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

Clinical trial: Natural Dendritic Cell Vaccines in Metastatic Melanoma Patients

Summary: Dendritic cells (DCs) are the professional antigen-presenting cells of the immune system. As such they are currently used in clinical vaccination protocols in cancer patients, and both immunological and clinical responses have been observed. Several subsets of dendritic cells have been characterized in the peripheral blood. One such subset is referred to as plasmacytoid dendritic cells (PDC), another as myeloid dendritic cells (myDC). To date PDC and myDC have not been evaluated for their capability to induce anti-tumor immune responses in patients. For this reason the investigators will perform a safety and efficacy study with PDC and myDC in stage IV melanoma patients.


Eligibility: Inclusion Criteria:
  -  Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x upper limit of normal
  -  Histological proof of cutaneous melanoma
  -  Melanoma expressing tyrosinase and/or gp100 (approximately 20% of cells or more determined by immunohistochemistry staining)
  -  HLA Type A2
  -  WBC > 3.0 * 10E9/l, lymphocytes > 0.8 * 10E9/l, platelets > 100 * 10E9/l, serum creatinine < 150 umol/l, serum bilirubin < 25 umol/l, normal liver function
  -  Expected adequacy of follow up
  -  Written informed consent
  Exclusion Criteria:
  -  autoimmune disorders, concomitant use of immunosuppressive drugs
  -  serious concomitant disease, serious active infections, other malignancy in the past 5 years with the exception of curatively treated carcinoma in-situ of the cervix/squamous cell carcinoma of the skin
  -  known allergy to shell fish (vaccine contains KLH)
  -  pregnancy or lactation
  -  clinical signs of CNS metastases, in patients with a clinical suspicion of CNS metastases, a CT scan of the brain should be performed to exclude this
  -  prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed

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

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: 69-year-old female with melanoma; genetic feature: high serum LDH levels

Clinical trial: Co-administration of Low Dose hCG at the Time of GnRH Agonist Trigger or 35 Hours Later for the Prevention of OHSS

Summary: This a prospective randomized double blind study involving patients at high risk of OHSS development with peak serum E2 levels < 4,000 pg/ml comparing the ongoing pregnancy rates in patients who receive adjuvant hCG 1,000 IU at the time of GnRH agonist trigger or adjuvant hCG 1,500 IU 35 hours after GnRH agonist trigger.

Detailed description: Ovarian hyperstimulation syndrome (OHSS) is an iatrogenic complication of controlled ovarian hyperstimulation which may result in significant morbidity and rarely mortality as well as significant financial and psychological distress. GnRH agonist trigger has been shown to be effective in OHSS prevention. However, the adoption of its use has not been widely accepted in view of concerns regarding potential impairment of implantation.
  Intensive luteal phase supplementation with estrogen (E2) and progesterone (P) is important due to the strong evidence of abnormal luteal phase serum E2 and P profiles. However, it has been shown that optimal conception rates is not achieved for high risk patients with peak serum E2 < 4,000 pg/ml despite aggressive steroidal supplementation. It has been proposed that the use of adjuvant low dose hCG at the time of GnRH agonist trigger or 35 hours later will rescue some of the corpora lutea and help improve corpora lutea function and improve pregnancy rates.
  The study will evaluate patients at high risk of OHSS development with peak serum E2 < 4,000 pg/mL to determine whether timing of low dose hCG administration affects ongoing pregnancy rates or risk of OHSS. Markers of corpus luteum function such as serum 17 hydroxy-progesterone and prorenin during the luteal phase and early pregnancy will help elucidate further the effect of adjuvant low dose hCG with GnRH agonist trigger on corpus luteum function.

Eligibility: Inclusion Criteria:
  -  Normal baseline serum follicle stimulating hormone, polycystic ovarian syndrome (PCOS), Polycystic ovarian morphology, Previous high responder or previous OHSS, must have > 14 follicles of over 11 mm in diameter and with peak serum E2 levels < 4,000 pg/mL on the day of trigger of oocyte maturation.
  Exclusion Criteria:
  -  Hypothalamic dysfunction, Patients with < 14 follicles < 11 mm in diameter, peak serum E2 levels >= 4,000 pg/mL.

