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

Clinical trial: Lacrimal Drainage System Obstruction Associated to Radioactive Iodine Therapy for Thyroid Carcinoma

Summary: The radioactive radioiodine therapy (Na131I) for the treatment of differentiated thyroid carcinoma is a procedure used for ablation of remaining thyroid tissue after thyroidectomy and metastases. Although serious complications are uncommon after treatment, there are well-documented adverse reactions secondary to the involvement of the salivary glands, such as dry mouth, pain in the parotid glands and dysphagia, even after administration of low doses of radioiodine. However, ocular complications of such treatment are scarcely reported in literature.
  Among them the investigators can mention recurrent and chronic conjunctivitis, keratoconjunctivitis sicca and dry eye, affecting 23% of patients undergoing radioactive iodine therapy. Dysfunction of the lacrimal gland is described in recent studies, especially after high cumulative dose of the drug. Likewise, epiphora and nasolacrimal duct obstruction have been reported as complications associated with the use of radioiodine, although studies are not available to assess its true incidence through the systematic evaluation of patients.
  It can be seen in routine practice that these patients would normally be referred for ophthalmological examination only if a complaint, what happens in the process of OVL already installed after the use of high doses of radioiodine. With the early evaluation of these patients, the investigators focused on detecting the process of ongoing obstruction in order to study interventions that prevent its final installation.


Eligibility: Inclusion Criteria:
  -  Thyroid carcinoma
  -  Previous thyroidectomy
  Exclusion Criteria:
  -  Potential causes of dry eye (autoimmune diseases, contact lens wearers or drugs that alter tear production, such as antihistamines and psychotropic)
  -  Use of other anti-neoplastic, such as 5-fluorouracil and docetaxel, which can cause epiphora and OVL
  -  Lacrimal gland / ocular trauma
  -  Radiation therapy for other diseases or radiotherapy of head and neck
  -  Patients with diseases that alter the neural control of tear secretion, hormone therapies, pterygium, Graves' disease with or without ophthalmopathy, blepharitis and other conditions that may reduce tear production or result in rapid evaporation.

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

Clinical trial: Evaluate the Safety and Tolerability of Vandetanib in Japanese Patients With Medullary Thyroid Carcinoma

Summary: Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma.

Detailed description: A Phase I/II, Open-label Study to Evaluate the Safety and Tolerability of Vandetanib 300 mg/day in Japanese Patients with Unresectable Locally Advanced or Metastatic Medullary Thyroid Carcinoma

Eligibility: Inclusion Criteria:
  -  Written consent from female or male Japanese patients aged 20 years and over. Evidence of non-childbearing status for women of childbearing potential, or postmenopausal status.
  -  Previous diagnosis of unresectable, locally advanced or metastatic, hereditary or sporadic Medullary Thyroid Carcinoma(MTC).
  -  Patients who have a good overall health status(World Health Organization (WHO) Performance status 0-2).
  -  Patients who have appropriate renal conditions confirmed by test results for taking part in the study.
  -  For patients with measurable disease(at least one lesion, not irradiated within 12 weeks of study registration, with longest diameter more or equal 10mm (lymph nodes minimum more or equal 15 mm) with CT or MRI).
  Exclusion Criteria:
  -  Patients with brain metastases or spinal cord compression.
  -  Patients with significant abnormal ECG (QTcB correction unmeasurable or more than 480 ms)findings and /or significant cardiac conditions or events, uncontrolled hypertension and evidence of severe lung disease.
  -  Abnormal electrolytes such as potassium, magnesium and calcium, or abnormal organ functions such as decreased creatinine clearance.
  -  Patients with significant abnormal laboratory findings (to include 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).
  -  Prior treatment (major surgery, radiation therapy, chemotherapy, or other investigational drugs) received within 28 days before registration.

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

Clinical trial: ImmunoTEP for Patients With Medullary Thyroid Carcinoma.

