNS Tumors Hodgkin Lymphoma Non Hodgkin Lymphoma Ewing Sarcoma Osteosarcoma Rhabdomyosarcoma Neuroblastoma Other All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation Participants will have had, or are scheduled to have clinical imaging evaluations which may FDG PET CT, or CT, or MRI within 4 weeks of entry No limit on age or gender Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board More than 6 MET PET scans within the previous 12 months Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent. for Open-Access All participants under the care of St. Jude physicians with known or suspected neoplastic disease are eligible for participation No limit on age or gender Female participants of childbearing age must not be lactating due to theoretical potential harm to the infant from exposure to radiation Informed consent signed by participant, parent, or guardian according to the guidelines of the institutional review board for Open-Access More than 6 MET PET scans within the previous 12 months Inability or unwillingness of research participant, parent, or legal guardian/representative to give written informed consent | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Thyroid Carcinoma Near total or total thyroidectomy because of struma multinodsa (nodular goiter) with or without substitution of thyroid hormone after operation Total thyroidectomy because of papillary carcinoma of thyroid gland (T1/T2 carcinoma, N1, M0) with planned radio-ablative therapy (RAT) without or with rhTSH Pat< 18 years Immune disease of thyroid gland (Graves disease) Severe immunodeficiency Immunosuppressive medication because of solid Organ transplantation Hepatitis A/B/C or HIV All for any surgical 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): 18.0-80.0, Chronic Rhinosinusitis CRS s/p sinus surgery nasal polyps | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 17.0-999.0, Sickle Cell Anemia Pulmonary Hypertension patients with Sickle Cell Anemia homozygous to hemoglobin S preserved physical capacity steady state of the disease Pulmonary Hypertension at rest Recent sickling crisis(<2 months) High Blood Pressure Atrial fibrillation Chronic obstructive pulmonary disease Last blood transfusion > 3 months before Signs of congestive heart failure or significant valve disease Normal global and regional systolic function on echocardiography | 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, Thymoma Availability of tumor tissue and patients with thymoma and thymic carcinoma NON Availability of tumor tissue and patients with thymoma and thymic carcinoma | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed newly diagnosed squamous cell carcinoma (SCC) of the head and neck , including any of the following sites Oral cavity Oropharynx, including base of tongue and tonsils Larynx Supraglottis Stage T2-T4, N0-N3 disease Unilateral or bilateral neck dissection planned No N2c disease (if bilateral disease is present) Has ≥ 1 clinically N0 neck side as defined by clinical exam (physical exam with CT scan and/or MRI) A N0 neck must be planned to be dissected for the patient to be eligible | 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 papillary thyroid cancer pregnancy Bleeding abnormality Prior history of head and neck cancer can not perform 99mTechnetium-MIBI SPECT-CT can not perform 131I remnant Ablation Prior any head and neck surgery within 3 months Prior deep neck infection within 3 months | 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 Carcinoma Histologically confirmed metastatic medullary or differentiated thyroid cancer. Diagnosis must be confirmed at University of Wisconsin Patients must have measurable disease as defined by At least 3 weeks from the completion of major surgery, chemotherapy, or other systemic therapy or local liver therapy to study registration No concurrent chemotherapy or radiation therapy ECOG Performance Status of ≤ 2 Ability to provide written informed consent obtained prior to participation in the study and any related procedures being performed Adequate bone marrow, kidney, liver function Left ventricular ejection fraction ≥ the lower limit of the institutional normal Those with differentiated thyroid cancer must have radioactive iodine resistant disease, defined by failure to incorporate 131-Iodine after therapy, FDG-avidity on a PET scan, or progression of measurable disease after 131-Iodine therapy or an allergy to radioactive iodine Hypertension must be well controlled (to less than 150/90 mmHg) on a stable regimen of anti-hypertensive therapy Prior HDAC, DAC, HSP90 inhibitors or valproic acid for the treatment of cancer Patients who will need valproic acid for any medical condition during the study or within 5 days prior to first LBH589 treatment Impaired cardiac function Concomitant use of drugs with a risk of causing torsades de pointes Patients with unresolved diarrhea > CTCAE grade 1 Impairment of gastrointestinal (GI) function or GI disease that may significantly alter the absorption of oral LBH589 Other concurrent severe and/or uncontrolled medical conditions Women who are pregnant or breast feeding or women of childbearing potential (WOCBP) not willing to use a double barrier method of contraception during the study and 3 months after last study drug administration. Women of childbearing potential must have a negative serum pregnancy test within 7 days of the first administration of oral LBH589 Male patients whose sexual partners are WOCBP not using a double method of contraception during the study and 3 months after the end of treatment Patients with a history of another primary malignancy that, in the opinion of the investigator, would interfere with the assessment of the primary endpoints of the study | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 20.0-80.0, Carpal Tunnel Syndrome presence of at least one of the following primary symptoms: 1. numbness, tingling pain, or paresthesia in the median nerve distribution; 2. precipitation of these symptoms by repetitive hand activities, which could be relieved by resting, rubbing, and shaking the hand; and 3. nocturnal awakening by such sensory symptoms plus the presence of 1 or more of the following standard electrophysiologic (1) prolonged distal motor latency (DML) to the abductor pollicis brevis (APB)(abnormal Z4.7 ms, stimulation over the wrist, 8 cm proximal to the active electrode) (2) prolonged antidromic distal sensory latency (DSL) to the second digit (abnormal Z3.1 ms; stimulation over the wrist, 14 cm proximal to the active electrode); and (3) prolonged antidromic wrist-palm sensory nerve conduction velocity (W-P SNCV) at a distance of 8 cm (W-P SNCV, abnormal <45 m/s) symptoms occurring less than 3 months before the study or symptoms improving during the 1-month initial observation period (to patients who might have spontaneous resolution of symptoms); 2. severe CTS that had progressed to visible muscle atrophy; 3. in our study, mild CTS referred to patients with decreased conduction velocity over the palm-wrist segment and delayed DSL, with normal median SNAP amplitude and CMAP amplitude of the APB. Moderate CTS referred to patients with abnormally delayed DML and DSL with either decreased median SNAP amplitude or decreased CMAP amplitude of the APB muscle. Thus, CTS patients with the presence of either fibrillation potentials or reinnervation on needle EMG in the APB were excluded (to ensure the of only mildly or moderately affected individuals); 4. clinical or electrophysiologic evidence of accompanying conditions that could mimic CTS or interfere with its evaluation, such as cervical radiculopathy, proximal median neuropathy, or significant polyneuropathy; 5. evidence of obvious underlying causes of CTS such as diabetes mellitus, rheumatoid arthritis, hypothyroidism (acromegaly), pregnancy, alcohol abuse or drug usage (steroids or drugs acting through the central nervous system), use of vibrating machinery, and suspected malignancy or inflammation or autoimmune disease were documented as underlying causes for CTS; 6. recent peptic ulcer or history of steroid intolerance; 7. prior unpleasant experience with acupuncture or a bleeding diathesis; or 8. cognitive impairment interfering with the patient's ability to follow instructions and describe symptoms.- | 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): 18.0-55.0, Musculoskeletal Pain Signed and dated informed consent prior to participation Subjects in good health as determined by the Investigator Age 18-55 Willing to abstain from any physical therapy, hard physical work, exercise or sauna during the study observation period (Screening to Final Visit) For females, subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within 1 year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e., less than 1% per year when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomized partner). Oral contraceptive medications are allowed in this study. Female subjects, who are surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) are also allowed for participation Participation in another clinical study within the last 30 days and during the study Subjects who are inmates of psychiatric wards, prisons, or other state institutions Investigator or any other team member involved directly or indirectly in the conduct of the clinical study Pregnancy or lactation Alcohol or drug abuse Malignancy within the past 2 years with the exception of in situ removal of basal cell carcinoma Skin lesions, dermatological diseases or tattoo in the treatment areas Known hypersensitivity or allergy (including photoallergy) to NSAID´s including celecoxib, sulfonamides and ingredients used in pharmaceutical products and cosmetics including galactose Varicosis, thrombophlebitis and other vascular disorders of the lower extremities Major traumatic lesions (e.g. fracture, tendon or muscle ruptures) of the musculo-skeletal system of the lower limbs | 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, HIV Infection Liver Failure Evidence of Liver Transplantation Age ≥ 18 Documented HIV-1 infection, hepatitis B or C co-infection is allowed Plasma viral load at screening visit below 50 copies per mL for at least 6 months Patient with severe liver failure (Meld Score ≥ 15 and/or refractory ascites and/or haemorrhage of digestive tract and/or hepatic encephalopathy) for taking part into period 1 Patient eligible for the liver transplant waiting list or immediate post transplantation for taking part into period 2 Abstinence from alcohol intake for at least 6 months (WHO norm) Withdrawal from intravenous drug use for at least 6 months (methadone substitution is permitted) No ongoing class C opportunistic infection (1993 CDC classification) Patient whose clinical and immunovirological condition allows triple therapy with raltegravir + 2 NRTI or raltegravir + NRTI + enfuvirtide Patient whose HIV population, according to cumulative genotypes carried out on viral RNA together with treatment history (if available and interpreted as per the ANRS-AC11 algorithm version no.19) does not present a profile of mutations associated with resistance to raltegravir and is sensitive to at least two fully active* agents selected among nucleoside/nucleotide reverse transcriptase analogs NRTI (abacavir, lamivudine, emtricitabine, tenofovir) or enfuvirtide *An ARV agent is considered to be fully active if the cumulative genotypes do not show any mutation associated with resistance or any mutation associated with "possible resistance" More than two virological failures during antiretroviral treatment Currently receiving treatment with an agent in development (apart from an authorization for temporary use) Plasma viral load at screening visit ≥ 50 copies per mL during at least the last 6 months Pregnant women, or women liable to become pregnant, breast-feeding women, no contraception, or refusal to use contraception All conditions (including but not limited to alcohol intake and drug use) liable to compromise, in the investigator's opinion, the safety of treatment and/or the patient's compliance with the protocol Patient not having any effective options for NRTI +/ enfuvirtide (defined in the criteria) Ongoing treatment with interferon-alpha or ribavirin for hepatitis C Concomitant medication including one or more agents liable to induce UGT1A1 and reduce raltegravir concentrations anti-infective agents: rifampicin/rifampin | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.5-999.0, HIV Infection Rheumatic Disease Cancer Transplant Pediatrics medically recommended influenza A(H1N1) immunization signed informed consent failure or refusal to provide sufficient blood for antibody determination | 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 Neoplasms head and neck cancer patients (localized to the larynx, pharynx and oral cavity) treated with curative radiotherapy complete loss of tumor WHO performance status between 0-1 and expected ability to complete the training protocol No parenteral feeding above the age of 18 written concent other malignant diseases pregnancy undergoing systematic resistance training or creatin ingestion Alcohol abuse | 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): 18.0-59.0, First Episode Psychosis Aged 18-59 years and meet DSM-IV diagnostic for first episode of schizophrenia, schizophreniform disorder, schizoaffective disorder or psychotic disorder NOS as assessed by using the Structured Clinical Interview for DSM-IV, research version Meeting DSM-IV for another axis I diagnosis, including substance abuse or dependence Needing another nonantipsychotic psychotropic medication at enrollment Having a serious or unstable medical illness Pregnant or lactating women or women without adequate contraception will be also excluded | 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 Melanoma ENTRY Locally advanced or metastatic melanoma Measurable Histologically or cytologically confirmed Surgically incurable HLA-A2 positive and tumors that present HLA-A2.1/p53aa264-272 complexes PRIOR/CONCURRENT If prior Proleukin treatment, must have had clinical benefit No prior systemic cytotoxic chemotherapy for melanoma No concurrent radiotherapy, chemotherapy, or other immunotherapy More than 4 weeks since prior major radiotherapy | 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, Breast Cancer History of breast cancer treated by conservative surgery Normal radiological assessment normal (ACR1 or ACR2) Moderate Deformations (Type I and II of the classification of Clough) Delay with regard to the end of the radiotherapy superior or equal to one-year-old Moderated radio-dystrophies (< Grade 2 of the score LENT/SOMA) Signature of the informed consent Patient benefiting from social security Patient of more than 18 years old Abnormal radiological assessment (ACR3, ACR4 or ACR5) Absence of fatty excess radio surgical relapses with vast fibroses of the breast (> Grade 2 of the score LENT/SOMA) Patient under 18 years old administrative difficulties: impossibility to provide enlightened information to the patient, the refusal to sign the consent pregnant women or breast feeding women patient under legal guardianship bilateral breast cancer regardless histologic type | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-60.0, Thyroidectomy Distress Surgery (a) a minimally invasive follicular thyroid carcinoma ≤4 cm in diameter, or (b) a papillary thyroid carcinoma ≤2 cm in diameter (a) previous neck operations (b) age <21 or >65 years (c) prior