araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Prevention of Hypocalcemia in Patients Undergoing Total Thyroidectomy Plus Central Neck Dissection

Summary: the increased risk of hypocalcemia following total thyroidectomy plus central neck dissection can be minimized by routine administration of oral calcium and vitamin D supplements during the early postoperative period.

Detailed description: Of patients with differentiated papillary thyroid carcinoma, group D underwent total thyroidectomy alone and groups A-C underwent total thyroidectomy plus CND. The latter were randomized to oral calcium (3 g/day) plus vitamin D (1 mcg/day) (group A, n = 49), calcium alone (group B, n = 49), or no supplements (group C, n = 50). Hypocalcemic symptoms, serum calcium, and parathyroid hormone (PTH) levels were compared among the groups.

Eligibility: Inclusion Criteria:
  -  Differentiated papillary thyroid carcinoma
  -  Undergoing total thyroidectomy plus central neck dissection
  Exclusion Criteria:
  -  Previous thyroid or neck surgery
  -  Patients with parathyroid diseases
  -  Other thyroid malignancies
  -  Early loss of follow-up without proper evaluation of postoperative serum calcium levels and symptoms

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Clinical Evaluation of 18F-DOPA Positron Emission Tomography in Medullary Thyroid Cancer

Summary: Medullary thyroid carcinoma (MTC) is a rare tumor arising from C cells of the thyroid gland and belonging to the endocrine tumors. 18F-DOPA PET, based on tha capacity of endocrine tumor cells to take-up, decarboxylate and store amino-acids, such 3-4-dihydroxyphenylalanine(DOPA), is used for imaging endocrine tumors. The aim of the study was to evaluate the contribution of 18F-DOPA whole-body PET for the detection of recurrences in patients with proven recurrent MTC without evidence of recurrence or metastases on several imaging modalities.

Detailed description: In patients MTC and persistently elevated calcitonin levels, the challenge is finding the site of residual disease. Since the only satisfying treatment is surgery, the early detection and precise location is important. Tumor localization techniques usually performed, including ultrasonography of the neck and liver, chest and abdomen, bone scintigraphy, isotopic scanning and even PET with FDG are poorly sensitive. The use of 18F-DOPA may be more sensitive and specific engineering for localization metastatic disease. The study include 100 patient with persistent MTC demonstrated by elevated tumor markers (calcitonin and CEA) and no evidence of recurrence on morphological imaging procedures. 18F-DOPA whole-body PET is performed 30 minutes after IV injection of 4 MBq/kg of 18F-DOPA, the patient fasted for 6 hours prior the start of the examination.
  All 18F-DOPA PET are evaluated independently by two experienced nuclear medicine physicians and any tracer accumulation exceeding the normal uptake tissue is rated as pathologic finding. The sensibility and efficiency of 18F-DOPA PET will be analysed and Malignant tissue confirmed by histology after surgery or biopsy or by follow-up for one year.

Eligibility: Inclusion criteria:
  -  Patients up to 18 years old with medullary thyroid cancer / carcinoma
  -  Patients with medullary thyroid cancer / carcinoma recurrence, which have a high calcitonin level / rate, more than 100pg/ml, associated - or not - to a high CEA (Carcinoembryonic Antibodies) level / rate, dated from less than 3 months
  -  Patients with a less than 3 months conventional imaging checkup (cervical ultrasonography, cervical-chest-abdomen tomography and / or magnetic resonance imaging, abdomen ultrasonography, osseous / bones radionuclide imaging), in which the tumor site not certainty located
  -  Informed Consent Form signed and dated by patients
  -  Patients which are "SECURITE SOCIALE" affiliated
  Exclusion criteria:
  -  Pregnant or suckling women
  -  Women able to procreate, without efficient birth control
  -  Patients already included in another Nuclear Medicine or Imaging research protocol using ionizing radiations; the efficient dose accumulation will not exceed 20 mSv.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Safety and Tolerability of Retinoid QLT091001 in Healthy Volunteers

Summary: Healthy volunteer subjects will receive retinoid QLT091001 once-daily for 7 days for safety observation.


