araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Proof of Concept Study to Assess the Efficacy, Safety and Pharmacokinetics of LFG316 in Patients With Paroxysmal Nocturnal Hemoglobinuria

Summary: To determine whether LFG316 can induce a hematological response, as measured by reduction in hemolytic activity, in patients with PNH.


Eligibility: Inclusion Criteria:
  -  Male and female patients between the age of 18-75 (inclusive), or 18-65 (applicable in Czech Republic) with a diagnosis of PNH prior to screening
  -  A documented PNH clone size of ≥10% by RBCs and/or granulocytes
  -  Serum LDH levels at least 1.5-fold above the upper limit of normal (ULN) at screening
  -  Negative pregnancy test for women of child bearing potential at screening
  -  Previous vaccination against Neisseria meningitidis is required at least 2 weeks prior to first dosing.
  Exclusion Criteria:
  -  Known or suspected hereditary complement deficiency
  -  History of recurrent meningitis, history of meningococcal meningitis despite vaccination
  -  Presence or suspicion (based on judgment of the investigator) of active bacterial infection within 2 weeks prior to first dose of LFG316, or recurrent bacterial infections
  -  Under active therapy with other agents interfering with the complement system
  -  Severe concurrent co-morbidities that are a likely caused by underlying autoimmune diseases other than PNH
  -  Women of child-bearing potential, unless they are using highly effective methods of contraception during dosing and for 50 days after the last dose of LFG316.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: fPAM for the in Vivo Depth Measurement of Pigmented Lesions and Melanoma Depth

Summary: The investigators propose the use of functional photoacoustic microscopy (fPAM) to evaluate both benign and malignant pigmented lesions for tumor depth. Through fPAM analysis followed by histological examination, the investigators anticipate that they will be able to non-invasively determine tumor depth of pigmented lesions (moles and melanoma). In melanoma, tumor depth (Breslow's depth) is not only an important prognostic indicator, but also directs surgical treatment. The ultimate goal is to develop a sensitive clinical tool that will allow non-surgical evaluation of pigmented lesions, which eventually, will aid in melanoma diagnosis and management - potentially an earlier and more definitive surgical management.
  In addition, the investigators propose to use the combination of fPAM and single-cell PAM to respectively image CTCs in trunk vessels and cuticle capillaries. Based on the investigators' murine models, the investigators anticipate that they will be able to differentiate CTCs from other blood cells and reliably calculate CTC concentration in a non-invasive manner. CTC concentration has been demonstrated to be a valuable indicator of a melanoma's metastatic potential and a potential tool in evaluating treatment efficacy. The ultimate goal is to develop a sensitive imaging device that will allow accurate evaluation of the risk of melanoma recurrence and metastases, that may facilitate treatment monitoring.


Eligibility: Inclusion Criteria:
  Outcome Measure #1 and #2
  -  Healthy individuals with pigmented lesions or a partially biopsied melanoma whose treatment plan includes excision
  -  Participants must be 18 years or older
  -  Participants must be able to understand and willing to sign a written informed consent document
  Outcome Measures #3 and #4
  -  Patients with either cutaneous, visceral or brain melanoma metastases.
  -  Participants must be 18 years or older.
  -  Participants must be Eastern Cooperative Oncology Group (ECOG) status 0-3.
  -  Participants must be able to understand and willing to sign a written informed consent document.
  Exclusion Criteria:
  -  Minors, pregnant patients, incarcerated individuals, and individuals unable to give informed consent will be excluded from this study
  -  ECOG status > 3

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma

Summary: This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.


Eligibility: Inclusion Criteria:
  -  Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
  -  Written informed consent granted
  Exclusion Criteria:
  - Do not fulfill one or more inclusion criteria

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: CA-125 and Severity of Pre-Eclampsia

Summary: The Aim of this study is to determine the relationship between serum concentrations of cancer antigen-125 (CA-125) and pre-eclampsia severity.