vocal fold paralysis or a history of voice or laryngeal disease requiring therapy (d) a malignancy with definite extrathyroid invasion, multiple lateral neck node metastasis, perinodal infiltration at a metastatic lymph node, or distant metastasis; and/or (e) a lesion located in the thyroid dorsal area (especially adjacent to the tracheoesophageal groove) caused by possible injury to the trachea, esophagus, or recurrent laryngeal nerve (RLN) | 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 for patient participants Individuals with papillary thyroid carcinoma who have had complete resection of their thyroid at surgery (total or near-total thyroidectomy, or hemi [subtotal] with completion thyroidectomy)on or after September 1, 2009 Age at time of first thyroid cancer surgery must be at least 18 years or older The papillary thyroid cancer TNM pathologic stage must be pT1 or pT2, N0 (or Nx), M0 (or Mx) (TNM stage, AJCC VI) (ie. primary tumor size 1-4 cm, no known positive lymph nodes at the time of primary surgery, no extension of the tumor outside the thyroid, no venous or lymphatic invasion, and no known distant metastases at primary surgery, with no tall cell features, as per surgical pathology report) Must be able to communicate in spoken and written English Must be able to use a computer Must be able to provide informed consent on one's own (without any need for translation) for patient participants Participants not meeting Concurrent diagnosis of medullary or anaplastic or poorly differentiated thyroid cancer or thyroid lymphoma Prior radioactive treatment for thyroid cancer Individuals who have been taken off their thyroid hormone for testing or treatment, will not be eligible for the study while off this medication Individuals who are unwilling for investigators to confirm their pathologic stage of disease through review of pathology report(s) will be ineligible for the study for the physician feedback component of this study Physicians and surgeons caring for thyroid cancer patients, in active practice at University Health Network in Toronto, Ontario, Canada | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Thyroid Cancer Patients with first time surgery for proven papillary thyroid cancer > 10 mm Patients with first time surgery for a cytologic diagnosis of follicular neoplasia or suspected (not proven) malignancy Age below 18 years Pregnancy or lactation Inability to understand written and oral information or to comply with scheduled follow-up | 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): 20.0-76.0, Thyroid Neoplasm Lymphatic Metastasis Papillary thyroid carcinoma with central neck metastasis No evidence of lateral neck metastasis as determined by high-resolution neck ultrasonography and computed tomography History of previous thyroid operation Isthmic thyroid lesion | 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, Indeterminate Thyroid Nodules Indeterminate or benign pathology on fine needle aspirate biopsy Scheduled to undergo total or hemi-thyroidectomy > 18 years old Previous thyroid surgery Previous neck surgery in field of thyroidectomy Previous neck irradiation Pre-operative hypocalcemia or hypoparathyroidism Biopsy suggestive of thyroid cancer Neck nodes suspicious for or with known cancer Pre-operative vocal cord dysfunction | 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, Colorectal Cancer Advanced unresectable or recurrent colorectal cancer patients which meet the following Willing to sign ICF Could orally take investigational product Pathology diagnosis is adenocarcinoma Above 20 years No previous treatment(including: radiotherapy,chemotherapy and immunotherapy) For recurrent cases, if the patient had received adjuvant chemotherapy that didn't S-1 and L-OHP in 180 days ago, he/she could be enrolled in With target lesions with diameter which is longer than 1cm in spiral CT or MRI examination within 30 days Lab test within 15 days meet following Hemoglobin higher than 9.0g/dL The patient who meet the following should be excluded from this trial Patients who have severe drug allergic history(including: platinum related drugs,5-FU,FT,LV,5-HT3 receptor antagonist) Attended other clinical trial within 4 weeks Received transfusion of blood,related products or G-CSF within 15 days Received surgery within 4 weeks and the effect hadn't vanished Have diarrhea Have complication of active infection(infection caused fever higher than 38℃) Have complication of poor controlled hypercalcemia,hypertension,diabetes Have complication of severe ECG abnormal or other heart disease which will affect clinical treatment(including: cardiac dysfunction,myocardial infarction,angina) Have complication of severe pulmonary disease(including:interstitial pneumonia,pulmonary fibrosis,severe emphysema) | 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, Breast Cancer Fatigue Age > 18 years 2. Pathologic diagnosis of stage 0-III breast cancer (any histologic subtype) in either breast or both breasts 3. Previous resection of tumor, either by mastectomy or partial mastectomy, ±sentinel lymph node biopsy, ±axillary lymph node dissection 4. A likelihood of having radiation therapy or chemotherapy following surgery as determined by the on-site principal investigator (PI) or co-investigator 5. Signed informed consent which has been reviewed and approved by the Institutional Review Board and no condition that impairs the ability to provide informed consent (e.g. uncontrolled psychiatric illness) for the radiation therapy (RT) alone group will 1. Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields, unilateral or bilateral) via standard or Canadian Fractionation, +/ regional nodal irradiation. 2. No planned chemotherapy for this tumor for the RT + chemotherapy (CT) group will 1. Planned 3-D conformal radiation therapy to the whole breast (2 tangential fields, unilateral or bilateral) via standard or Canadian fractionation (photons followed by a photon, electron, or mixed photon/electron boost), +/ regional nodal irradiation. 2. Planned adjuvant chemotherapy (any regimen except for biologic therapy alone) Continuous/chronic treatment with opiate/opioid analgesics for 3-6 months prior to enrollment. In addition, patients receiving radiation therapy alone who have taken opiate analgesics from their surgery within 72 hours of the post-surgery/pre-radiation therapy blood draw (at 1-6 weeks prior to the start of radiation therapy) will be removed from the study. Patients receiving chemotherapy and radiation therapy who have taken opiate analgesics from their surgery within 72 hours of the blood draw prior to cycle 1 of chemotherapy will be removed from the study. 2. Prior radiation therapy to the chest or brain 3. Patients diagnosed with Stage IV breast cancer 4. History of illegal drug use within 6 months prior to enrollment 5. At point of enrollment, diagnosis of major depression, bipolar disorder, seasonal affective disorder, or anxiety disorder for which the patient is currently taking any of the following medications: selective serotonin reuptake inhibitors (SSRIs), Tricyclic antidepressants, monoamine oxidase inhibitors, lithium, benzodiazepines, barbiturates, drugs acting on the 5-HT receptors. Patients meeting these may still enroll in the study if they are on a chronic, stable, low-dose regimen for at least 3 months prior to enrollment, as determined by the on-site PIs and co-investigating physicians. Patients having to begin on a regimen of any of these medications while on the study may continue on the study. 6. Anemia of any etiology at initial visit (Hct <33%) and the following baseline fatigue scores on the Fatigue Symptom Inventory (FSI): Average score for question #s 1-4 > 5; and/or Average score for question #s 5-11 > 5. Patients with Hct<33% but who have no baseline fatigue (as indicated by baseline scores on the FSI as follows: average score for question #s 1-4 < 5 and average scores for question #s 5-11 < 5) are eligible to participate. 7. Endocrine disorders that can cause fatigue: Addison's disease, uncorrected hypothyroidism (patients taking thyroid replacement therapy for at least 3 months prior to enrollment patients are eligible), central endocrine deficiency, polyglandular autoimmune failure. 8. Patients with thyroid disease (hypothyroidism or hyperthyroidism) that was diagnosed within 3 months of cancer diagnosis or patients with previously stable thyroid disease who have experienced symptoms or have had to change their medication doses within 3 months of cancer diagnosis. Patients with stable disease who have no had to change medication doses within 3 months of cancer diagnosis. Patients with stable disease who have not had to change medication doses within 3 months of cancer diagnosis may enroll as long as baseline fatigue scores do not meet for exclusion. Patients enrolled in the study who have to alter doses of thyroid medications or who are newly diagnosed with thyroid disease while on the study will be removed from the study, and will not count towards our total patient accrual. 9. Uncontrolled autoimmune diseases that can cause fatigue, including fibromyalgia and fatigue syndromes. If these are controlled, enrollment or maintenance of the patient on the protocol may continue at the discretion of the enrolling principal investigator. 10. Sleep disorder diagnosed within 3 months of enrollment and the following baseline fatigue scores on the FSI: Average score for question #s 1-4 > 5; and/or average score for question #s 5-11 > 5. Patients diagnosed with a sleep disorder within 3 months of enrollment and with FSI scores < 5 on question #s 1-4 and #s 5-11 are eligible. 11. Activity-limiting heart or lung disease 12. Renal failure (BUN and creatinine should be within the normal range for the prior 6 months) 13. Baseline fatigue as indicated by the following baseline scores on the FSI: Average score for question #s 1-4 > 5; and/or Average score for question #s 5-11 > 5. 14. Patients receiving chemotherapy or radiation therapy at any site other than Massachusetts General Hospital 15. Hepatitis or chronic liver disease (albumin <3 g/dL or >6 g/dL; ALT >60 U/L or < 5 U/L, AST > 40 U/L or <5 U/L) 16. Untreated chronic infection (e.g. tuberculosis, osteomyelitis, abscess). Patients being treated for these may be enrolled in, or continue on the protocol at the discretion of the principal investigators | 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 Adenocarcinoma Recurrent Prostate Carcinoma Stage IV Prostate Cancer All patients must have a histologically or cytologically proven diagnosis of adenocarcinoma of the prostate; note: If there is no formal biopsy report documenting the diagnosis of prostate cancer, the patient can be allowed on trial if the PSA level is at least 20, and there are at least three definitive metastatic lesions seen on scan; all patients must have had metastatic (M1) disease as evidenced by soft tissue and/or bony metastases prior to androgen deprivation therapy initiation; patients must have at least one of the following at the time they started androgen deprivation therapy Visceral disease (liver, lung, or other viscera) Bone metastases to sites in either the axial (spine, pelvis, ribs, or skull) and/or the appendicular (clavicle, humerus, or femur) skeleton Lymph node disease not considered to be encompassed within a single radiotherapy port (e.g., above the aortic bifurcation, etc.) Patients who have measurable disease must have radiographic assessment (at least an abdominal/pelvic computed tomography [CT]) within 28 days prior to registration; non-measurable disease must also be assessed (e.g., bone scan) in all patients within 56 days prior to registration; all disease must be assessed and documented on the Baseline Tumor Assessment Form Patients must have a PSA >= 5 ng/mL obtained within 90 days prior to initiation of androgen deprivation therapy Patients with known brain metastases are not eligible; brain imaging studies are not required for if the patient has no neurologic signs or symptoms, but if brain imaging studies are performed, they must be negative for disease Patient must have had no more than 30 days of prior medical castration for metastatic prostate cancer (prior androgen deprivation therapy is allowed if it was received with curative intent in the neoadjuvant, concurrent, and/or adjuvant fashion and at least 2 years have elapsed since completion of androgen deprivation therapy); the start date of medical castration is considered the day the patient first received an injection of a LHRH agonist, not an oral antiandrogen; if the method of castration is luteinizing hormone releasing hormone (LHRH) agonists (i.e., leuprolide or goserelin), the patient must be willing to continue the use of LHRH agonists and add bicalutamide for combined androgen deprivation therapy (ADT) during protocol treatment; the 30 day window begins from the date of receiving the LHRH agonist, not the oral antiandrogen; if the patient was on a different antiandrogen (e.g. flutamide), the patient must be willing to switch over to bicalutamide; patients must not have received bilateral orchiectomy; patients must not have received or be planning to receive LHRH antagonists (i.e., Degarelix); however, if the patient was initiated on a LHRH antagonist within the 30 day window and is willing to switch to a LHRH agonist with bicalutamide, he may enroll on the late induction group Patients who have not already started androgen deprivation therapy must be offered the opportunity to participate in the translational medicine studies; once a patient has started any form of antiandrogen (i.e., either bicalutamide or LHRH agonist), he is not eligible for any translational medicine studies Patients must not have received any prior cytotoxic chemotherapy for metastatic prostate cancer; prior cytotoxic chemotherapy with curative intent in the neoadjuvant or adjuvant setting is allowed; patients must not have received any prior treatment with agents that directly inhibit IGF or IGFRs | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-80.0, Thyroid Neoplasm Cases with tumors larger than 1 cm in size or with suspicious central neck node metastasis in Papillary thyroid cancer The patient with definite metastatic lymph node in lateral neck compartment | 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): 18.0-80.0, Carcinoma papillary carcinoma of thyroid (less than 4cm) no evidence of lymph node metastasis in preoperative work-up result the patients who accept this study large thyroid cancer( > 4cm) morbid anticoagulation agent usage endoscopic or robotic thyroid operation evidence of lymph node metastasis or extrathyroidal extension in preoperative US and CT scan | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed thyroid cancer Progressive or refractory disease within the past 6 months Locally advanced or metastatic disease Measurable disease, defined as ≥ 1 measurable lesion defined by Not amenable to surgical resection or external-beam radiotherapy or refractory to radioiodine therapy No untreated brain metastasis ECOG performance status 0-2 Life expectancy > 3 months ANC ≥ 1,500/mm³ Platelet count ≥ 100,000/mm³ | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Cancer Pathologically confirmed differentiated thyroid cancer Patient with locally advanced tumor (T4a, tumor of any size extending beyond the thyroid capsule to invade subcutaneous soft tissues, larynx, trachea, esophagus, or recurrent laryngeal nerve or T4b, tumor