Eligibility: Inclusion Criteria:
  -  Healthy subjects with ECG within normal limits and normal blood pressure and resting heart rate
  Exclusion Criteria:
  -  Subjects with any clinically important abnormal physical finding at screening.
  -  Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 60 days of baseline.
  -  Female subjects who are either pregnant or lactating.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Fluvastatin 80 mg Ret. vs Combination With Ezetimibe 10 mg in Patients With High Cardiovascular Risk

Summary: Patients with coronary heart disease (CHD) or CHD equivalent (e. g. diabetes mellitus) often have abnormalities in lipids (hypercholesterolemia). Besides, hypercholesterolemia is an evident risk factor for atherosclerosis. Hitherto, there are only few studies of patients with primary hypercholesterolemia where the combination therapy with statins (HMG-Co-reductase inhibitors) and ezetimib was investigated. This combination therapy should be more effective in reducing low density lipoprotein cholesterol (LDL-C) and total cholesterol levels compared to monotherapy.

Detailed description: Ezetimibe, a cholesterol-absorption inhibitor, significantly lowers low-density lipoprotein cholesterol (LDL-C) when administered in addition to statin treatment. The effect of ezetimibe on the incidence and progression of vascular disease is elusive. Therefore, our objective was to examine the effects of fluvastatin and fluvastatin plus ezetimibe on lipoprotein subfractions in patients with diabetes mellitus and/or coronary heart disease.

Eligibility: Inclusion Criteria:
  -  Patients with CHD or CHD equivalent with LDL 100-160 mg/dl
  -  Male or female sex
  -  Normal values of CK, AST and ALT
  -  Normal kidney function
  Exclusion Criteria:
  -  CHD Stage III-IV
  -  St. p. myocardial infarction or coronary artery bypass grafting
  -  Pregnancy or breastfeeding
  -  Premenopausal women without certain contraception
  -  Known hypersensitivity to HMG-CoA reductase inhibitors or ezetimib

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

Summary: RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.
  PURPOSE: This phase II trial is studying how well everolimus works in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer.

Detailed description: OBJECTIVES:
  Primary
  -  To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.
  Secondary
  -  To determine maximum percentage of tumor reduction in these patients.
  -  To describe activity time to event endpoints.
  -  To assess toxicity.
  -  To determine evolution of serum thyroglobulin.
  -  To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
  -  To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.
  OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:
  -  Progressive or recurrent disease
  -  Metastatic disease
  -  Unresectable disease
  -  Meeting any of the following thyroid cancer subtypes:
  -  Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory
  -  Undifferentiated thyroid cancer (i.e., anaplastic disease)
  -  Medullary thyroid cancer
  -  Must have received prior everolimus or other mTOR inhibitor therapy
  -  Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed
  PATIENT CHARACTERISTICS:
  -  Karnofsky performance score 70-100%
  -  ANC ≥ 1,500/mm^³
  -  Platelet count ≥ 100,000/mm³
  -  Hemoglobin ≥ 5.6 mmol/L
  -  Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
  -  ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)
  -  Serum creatinine ≤ 2 times ULN
  -  Negative pregnancy test
  -  No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: A Study of Vemurafenib (RO5185426) in Participants With Metastatic or Unresectable Papillary Thyroid Cancer Positive for the BRAF V600 Mutation

Summary: This open-label, multi-center study will evaluate the safety and efficacy of Vemurafenib (RO5185426) in participants with metastatic or unresectable papillary thyroid cancer (PTC) positive for the BRAF V600 mutation and resistant to radioactive iodine therapy. Participants will receive vemurafenib 960 milligrams (mg) orally twice daily until progressive disease or unacceptable toxicity occurs.


Eligibility: Inclusion Criteria:
  -  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 RECIST criteria within the prior 14 months
  -  Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  -  Adequate hematological, renal and liver function
  Exclusion Criteria:
  -  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

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Biomarkers for Angiogenesis in Renal Cell Carcinoma and Neuro-endocrine Tumours.

