araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Summary: To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Detailed description: To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.

Eligibility: Inclusion Criteria:
  1. Older than 18 years and younger than 80 years of age.
  2. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
  3. The only treatment for melanoma is surgical treatment.
  4. Complete resection of melanoma.
  5. Single primary invasive cutaneous melanoma
  6. Signed ethical committee approved informed consent
  7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference
  Exclusion criteria
  1. Pregnant/lactating women or planning on becoming pregnant during the study
  2. Known hypersensitivity to vitamin D or its components.
  3. Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
  4. Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
  5. History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
  6. History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
  7. History of small intestine resection.
  8. History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
  9. Chronic alcohol abuse.
  10. Medical or logistic problems likely to preclude completion of the study.
  11. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
  12. Intake of vitamin D supplements within 6 months prior to entry of the study.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Clinical and Histopathologic Characteristics of BAP1 Mutations

Summary: The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.


Eligibility: Inclusion Criteria:
  All consents:
  -  > or = to 18 years of age
  -  Ability to provide informed consent
  Consent 1:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  Consent 2:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Age<50 at diagnosis
  -  No history of asbestos exposure
  -  Personal history of choroidal nevus, uveal melanoma, melanoma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography AND one of the following:
  -  More than one clinical risk factor, which may include: orange pigment, thickness > 1 < 2.5mm
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  AND one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Metastatic uveal melanoma
  -  Histologically proven diagnosis of metastatic uveal melanoma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives
  Consent 3:
  -  Relative of patient with germline BAP1 mutation identified through identified testing
  Exclusion Criteria:

Relevance to patient case: possibly relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Safety and Efficacy of LEE011 and LGX818 in Patients With BRAF Mutant Melanoma.

Summary: To evaluate the safety, tolerability and efficacy of LEE011 and LGX818 when administered orally to patients with BRAF mutant melanoma.

Detailed description: In response to developments in the treatment of melanoma, the sponsor reviewed the data from the ongoing study and decided to halt further enrollment of patients in the Phase Ib part of the study. Consequently, the Phase II part of the study was not performed. Early termination of the study was not due to any safety concerns.

Eligibility: Inclusion Criteria:
  -  Age ≥18 years.
  -  Diagnosis of locally advanced or metastatic melanoma along with written documentation of BRAF V600 mutation.
  -  ECOG performance status of 0 - 2.
  -  Patients enrolled into Phase Ib must have evidence of evaluable and/or measurable disease as determined by RECIST v1.1.
  -  Patients enrolled into Phase II (BRAFi naïve and resistant) must have evidence of measurable disease as determined by RECIST v1.1.
  -  Archival tumor tissue must be obtained for patients enrolled in Phase Ib and Phase II arm 1a/b- BRAFi naïve patients. If an archival tumor tissue is not available, a fresh tumor sample is acceptable.
  -  For patients enrolled in the phase II arm 2, patients must agree to undergo a fresh tumor biopsy unless one was collected prior to study entry but at the time of disease relapse from the most recent BRAFi treatment.
  Exclusion Criteria:
  -  Symptomatic brain metastases.
  -  Symptomatic or untreated leptomeningeal disease.
  -  Patients with inadequate laboratory values during screening.
  -  In the phase II BRAFi naïve arms (1a/b), prior exposure to CDK4/6 inhibitor (e.g., PD 0332991)
  -  Impaired cardiac function or clinically significant cardiac diseases.
  -  Impairment of gastro-intestinal (GI) function or GI disease that may significantly alter the absorption of LEE011 or LGX818.
  -  Patients with concurrent severe and/or uncontrolled concurrent medical conditions.
  -  Previous or concurrent malignancy.
  -  Major surgery < 2 weeks before starting study treatment
  -  Known diagnosis of human immunodeficiency virus (HIV) or hepatitis C.
  Other protocol-defined inclusion/exclusion criteria may apply.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Differential Plasma MicroRNA Profiles in ED and Normal Erectile Function in Older Males

Summary: Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging population and the increase in life expectancy, an increase in the prevalence of ED is expected in the years to come. Currently, the mechanism of ED is not fully understood. MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression post-transcriptionally. It has been included in many in vitro physiology and pathophysiology processes, which also involved in the process of ED. This research was designed to investigate the differential plasma MiRNA profiles in ED and normal erectile function in older males. The results might tell us which MiRNA and how did it involved in the process of ED in aging.