invades prevertebral fascia or encases carotid artery or mediastinal vessels or N1b, unilateral, bilateral, or contralateral cervical or mediastinal lymph node positive), or locoregionally recurrent tumor All patients must have radiographically assessable disease No previous irradiation to the planned field Age of ≥ 18 years Performance status of 0 to 2 on the Eastern Cooperative Oncology Group (ECOG) score Required Entry Laboratory Parameters WBC count ≥ 1,000/mm3; hemoglobin level ≥ 7.5 g/dL; platelet count ≥ 100,000/mm3; creatinine ≤ 3.0 mg/dL Oral intake (including J-tube feeding) of ≥ 1,500 calories/day should be maintained Signed informed consent form prior to study entry Patient with anaplastic carcinoma (focal anaplastic change associate with differentiated thyroid cancer is not excluded) Age of <18 years Previous history of RT adjacent to planned field Poor performance status of 3 to 4 on the Eastern Cooperative Oncology Group (ECOG) score Pregnant or breast feeding status Previous history of uncontrolled other malignancies within 2 years | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, High Risk Cutaneous Squamous Cell Carcinoma Major criterion and at least one minor Major criterion: > 6 mm depth of invasion Minor (one or more) Greater than 2cm diameter Recurrent (prior Mohs, wide local excision, electrodesiccation and curettage, topical imiquimod or 5 fluorouracil, cryotherapy or photodynamic therapy) High risk location: any portion of cutaneous lip, ear, temple, scalp Immunosuppressed host (organ transplant recipient or chronic lymphocytic leukemia) Perineural invasion (yes/no; nerve involved must be greater than 0.1mm) Direct involvement of subcutaneous tissue (Clark's V), muscle, cartilage,or bone Satellite metastases Clinically abnormal lymph node exam Location other than head or neck Exclusively mucosal squamous cell carcinoma Previous head and neck radiation In situ disease, keratoacanthoma subtypes, metatypical or collision tumors Inability of subject to give written informed consent Pregnancy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Metastatic Diffuse Gastric Cancer Including Carcinoma of the Gastro-esophageal Junction Has given written Informed Consent Histologically confirmed, unresectable, metastatic diffuse gastric cancer including carcinoma of the gastro-esophageal junction No prior chemotherapy for gastric cancer except adjuvant and/or neo-adjuvant chemotherapy more than 12 months ago Life expectancy of at least 3 months Able to take medications orally ECOG performance status 0 to 1 Adequate organ function (bone marrow, kidney and liver) Certain type(s) of non-measurable lesion(s), if the only one(s) Certain serious illness or medical condition(s) Lost greater than or equal to 10% of body weight in the 3 months proceeding signing the ICF Treatment with drugs interacting with S-1, 5-FU, or cisplatin Pregnant or lactating female Known hypersensitivity to fluoropyrimidines or cisplatin. 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, Neoplasms Adult participants. >/= 18 years of age Histologically confirmed metastatic or unresectable papillary thyroid cancer for which standard curative or palliative measures do not exist or are no longer effective; participants whose tumors exhibit areas of "other histology" may be enrolled, provided the tumor histology remains predominantly papillary Positive for BRAF V600 mutation (Roche Cobas 4800 BRAF V600 Mutation Test) Radioactive Iodine resistant disease Prior therapy excluding (Cohort 1, TKI Naive) or including (Cohort 2, TKI Experienced) TKI Clinically relevant disease progression according to within the prior 14 months Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 Adequate hematological, renal and liver function Histological diagnosis other than papillary PTC, including squamous cell variants of PTC or PTC with areas of squamous metaplasia Active or untreated central nervous system metastases History of or known carcinomatous meningitis Anticipated or ongoing administration of any anti-cancer therapies other than those administered in the study Active squamous cell skin cancer that has not been excised or adequately healed post excision Previous treatment with any agent that specifically and selectively targets the MEK or BRAF pathway Prior radiotherapy to the only measurable lesion Clinically relevant cardio-vascular disease or event within the prior 6 months | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 30.0-70.0, Facial and Neck Rhytides 70 years of age Subjects with clinical evidence of neck wrinkles moderate to severe in severity as specified by a grade 4-9 on the Fitzpatrick Wrinkle Assessment Scale Willingness and ability to comply with protocol requirements, including returning for follow-up visits and abstaining from exclusionary procedures for the duration of the study Willingness and ability to provide written photo consent and adherence to photography procedures(i.e., removal of jewelry and makeup) Willingness and ability to provide written informed consent prior to performance of any study related procedure Subjects who are pregnant, nursing, planning to become pregnant, and/or not using a reliable form of birth control Subjects who have had prior exposure to any hyaluronic acid, or any other filler, injection for any purpose in the 12 months preceding study enrollment through the duration of the study Subjects who have had prior exposure to any botulinum toxin for rhytids in the treatment area in the 6 months preceding study enrollment through the duration of the study Subjects who have had a prior cosmetic procedure to improve rhytids in the treatment area (i.e.,rhytidectomy, CO2/erbium laser resurfacing, Thermage/Thermacool radiofrequency treatment)within 12 months or who have visible scars that may affect evaluation of response and/or quality of photography Microdermabrasion, or prescription level glycolic acid treatments within 3 months prior to study participation or during the study Active cut, wound, or infection on the skin Oral Isotretinon within the past 12 months Active HSV-1 History of keloids or hypertrophic scarring Existing or history of skin malignancy in the treatment area during the past 12 months | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Neoplasms AJCC Stage III/IV histologically confirmed HNSCC of oral cavity, larynx, oropharynx or hypopharynx; age of 18 years or more adequate liver (SGOT, SGPT, ALP ≤ 3x normal) kidneys (creatinine clearance ≥ 60ml/min heart (no arrythmias, no heart failure) and bone marrow (WBC ≥ 4,000/μL, granulocytes ≥ 1,500/μL, Hb ≥ 10g/dL, platelets ≥ 100,000/μL) function ECOG performance status 0 or 1 and stage III or IVa to b with measurable lesions written informed consent prior radiotherapy chemotherapy concurrent active malignancies pregnancy breast-feeding | 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): 18.0-90.0, Neck Mass patients (age range from 18 to 90 years old) with neck lumps, receiving sonographic examination and FNA cytologic study No cytology data | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 20.0-999.0, Papillary Thyroid Carcinoma Patients with papillary thyroid carcinoma who underwent thyroidectomy Age was over 20 years old Keloid Previous neck or anterior chest operation history The patients who underwent combined radical neck dissection The patient with postoperative wound problem The patient with underlying systemic disease which can make influences on the wound healing process The patient who can not read and understand the questionnaire | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Head and Neck Cancer Histologically confirmed squamous cell carcinoma of the head and neck Locally advanced or metastatic disease No patients with locally advanced disease for whom radiotherapy is indicated Recurrent disease Incurable disease Measurable disease by Recurrent disease within a prior radiation field can be considered to be measurable Patients may have received 1 line of prior chemotherapy (but not a taxane) for locally advanced or metastatic disease Patients may have received prior radiation therapy for locally advanced or metastatic disease (but must have completed the radiotherapy > 6 months before recruitment) No disease relapsed within 6 months of radiotherapy | 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, Influenza Common Cold Healthy male volunteers Body mass index between 18.0-29.9 kg/m^2 | 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, Papillary Thyroid Carcinoma age ≥ 20years papillary thyroid carcinoma patients who underwent conventional open or robotic bilateral total thyroidectomy at YUHS(Yonsei University Health System) patient who underwent postoperative low doe (30mCI) RAI ablation therapy at YUHS pregnant, lactating women patient who underwent postoperative low dose RAI at another hospital patient with distant metastasis patient who underwent combined operation with bilateral total thyroidectomy (ex) Modified radical neck dissection, selective neck node excision d/t lateral neck node metastasis patient who underwent High dose (more than 30 mCI) RAI therapy | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 19.0-999.0, Metabolic Syndrome presence of metabolic syndrome by International Diabetes Foundation referral to metabolic syndrome program at St. Paul's Hospital age > 19 years unwillingness to participate in research study unwillingness to comply with dietary intervention following a weight reducing diet abusing alcohol or other psychoactive substances on psychiatric medication associated with weight gain plans to travel during the study period food allergies or intolerances that will interfere with their adherence to either of the study diets | 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, Papillary Thyroid Microcarcinoma age≥20 years old Conventional type papillary thyroid microcarcinoma (0.5cm≤tumor size≤1.0cm) group 1: no lymph node metastasis /group 2: with lateral neck node metastasis tumor with capsular invasion (T3 tumor) distant metastasis combined underlying thyroiditis | 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, Goiter, thyroid pathology qualified for first-time bilateral neck surgery in a female patient with small to moderate sized goiter (below 100 ml in volume) male gender previous neck surgery unilateral thyroid pathology eligible for unilateral lobectomy goiter volume above 100 ml preoperatively diagnosed RLN palsy abnormal preoperative voice assessment on GRBAS scale pregnancy or lactation age below 18 years high-risk patients ASA 4 grade (American Society of Anesthesiology) inability to comply with the scheduled follow-up protocol | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 16.0-999.0, Thyroid Cancer TNM is assessed against TNM7 (7th edition 2009) or TNM8 (8th edition 2017, in use in the UK from 01/01/2018). using TNM7 Histological confirmation of well differentiated thyroid carcinoma: MDT decision for based on overall clinico-pathological assessment is critical R0 total thyroidectomy (in one or two stages, no residual disease present; Rx at the discretion of the MDT) within the last 6 months Negative pregnancy test in women of child bearing potential Aged 16 or over WHO performance status 0 self-caring Histological confirmation of differentiated thyroid carcinoma:MDT decision for based on overall clinico-pathological assessment Papillary thyroid cancer (PTC) Non aggressive histological features (small foci of aggressive histology allowed at the discretion of the MDT) pT1a Papillary and Follicular carcinoma which is unifocal and ≤1cm in size, without any positive nodes or unfavourable clinical features, treated by lobectomy Up to 4cm non-invasive Encapsulated Follicular Variant of Papillary Thyroid Cancer (eFVPTC) with no capsular or vascular invasion (>4 cm can be included at the discretion of the MDT) non-invasive follicular tumour with papillary-like nuclei (NIFTP) Anaplastic, poorly differentiated or medullary carcinoma R1 or R2 thyroidectomy Patients with pN1b Aggressive Papillary thyroid cancer with any of the following features Widely invasive | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-75.0, Nasopharyngeal Carcinoma Age range: 18-75 years old Histological confirmed incurable relapsed or metastatic nasopharyngeal carcinoma Prior exposure of at least one line of platinum-containing regimen ECOG performance status 0-1 Life expectancy of more than 3 months Bone marrow function: ANC≧1.5×109/L, PLT≧100×109/L, Hb≧80g/L Liver function: total bilirubin, ALT and AST <1.5×UNL Renal function: Cr<1.5×UNL, CCR≧50ml/min Without > 1 grade of neuropathy With curable treatment option With CNS involvement Prior platinum exposure only in neo-adjuvant/adjuvant setting or concurrently used with radiotherapy Treated with > 2 lines of palliative chemotherapy With prior exposure of S-1 or oxaliplatin History of other malignancies except cured basal cell carcinoma of skin and carcinoma in-situ of uterine cervix Significant active infection Pregnant or lactating 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): 0.0-999.0, Papillary Thyroid Carcinoma Patients with papillary thyroid cancer Patients who do not want to be a part of this study | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-80.0, Thyroid Cancer Hashimotos Thyroiditis All patients undergoing thyroidectomy for a variety of indications at University of Texas Medical Branch in Galveston between June 2011-May 2012 Age 18-80 years old History of previous radiotherapy to head and neck and History of radioactive iodine therapy | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-65.0, Thyroid Cancer Patients Age 18-65 Hypothyroid patients under treatment with levothyroxin Normal euthyroid patients with no goiter Pregnancy or lactation Severe lung or gasterointestinal disease Heart failure or renal failure | 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, Femur Fracture Displaced femoral neck fracture Age 65 years or older Acute, femoral neck fracture Cognitive impairment Active Infection Limited functional capacity (nursing home resident, non-ambulatory, severe cardiorespiratory disease) Limited life expectancy Pathologic fracture (tumor) Acetabular fractures | 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): 2.0-30.0, Childhood Hepatocellular Carcinoma Papillary Thyroid Cancer Previously Treated Childhood Rhabdomyosarcoma Recurrent Childhood Liver Cancer Recurrent Childhood Rhabdomyosarcoma Recurrent Thyroid Cancer Recurrent Wilms Tumor and Other Childhood Kidney Tumors Patients must have had histologic verification of one of the malignancies listed below at original diagnosis or at relapse Rhabdomyosarcoma (RMS) Wilms tumor Hepatocellular carcinoma (HCC) Papillary thyroid carcinoma (PTC) Patients must have relapsed or refractory disease (RMS, Wilms tumor, HCC, PTC) Patients must have radiographically measurable disease; measurable disease is defined as the presence of at least one lesion on magnetic resonance imaging (MRI) or computed tomography (CT) scan that can be accurately measured with the longest diameter a minimum of 10 mm in at least one dimension (CT scan slice thickness no greater than 5 mm) The following do not qualify as measurable disease Malignant fluid collections (e.g., ascites, pleural effusions) Bone marrow infiltration | 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 a pathological diagnosis of papillary thyroid cancer in a patient with negative cervical lymph nodes on pre-, or