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

Clinical trial: The Effect of Lanthanum Carbonate on Fibroblast Growth Factor 23

Summary: To compare the effect of lanthanum carbonate with calcium carbonate on serum FGF23 levels in hemodialysis patients.

Detailed description: The investigators enrolled patients on maintenance hemodialysis and randomized them to two groups. One group will receive lanthanum carbonate and another group will receive calcium carbonate. The investigators will compare serum FGF23 levels between two groups after they receive above medication for 6 months.

Eligibility: Inclusion Criteria:
  -  Age > 18 years old
  -  Chronic renal failure on maintenance hemodialysis 3 times a week for at least 3 months Serum calcium:8-10.5 mg/dL
  -  Serum phosphate:3.5-6 mg/dL(before washout period)
  -  Serum phosphate ≧6 mg/dL after washout period
  -  Serum i-PTH: 150-600 pg/mL
  Exclusion Criteria:
  -  Diabetes mellitus
  -  Post parathyroidectomy
  -  Life expectancy< 6 months
  -  Liver disease(hepatitis B,C or liver dysfunction)
  -  Severe gastrointestinal disorders or other severe comorbidity
  -  Poor compliance
  -  Intolerance to lanthanum or calcium carbonate
  -  Active infection
  -  Malnutrition(serum albumin<3 g/dL or clinical assessment)
  -  Kt/V< 1.2 (inadequate dialysis)
  -  Serum phosphate>7.5 mg/dL after washout period

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

Clinical trial: Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

Summary: This study is based on the hypothesis that stimulation of the immune response against the tumor can help destroy residual tumor in melanoma patients with very high risk for disease recurrence and in patients with relatively low tumor burden who already got first line treatment for their disease.
  Ongoing clinical trials in the Hadassah Hospital have shown that vaccination of patients with a cell line of tumor cells from the patient himself, or with a combination of three cell lines that partially match the patient's cell characteristics, could improve the immune response against the tumor, was associated with improved disease-free and overall survival.
  In this study, the investigators will evaluate the efficacy of a modified tumor cell vaccine, in terms of immune response,improved disease-free and overall survival. The vaccine consists of a cell line that has a high expression level of melanoma molecules, and has been genetically modified to induce a strong immune response.


Eligibility: Inclusion Criteria:
  1. Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
  2. Cutaneous malignant melanoma AJCC stage IIb (over 4 mm) or IIc (ulcerated melanoma over 4mm).
  3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post surgical removal of lymph nodes.
  4. Metastatic melanoma AJCC stage IV, completely resected.
  5. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
  6. Melanoma can be of either mutant or wild-type B-RAF.
  7. Karnofsky performance status over 80 (Normal activity with effort).
  8. No active cardio-respiratory disease.
  9. Hematocrit over 25% and WBC over 3000.
  10. Informed consent of the patient.
  Exclusion Criteria:
  1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
  2. Active brain metastases requiring cortico-steroids.
  3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
  4. Active serious infection.
  5. Allergy to penicillin.
  6. Patient's wish to withdraw from the study at any stage.

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

Clinical trial: Efficacy, Safety Study and Benefit of Alkali Therapy in Sickle Cell Disease

Summary: The objective of this study is to assess the effect of alkali administration on bicarbonate and potassium levels in patients with Sickle Cell Disease (SCD) and depressed serum bicarbonate levels. The study is a prospective non-blinded evaluation of tolerability and efficacy of alkali repletion with 4 weeks of observation and two sequential 4 week courses of escalating oral sodium bicarbonate treatment.