Detailed description: Although the source of CA-125 during pregnancy is the fetal chorion, amniotic fluid, and maternal decidua, the perinatal dynamics of maternal serum CA-125 requires clarification. Clinical studies of CA-125 levels and its function in hypertensive pregnant patients are limited and offered contradictory results (Cebesoy et al., 2009).
  And so we investigate CA-125 in normal pregnancy and in pre-eclampsia, comparing mild and sever pre-eclampsia to determine relationship of CA-125 and severity of the disease.
  Patients will be divided in three groups:
  -  Control: 40 normal healthy pregnant women attending the ER in labor.
  -  Mild pre-eclampsia: 40 patients fulfilling the following criteria.
  -  Blood pressure: systolic blood pressure >140 and <160 , Diastolic blood pressure >90 and <110
  -  Proteinuria: 300 mg (+) assessed by urine urignost 3A® (urine strips from DIALAB).
  -  No symptoms of severity as headache.
  -  Normal investigations for different organ function (as liver and kidney function).
  -  Severe pre-eclampsia :40 patients fulfilling anyone or more of the following criteria (The American College of Obstetricians and Gynecologists, 2010)(ACOG):
  -  Systolic blood pressure > 160 mmHg
  -  Diastolic blood pressure > 110 mmHg (on two occasions at least 6 hours apart while the patient is on bed rest)
  -  Proteinuria of 5000mg (5g) or higher on a 24-hour urine collection or at least 3+ on two random urine samples collected at least 4 hours apart
  -  Oliguria < 500 mL urine output in 24 hours
  -  Cerebral or visual functional disturbances (cns irritability)
  -  Pulmonary edema or cyanosis (not due to excessive intravenous volume replacement)
  -  Epigastric or right-upper quadrant abdominal pain
  -  Impaired liver function on laboratory analysis (elevated aspartate aminotransferase (AST), alanine amino transferase(ALT), or lactate dehydrogenase(LDH))
  -  Thrombocytopenia (platelet count < 150,000/uL)
  -  Fetal growth restriction.

Eligibility: Inclusion criteria:
  -  pregnant women 3rd trimester
  -  any age
  -  medically free at least by history
  -  signs and or symptoms of pre-eclampsia
  Exclusion Criteria:
  -  Other causes elevate CA-125 as: ovarian cancer, endometrial cancer, breast cancer and benign conditions as: endometriosis and liver cirrhosis.
  Chronic hypertension
  -  Diabetes Mellitus (DM)
  -  Liver diseases
  -  Thyroid disorders
  -  Kidney diseases
  -  Cardiac diseases

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Effect of W-3 Polyunsaturated Fatty Acids on Serum Albumin Concentration in Patients With Acute Heart Failure, Hypoalbuminemia, and High Inflammatory Activity

Summary: Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin

Detailed description: Assess whether high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity, promotes an increase in serum albumin
  Assess the effect of high doses of ?-3 fatty acids added to standard treatment of patients with acute hearta failure, hypoalbuminemia and high inflammatory activity on:
  -  Inflammatory activity (C-reactive protein)
  -  The development of biomarkers (NTproBNP).
  -  The prognosis of patients evaluated by the combined event of death from any cause or readmission for heart failure within three months after randomization.

Eligibility: Inclusion Criteria:
  -  Patients aged 18 years or olders hospitalized for acute heart failure, chronic decompensated or new onset of any etiology, presenting hypoalbuminemia (serum albumin ?3,4 g / dl) and high inflammatory activity (CRP ?2,5 mg / dl).
  Exclusion Criteria:
  -  Impending doom
  -  Participating in other clinical trials
  -  Treatment with ?-3 acids in the last month prior to admission
  -  Percutaneous or surgical treatment of the cause of heart failure during hospitalization.
  -  Pregnant women.
  -  Renal failure on dialysis.
  -  Chronic liver disease Child-Pugh B or C.
  -  Acute infectious process.
  -  Active malignant neoplasia.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: A Study of Two Different Dose Combinations of Nivolumab in Combination With Ipilimumab in Subjects With Previously Untreated, Unresectable or Metastatic Melanoma

Summary: The purpose of this study is to evaluate two different dose combinations of nivolumab and ipilimumab in the treatment of melanoma.


Eligibility: For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com
  Inclusion Criteria:
  -  Subject must have been diagnosed with stage III or/and stage IV histologically confirmed melanoma [per American Joint Committee on Cancer (AJCC) staging system] that is unresectable or metastatic
  -  Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  -  Subject has not been treated by systemic anticancer therapy for unresectable or metastatic melanoma
  Exclusion Criteria:
  -  Subjects with active brain metastases or leptomeningeal metastases
  -  Subjects with ocular melanoma
  -  Subjects with active, known or suspected autoimmune disease
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Deformable Registration of Multi-parametric MRI to Intra-operative Transrectal Ultrasound for Prostate Brachytherapy

Summary: Objective:
  To focus the high dose radiation to the gross tumor in the prostate while maintaining adequate dose for control of microscopic disease elsewhere in the prostate.
  In order to test the incorporation of the robust MRI and TRUS fusion algorithm in the clinical setting the investigators planned a study of Focused therapy with a primary endpoint of accurate localization of the high risk region. This is a pilot study of dose painted permanent I-125 seed implant to verify absence of tumor cells outside a high risk region using multi-parametric MRI and deformable TRUS registration. The high risk region will be dose painted to 160 Gy and the rest of the prostate will receive the normal prescription dose.