intraoperative evaluation incidental diagnosis of papillary thyroid cancer following hemithyroidectomy and requiring completion thyroidectomy one-stage lymph nodes dissection based on therapeutic intent previous thyroid surgery incomplete follow-up information incomplete histopathology report ASA grade higher than 3 (American Society of Anesthesiology) | 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): 1.0-999.0, Locally Advanced and/or Metastatic Anaplastic Large Cell Lymphoma Locally Advanced and/or Metastatic Inflammatory Myofibroblastic Tumor Locally Advanced and/or Metastatic Papillary Renal Cell Carcinoma Type 1 Locally Advanced and/or Metastatic Alveolar Soft Part Sarcoma Locally Advanced and/or Metastatic Clear Cell Sarcoma Locally Advanced and/or Metastatic Alveolar Rhabdomyosarcoma General Locally advanced and/or metastatic anaplastic large cell lymphoma Locally advanced and/or metastatic inflammatory myofibroblastic tumor Locally advanced and/or metastatic papillary renal cell carcinoma type 1 Locally advanced and/or metastatic alveolar soft part sarcoma Locally advanced and/or metastatic clear cell sarcoma Locally advanced and/or metastatic alveolar rhabdomyosarcoma The above malignancies must be incurable by conventional surgery, radiotherapy, systemic therapy or any other means Proven presence of specific ALK and/or MET pathway alteration in tumor tissue is not mandatory for patient registration Availability of tumor material for central pathology review | 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 Carcinoma Histologically confirmed papillary thyroid carcinoma, including its variants, such as tall cell PTC or poorly differentiated thyroid carcinoma, that is metastatic or unresectable AND harbors a BRAF V600E mutation Evaluable disease, as defined by at least one lesion that can be accurately measured in at least one dimension on CT scan or ultrasound, if present in the neck Radioiodine-refractory disease Life expectancy > 6 months Able to swallow and retain oral medication Normal organ and marrow function Pregnant or breastfeeding Previous treatment with a specific BRAF or MEK inhibitor Receiving any other study agents Known brain metastases History of allergic reactions attributed to compounds of similar chemical or biologic composition to GSK2118436, bovine TSH, mannitol or iodine Active gastrointestinal disease or other condition that will interfere significantly with the absorption of drugs History of known glucose-6-phosphate dehyrogenase (G6PD) deficiency Corrected QT interval >/= 480 msecs; history of acute coronary syndromes (including unstable angina), coronary angioplasty, or stenting within the past 24 weeks; Class II, III, or IV heart failure, abnormal cardiac valve morphology; or history of known cardiac arrhythmias Taking herbal remedies Subjects with significant symptoms from their thyroid cancer, or have a large burden of rapidly progressive iodine-refractory PTC who are in need of other systemic therapy, as judged by their treating physician | 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, Thyroid Cancer an age between 20 and 80 years old who are diagnosed as thyroid cancer or suspicious papillary thyroid cancer in fine needle aspiration biopsy 2. patients who are agree with the study enrollment an age under 20 or over 80 years 2. severe co-morbidities that were contraindications for thyroid surgery (e.g., severe liver, heart, kidney, or pulmonary problems) 3. a lack of consent to participate in the study 4. the inability to a patient in clinical trials according to the regulations or laws in Korea 5. the inability to complete regular follow-up visits (e.g., immigration) 6. the use of modified radical neck dissection due to lateral neck node metastasis 7. prior thyroid surgery or cervical irradiation 8. active enrollment in another clinical trial 9. the intention of the patient to undergo an additional operation at the time of the thyroid surgery (e.g., mastectomy and thyroidectomy at the same time) 10. the desire to undergo endoscopic or robot-assisted thyroidectomy | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 45.0-75.0, Diabetes Type 2 The diagnosis of type 2 diabetes will be based on the WHO guidelines. These are 2 fasting plasma glucose readings of greater than 7.0mmoll-1 or 2 random plasma glucose readings >11mmoll-1 in the absence of symptoms or concurrent illness or medication which might lead to hyperglycaemia (e.g. thiazide diuretics). Or one reading meeting the diagnostic level with the presence of symptoms of polyuria, polydipsia, nocturia, fatigue or blurring of vision. The final diagnostic method of diagnosis type 2 diabetes is a positive oral glucose tolerance test (OGTT) using a 75g glucose load. If doubt exists on the diagnosis of diabetes an OGTT will be performed Diabetes managed by diet alone or diet and metformin. If metformin is used the dose should have been stable for a minimum of 3 months prior to the start of the study Hba1c up to and including 9.9% Age 45-75 If female, should be post-menopausal BMI 25-39kgm-2 Patients will have attended a structured group patient education programme (and be on stable medication for hypertension, lipids and gout (if appropriate) for 3 months prior to entry into the study. Subjects will be encouraged to incorporate the chocolate into their diet as advised during the education programme Having obtained his/her or his/her legal representative's informed consent Patients with concurrent illness or any changes in medication in the last 3 months Patients whose diabetes is managed with TZDs, DPP-IV inhibitors, GLP-1 analogues, insulin or sulphonylureas or prandial regulators Patients not wishing to allow disclosure to their GPs Pregnancy Hba1c at recruiting stage of >10.0% Patient who cannot be expected to comply with treatment Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study Patients who consuming more than 20g/d of chocolate or having a very high polyphenol content of their diet, who are not willing to change their diet Patients taking high dose antioxidant supplements including single and multivitamin preparations including A,C,E Women on HRT treatment | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-80.0, Paralytic Stroke Cough Stroke patients with confirmed unilateral brain lesion Gross aspiration confirmed via FEES or VFSS that would require non oral feeding for group 1 No gross evidence of dysphagia that would require non oral feeding for group 2 No prior episode of stroke or dysphagia for the healthy control group Episode of acute pneumonia or pulmonary embolism at time of enrollment Previous history of chronic respiratory disorders or other systemic disorders that may affect respiratory function ( ex, rheumatoid arthritis, chronic renal disease, spinal cord injury) Stroke patients with multiple brain lesions Episode of Diaphragm weakness due to peripheral polyneuropathy or unilateral phrenic nerve palsy Previous episode of abdominal or thoracic surgery within one year of enrollment Concomitant diagnosis of myopathy, muscular dystrophy or other disorders that may affect respiratory muscles Episode of rib fracture within one year of enrollment Chronic alcoholism Patient with previous diagnosis of dementia or with impaired cognitive function that may limit full participation at the evaluation | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Neoplasms Differentiated Thyroid Cancer Patients with a history of differentiated thyroid cancer After complete thyroidectomy and ablation of functional remnants with 131I Planned for blind high dose 131I treatment based on biochemically suspected recurrence, defined as a Tg-level above 2.0 ng/ml Ultrasonography of the neck performed < 2 months prior to inclusion Age < 18 years Pregnancy Incapacitated subjects Contrast enhanced CT performed < 4 months prior to I-131 therapy performed < 12 months prior to Indication for other therapy modality (ie. surgery in case of a positive ultrasonography, radiotherapy, embolization or chemotherapy) | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Extensive Stage Small Cell Lung Carcinoma Large Cell Lung Carcinoma Neuroendocrine Carcinoma Small Cell Carcinoma Stage IV Non-Small Cell Lung Cancer AJCC v7 PHASE I (phase I) Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception Patients must have histologically or cytologically confirmed Extensive stage small cell lung cancer (SCLC) or Stage IV (M1a or M1b according to American Joint Committee on Cancer [AJCC] Staging Manual, 7th edition) large cell neuroendocrine non-small cell lung cancer (NSCLC) or Small cell carcinoma of unknown primary or extrapulmonary origin and must be a candidate for systemic therapy NOTE: The extensive disease SCLC classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy Patients must have measurable or non-measurable disease based on Response Evaluation in Solid Tumors (RECIST) 1.1; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to registration (Phase I) (phase I) Patients have active seizure(s) or history of seizure(s) Patients have history of allergic reactions attributed to compounds of similar chemical or biologic composition to veliparib or other agents used in the study PHASE II (phase II) Women must not be pregnant or breastfeeding; breastfeeding must be discontinued or the subject is not eligible for the study All females of childbearing potential must have a blood test within 2 weeks prior to randomization to rule out pregnancy; a female of childbearing potential is any woman, regardless of sexual orientation or whether they have undergone tubal ligation, who meets the following 1) has not undergone a hysterectomy or bilateral oophorectomy; or 2) has not been naturally postmenopausal for at least 24 consecutive months (i.e., has had menses at any time in the preceding 24 consecutive months) with the current month counted as month 1 Women of childbearing potential and sexually active males must be strongly advised to use an accepted and effective method of contraception Patients must have extensive stage, histologically or cytologically confirmed small cell lung cancer; NOTE: the extensive disease classification for this protocol includes all patients with disease sites not defined as limited stage; limited stage disease category includes patients with disease restricted to one hemithorax with regional lymph node metastases, including hilar, ipsilateral and contralateral mediastinal, and/or ipsilateral supraclavicular nodes; extensive disease patients are defined as those patients with extrathoracic metastatic disease, malignant pleural effusion, bilateral or contralateral supraclavicular adenopathy Patients must have measurable disease based on 1.1; baseline measurements and evaluations of all sites of disease must be obtained =< 4 weeks prior to registration ECOG performance status 0 or 1 Absolute neutrophil count >= 1,500/mm^3 | 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, Renal Cell Carcinoma Locally recurrent or metastatic RCC requiring systemic therapy following treatment (tx) with sorafenib, sunitinib, pazopanib, or placebo on an adjuvant study Required to have primary or recurrence tumor samples containing clear cell variant RCC with <50% of any other histology Recurrence must occur ≥ 3 months following end of exposure to the adjuvant intervention Received ≥ 3 six week cycles of prior adjuvant tx with sorafenib, sunitinib, pazopanib or placebo in the adjuvant setting on a clinical trial, or recurrence >3 months of tx on an adjuvant placebo arm Required to have measurable recurrent or metastatic disease that is not curable by standard radiation therapy or surgery Male or female, ≥ 18 years old ECOG PS 0 or 1 Blood pressure (B/P) must be controlled at time of enrollment. Tx with antihypertensive medication(s) is allowed. Controlled B/P is defined as in clinic measurement of systolic B/P ≤ 140 mm Hg AND diastolic B/P ≤ 90 mm Hg. If B/P is uncontrolled at time of planned enrollment, tx or optimization with antihypertensive medication(s) may be initiated in order to control B/P. Patient may be considered for enrollment when this has happened Women must not be pregnant or breastfeeding Men and women who are of reproductive potential must be willing to employ an effective method of birth control/contraception | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Thyroid Cancers That Contain the PAX8-PPARgamma Fusion Gene Patients must have histologically confirmed thyroid carcinoma with the PAX8-PPARgamma translocation (translocation testing will be performed on archived tissue during the screening period). Refractory to radioactive iodine (RAI) as defined by: the tumor does not concentrate RAI; or the patient has had RAI within the last 16 months and has had progression despite that RAI; or the last RAI treatment was >16 months ago and the patient progressed after at least two RAI treatments; or the patient has received RAI treatments with a cumulative RAI dose of ≥22.2 GBq (600 mCi) Not a candidate for surgery or RAI therapy with curative intent. Lesions that would be treated by external beam radiation therapy (EBRT) based on standard of care can be so treated, but then cannot be used as target lesions. 2. Measurable disease by 1.1 criteria. 3. Documented disease progression by 1.1 in the past 14 months. 4. Availability of histological material (primary tumor or metastases) for review of the diagnosis and demonstration of PAX8-PPARgamma fusion gene. 5. Adequate TSH suppression (<0.5 mIU/L) 6. Prior chemotherapy or surgery must have been completed at least 28 days prior to registration, and all toxicities must have resolved. 7. Prior radioactive iodine must have been completed at least 6 months prior to registration, or there must be documented disease progression since such therapy if it was within 6 months. Sites that have received EBRT must have disease progression post-EBRT to be used as sites of measurable disease. 8. Life expectancy of greater than 6 months. 9. ECOG performance status 2 or less. 10. Patients must have normal organ function as defined below: AST(SGOT)/ALT(SGPT) less than 2.5 X institutional upper limit of normal (within 1 month of study Day 1) 11. Patients must be able to consume oral medications. 12. Women of childbearing potential must have a negative pregnancy test at baseline prior to receiving any study drug and must practice effective contraception while on study. (Pregnant or lactating patients are excluded). 13. All patients must sign an informed consent prior to enrollment Patients may not be receiving any other investigational agents. 2. Patients with known untreated brain metastases. 3. History of allergic reactions attributed to compounds of similar chemical or biologic composition to pioglitazone. 4. Diagnosis of diabetes mellitus or current therapy with any drugs used to treat diabetes mellitus, including but not limited to insulin, sulfonylureas, metformin, rosiglitazone (Avandia), and pioglitazone (Actos) within 14 days of study Day 1 5. Therapy with rosiglitazone (Avandia) or pioglitazone (Actos) at any time since the diagnosis of thyroid cancer. 6. Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, congestive heart failure, unstable angina pectoris, or cardiac arrhythmias. 7. Pregnant women are excluded from this study because pioglitazone is a U.S. Food and Drug Administration Pregnancy Category C drug. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with pioglitazone, breastfeeding should be discontinued if the mother is treated with pioglitazone. 