Summary: The aim of this study is to optimize pretargeting parameters using pharmacokinetic and imaging data for immuno-PET using anti-CEA x anti-HSG TF2 BsMAb and 150 MBq of 68Ga-IMP-288 peptide in MTC patients with abnormal Ct serum level after initial complete surgery and at least one abnormal lesion

Detailed description: Variation of TF2 molar dose, IMP-288 molar dose and pretargeting interval will be performed in 4 to 5 cohorts of 3 patients, receiving 30 to 120 nmol of TF2 and 1.5 to 6 nmol of peptides 1 to 3 days apart. Blood samples will be obtained after TF2 and 68Ga-IMP-288 injections.
  A last cohort (cohorte number 5 or 6) with optimal conditions will be proposed. Whole-body PET images will be recorded 60 and 120 minutes after 68Ga-IMP-288 injection to assess semi-quantitatively tumor targeting and tumor/background ratio. Moreover, the targeting sensitivity of the TF2-pretargeted 68Ga-IMP-288 will be compared to standard methods of tumor.
  some patient will have a second immuno-TEP for their follow up in the first examen was the most sensible.

Eligibility: Inclusion Criteria:
  -  Histological diagnosis of CMT
  -  Calcitonin> 150 pg / ml
  -  Complete treatment of the primary tumor
  -  at least one detectable lesion more than 10 mm on conventional imaging: bone lesions can be taken into account if they extend outside of the bone and the party extra bone is measurable.
  -  Age ≥ 18 years
  -  Negative pregnancy test for women of childbearing age in the previous 2 days immuno-PET. Women of childbearing potential should use effective contraception take continuously for 3 months.
  -  KPS ≥ 70 or ECOG 0-1 and life expectancy of at least 6 months
  -  Absence of serious illness or co-morbidity assessed risk
  -  Creatinine ≤ 2.5 normal
  -  Absence of cancer treatment within 6 weeks prior to the immuno-PET
  -  No history of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
  -  Lack of anti-antibodies in patients who have previously received antibodies and hypersensitivity to antibody or protein
  -  Informed consent signed
  -  Social Insurance
  Exclusion Criteria:
  -  Pregnancy or breastfeeding
  -  Serious illness or co-morbidity assessed risk
  -  History of cancer within 5 years, except skin cancer other than melanoma or carcinoma in situ of the cervix
  -  Presence of anti-antibodies in patients who have previously received antibodies
  -  Known hypersensitivity to antibody or protein
  -  Need to establish a cancer treatment within 3 months of immuno-PET (before stock evaluation 3 months)
  -  Inability intellectual sign consent
  -  Patient protected by law

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

Clinical trial: The Efficacy of CASAD in Patients With Diarrhea Related to Medullary Thyroid Cancer

Summary: Diarrhea in patients with MTC (Medullary Thyroid Cancer) can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. Diarrhea can also lead to increased cost of care, reduced quality of life, and treatment delays. Not all patients benefit from conventional anti-diarrheal therapy. CASAD is proven to reduce diarrhea in humans and animals. Clays have water-binding effects, increase the absorptive capacity of the intestinal mucosa, and absorb the excess cytokines which are possible mechanisms of diarrhea in MTC. In this study, we will investigate if starting 1 g CASAD three times a day will ameliorate the severity of diarrhea in patients with MTC. Diarrhea in patients with MTC can be debilitating and, in some cases life threatening. Findings in such patients include volume depletion, renal insufficiency, and electrolyte disorders. We hypothesize that adding CASAD 3 grams/day will reduce the incidence and ameliorate the severity of diarrhea in patients with MTC.