Detailed description: Primary end-point:
  Feasibility of dose painting will be determined by the absence of tumor outside the high-risk region on an intra-operative trans-perineal biopsy.
  Frozen sections will not be obtained, however on receipt of the final pathology 2-4 weeks after the procedure 2 possible scenarios arise:
  1. There is no evidence of cancer: this confirms the accuracy of the TRUS MRI registration.
  2. There is evidence of tumor on the stereotactic biopsy: In this case a regular dosimetric check (this is performed in the Standard of care procedure and is known as post-operative dosimetry) will be performed to determine whether adequate dose was delivered. If not, as the involved needle position was recorded in the treatment plan and labeled with co-ordinates, the regular possibility of accurately adding radioactive seeds is possible.

Eligibility: Inclusion Criteria:
  -  Men suitable for monotherapy with permanent Iodine 125 implant
  -  Age > 50 yrs
  -  PS 0-2 (WHO)
  -  Histologic diagnosis of prostate adenocarcinoma made on transrectal guided prostate biopsy with no fewer than 12 cores taken
  -  No more than 50% of cores involved (summary)
  -  MRI of Prostate with Diffusion Weighted Imaging and Dynamic Contrast Enhancement with demonstrable lesion compatible with biopsy result
  -  Gleason sum no greater than 3+4 =7 in any core
  -  Clinical T stage no higher than T T (tumor) 2A
  -  Prostate volume ≤60 cc
  -  Serum prostate-specific antigen (PSA) no higher than 15 ng/mL
  -  No prior history of malignancy except non-melanoma skin cancer
  -  Must be suitable for general or spinal anesthesia
  Exclusion Criteria:
  Have anesthesia surgical assignment category IV or greater
  -  Cannot cease anti-coagulant therapy
  -  Had a malignancy, other than prostate or skin cancer (except malignant melanoma), within 5 years
  -  urethral stricture
  -  Prior prostate cancer therapies

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Yervoy Pregnancy Surveillance Study

Summary: The study is a global safety surveillance study of pregnancy outcomes in women who were exposed to ipilimumab during pregnancy and pediatric outcomes up to 5 years of age


Eligibility: Inclusion Criteria:
  -  Documented exposure to Yervoy while pregnant or within 90 days of discontinuing treatment
  Exclusion Criteria:
  -  Women whose ipilimumab exposure is outside the window of pregnancy exposure
  -  Pregnancies for which there is only paternal exposure to Yervoy
  Other protocol defined inclusion/exclusion criteria could apply

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Phase II Evaluating Endoresection of the Tumor Scar or Transpupillary Thermotherapy When Endoresection is Not Feasible After Proton Beam Therapy for the Treatment of Large Uveal Melanomas (Endoresection-Laser)

Summary: Study the efficacy of endoresection of the tumor scar or, when surgery is not possible, transpupillary thermotherapy on the tumor scar to prevent neovascular glaucoma and secondary enucleation


Eligibility: Inclusion Criteria:
  -  Tumor of 7 mm of thickness or more
  -  Patients treated by proton beam therapy
  -  Patients aged at least 18 years
  -  Patients clearly informed of the study, having received the letter of information and signed the consent
  Exclusion Criteria:
  -  Massive extrascleral extension posterior to the equator
  -  Patients with metastasis at diagnosis.
  -  Patients with glaucoma before the radiation therapy
  -  Patients with opaque media preventing transpupillary thermotherapy
  -  Patients for whom follow up will be difficult due to geographical, social or psychological reasons

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Clinical and Histological Features of Head and Neck Melanoma

Summary: The worldwide incidence of cutaneous melanoma has been increasing for the last 30 years in western populations. Among all melanomas, those located on the head and neck are more frequent than expected regarding the surface of this anatomical area, occur in older subjects than melanomas at other sites and have a worse prognosis than melanomas at other sites. The question whether head and neck melanomas could be a distinct entity has been debated.

Detailed description: Aim of the study was to compare clinical and histological characteristics between head and neck melanomas and melanomas at other sites.

Eligibility: Inclusion Criteria:
  -  patients with melanoma
  -  melanoma diagnosed between January 2004 and December 2011
  -  patients living in Champagne-Ardenne

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Elevated LDH Serum Levels and FDG-PET in Metastatic Melanoma Patients

Summary: A retrospective study investigating the relationship between FDG-PET uptake and LDH levels.

Detailed description: Patient characteristics, tumour characteristics including the BRAF mutation status and baseline serum S100B and LDH levels of each patient will be retrospectively determined from the electronical patient file. In each patient, tumour burden and 18F-FDG uptake of the tumour lesions will be measured using multiple standard quantification parameters of the baseline 18F-FDG-PET scan. Tumour burden will also be measured on the baseline contrast enhanced CT scan. The correlation of each FDG-PET parameter with baseline LDH and S100B levels, respectively, will be analyzed using univariate and multivariate regression analysis.