8. No concurrent radiotherapy or chemotherapy may be given to the patient during the administration of the study drug. 9. Patients with uncontrolled malabsorption syndromes. 10. Patients with a history of congestive heart failure of any New York Heart Association class. 11. Any medical or psychiatric illness which, in the opinion of the principal investigator, would compromise the patient's ability to tolerate this treatment regimen. 12. Use of rifampin (strong CYP2C8 inducer) within 14 days of study Day 1. 13. Other current malignancy than the disease under study. 14. Grade 2 or worse edema within 14 days of study Day 1, per CTCAE v4 | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Gastric Cancer Any patients age at GC cancer diagnosis was included. Male and female patients were either included. Healthy volunteers were not included. At the time of diagnosis of cancer patients must be a province of Cremona inhabitants (districts of Crema, Cremona or Casalmaggiore). Informed consent signature was required. TUMOR Diagnosis must be performed from 2010 Juanuary, the 1st to 2013 December, 31st .The diagnosis must be of a infiltrating malignant tumor. The diagnosis should be of a primary tumor. Precancerous diagnosis were not considered. Recidivate tumor were not considered. The site of localization of the tumor at diagnosis must be stomach or gastro - esophageal junction as site of tumor onset. HDGC : Gastric cancer is a known manifestation of inherited cancer predisposition syndromes similar to hereditary nonpolyposis colon cancer and Li-Fraumeni syndrome. According to the OMIM database, more than 90 per cent of gastric cancers are sporadic, whereas less than 10 per cent are hereditary (HDGC). Germline E-cadherin inactivating mutations in the CDH1 gene are responsible for the development of GC in approximately 30% of families with the hereditary diffuse gastric cancer syndrome (HDGC). Diagnostic for HDGC are formulated by the International Gastric Cancer Linkage Consortium in 1999 and then they are reviewed in 2010. In order to individuate HDGC case and to included them in a specialist counselling and CDH-1 gene mutation evaluation, by International GC Linkage Consortium 2010 guidelines were followed | 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, Prosthetic Joint Infections Males or females age >18 years 2. Ability to provide informed consent 3. A plain anterior-posterior (AP) and frog leg lateral X-ray of the hip or knee within 6 weeks of enrollment 4. Need for operative intervention in the opinion of the surgeon to correct the pain in the prosthetic joint 5. Prosthetic joint implant that has been in site for more than 3 months prior to enrolment 6. Having adequate general health to be expected to tolerate surgery adn to survive for 6 months from the time of informed consent 7. Women must be either postmenopausal or surgically sterile 8. Ability to return for all study assessments 9. Clinically euthyroid, or on stable thyroid replacement therapy Subjects who are unable to comply with study requirements 2. Indication, in the opinion of the principal investigator, for urgent surgery that would preclude the time needed for PET-CT scanning 3. History of an inherited mitochondrial disorder (e.g., Leber's hereditary neuropathy; neuropathy; ataxia, retinitis pigmentosa and ptosis [NARP]; myoneurogenic gastrointestinal encephalopathy [MNGIE]; myocolonic epilepsy with ragged red fibers [MERFF]; and mitochondrial myopathy, encephalomyopathy, lactic acidosis and stroke-like syndrome [MELAS]) 4. Alanine aminotransferase (ALT) >5x the upper limit of normal (ULN) OR aspartate aminotransferase (AST) >5X ULN 5. Creatinine clearance <30 mL/min 6. Body mass that exceeds the rating of the CT table 7. Hypersensitivity to iodine 8. Any condition that would put the subject at reasonable risk in the opinion of the investigator | 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 Primary papillary thyroid cancer (PTC), which appears to be stage T3 or T4 on imaging or with macroscopic lymph node involvement AND requires surgical resection. 2. Persistent or locally recurrent PTC with macroscopic lymph node involvement which requires surgical resection. 3. Patients deemed inoperable (no scheduled surgery) are eligible for this trial, as they could be surgical candidates after treatment with vemurafenib. Inoperable patients must be naïve to therapies targeting the MAPK pathway. 4. BRAF V600E mutation detected in the primary tumor or the recurrent/persistent tumor. 5. Total bilirubin </= 1.5 x upper limit of normal (ULN). Patients with Gilbert's syndrome are excluded from this requirement. Aspartate transaminase (serum glutamic oxaloacetic transaminase) / alanine transaminase (serum glutamic pyruvic transaminase) (AST[SGOT]/ALT[SGPT]) </= 2.5 x ULN, (5 x ULN for patients with concurrent liver metastases). Serum creatinine </= within 1.5 x ULN. Absolute neutrophil count (ANC) >/= 1.0 x 10^9/L; platelets >/= 100 x 10^9/L, HgB>9 mg/dL 6. Antiangiogenic therapy, specifically vascular endothelial growth factor (VEGF) and VEGF receptor (VEGFR) inhibitors, can interfere with wound healing and therefore will only be allowed if the agent has been discontinued for at least 14 days prior to day 1. Group C patients must be naïve to therapies which target mitogen-activated protein kinase (MAPK). 7. Ability to swallow pills. 8. Eastern Cooperative Oncology Group (ECOG) performance status </= 2 9. Age >/= 18 10. Ability to provide consent Histological diagnosis other than PTC. Patients with anaplastic tumors are not eligible. However, patients whose tumors contain areas of un-differentiated or dedifferentiated histology may enroll provided the original diagnosis was clearly PTC, and the tumor histology remains predominantly papillary at enrollment. 2. Refractory nausea and vomiting, malabsorption, or significant bowel resection that would preclude adequate absorption. 3. Known hepatitis B or C virus (HBV or HCV) infection, unless the patient has been cleared for chemotherapy from experts on viral hepatitis (infectious disease specialists or hepatologists). 4. Pregnant or lactating women. All pre-menopausal women being screened must have a negative serum pregnancy test within 14 days prior to commencement of dosing. Women of non-childbearing potential may be included if they are either surgically sterile or have been postmenopausal for >/= 1 year 5. Untreated brain metastases. 6. Chemotherapy or targeted therapy within 14 days or 5 half-lives (whichever is longer) prior to the start of study treatment. 7. Patients with history of long QT syndrome, uncorrectable electrolyte abnormalities, or QTc>500msec. 8. History of significant cardiac disease or uncontrolled arrhythmias | 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, Cervical Cancer Patients (who have been adequately clinically staged) with primary, untreated, histologically confirmed carcinoma of the uterine cervix (including clear cell and small cell carcinoma), with metastatic lymphadenopathies (any of pelvis or PAN >1.5 cm in short diameter, with/without biopsy proven inguinal lymph node [ING]) 2. Patients with Eastern Cooperative Oncology Group (ECOG) Performance Status of 0, 1, 2 3. Patients with adequate bone marrow function: absolute neutrophil count (ANC) greater than or equal to 1,500/mcl, platelets greater than or equal to 100,000/mcl at the beginning. 4. Patients with adequate renal function: creatinine equal to or less than 2.0 mg%. 5. Patients who have signed an approved informed consent and authorization Patients with recurrent LN(s) which was(were) previously irradiated. 2. Patients who have diagnosis of other malignance tumors except papillary or follicular thyroid cancer or skin cancer 3. Patients with metastatic lymphadenopathies other than pelvis, PAN, ING (e.g. supraclavicular or mediastinal metastatic lymphadenopathy) 4. Patients with distant organ metastasis (e.g. bone, lung, brain…) | 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, Rectal Carcinoma Low-lying, low to moderate-risk pathologically-confirmed rectal cancer (stage uT3n) or uT1-3N+ Negative workup for distant disease > 18 years of age Pre-treatment workup completed including history and physical CT or MRI of the abdomen and pelvis endoscopic tumor evaluation (biopsy, blood work to assess CEA and hematopoietic, renal and liver function) if female of child-bearing age, negative pregnancy test Recommendation to undergo preoperative concurrent chemoradiation, as determined by the treating physician Not deemed a candidate for preoperative chemoradiation for medical reasons, such as uncontrolled infection (including HIV), uncontrolled diabetes mellitus or cardiac disease Hemoglobin ≤ 10.0 g/dL (transfusion allowed to achieve or maintain levels) ANC ≤ 1,500/cubic mm³ Platelet count ≤ 100,000/mm³ ALT and AST ≥ 2.5 times upper level of normal (ULN) Alkaline phosphatase ≥ 2.5 times ULN Total bilirubin ≥ 1.5 times ULN Creatinine clearance < 50 mL/min Creatinine ≥ 1.5 times ULN Not deemed a candidate for concurrent preoperative chemoradiation for social reasons, such as psychiatric illness | 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, Lung Cancer Patients must have suspicious lung nodule for clinical stage I/recurrent Lung Cancer 2. Mass Tumor size < 7 cm 3. Patient must have a CT scan of the chest with upper abdomen within 90 days prior to date of pre-registration. 4. Patient must have ECOG/Zubrod performance status 0,1, or 2. 5. Resected lung cancers with positive margins Patient has already received high dose radiation to the area 2. Cancerous nodule is very close to the esophagus or spinal chord, thereby increasing the risk of radiation treatment 3. Pregnancy or unwillingness to practice a form of birth control (i.e. abstinence, oral contraceptives, 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): 20.0-60.0, Hashimoto Thyroiditis Hashimoto's thyroiditis Euthyroid state (free T4 and thyroid-stimulating hormone level within normal limit) Never receive immunomodulators or immunosuppressants Planned pregnant or already pregnant women Renal insufficiency Hepatic insufficiency Anemia Agranulocytosis Thrombocytopenia Glucose-6-phosphate dehydrogenase deficiency Porphyria cutaneous tarda Allergy to 4-aminoquinolone | 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, Multiple Myeloma, Neoplasms Histologically confirmed solid tumors (excluding melanoma and papillary thyroid cancer) or multiple myeloma refractory to standard therapy or for which standard or curative therapy does not exist or is not considered appropriate by the investigator Patients with multiple myeloma must have received at least one line of prior systemic therapy for the treatment of multiple myeloma Eastern Cooperative Oncology Group (ECOG) performance status > 2 Uncontrolled concurrent malignancy Active or untreated CNS metastases History of known carcinomatous meningitis Prior treatment with a BRAF or MEK inhibitor (prior sorafenib is allowed) Uncontrolled, severe medical illness or condition as defined in protocol MO28072 | 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, Pancreas Cyst Pancreas Mass greater than 18 years old not pregnant referred for endoscopic ultrasound have a cyst or mass of the pancreas needing diagnosis pregnant less than age 18 no mass or cyst found | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-60.0, Closed Multiple Fractures of Upper and Lower Limbs Between 18 and 60 years 2. Patients with closed limb fracture(s) 3. VAS score of at least 6 Acute pulmonary infection 2. Previous coronary artery diseases,ACS,congestive heart failure, 3. suspected aortic dissection 4. History of uncontrolled hypertention or blood pressure > 140/90mmHg 5. Brain injury with focal neurological deficit or loss of consciousness 6. Central nervous system mass lesion,hydrocephalus, or other states with increased intracranial pressure 7. Glaucoma and acute globe injury 8. History of porphyria 9. Previous hyperthyroidism or thyroid hormone replacement 10. Pregnancy or laction 11. Major psychiatric disorder 12. Previous allergic reaction to the agents administered in the study 13. Patient declined to provide written informed conse | 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, Poorly Differentiated Thyroid Gland Carcinoma Recurrent Thyroid Gland Carcinoma Stage I Thyroid Gland Follicular Carcinoma Stage I Thyroid Gland Papillary Carcinoma Stage II Thyroid Gland Follicular Carcinoma Stage II Thyroid Gland Papillary Carcinoma Stage III Thyroid Gland Follicular Carcinoma Stage III Thyroid Gland Papillary Carcinoma Stage IVA Thyroid Gland Follicular Carcinoma Stage IVA Thyroid Gland Papillary Carcinoma Stage IVB Thyroid Gland Follicular Carcinoma Stage IVB Thyroid Gland Papillary Carcinoma Stage IVC Thyroid Gland Follicular Carcinoma Stage IVC Thyroid Gland Papillary Carcinoma Tall Cell Variant Thyroid Gland Papillary Carcinoma Thyroid Gland Oncocytic Follicular Carcinoma Patients must have histologically or cytologically confirmed papillary thyroid cancer, follicular thyroid cancer or hurthle cell thyroid cancer (cancer, follicular variant of papillary thyroid cancers or any of the above mixed histology will be allowed; these patients will be enrolled on Arm A of the trial); patients with the following aggressive histologies will be enrolled on Arm B of the trial; tall cell, insular or poorly differentiated thyroid cancer Patients must have measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as >= 2.0 cm with conventional techniques or as >= 1.0 cm (or >= 1.5 cm in short axis for lymph node) with spiral computed tomography (CT) scan, magnetic resonance imaging (MRI), or calipers by clinical exam Patients must have radioactive iodine (RAI)-refractory/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 Response Evaluation in Solid Tumors (RECIST) 1.1 within 12 months of prior RAI therapy One or more measurable lesion present after cumulative RAI dose of >= 600 mCi Patients must have "progressed on" up to 2 lines of prior vascular endothelial growth factor receptor (VEGFR)-targeted therapy (including but not limited to sorafenib, sunitinib, vandetanib, pazopanib, or lenvatinib) as defined by progressive disease per while receiving VEGFR-targeted therapy; Note: patients who progressed on kinase inhibitor that target VEGFR and MET will not be eligible Prior external beam radiation, systemic cytotoxic chemotherapy or BRAF or non-VEGFR-targeted therapies will be allowed, provided that >= 4 weeks has elapsed since receiving prior treatment and they have recovered to =< grade 1 treatment-related toxicities Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Prior treatment with cabozantinib or any tyrosine kinase inhibitor that targets MET or monoclonal antibody (mAb) targeting MET (such as onartuzumab [MetMAb]) The subject has received radionuclide treatment =< 6 weeks of the first dose of study treatment The subject has received any other type of investigational agent =< 28 days before the first dose of study treatment The subject has not recovered to baseline or Common Terminology for Adverse Events (CTCAE) =< grade 1 from toxicity due to all prior therapies except alopecia and other non-clinically significant adverse events (AEs) The subject has active brain metastases or epidural disease; subjects with brain metastases previously treated with whole brain radiation or radiosurgery or subjects with epidural disease previously treated