Summary: The primary objective of this study is to analyse the concentration dopamine and serotonin in thrombocytes of patients with renal cell carcinoma and neuro-endocrine tumours compared to the concentrations of these catecholamines in healthy volunteers. The concentration dopamine and serotonin in thrombocytes with and without medication will also be evaluated.

Detailed description: -  To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and low grade neuroendocrine tumours.
  -  To compare these concentrations with the concentrations catecholamines in thrombocytes of healthy controls.
  -  To analyse the concentration catecholamines in thrombocytes of patients with clear cell renal cell carcinoma and patients with low grade neuroendocrine tumours with and without medication.

Eligibility: Inclusion Criteria:
  -  Age 18 years old or older.
  -  Patients with clear cell renal cell carcinoma with metastases or patients with a low-grade neuro-endocrine tumor with metastases.
  -  Written informed consent
  Exclusion Criteria:
  -  Use of L-dopa or SSRI.
  -  Patients with a second primary malignancy.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: BRAF V600E Mutations In Papillary Thyroid Carcinoma

Summary: The purpose of this study is to determine whether BRAF V600E mutation in our patients with papillary thyroid cancer has an association with poor prognosis.

Detailed description: Papillary thyroid carcinoma (PTC) is the most common type of thyroid malignancy and BRAF V600E mutation is the most common genetic alteration identified in PTC, ranging from 25 to 80%, with the average rate about 45%. Various studies demonstrated a relationship between BRAF V600E mutation and aggressive characteristics of the cancer, including the worse patient prognosis. But,there are no studies from Turkey regarding this topic. So the investigators will examine BRAF V600E mutation in our patients with PTC and try to assess the role of this mutation in prognosis and further management of the patients.

Eligibility: Inclusion Criteria:
  -  Patients with papillary thyroid cancer
  Exclusion Criteria:
  -  Patients who do not want to be a part of this study

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: To Compare The Effects Of Two Doses Of Vandetanib In Patients With Advanced Medullary Thyroid Cancer

Summary: The purpose of this study is to give patients with medullary thyroid cancer either 300mg/day or 150mg/day vandetanib and compare how well each dose affects how their cancer responds. It will also help the investigators understand the side effects of different doses in these patients.

Detailed description: An International, Randomised, Double-Blind, Two-Arm Study To Evaluate The Safety And Efficacy Of Vandetanib 150 And 300mg/Day In Patients With Unresectable Locally Advanced Or Metastatic Medullary Thyroid Carcinoma With Progressive Or Symptomatic Disease

Eligibility: Inclusion Criteria:
  -  Written consent from Female or male patients aged 18 years and over. Previously confirmed histological diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic MTC Objective disease progression within the previous 14 months prior to enrolment, and/or
  -  Have one or more symptoms that the Investigator believes to be related to the patient's MTC.
  -  World Health Organisation (WHO) or Eastern Cooperative Oncology Group (ECOG) Performance status 0-2.
  -  Has measurable disease (at least one lesion, not irradiated within 12 weeks of study randomisation, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
  -  Lesions must be amenable to accurate and repeat measurement.
  Exclusion Criteria:
  -  Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before randomization.
  -  Abnormal liver function tests (bilirubin more than 1.5xULRR, and ALT, AST, or ALP more than 2.5xULRR or 5.0xULRR if related to liver metastases).
  -  Significant cardiac conditions or events such as reduced cardiac functions, symptomatic cardiac arrhythmia requiring treatment, congenital long QT syndrome, history of drug-induced QT prolongation, or QTcF correction unmeasurable or more than 450 ms.
  -  Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
  -  For women only - currently pregnant or breast feeding.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: An Active Surveillance Program for Cases of Medullary Thyroid Carcinoma (MTC)

Summary: This study is conducted in the United States of America (USA). The aim of the study is to monitor the number of annual new cases of medullary thyroid carcinoma (MTC) and to establish a registry for these new cases in order to identify any possible increase related to the introduction of liraglutide, exenatide once-weekly, and other GLP-1 receptor agonists into the US market.