Eligibility: Inclusion Criteria:
  -  Patients with medullary thyroid cancer
  -  Men and women from all ethnic and racial groups
  -  Diarrhea ( >=3 loose bowel movements per day)
  -  Duration of diarrhea of at least 1 week
  Exclusion Criteria:
  -  Patients with MEN 2b (since these patients may have megacolon)
  -  Patients taking any clay products
  -  History of significant neurological or psychiatric disorders that would impede giving consent, treatment, or follow up.
  -  Patients who cannot comply with medications
  -  Patients whose current medication schedule would not permit an approximate 2 hour window between administration of CASAD and other scheduled medications.
  -  Pregnancy or lactation
  -  Patients receiving systemic chemotherapy (includes tyrosine kinase inhibitors)

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

Clinical trial: Study Comparing Complete Remission After Treatment With Selumetinib/Placebo in Patient With Differentiated Thyroid Cancer

Summary: The study is designed to evaluate the clinical efficacy, safety and tolerability of selumetinib with radioactive iodine therapy in patients with differentiated thyroid cancer.

Detailed description: A Randomised, Double Blind Study to Compare the Complete Remission Rate Following a 5-Week Course of Selumetinib or Placebo and Single Dose Adjuvant Radioactive Iodine Therapy in Patients with Differentiated Thyroid Cancer.

Eligibility: Inclusion Criteria:
  Differentiated thyroid cancer Tumor >4 cm, or Gross extra-thyroid extension, or 1 lymph node >1 cm, or 5 or more lymph nodes of any size Previous thyroidectomy Must be able to receive radioactive iodine therapy Must be able to receive Thyroid Stimulating Hormone suppression
  Exclusion criteria:
  Metastaic disease Anaplastic thyroid cancer, medullary thyroid cancer or Hurthle cell carcinoma Presence of anti-Tg antibodies Previous treatment with any radiation Unresolved toxicity ≥ common terminology criteria for adverse event Grade 2

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

Clinical trial: Glycaemic Control of Weekly LAPS-Exendin Versus Placebo in Subjects of Type 2 Diabetes

Summary: The purpose of this study is to determine the optimal dose or doses of HM11260C, when administered once a week under the skin, to improve the control of blood sugar levels in patients with early-stage type 2 diabetes mellitus (T2DM).


Eligibility: Inclusion Criteria:
  -  Ages eligible for study : 18 years to 74 years
  -  Genders eligible for study : Male and Female
  -  Diagnosed with T2DM
  -  Received diet and exercise therapy with or without metformin monotherapy
  -  HbA1c levels of between ≥ 7.0% and ≤ 10.0%
  -  Females of childbearing potential who are not pregnant and agree to use a reliable method of birth control
  -  Written informed consent must be obtained
  Exclusion Criteria:
  -  Pregnant or nursing (lactating) women
  -  Diagnosis of type 1 diabetes mellitus
  -  Uncontrolled diabetes defined as a FPG level of > 240 mg/dL
  -  A significant change in body weight in the 3 months before screening
  -  Any history of GI intolerance
  -  Personal or family history of medullary thyroid cancer (MTC) or a genetic condition that predisposes to MTC
  -  Known history of chronic pancreatitis
  -  A history of alcohol or drug abuse or drug addiction

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

Clinical trial: CAPRELSA® REGISTRY: a Belgian Registry to Evaluate the Use of Vandetanib (Caprelsa®) in Current Clinical Practice

Summary: In this registry it is planned to include all Belgian patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic Medullary Thyroid Cancer (MTC) who have been prescribed Caprelsa® (vandetanib).
  The characteristics of patients receiving Caprelsa® (vandetanib) will be described. Therefore real life data regarding demographic characteristics, evolution of the disease, RET mutation status, the treatment before, during and after vandetanib, dose and duration of treatment with Caprelsa® (vandetanib) and time of progression or death (if applicable) will be included.


Eligibility: Inclusion criteria
  The subject population that will be observed in this registry, must fulfil all of the following criteria:
  1. Provision of subject Informed Consent
  2. Patients diagnosed with aggressive and symptomatic unresectable locally advanced or metastatic MTC
  3. Patients who already received a prescription for vandetanib in accordance with the scientific leaflet and fulfilling the reimbursement criteria of vandetanib and who are currently treated or have been treated with vandetanib 100 mg or 300 mg tablets.
  The prescription of the medicinal product is clearly separated from the decision to include the subject in the registry.
  Exclusion criteria Not applicable since patients participating in another study can take part in this registry.