with radiation or surgery who are asymptomatic and do not require steroid treatment for at least 2 weeks before starting study treatment are eligible; baseline brain imaging with contrast-enhanced CT or MRI scans for subjects with known brain metastases is required to confirm eligibility; eligible patients with brain metastases can be taking anti-convulsant medications but only non-enzyme inducing anti-epileptic agents (NEIAED) will be allowed The subject requires concomitant treatment, in therapeutic doses, with anticoagulants such as warfarin or warfarin-related agents, heparin, thrombin or factor xabans (Xa) inhibitors, or antiplatelet agents (e.g., clopidogrel); low dose aspirin (=< 81 mg/day), low-dose warfarin (=< 1 mg/day), and prophylactic low molecular weight heparin (LMWH) are permitted The subject requires chronic concomitant treatment of strong cytochrome P450, family 3, subfamily A, polypeptide 4 (CYP3A4) inducers (e.g., dexamethasone, phenytoin, carbamazepine, rifampin, rifabutin, rifapentin, phenobarbital, and St. John's Wort) or strong CYP3A4 inhibitors (ketoconazole, itraconazole, clarithromycin, indinavir, nefazodone, nelfinavir, ritonavir, voriconazole, and posaconazole); Note: because the lists of these agents are constantly changing, it is important to regularly consult a frequently-updated lists; medical reference texts such as the Physicians' Desk Reference may also provide this information; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product The subject has experienced any of the following Clinically-significant gastrointestinal bleeding =< 6 months before the first dose of study treatment Hemoptysis of >= 0.5 teaspoon (2.5 mL) of red blood =< 3 months before the first dose of study treatment | 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): 18.0-80.0, Rectal Cancer Patients with low rectal carcinoma(The lowest margin of tumor located 3 cm from anal verge ; ≤ 2 cm from dentate lines; 1 cm from anorectal rings Local spread restricted to the rectal wall or the internal anal sphincter Adequate preoperative sphincter function and continence Absence of distant metastasis Contraindications to major surgery and American Society of Anesthesiologists (ASA) Physical Status scoring 4 Metastatic rectal cancer Those in Dukes stage D (T4 lesion) Undifferentiated tumours Local infiltration of external anal sphincter or levator ani muscles Tumor located more than 2 cm above the dentate line Presence of fecal incontinence Patients unwilling 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, Low Risk Differentiated Thyroid Cancer Patients with differentiated thyroid cancer (papillary, follicular or with Hurthle cells) in the absence of aggressive histological subtypes (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing or with an anaplastic component) 2. Patients having undergone a total thyroidectomy with complete (R0) tumor resection, with or without lymph node neck dissection 3. Total thyroidectomy performed 2 to 5 months before 4. Patients with low risk of recurrence: pT1amN0 or pT1amNx with a sum of the size of the lesions above 1 cm and equal to or less than 2 cm, or pT1bN0 or pT1bNx (TNM 2010 classification). (Patients with less than 6 lymph nodes in the neck dissection will be classified as Nx) 5. Post-operative neck ultrasound (performed 2 to 5 months after surgery) showing the absence of abnormalities in the lateral lymph node compartments, or if abnormalities, no lymph nodes with abnormal cytology and/or thyroglobulin concentration in the aspirate fluid > 10 ng/mL 6. Age >=18 years 7. Performance status of 0 or 1 8. Patients who signed the informed consent 9. Patients who can be followed-up annually during 5 years in order to assess the objectives of the study 10. Women of childbearing age should have a negative pregnancy test before any radioiodine administration 11. Both patients with or without thyroglobulin antibodies are eligible Patients having undergone less than a total thyroidectomy 2. Patients with aggressive histotype (poorly differentiated, tall-clear-cylindric cell, diffuse sclerosing, or with an anaplastic component) 3. Patients having undergone surgery less than 2 months or more than 4 months before 4. Patients with cancer classified as pT1a unifocal (in which ablation is not necessary), or pT1N1, pT2, pT3, pT4 or N1 (who have a higher risk of recurrence) (classification TNM 2010) 5. Patient with known distant metastasis 6. Abnormal post-operative neck ultrasound of the lateral lymph node compartments 7. Patients with another malignancy not in remission for at least 2 years (except for in situ cervix uterine cancer, basocellular skin cancer) 8. Patients with a recent history of drugs affecting thyroid function, including injection of radiocontrast agents during the last 8 weeks. 9. Patients previously treated with radioactive iodine or who previously underwent a whole body scan with radioactive iodine 10. Pregnant or breast feeding women 11. Subject with any kind of disorder that may compromise his/her ability to give written informed consent and/or to comply with study procedures | 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, Thyroid Neoplasms Diagnosis of localized or metastatic unresectable medullary thyroid cancer (MTC). The histological diagnosis of MTC must be confirmed on review of submitted tumor tissue by the Laboratory of Pathology in the National Cancer Institute Measurable disease, defined as at least one lesion that can be accurately measured in at least one dimension (longest diameter to be recorded for non-nodal lesions and short axis for nodal lesions) as greater than or equal to 20 mm with conventional techniques or as greater than or equal to 10 mm with spiral computed tomography (CT) scan Disease amenable to biopsy and agree to undergo biopsy for molecular analysis The last dose of previous therapy targeting rearranged during transfection (RET) kinase must be given at least 4 weeks prior to the first dose of ponatinib Previous treatment with cytotoxic chemotherapy, immunotherapy, or radiotherapy are permitted, if the last dose was given at least 4 weeks prior to the first dose of ponatinib Patient must have failed (progressed on or been intolerant of) prior treatment with cabozantinib and vandetanib Age greater than or equal to 18 years old Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2 Normal organ and marrow function as defined below Leukocytes greater than or equal to microL Patients who are receiving any other investigational agent Patients with brain metastases or spinal cord compression unless they completed radiation therapy greater than or equal to 4 weeks prior to the first dose of ponatinib and are stable without steroids or anti-convulsant therapy for greater than or equal to 10 days Medications that are known to be associated with Torsades de Pointes Uncontrolled hypertension (systolic blood pressure > 150 or diastolic blood pressure > 100 Significant or active cardiovascular disease, specifically including but not restricted to History of myocardial infarction History of atrial or ventricular arrhythmia Unstable angina within 6 months prior to first dose of ponatinib History of congestive heart failure Left ventricular ejection fraction fraction (LVEF) less than lower limit of normal | 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, Refeeding Syndrome authoritative written consent suspected of or diagnosed with head and neck cancer Increased risk of Refeeding syndrome, defined by one of the below A-score of 1 in the Nutritional Risk Screening 2002 (NRS 2002) high levels of alcohol consumption (men>168g alcohol/week corresponding to approximately 14 units, women>84g alcohol/week corresponding to approximately 7 units) anamnesis with prior radiation therapy Head and neck pain that require pain management or inhibits food intake the presence of problems with eating that are so serious that the food intake is inhibited minor or declared incapable of managing own affairs patients that are incapable of understanding and communicating in Danish patients with dementia if the patient is not diagnosed with head and neck cancer | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 40.0-75.0, Hypothyroidism Thyroid Diseases Endocrine System Diseases 75 years old Diagnosis of overt or subclinical hypothyroidism in two occasions with a minimum interval period of three months Pregnant or lactating women Severe hepatic or renal dysfunction Psychiatric disabilities, acute cardiovascular and cerebrovascular diseases, chronic respiratory diseases, familiar hypercholesterolemia, malignancy, cholelithiasis, pancreatitis, bowel diseases and other disorders influencing lipid and bile acid metabolism Taking lipid-lowering agents and other drugs influencing thyroid function, lipid and bile acid metabolism Obviously poor 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): 16.0-999.0, Osteoarthritis of the Knee Undergoing primary total knee arthroplasty for osteoarthritis Defined poor outcome (Oxford Knee Score less than or equal to 26) at first post-op review (6 weeks) Patients are able to consent and willing to comply with the study protocol Patients undergoing revision knee arthroplasty or fully constrained knee arthroplasty Knee replacement for a diagnosis other than osteoarthritis Patients unable to attend the study physiotherapy intervention centre Procedures done purely for pain relief (such as for patients with no walking capacity) Patients already receiving ongoing structured post-operative exercise rehabilitation | 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, Weight Loss Cachexia Clinical diagnosis of NSCLC No other active cancer Must be able to consent Fluent in Norwegian Other active cancer than NSCLC Younger than 18 years | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Differentiated Thyroid Cancer Provision of informed consent to participate in the study as well as provision of informed consent to provide a sample of a previously obtained archival tumour biopsy Female or male aged 18 years and older with previously confirmed histological diagnosis of locally advanced or metastatic differentiated (excluding minimally invasive follicular) thyroid cancer not amenable to surgical resection, external beam radiotherapy or local therapy Measurable disease defined as at least one lesion, not irradiated within 12 weeks of the date of randomisation, that can be accurately measured at baseline Participants must have experienced progression within 14 months and be RAI-refractory/resistant or unsuitable for RAI Thyroid-stimulating hormone (TSH) suppression below 0.5 mU/L is required World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2 Negative pregnancy test (urine or serum) for female participants of childbearing potential Inadequate organ function as defined by: (1) Alanine aminotransferase (ALT), aspartate aminotransferase (AST), or alkaline phosphatase (ALP) greater than 2.5 x upper limit of normal (ULN), or greater than 5.0 x ULN if judged by the Investigator to be related to liver metastases. (2) Serum bilirubin greater than 1.5 x ULN. This criterion does not apply to participants with known Gilbert's Disease. (3) Creatinine clearance <50 mL/min (calculated by Cockcroft-Gault formula) Risk of prolonged interval between Q and T (QT) on an electrocardiogram (ECG) corrected for heart rate (QTc) as defined by: (1) Current therapy with any medication known to be associated with Torsades de pointes or potent inducers of cytochrome CYP3A4. (2) History of QT prolongation. (3) Congenital long QT syndrome. (4) QT interval corrected for heart rate by the Bazett's method (QTcB) correction unmeasurable or greater than 480 ms on screening ECG Previous therapy with approved or investigational tyrosine kinase or anti vascular endothelial growth factor (VEGF) receptor inhibitors or targeted therapies (e.g. multi-targeted kinase inhibitors such as sorafenib, AMG-706, sunitinib, pazopanib, lenvatinib) RAI therapy within 12 weeks prior to first dose of study drug, and radiation therapy other than RAI, including external beam, if not completed prior to randomization | 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, Hyponatremia Cirrhosis Screening within 24 hours of admission Na level less than 130mEq/L Presence of fluid overload with either history of ascites or edema Cr < 2.0mg/dl Planned length of stay after randomization of at least 24 hours Anticipated survival of at least 8 days Ability to provide informed consent Hospitalization greater than 24 hours at screening Depletional hyponatremia Hyponatremia due to hyperglycemia Acute and transient hyponatremia associated with head trauma or post-operative states Hyponatremia due to primary polydipsia, adrenal insufficiency, or hypothyroidism Urgent need for treatment of hyponatremia with saline or hypertonic saline Treatment with demeclocycline, lithium chloride, and urea Cr greater than 2.0mg/dl Stage 3 or 4 hepatic encephalopathy Inability 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): 18.0-999.0, Stage II Breast Cancer Stage IIIA Breast Cancer Pre-Registration Clinical stage T1-3 N1 M0 breast cancer at diagnosis (prior to the start of neoadjuvant chemotherapy) by American Joint Committee on Cancer (AJCC) staging 7th edition No inflammatory breast cancer No other malignancy within 5 years of registration with the exception of basal cell or squamous cell carcinoma of the skin treated with local resection only or carcinoma in situ of the cervix All patients must have had an axillary ultrasound with fine needle aspiration (FNA) or core needle biopsy of axillary lymph nodes documenting axillary metastasis at the time of diagnosis, prior to or at most 14 days after starting neoadjuvant chemotherapy * Note: Biopsy of intramammary nodes does not fulfill Patients must have had estrogen receptor, progesterone receptor and HER2 status (by immunohistochemistry [IHC] and/or in situ hybridization [ISH]) evaluated on diagnostic core biopsy prior to start of neoadjuvant chemotherapy * Note: If HER2 status has not been clearly determined (i.e. equivocal/indeterminate), then patients should not be enrolled Patients must have completed all planned neoadjuvant chemotherapy prior to surgery; sandwich chemotherapy is not allowed (i.e. anthracycline/cytoxan or taxane chemotherapy planned to be given after surgery); patients must have completed at least 4 cycles of neoadjuvant chemotherapy consisting of an anthracycline and/or taxane-based regimen without evidence of disease progression in the breast or the lymph nodes * Note: Delays/dose modifications due to toxicities/adverse events are allowed as long as a minimum of 4 cycles of neoadjuvant chemotherapy is administered; more than 4 cycles of neoadjuvant chemotherapy (NAC) may be administered at the discretion of the treating medical oncologist Patients with HER-2 positive tumors must have received neoadjuvant trastuzumab, or trastuzumab + pertuzumab, or other approved anti-HER-2 therapy (either with all or with a portion of the neoadjuvant chemotherapy regimen); therapy must be Food and Drug Administration (FDA)-approved targeted anti-HER2 therapy, but additional therapies are allowed as are non-trastuzumab regimens if administered in the context of an Institutional Review Board (IRB)-approved clinical trial All patients must have a clinically negative axilla (no bulky adenopathy) on physical examination documented at the completion of neoadjuvant chemotherapy * Note: an ultrasound of the