Eligibility: Inclusion Criteria:
  - All patients >18 years with histologically proven metastatic melanoma (American Joint Committee on Cancer [AJCC] stage IV melanoma) treated in the UMCG between May 2014 and December 2015.
  Exclusion Criteria:
  -  participation in interventional studies
  -  missing baseline 18F-FDG PET scan and/or baseline contrast enhanced CT scan
  -  missing baseline serum LDH level
  -  missing BRAF mutation status, concurrent malignancies or a history of previous malignancies.

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Screening Study for Cervical Pre-cancer and Cancer Prevention in South African Women.

Summary: Nearly 8 000 new cervical cancer cases are diagnosed in South Africa per year; many are still undiagnosed and about 50% of diagnosed cases succumb per year. Although the current prevalence of pre-cancer cervical disease is largely unknown, data from local studies suggest regional differences and an increase in the prevalence of cytological abnormalities when compared with historical data. Low frequency in cytology screening is the primary factor attributable to development of invasive cervical cancer and almost one-third of all cervical cancer patients had previous negative cytology. Due to the low sensitivity of cytology it can be assumed that the true prevalence of pre-cancer disease is underestimated by all available data. One round of optimal cervical cytology will detect around 50% of existing pre-cancer cervical disease as identified and proven using colposcopy and directed biopsy. It is now widely accepted that primary screening with a human papilloma virus (HPV) test can improve the sensitivity of screening and that even a single round of HPV screening can rapidly reduce the incidence of invasive cervical cancer and related mortality within a few years.
  South Africa has a high prevalence of HIV infection and a delay in or failure to initiate antiretroviral therapy (ART). These facts, together with the largely unscreened status of the female population and the high incidence of cervical cancer all suggest that HPV infection and precursors to cervical cancer are both unusually common among South African women. Accurate current knowledge of the performance of newer generation HPV based screening tests in HIV-infected and general female population are essential for cost-analysis and planning for national prevention and screening programs. This study will aim to demonstrate the feasibility and efficacy of new generation HPV deoxyribonucleic acid (DNA) based screening assays in a South African setting.
  The investigators hypothesize that HPV testing followed by normal and special cytology tests will be a successful screening model for a South African population.


Eligibility: Inclusion Criteria:
  -  Informed consent accepted and signed
  -  Health seeking behaviour or request for a cervical cancer screening test
  -  Willing and able to receive test result by automated text message or clinic visit
  Exclusion Criteria:
  -  Current pregnancy
  -  Hysterectomy
  -  Current or previous treatment for gynaecological cancer
  -  Hesitant or unable to undergo screening and treatment if indicated

Relevance to patient case: not relevant
Patient case: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: A Study of the Anti-PD1 Antibody PDR001, in Combination With Dabrafenib and Trametinib in Advanced Melanoma

Summary: To evaluate the safety and efficacy of the combination of an anti-PD-1 antibody (PDR001), a BRAF inhibitor (dabrafenib) and a MEK inhibitor (trametinib) in unresectable or metastatic BRAF V600 mutant melanoma


Eligibility: Inclusion criteria Part 1: Safety run-in
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  Aspartate transaminase (AST) < 2.5× ULN and Alanine transaminase (ALT) < 2.5× ULN
  -  ECOG performance status ≤ 1
  Part 2: Biomarker cohort
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  At least two cutaneous or subcutaneous or nodal lesions for tumor sample collection
  -  ECOG performance status ≤ 2
  Part 3: Double-blind, randomized, placebo-controlled part
  -  Histologically confirmed, unresectable or metastatic melanoma with BRAF V600 mutation
  -  ECOG performance status ≤ 2
  Exclusion Criteria:
  Part 1: Safety run-in
  -  Subjects with uveal or mucosal melanoma
  -  Any history of CNS metastases
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Parts 2 & 3: Biomarker cohort & double-blind, randomized, placebo-controlled part
  -  Subjects with uveal or mucosal melanoma
  -  Clinically active cerebral melanoma metastasis
  -  Prior systemic anti-cancer treatment for unresectable or metastatic melanoma
  -  Prior loco-regional treatment for unresectable or metastatic melanoma in the last 6 month
  -  Prior neoadjuvant and/or adjuvant therapy for melanoma completed less than 6 months
  -  Radiation therapy within 4 weeks prior to start of study treatment
  -  Active, known, suspected or a documented history of autoimmune disease
  Other protocol-defined Inclusion/Exclusion may apply.

Relevance to patient case: not relevant