Relevance to patient case: definitely relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Sorafenib Phase II Study for Japanese Anaplastic or Medullary Thyroid Carcinoma Patients

Summary: The objectives of this study are to evaluate safety, efficacy and pharmacokinetics of sorafenib for the treatment of Japanese patients with anaplastic thyroid carcinoma (ATC) or locally advanced or metastatic medullary thyroid carcinoma (MTC).


Eligibility: Inclusion Criteria:
  -  Japanese patients with ATC (Anaplastic thyroid carcinoma) or locally advanced or metastatic MTC (medullary thyroid carcinoma)
  -  Not a candidate for surgery or radiotherapy with curative intent
  -  Histologically or cytologically confirmed ATC or MTC
  -  Measurable or non-measurable disease (but clinically evaluable) according to RECIST 1.1.
  -  Age >= 18 years
  -  Adequate bone marrow, liver and renal function to be conducted within 14 days prior to treatment
  -  Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0 or 1
  -  Life expectancy of at least 12 weeks
  Exclusion Criteria:
  -  Histologic subtypes of thyroid cancer other than anaplastic or medullary carcinoma
  -  Prior anti-cancer treatment with tyrosine kinase inhibitors, monoclonal antibodies (licensed or investigational) that target VEGF or VEGF (vascular endothelial growth factor) receptors or other targeted agents
  -  Prior chemotherapy for thyroid cancer (only one regimen is allowed)
  -  Major surgery, open biopsy, or significant traumatic injury within 30 days prior to enrollment in the study.
  -  Subjects with tracheal, bronchial or esophageal infiltration with significant risk of bleeding but without having received local treatment prior to enrollment in the study

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

Clinical trial: Treatment of Diabetic Neuropathy With Liraglutide

Summary: The purpose of this trial is to explore whether liraglutide has a long term effect on clinical symptoms and biomarkers in patients with diabetic neuropathy.


Eligibility: Inclusion Criteria:
  -  Abile person of Northern European descent
  -  Age between 18 to 65 years
  -  A verified diagnosis of DM type 1 for minimum 2 years (HbA1C=7%)
  -  Stable DM treatment (Treatment is considered stable when the patient has been treated with basal-bolus insulin, premixed insulin or continously infused insulin with an insulin dose considered stable by investigator for at least 3 months prior to screening.)
  -  The participants must be able to read and understand Danish.
  -  Peripheral diabetic neuropathy ensured by having abnormal nerve conduction velocity
  -  BMI equal to or above 22
  -  Personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
  -  Patients willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other trial procedures.
  Exclusion Criteria:
  -  Diabetes mellitus type II
  -  Estimated glomerular filtration rate (s-creatinin/eGRF) < 60 ml/min/1.37m2
  -  Calcitonin > 25
  -  HbA1c level < 7%
  -  Patients with any clinically significant laboratory abnormalities, that in the opinion of the investigator may increase the risk associated with trial participation or may interfere with the interpretation of the trial results.
  -  Patients on GLP-1 receptor agonist treatment (exenatide, liraglutide or others) or pramlintide or any DPP-4 inhibitor within 3 months prior to screening.
  -  Other neurological and/or psychiatric disease
  -  Treatment of other endocrinological disease except hypothyreosis
  -  Malignant neoplasms requiring chemotherapy, surgery, radiation or palliative care in the previous 5 years.
  -  Family or personal history of multiple endocrine neoplasia type 2 (MEN2) or familial medullary thyroid carcinoma.
  -  Personal history of non-familial medullary thyroid carcinoma
  -  Known abuse or alcohol and/or medicine (Alcohol use in accordance with the recommendations by the Danish Health and Medicines Authority are allowed).
  -  Known allergy to liraglutide.
  -  Participation in other clinical trials less than 3 months prior to inclusion
  -  Female patients who are pregnant or lactating, or intend to become pregnant and male patients who intend to father a child during course of the study.
  -  In women, a serum pregnancy test will be conducted at baseline based on h-CG in the blood. The investigator will have to ensure that fertile female patients use a safe contraception method during the study and for at least 15 hours after termination of the study medication period.