axilla is not required at completion of neoadjuvant chemotherapy; if performed, its findings do NOT impact No more than 8 weeks of neoadjuvant endocrine therapy prior to the start of neoadjuvant chemotherapy | 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, Ischemic Heart Disease Congestive Heart Failure s/p acute myocardial infarction 14-30 days ability to perform exercise unstable angina chronic atrial fibrillation severely reduced LV function NYHA 4 severe valvular disease | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Metastatic Thyroid Gland Carcinoma Unresectable Thyroid Gland Carcinoma Patients must have histologically confirmed malignancy that is metastatic or unresectable and for which standard curative measures do not exist or are no longer effective Patients must have measurable and histologically or cytologically confirmed thyroid cancer with a BRAF V600E or V600K (c. 1799 T to A and c.1799_1800TG>AA) mutation that is not considered curable by surgery; confirmation will be done at Memorial Sloan Kettering (MSK); only tumors with a BRAFV600E or BRAFV600K mutation will be eligible for the clinical study; BRAF status will be assessed in a Clinical Laboratory Improvement Amendments (CLIA) certified laboratory; BRAF status may also be tested with any Food and Drug Administration (FDA)-approved test (such as Cobas 4800 BRAF V600 Mutation Test) The tumor is considered to be radioactive-iodine refractory by any of the following Total lifetime dose of radioactive iodine > 600 mCi Absent or insufficient radioactive iodine uptake in either all lesions or an index lesion which has never been resected or received external beam radiation therapy as documented on a radioactive iodine scan (insufficient uptake must be confirmed by either an endocrinologist or nuclear medicine physician) Progression of disease (by imaging or thyroglobulin) within 6 months of radioactive iodine treatment Fludeoxyglucose F 18 (FDG)-avid lesion (standard uptake variable maximum [SUVmax] >= 3) on a FDG-positron emission tomography (PET) scan No recent treatment for thyroid cancer as defined as No radioactive iodine therapy is allowed if given < 3 months prior to initiation of this protocol therapy; a diagnostic study using < 10 mCi of radioactive iodine (RAI) is not considered radioactive iodine therapy No external beam radiation therapy < 4 weeks prior to initiation of therapy on this protocol Prior systemic anti-cancer therapy (chemotherapy with delayed toxicity, extensive radiation therapy, immunotherapy, biologic therapy, or vaccine therapy) within the last 3 weeks; chemotherapy regimens without delayed toxicity within the last 2 weeks preceding the first dose of study treatment Use of other investigational drugs within 28 days (or five half-lives, whichever is shorter; with a minimum of 14 days from the last dose) preceding the first dose of study treatment and during the study Current use of a prohibited medication; patients receiving any medications or substances that are strong inhibitors or inducers of cytochrome P450, family 3, subfamily A (CYP3A) or cytochrome P450, family 2, subfamily C, polypeptide 8 (CYP2C8) are ineligible; current use of, or intended ongoing treatment with: herbal remedies (e.g., St. John's wort), or strong inhibitors or inducers of P-glycoprotein (Pgp) or breast cancer resistance protein 1 (Bcrp1) should also be excluded; it is important to regularly consult a frequently-updated list of these agents; as part of the enrollment/informed consent procedures, the patient will be counseled on the risk of interactions with other agents, and what to do if new medications need to be prescribed or if the patient is considering a new over-the-counter medicine or herbal product Prohibited: strong inducers of CYP3A or CYP2C8, since concentrations of dabrafenib may be decreased Antibiotics: rifamycin class agents (e.g., rifampin, rifabutin, rifapentine) Anticonvulsant: carbamazepine, oxcarbazepine phenobarbital, phenytoin, s-mephenytoin Miscellaneous: bosentan, St. John's wort Prohibited: strong inhibitors of CYP3A or CYP2C8, since concentrations of dabrafenib may be increased Antibiotics: clarithromycin, telithromycin, troleandomycin Antidepressant: nefazodone | 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): 20.0-90.0, Thyroid Cancer Histologically proven diagnosis of thyroid cancer (papillary, follicular/Hürthle cell variant, medullary) Patients with metastatic or unresectable thyroid cancer for which curative measures (surgical resection, external-beam radiation therapy, or radioactive iodine) were no longer effective Documented evidence of disease progression (based on radiographic imaging), according to Response Evaluation in Solid Tumors (RECIST) within 6 months before entry into the study for papillary follicular/Hürthle cell variant Prior therapy with surgery, 131I treatment, chemotherapy, radiotherapy will be allowed, but not within 3 weeks of treatment Patients who received a prior biologic treatment (kinase inhibitor, vaccine or antibody-based therapy), except prior VEGFR/FGFR inhibitor therapy, can be allowed after 3 weeks of treatment Patients must have at least one measurable lesion, which has not been externally irradiated, as defined by version 1.1 Age : 20-90 Performance status of Eastern Cooperative Oncology Group 0 to 2 Life expectancy > 3 months Adequate bone marrow function: ANC≥1,500/uL, hemoglobin≥9.0 g/dL (can be corrected by transfusion) and platelet≥100,000/uL Patients with CNS metastases Patients with another primary malignancy within 3 years prior to starting study drug, with the exception of adequately treated in-situ carcinoma of the uterine cervix, or skin cancer (such as basal cell carcinoma, squamous cell carcinoma, or non-melanomatous skin cancer) Patients who have received the last administration of an anticancer therapy including chemotherapy, immunotherapy, hormonal therapy and monoclonal antibodies (but excluding nitrosurea, mitomycin-C, targeted therapy and radiation) ≤ 4 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy Patients who have received the last administration of nitrosurea or mitomycin-C ≤ 6 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy Patients who have received targeted therapy (e.g. sunitinib, sorafenib, pazopanib) ≤ 2 weeks prior to starting study drug, or who have not recovered from the side effects of such therapy Patients who have had radiotherapy ≤ 4 weeks prior to starting study drug, or ≤ 2 weeks prior to starting study drug in the case of localized radiotherapy (e.g. for analgesic purpose or for lytic lesions at risk of fracture), or who have not recovered from radiotherapy toxicities Pregnant or breast-feeding women Fertile males not willing to use contraception, as stated above Patients unwilling or unable to comply with the protocol | 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): 18.0-80.0, Squamous Cell Carcinoma of the Head and Neck years of age Karnofsky performance status greater than 70 or ECOG ≥ 2 Cytological or histological documentation of squamous cell carcinoma of the head and neck, including the tongue, with a minimum tumor size of 6cm in any dimension History of adequate hepatic function (endoscopic or percutaneous drainage as needed): a. AST (SGOT) / ALT (SGPT) ≤ 5X institutional ULN Chemotherapy naive History of adequate renal and bone marrow function: 1. Leukocytes ≥ 3000/uL 2. ANC ≥ 1500/uL 3. Platelets ≥ 100000/UI 4. Serum Creatinine ≤ 2.0 mg/dL Women with a positive urine pregnancy test are excluded from this study; women of childbearing potential (defined as those who have not undergone a hysterectomy or who have not been postmenopausal for at least 24 consecutive months) must agree to refrain from breast feeding and practice adequate contraception as specified in the informed consent. Adequate contraception consists of oral contraceptive, implantable contraceptives, injectable contraceptives, a double barrier method, or abstinence Subjects with active infections such as pneumonia, or wound infections that would preclude study procedures Subjects with known presence of central nervous system or brain metastases Subjects with prior radiotherapy to the head and neck region Subjects will be excluded if deemed unable to comply 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): 18.0-999.0, Head-and-neck Carcinoma tumor is located in a previously irradiated area with at least 50 Gy or there is an overlap of radiation fields with resulting total doses greater than 90 Gy to expect tumor size and localization allow high dose re-irradiation (individual decision) of distant metastases Time interval between pre-irradiation and re irradiation at least 1 year for local recurrence; at least 6 months for secondary tumor disease age ≥ 18 years previous radiotherapy treatment plans available pre-treatment imaging (pre re-irradiation) available good general condition (ECOG 0-1) dental treatment performed, if necessary no description of the R status after resection of the tumour pregnancy no written informed consent distant metastases interval between first and second irradiation < 6 months at secondary tumor or <1 year when local recurrence of previously irradiated tumor simultaneous participation in another intervention study , if further treatment must be carried out | 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 Age 18 years and older Diagnosis: single, cytology-proven papillary thyroid carcinoma measuring 1 cm or less in diameter (microcarcinoma, T1a), without visible extrathyroidal extension, and with negative central and lateral neck lymph nodes by ultrasound Patient refusal to participate History of prior thyroid or parathyroid surgery Previous recurrent laryngeal nerve injury Inability to make decisions or comply with follow up Co-existing indication for thyroidectomy Aggressive cytological or molecular features Multifocal papillary thyroid carcinoma Pregnant or breast-feeding Anatomically unfavorable location of the tumor (proximity to recurrent laryngeal nerve or trachea) Documented or suspected distant metastasis | 1 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Gastric Cancer Age over 18 years old Histologically or cytologically documented gastric adenocarcinoma Performance status (ECOG scale): 0-2 Life expectancy ≥ 3 months No previous treatment(including: radiotherapy,chemotherapy and immunotherapy) Prior systemic therapy (for instance, cytotoxic chemotherapy or active/passive immunotherapy) for adjuvant or neoadjuvant treatment for non-metastatic (M0) disease has been completed within 6 months prior to initiation of study treatment WIth Measurable Target lesion Patients should sign a written informed consent before study entry History of hypersensitivity to fluoropyrimidines, S-1, oxaliplatin or the ingredients product Inadequate hematopoietic function: WBC≦5,000/mm3; ANC≦2,000/mm3; Platelet≦100,000/mm3 Inadequate organ function which is defined as below: Total bilirubin >2 pper limit of normal range (ULN); ALT / AST > 2.5 upper limit of normal range (ULN) (>5.0 x ULN if hepatic metastasis); serum creatinine > 2 upper limit of normal range (ULN) Symptomatic peripheral neuropathy ≥ NCI CTC AE grade 1 Receiving a concomitant treatment with other fluoropyrimidines or fluorocytosine Pregnancy or lactation women, or women with suspected pregnancy or men unless using a reliable and appropriate contraceptive method Mental status is not fit for chemotherapy therapy presence of serious concomitant illness which might be aggravated by study medication History of ventricular arrhythmia or congestive heart failure Active cardiac disease e.g. decompensate myocardial infarction within the 6-month period preceding entry into the study Significant co-morbid medical conditions, including, but not limited to, Chronic obstructive pulmonary disease, interstitial pneumonia ,pulmonary heart failure, renal failure, hepatic failure, haemorrhagic peptic ulcer, mechanical, paralytic or poor control diabetes | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 40.0-65.0, Adult Lymphoblastic Lymphoma Disease ALL in complete remission (CR) at the time of transplant. Remission is defined as "less than 5.0% bone marrow lymphoblasts by morphology," as determined by a bone marrow aspirate obtained within 2 weeks of study registration Philadelphia chromosome positive ALL is allowed Lymphoid blastic crisis of CML will be included (provided that patients achieve CR) Age Equal or above age 40 and up to 65 years. If younger than 40, there must be comorbidities which preclude the patient to undergo CyTBI conditioning regimen Organ Function All organ function testing should be done within 28 days of study registration Cardiac: Left ventricular ejection fraction (LVEF) ≥ 50% by MUGA (Multi Gated Acquisition) scan or echocardiogram Pulmonary: FEV1 (Forced expiratory volume in 1 second) and FVC (Forced vital capacity) ≥ 50% predicted, DLCO (alveolar diffusion capacity for carbon monoxide) (corrected for hemoglobin) ≥ 50% of predicted Renal: The estimated creatinine clearance (CrCl) must be equal or greater than 60 mL/min/1.73 m2 as calculated by the Cockcroft-Gault Formula: CrCl = (140-age) x weight (kg) x 0.85 (if female)/72 x serum creatinine (mg/dL) Hepatic Non-compliant to medications No appropriate caregivers identified HIV1 (Human Immunodeficiency Virus-1) or HIV2 positive Active life-threatening cancer requiring treatment other than ALL Uncontrolled medical or psychiatric disorders Uncontrolled infections, defined as positive blood cultures within 72 hours of study entry, or evidence of progressive infection by imaging studies such as chest CT scan within 14 days of registration Active central nervous system (CNS) leukemia Preceding allogeneic HSCT Receiving intensive chemotherapy within 21 days of registration. Maintenance type of chemotherapy will be allowed | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Breast Cancer Nos Metastatic Recurrent Women Aged 18 years and over With an invasive breast cancer diagnosed by cytology or histology Tumors cT0 to cT3, CN0-3 No clinical evidence of metastasis at the time of Untreated including scored for breast cancer surgery in progress Patient receiving a social security system Patient mastering the French language Free and informed consent for additional biological samples, different questionnaires and collecting information on resource usage Metastatic breast cancer Local recurrence of breast cancer History of cancer within 5 years prior to entry into the trial other than basal cell skin or carcinoma in situ of the cervix Already received treatment for breast cancer ongoing Blood transfusion performed for less than six months Persons deprived of liberty or under supervision (including guardianship) | 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 Newly diagnosed with a first occurrence of thyroid cancer <2-4 weeks of diagnosis (i.e., histologically confirmed thyroid cancer (papillary, follicular, or medullary type; TNM classification system) Willing to participate in the EG meetings >18 years Alert and capable of giving free and informed consent Able to speak and read English or French Anaplastic thyroid cancer Karnofsky Performance Status (KPS) score <60 (rated by the Research Coordinator (RC) or referring physician) or expected survival <6 months according to clinical judgment | 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, Chronic Pain Women Clinical diagnosis of chronic pelvic pain More than eighteen years Non-menstrual