Eligibility: Inclusion Criteria:
  -  older males with erectile dysfunction
  Exclusion Criteria:
  -  have some other general diseases, e.g. hypertension, vascular diseases, depression, chronic kidney disease, diabetes.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Lymph Node Mapping Using Indocyanine Green Solution in Diagnosing Patients With Malignant Melanoma

Summary: This clinical trial studies lymph node mapping using indocyanine green solution in diagnosing patients with malignant melanoma. Diagnostic procedures, such as lymph node mapping using indocyanine green solution, may help find out how far the melanoma has spread and may help in planning cancer treatment.

Detailed description: PRIMARY OBJECTIVES:
  I. To show that indocyanine green (ICG) (indocyanine green solution) is equal to both isosulfan blue (ISB) and technetium Tc 99m sulfur colloid (TSC) and will allow all lymph node mapping to occur in the operating room (OR).
  OUTLINE:
  Patients receive peri-tumoral, intradermal injections of isosulfan blue and indocyanine green solution. During surgery, patients undergo identification of the sentinel lymph node and imaging using a laser with videocamera (SPY Elite camera).

Eligibility: Inclusion Criteria:
  -  Ability to understand and willingness to sign informed consent document
  -  Signed written informed consent
  -  Patients with malignant melanoma (MM) undergoing sentinel lymph node biopsy (SNLB)
  -  Complete blood count (CBC) and metabolic panel within 6 months
  Exclusion Criteria:
  -  History of hepatic or renal failure
  -  Allergy to iodine containing products
  -  Patients who are pregnant or may be pregnant
  -  Patients with psychiatric or addictive disorders that in the opinion of the research team, may not be able to meet study requirements

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction

Summary: Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training with the device "PHENIX Neuromuscular Stimulation Therapy Systems" on the recovery of pelvic floor function for primiparous women.


Eligibility: Inclusion Criteria:
  -  primiparous delivery
  -  term delivery
  -  single childbirth
  -  aged from 18-50yrs
  Exclusion Criteria:
  -  urinary incontinence before pregnancy
  -  fecal incontinence before pregnancy
  -  organ prolapse before pregnancy
  -  history of childbirth or induced labor with pregnancy more than 28 weeks
  -  multiparity
  -  newborn weight less than 2500 grams or more than 4000 grams
  -  precipitate labor
  -  complication of pregnancy
  -  asthma
  -  long-term abdominal pressure(chronic cough>1 month,chronic constipation)
  -  diabetes
  -  sciatica
  -  history of pelvic operation

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Vascular Response to Brachytherapy Using Functional OCT

Summary: The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.

Detailed description: Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Major challenges to providing care to patients with uveal melanoma include the inability to accurately predict long-term vision in an eye treated with radiation, due to a poor understanding of the nature of radiation retinopathy and optic neuropathy. Optical coherence tomography (OCT) is a commonly used ophthalmic imaging modality that provides precise, real-time data in vivo in a non-invasive manner. Our research group has recently developed two novel functional OCT technologies: (1) Doppler OCT to quantitatively measure total retinal flow and (2) OCT angiography technology to map optic nerve head, retinal, and choroidal blood flow with unprecedented accuracy. The investigators believe this technology can be utilized to improve understanding of radiation-induced vascular changes in the optic nerve and retina that cause vision loss in patients treated with radiation, as well as provide a tool to monitor tumor response to treatment.
  In this study, the investigators intend to utilize these novel functional OCT technologies to describe the changes over time in optic nerve head and retinal blood flow after I-125 radiation therapy, and to evaluate the relationship between changes in flow and decreased vision. The investigators will also study the association between changes in flow and the total radiation doses received by the optic nerve head and macula, which varies based upon tumor location and size.

Eligibility: Inclusion Criteria:
  -  Adults age 18 and older with uveal melanomas involving the ciliary body and/or the choroid undergoing I-125 plaque brachytherapy.
  Exclusion Criteria:
  -  Inability to give informed consent.
  -  Inability to maintain stable fixation for OCT imaging
  -  Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
  -  A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  -  Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
  -  Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Peritonitis and Loss of Residual Renal Function, Technique Failure and Mortality in Peritoneal Dialysis Patients

Summary: The primary objective is to analyze peritonitis rate and peritonitis bacteriology as risk factors for loss of residual renal function, technique failure and mortality in chronic kidney disease patients.
  Secondary objectives are: To know the current rate of peritonitis in peritoneal dialysis population and to understand the bacteriological profile of peritonitis.
  To know the rate and risk factors other than peritonitis involved in the loss of residual renal function.
  To analyze the utility of alternative diagnostic tests, such as reagent strips, for early detection of peritonitis when traditional tests are not available.
  To analyze the simultaneous measurement of serum creatinine and cystatin-C as alternative measurements of peritoneal clearance and residual renal function.