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

Clinical trial: Phase 1/1b Study of MGCD516 in Patients With Advanced Cancer

Summary: MGCD516 is a receptor tyrosine kinase (RTK) inhibitor shown in preclinical models to inhibit a closely related spectrum of RTKs including MET, AXL, MER, and members of the VEGFR, PDGFR, DDR2, TRK and Eph families. In this study, MGCD516 is orally administered to patients with advanced solid tumor malignancies to evaluate its safety, pharmacokinetic, metabolism, pharmacodynamic and clinical activity profiles.
  During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed; during the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations.
  Patients anticipated to be enrolled in Phase 1b will be selected based upon having a tumor type, including but not limited to, non small cell lung cancer and head and neck cancer positive for specific activating MET, NTRK2, NTRK3, or DDR2 mutations, MET or KIT/PDGFRA/KDR gene amplification, selected gene rearrangements involving the MET, RET, AXL, NTRK1, or NTRK3 gene loci, or having loss of function mutations in the CBL gene. In addition patients with clear cell renal cell carcinoma refractory to angiogenesis inhibitors or metastatic prostate cancer with bone metastasis will be enrolled.

Detailed description: During the Phase 1 segment, the dose and regimen of MGCD516 will be assessed.
  During the Phase 1b segment, the clinical activity of MGCD516 will be evaluated in selected patient populations. Patients anticipated to be enrolled in Phase 1b will be selected based upon the following cancer diagnosis:
  Non-small cell lung cancer with genetic alterations in MET, AXL, RET, TRK, DDR2, KDR, PDGFRA, KIT or CBL.
  Head and neck squamous cell carcinoma with genetic alterations in MET.
  Clear cell renal cell carcinoma refractory to angiogenesis inhibitors.
  Metastatic prostate cancer with bone metastases.
  Other cancer diagnosis having a selected genetic alteration in MGCD516 target RTKs.

Eligibility: Inclusion Criteria:
  -  Metastatic or unresectable solid tumor malignancy
  -  Standard treatment is not available
  -  Adequate bone marrow and organ function
  Exclusion Criteria:
  -  History of a significant cardiovascular illness
  -  Prolonged corrected QT (QTc) interval
  -  Left ventricular ejection fraction < 40%
  -  Symptomatic or uncontrolled brain metastases
  -  Other active cancer

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with medullary thyroid carcinoma; genetic feature: RET

Clinical trial: Transvaginal Ultrasound Cervical Length Measurements in Twin Gestations

Summary: The purpose of this study is to determine if the use of routine transvaginal cervical length ultrasound can be used to prevent preterm deliveries in twin gestations.

Detailed description: This is a randomized controlled trial to determine whether there is a difference in the rate of preterm birth among women with twin pregnancies whose clinicians are aware of transvaginal ultrasound cervical length measurements compared to those managed without this information. The study group had transvaginal cervical length ultrasound monthly from 16-28 weeks and were managed with a standard algorithm for activity restriction and cerclage depending on the cervical length. The control group had digital cervical exams and routine transvaginal cervical length ultrasound was not utilized. The primary outcome was the mean length of gestation. Secondary outcomes included percentage of deliveries < 35 weeks, maternal and neonatal outcomes.

Eligibility: Inclusion Criteria:
  -  Twin pregnancy
  -  Gestational age < 20 weeks
  Exclusion Criteria:
  -  History of incompetent cervix with plans to place a cerclage
  -  History of possible cervical incompetence with preexisting plans to monitor cervical length
  -  Prior preterm birth at < 28 weeks gestational age
  -  Plans to leave the area before delivery
  -  Known major fetal anomaly
  -  Known diagnosis of twin-twin transfusion syndrome
  -  Age < 18
  -  Monoamniotic twins

Relevance to patient case: not relevant