or noncyclic pelvic pain Duration of pain of at least 6 months Duration of pain less than 6 months Women who were pregnant in the last 12 months | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Coronary Artery Stenosis Age ≥ 18 years Patient with an indication for PCI including angina (stable or unstable), silent ischemia (in absence of symptoms a visually estimated target lesion diameter stenosis of ≥70%, a positive non-invasive stress test, or FFR ≤0.80 must be present), or recent STEMI. For STEMI the time of presentation to the first treating hospital, whether a transfer facility or the study hospital, must be >24 hours prior to randomization and enzyme levels (CK-MB or Troponin) demonstrating that either or both enzyme levels have peaked Non-target vessel PCI are allowed prior to randomization depending on the time interval and conditions as follows: a. During Baseline Procedure: i. PCI of non-target vessels performed during the baseline procedure itself immediately prior to randomization if successful and uncomplicated defined as: <50% visually estimated residual diameter stenosis, TIMI Grade 3 flow, no dissection ≥ NHLBI type C, no perforation, no persistent ST segment changes, no prolonged chest pain, no TIMI major or BARC type 3 bleeding. b. Less than 24 hours prior to Baseline Procedure: i. Not allowed (see #3). c. 24 hours-30 days prior to Baseline Procedure: i. PCI of non-target vessels 24 hours to 30 days prior to randomization if successful and uncomplicated as defined above. ii. In addition, in cases where non-target lesion PCI has occurred 24-72 hours prior to the baseline procedure, at least 2 sets of cardiac biomarkers must be drawn at least 6 and 12 hours after the non-target vessel PCI. If cardiac biomarkers are initially elevated above the local laboratory upper limit of normal, serial measurements must demonstrate that the biomarkers are falling. d. Over 30 days prior to Baseline Procedure: iii. PCI of non-target vessels performed greater than 30 days prior to procedure whether or not successful and uncomplicated Patient or legal guardian is willing and able to provide informed written consent and comply with follow-up visits and testing schedule. Angiographic (visual estimate) Treatment of up to three de novo target lesions, maximum of one de novo target lesion per vessel Target lesion(s) must be located in a native coronary artery with visually estimated diameter of ≥2.5 mm to ≤4.25 mm and diameter stenosis ≥50% to <100% Lesion must be ≤28 mm long and can be covered by a single study stent with maximum length of 33 mm (note: multiple focal stenoses may be considered as a single lesion and be enrolled if they can be completely covered with one stent) TIMI flow 2 or 3 If more than one target lesion will be treated, the RVD and lesion length of each must meet the above criteria Planned procedures after the baseline procedure in either the target or non-target vessels STEMI within 24 hours of initial time of presentation to the first treating hospital, whether at a transfer facility or the study hospital or in whom enzyme levels (either CK-MB or Troponin)have not peaked PCI within the 24 hours preceding the baseline procedure and randomization Non-target lesion PCI in the target vessel within 12 months of the baseline procedure History of stent thrombosis Cardiogenic shock (defined as persistent hypotension (systolic blood pressure <90 mm/Hg for more than 30 minutes) or requiring pressors or hemodynamic support, including IABP Known LVEF <30% Subject is intubated Relative or absolute contraindication to DAPT for 12 months (including planned surgeries that cannot be delayed, or subject is indicated for chronic oral anticoagulant treatment) Hemoglobin <10 g/dL | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Complications Elective surgery patients (adults) scheduled to undergo hepatectomy at FMC from May 2013 to May 2015 Patients will be excluded if they are unable to give informed consent | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Melanoma Thyroid Cancer Colorectal Cancer Non-small Cell Lung Cancer Cholangiocarcinoma Histiocytosis Hairy Cell Leukemia Age ≥ 18 years Measurable disease by 1.1 (solid tumors) ECOG performance status of 0-2 Life expectancy ≥ 3 months Adequate hematologic, hepatic, and renal function: 1. Solid Tumors Absolute neutrophil count ≥ 1.5 × 109/L, Hgb > 9 g/dL, platelet count ≥ 100 × 109/L, AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula) 2. Hairy Cell Leukemia Absolute neutrophil count ≤ 1.0 × 109/L, Hgb ≤ 10.0 g/dL or platelet count ≤ 100 × 109/L; AST/ALT ≤ 2.5 × ULN, bilirubin ≤ 2, creatinine ≤ 1.5 × ULN or calculated CrCl >50 mL/min (Cockcroft-Gault formula) Women of child-bearing potential must have a negative serum pregnancy test within 14 days of initiating study drug and must agree to use an acceptable method of birth control from the time of the negative pregnancy test up to 6 months after the last dose of study drug. Urine pregnancy testing during the study and in follow-up per country specific requirements. Fertile men must also agree to use an acceptable method of birth control while on study drug and up to 6 months after the last dose of study drug Completion of previous chemotherapy, immunotherapy, or radiation therapy at least 2 weeks before study drug initiation, with resolution of all associated toxicity (to ≤ Grade 1 or Baseline) Willingness and ability to provide written informed consent prior to any study-related procedures and to comply with all study requirements Extension Cohorts (except 1b) Previous treatment with a selective BRAF/MEK/EKR inhibitor Symptomatic brain metastases. Patients with untreated brain metastasis ≤ 1 cm can be considered eligible if deemed asymptomatic by the investigator upon consultation with the medical monitor and do not require immediate radiation or steroids. Patients with brain metastasis that is treated and stable for 1 month may be considered eligible if they are asymptomatic and on stable dose of steroids or if they do not require steroids following successful local therapy Investigational drug use within 28 days (or < 5 half-lives, whichever is shorter) of the first dose of PLX8394 Major surgical procedure, open biopsy (excluding skin cancer resection), or significant traumatic injury within 14 days of initiating study drug (unless the wound has healed) or anticipation of the need for major surgery during the study Uncontrolled intercurrent illness Active secondary malignancy unless the malignancy is not expected to interfere with the evaluation of safety and is approved by the Medical Monitor. Examples of the latter basal or squamous cell carcinoma of the skin, in-situ carcinoma of the cervix, and isolated elevation of prostate-specific antigen. Patients with a completely treated prior malignancy and no evidence of disease for ≥ 2 years are eligible Refractory nausea and vomiting, malabsorption, external biliary shunt, or significant bowel resection that would preclude adequate absorption Baseline mean QTcF ≥ 450 ms (males) or ≥ 470 ms (females) Women who are breast-feeding or pregnant | 2 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-999.0, Blood Pressure Depression Panic Attack Fibromyalgia POTS Inappropriate Sinus Tachycardia Coronary Heart Disease Acute Coronary Syndrome (ACS) Acute Myocardial Infarction (AMI) Cerebrovascular Disease (CVD) Transient Ischemic Attack (TIA) Atrial Fibrillation Diabetes Mellitus Cancer Systolic Heart Failure Diastolic Heart Failure Chronic Fatigue Syndrome Syncope Vasovagal Syncope Any patient regardless of the age of gender Any non-correctable secondary cause of increase or decrease in blood pressure or a pathology that alters the prognosis before the entrance of the patient into this registry nephropathy prior to the admission familial dyslipidemia previous gastric bypass pre-existing heart failure chemotherapy-induced cardiotoxicity arrhythmogenic right ventricular dysplasia long QT syndrome hypertrophic cardiomyopathy | 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, Pleural Mesothelioma Malignant Advanced Peritoneal Mesothelioma Malignant Advanced Non-squamous Non-small Cell Lung Carcinoma Uveal Melanoma Hepatocellular Carcinoma Glioma Sarcomatoid Carcinoma Histologically proven advanced MPM, advanced peritoneal mesothelioma (for dose escalation cohort only) or non-squamous NSCLC (stage IIIB/IV) who have not been treated with prior chemotherapy or immunotherapy, except that NSCLC subjects with EGFR mutant or ALK positive must have had an EGFR tyrosine kinase inhibitor (TKI) or ALK inhibitor and progressed or been shown to be intolerant of therapy prior to enrolling in this trial, if such ALK inhibitor and EGFR targeted therapy are approved and available in the country in which patients are being enrolled OR Histologically proven metastatic uveal melanoma who have not been treated with prior chemotherapy (MTD cohort only), OR Histologically proven HCC who have failed (PD and/or side effects-been intolerant of) treatment with sorafenib. Failure is defined as having progressed radiographically on, or been intolerant to prior systemic therapy. Intolerance is defined as discontinuation due to an AE(s) on prior systemic therapy that was unacceptable to the treating physician and / or patient, with or without dose interruption and modification. Failure requires at least 14 days of treatment with sorafenib, except for a subject that has had a severe allergic reaction to sorafenib at any time, even less than 14 days of treatment with sorafenib and thus it would be imprudent to re-challenge them with that agent. Cirrhotic status of Child-Pugh grade A-B7 must be present. Child-Pugh status should be determined based on clinical findings and laboratory data during the screening period (Appendix E). Subjects on anti-coagulants are to receive 1 point for their INR status, as they are presumed to have a <1.7 baseline PT/INR.", OR Histologically proven high-grade glioma who have failed (PD and/or side effects) treatment with radiotherapy ± temozolomide, OR Sarcomatoid cancer of any line. 2. ASS1 deficiency (defined as ≤50% ASS expression) demonstrated on tissue specimen (cytospin samples are acceptable) by immunohistochemistry (IHC). For subjects previously treated with chemotherapy, this specimen may have been obtained before that chemotherapy. A new tissue specimen obtained after most recent chemotherapy is not required. Thus ASS1 deficiency is required for entrance into the study. If tissue is not available to determine ASS1 deficiency, then tissue must be obtained by biopsy to determine ASS1 status. 3. Measurable disease as assessed by modified for MPM and by 1.1 for peritoneal mesothelioma, NSCLC, uveal melanoma, HCC, glioma and sarcomatoid carcinoma 4. ECOG performance status of 0 5. Predicted life expectancy of at least 12 weeks Radiotherapy (except for palliative reasons), targeted therapy, or immunotherapy (except for uveal melanoma) the previous four weeks before study treatment. 2. Ongoing toxic manifestations of previous treatments. 3. Symptomatic brain or spinal cord metastases (patients must be stable for > 3 months post radiotherapy or surgery) for subjects with mesothelioma, NSCLC, uveal melanoma excludes subjects with HCC or glioma). 4. Major thoracic or abdominal surgery from which the patient has not yet recovered. 5. Serious infection requiring treatment with intravenous antibiotics at the time of study entrance, or an infection requiring intravenous therapy within 7 days prior to the first dose of study treatment | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 0.0-50.0, Complication of Surgical Procedure Infant * prior surgical treatment for gut chest surgery (non cardiac) or non-surgical infants who will require a minimum of 2 weeks of non-oral formula/breast milk feedings may be receiving oxygen therapy and intravenous therapy may have previously been treated for sepsis, pneumonia, received intravenous only intake, or managed with assisted ventilation. Maternal *must be able to read and comprehend English. Infant *infant receiving assisted ventilation | 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, Total Hip Replacement One total hip replacement, either a large metal head (>40) or a small metal head (<30) on a polyethylene bearing surface to 5 years s/p surgery minimum. No symptoms Any other bearing surface besides metal on poly, no other joint replacements, symptomatic | 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, Vulvar Neoplasm Patients with histological diagnosis of squamous cell carcinoma of the vulva Performance status 0-3 (ECOG) Adequate bone marrow function, liver and kidney Patients with a history of treatment of other invasive cancers in the last 5 years | 0 |
A 75 yo M w/ metastatic papillary thyroid cancer s/p XRT 19 sessions who presented with 2 days of worsening dysphagia for solids, poor oral intake, weight loss 20 pounds over last several weeks and some lethargy. Papillary thyroid cancer dx w/ right neck mass --s/p neck mass resection; unable to perform thyroidectomy --high bleed risk, proximity to trachea and recurrent laryngeal nerve and large tumor size --s/p XRT to neck --s/p RAI ablation --Metastatic to lymph nodes and adrenal glands * s/p hernia repair * s/p tonsillectomy | eligible ages (years): 18.0-999.0, Cancer Cachexia Definition of cachexia (see Section 11.1) fulfilled Age ≥ 18 years Confirmed tumor of any site Life expectancy of ≥3 months Subject must be willing to receive transfusion of blood products Patient must give written informed consent Females of childbearing potential (FCBP) must undergo pregnancy testing (serum) and pregnancy result must be negative.* Reliable contraception should be maintained throughout the study and for 28 days after study treatment discontinuation Unless practicing complete abstinence from heterosexual intercourse, sexually active FCBP must agree to use adequate contraceptive methods Males (including those who have had a vasectomy) must use barrier contraception (condoms) when engaging in sexual activity with FCBP. Males must agree not to donate semen or sperm Pregnant or breast feeding females Lack of written informed consent No consent for registration, storage and processing of the individual disease-characteristics and course as well as information of the family physician about study participation No consent for "Translational Research" and "Biobanking" (see separate documents "Aufbewahrung und Weiterverwendung von biologischem Material und von Daten für die biomedizinische Forschung" und "Biobankreglement" for the RUXexia Trial) Thrombocytopenia < 50 x 10e9/l Peroral intake not possible, in particular by stenosis of the esophagus New started treatment of the tumor (first 3 months of a new treatment). Patients with a new treatment of the cancer disease should delay screening/enrollment until 3 months after start of this treatment Presence of any medical/psychiatric condition or laboratory abnormalities which may limit full compliance with the study, increase the risk associated with study participation or study drug administration, or may interfere with the interpretation of study results and, in the judgment of the Investigator, would make the patient inappropriate for entry into this study Patients with a Myeloproliferative Neoplasm Patients receiving any "Prohibited Medications" (see protocol) within 7 days prior to the first dose of study drug | 1 |
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