Detailed description: This active surveillance program will monitor for any signal indicating a possible association between treatment with long-acting GLP-1 RAs and the development of MTC in the United States population. Given the very low incidence of MTC in the general population, the expected rate of exposure to long-acting GLP-1 RAs, the anticipated long latency of the potential outcome under study and the limited data on underlying risk factors for development of MTC other than RET proto-oncogene mutations, an active surveillance program is the most efficient means of identifying a possible association between MTC and products in the long-acting GLP-1 RAs class. Given the uncertainty of the association of MTC in humans treated with these drugs, a study duration of at least fifteen years from the time of market introduction of the first long-acting GLP-1 RA was thought to provide evidence of an association, if one exists. If such an association is identified, a case-control study will be initiated to quantify the association.
  The MTC registry is a Food and Drug Administration (FDA) post-marketing requirement for long-acting GLP-1 RA products. Because of the rarity of MTC and in order to minimize inconvenience to patients, physicians, and state cancer registries, FDA encouraged sponsors of long-acting GLP-1 RAs to work collaboratively to conduct this registry. Consequently, the MTC Registry Consortium has been formed for this purpose.
  The MTC Registry Consortium refers to the Sponsors with approved long-acting GLP-1 RAs who have a contractual agreement to participate in the MTC Registry.
  This active surveillance program for cases of MTC will be conducted with assistance from the North American Association of Central Cancer Registries (NAACCR). NAACCR is a collaborative umbrella organization for cancer registries, government agencies, professional organizations, and private groups in North America interested in improving the quality and use of cancer registry data. All of the central cancer registries in the U.S. and Canada are members of NAACCR, including those that participate in SEER.

Eligibility: Inclusion Criteria:
  -  A record of medullary thyroid carcinoma (MTC) identified from state/regional population-based cancer registries
  -  At least 18 years or older.
  There are no other inclusion or exclusion criteria.

Relevance to patient case: not relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Repeated Treatments of QLT091001 in Subjects With Leber Congenital Amaurosis or Retinitis Pigmentosa (Extension of Study RET IRD 01)

Summary: The purpose of this study is:
  -  To evaluate the safety of up to 3 additional courses of oral QLT091001 administered once daily for 7 days in subjects treated previously with a single 7-day course of QLT091001 in Study RET IRD 01
  -  To evaluate whether up to 3 additional courses of oral QLT091001 administered once daily for 7 days can maintain or improve visual function.


Eligibility: Inclusion Criteria:
  -  Subjects with LCA or RP due to RPE65 or LRAT deficiency who received a 7-day treatment course of QLT091001 and completed the Day 30 visit in Study RET IRD 01
  -  Subjects who meet any one of the following criteria at least 1 month after start of the 7-day treatment course in Study RET IRD 01:
  -  no increase in GVF (in at least 1 eye): Follow-up GVF increased ≤20% from baseline or
  -  decrease in GVF (in at least 1 eye): Follow-up GVF decreased below the highest previous response by ˃20% or
  -  Considered a reasonable candidate for retreatment, based on the Investigator's discretion, in consultation with the independent DSMB and the Sponsor, based on regression or lack of response in other parameters of visual function (e.g., subjective reports of changes in color vision or adaptation to low light) but who do not meet other (GVF) criteria for study entry
  Exclusion Criteria:
  -  Subjects with any clinically important abnormal physical finding at Screening.
  -  Subjects who have taken any prescription or investigational oral retinoid medication (e.g., Accutane,® Soriatane®) within 6 months of Day 0 and subjects who did not tolerate their previous oral retinoid medication will be excluded regardless of the time of last exposure.
  -  Subjects with liver failure, uncontrolled thyroid disease, hypersensitivity to retinoids, or hypervitaminosis A
  -  Subjects who have taken any supplements containing ≥10,000 IU vitamin A within 60 days of screening

Relevance to patient case: not relevant