Eligibility: Inclusion Criteria:Inclusion criteria include: adult patients with signed informed consent given; there should not be selection for age, gender, primary cause of renal disease.
  Exclusion Criteria:Patients will not be included if they were previously in hemodialysis or received renal transplant. Patients will also be excluded if they are on immunosuppressive therapy, have diagnosis of cancer, or are seropositive for HIV or hepatitis.

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis

Summary: French cohorte about polyposis digestive diseases

Detailed description: Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis

Eligibility: Inclusion Criteria:
  -  APC Gene mutation
  -  MYH Homozygote mutation
  -  COWDEN Disease with PTEN gene mutation
  -  Peutz Jeghers Disease with STK 11 gene mutation
  -  Juvenile polyposis with SMAD 4 gene mutation
  Exclusion Criteria:
  -  heterozygote MYH Gene Mutation

Relevance to patient case: possibly relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Nevus Doctor Clinical Decision Support

Summary: The "Nevus doctor" is a dermatoscopy based computer decision support tool to assist general practitioners (GPs) in the classification of pigmented skin lesions (PSLs). The aim of the program "Nevus doctor" is to help GPs increase their diagnostic accuracy, in particular regarding the selection of suspicious PSLs that need biopsy or referral to specialist health care for further assessment. The aim of this study is to investigate the diagnostic performance of the decision support tool in a primary care setting in Norway. We hypothesize that the diagnostic accuracy of the computer program "Nevus doctor" is better than the performance of the GPs.

Detailed description: In the trial GPs examine patients who attend a primary health care center. A given PSL is first assessed clinically by the GP and afterwards photographed. A clinical photograph as well as a dermatoscopic photograph is taken, the latter using a dermatoscope attached to the lens of the camera. The dermatoscopic image is then processed by the computer program. The performance of "Nevus doctor" is compared with the GPs' assessment. A dermatologist reviews all cases based on the clinical and dermatoscopic photographs and this assessment serves as the reference standard.

Eligibility: Inclusion Criteria:
  -  Pigmented skin lesion
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 68-year-old male with melanoma; genetic feature: PTEN loss of function

Clinical trial: Bevacizumab Combined With Carboplatin Plus Paclitaxel Chemotherapy to Treat Metastatic Mucosal Melanoma

Summary: Mucosal melanoma is rare and associated with extremely poor prognosis.No effective treatment for advanced mucosal melanoma patients.Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

Detailed description: Mucosal melanoma is rare and associated with extremely poor prognosis.It is the second most common subtype in Asians.No effective treatment for advanced mucosal melanoma patients.Malignant melanoma is a highly vascular tumor in which vascular endothelial growth factor(VEGF) is strongly expressed and seems to play an important role in disease progression.A randomized phase II study evaluated the activity of Bevacizumab in combination with carboplatin plus paclitaxel(CPB arm) in patients with previously untreated advanced melanoma.Overall response rates was 25.5%,median overall survival time(OS) was 12.3 months in the CPB arm. Investigators conducted a randomized phase II study in patients with previously untreated metastatic mucosal melanoma to characterize the efficacy and safety of bevacizumab when combined with carboplatin plus paclitaxel.

Eligibility: Inclusion Criteria:
  1. Histologically confirmed mucosal melanoma with metastases and has no received any systemic treatment.
  2. ECOG performance status 0, 1
  3. Estimated life expectancy of 12 weeks or greater
  4. Age 18 years or older, male or female
  5. At least one measurable site (diameter≥1cm) of disease (RECIST 1.1).
  6. Adequate organ function
  7. Without symptoms of brain metastases and stable in neuro-functions.
  8. Willingness and ability to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures
  Exclusion Criteria:
  1. Mutations in C-KIT or BRAF-V600E, asked for other target treatments
  2. Pregnant or lactation women
  3. Acute infections without control.
  4. Heart disease history, cardiac function class≥NYHA II.
  5. HIV positive or chronic HBV/HCV in active stage.
  6. Brain metastases or primary tumor with positive symptoms
  7. Need anti-epileptic treatments
  8. Organ transplantation history
  9. Hemorrhagic tendency or related history
  10. Renal dialysis patients
  11. Diagnosis of any second malignancy within the last 3 years, except for adequately treated.
  12. Current treatment on another clinical trial
  13. The other improper situations which investigator judged.

Relevance to patient case: not relevant