Detailed description: Primary Objective:
  To assess the effect of alkali administration on bicarbonate and potassium levels in patients with SCD and depressed serum bicarbonate levels.
  Secondary Objectives:
  To assess the effect of alkali administration on improvement in hemolysis and on sequelae of impaired kidney function, ie, LDH, Hgb, reticulocyte count, red cell half-life, and muscle strength, Vitamin D levels, and markers of bone turnover, respectively.
  To assess the influence of alkali administrations on markers of kidney tubule inflammation.
  To evaluate intraparenchymal iron in patients with SCD and renal dysfunction. Safety and adverse events of alkali patients with sickle cell disease will be monitored. This research will supplement current knowledge about management of the clinically important subset of people with SCD who have renal insufficiency and acid-base perturbation.

Eligibility: Inclusion Criteria:
  -  Sickle cell disease patients with HbSS
  -  eGFR <90 ml/min/1.73m2 (determined by abbreviated 4 variable modification MDRD equation) and/or measured urinary albumin to creatinine ratio >30mg/g.
  -  Age ≥18 years
  Exclusion Criteria:
  -  Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda)
  -  Bicarbonate level >25 mEq/L
  -  Decompensated heart failure
  -  Uncontrolled systolic blood pressure >140 mm/Hg (the cutoff for systolic hypertension in SCD is lower than in non-SCD)
  -  Moderate-to-severe lower extremity edema
  -  Projected progression to ESRD within 6 months
  -  Kidney transplantation
  -  Treatment with immunosuppressives within the last 3 months
  -  Vasoocclusive (VOC) within 1 week of study entry
  -  Active (open) leg ulcer
  -  Change in hydroxyurea dose within the last 3 months, unless a self-limited interruption of a stable dose
  -  Blood transfusion within 8 weeks, unless on chronic transfusions
  -  Pregnancy
  -  Inability to give informed consent

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

Clinical trial: Modified Melanoma Vaccine for High Risk or Low Residual Disease Patients

Summary: This study is designed for patients who had malignant melanoma and, following tumor removal, are now free of disease, or have only very minor residual disease, and are at a very high risk of disease recurrence. These patients will be treated with the A2/4-1BBL melanoma vaccine, a compatible melanoma cell line that has been engineered to express a molecule termed 4-1BBL, which enhances the chances of the cell line to be recognized by the patient's immune system, and to induce its stimulation. The hypothesis that drives the study states that the immune response against the cell line will also be effective against the residual tumor that may still be present in the body.


Eligibility: Inclusion Criteria:
  1. Patients included in this protocol must carry one or more of the following tissue typing alleles: HLA-A2, -A24, -A33, -B35, -B49, -CW04/12(04/08). We estimate that 50% of melanoma patients will be eligible.
  2. Cutaneous malignant melanoma AJCC stage IIb (>4 mm) or IIc (ulcerated melanoma >4mm).
  3. Metastatic melanoma AJCC stage III (nodal involvement, N1-3a,b) post-surgical removal of lymph nodes.
  4. Metastatic melanoma AJCC stage IV, completely resected.
  5. Non-resectable metastatic melanoma of low burden disease and normal LDH who have undergone at least two treatment lines, including chemotherapy (DTIC, temodal, taxanes, platinum compounds), anti-CTLA-4 (ipilimumab) and B-RAF inhibitor if harboring the V600E BRAF mutation in their tumor.
  6. Non cutaneous malignant melanoma of respective stages including uveal and mucosal melanoma.
  7. Melanoma can be of either mutant or wild-type B-RAF.
  8. Karnofsky performance status > 80 (Normal activity with effort).
  9. No active cardio-respiratory disease.
  10. Not pregnant or nursing. Women must take contraceptives during the treatment period.Hematocrit >25% and WBC >3000.
  11. Informed consent of the patient.
  Exclusion Criteria:
  1. Administration of cytotoxic drugs or extensive radiotherapy less than 28 days prior to protocol administration.
  2. Active brain metastases requiring corticosteroids.
  3. Concurrent malignancy (other than skin cancer, carcinoma in situ of cervix and early stage prostate cancer).
  4. Active serious infection.
  5. Allergy to penicillin.
  6. Patient's will to withdraw from the study at any stage.
  7. HIV and chronic hepatitis B and C carrier

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

Clinical trial: LDH as a Biochemical Biomarker to Predict Organ Failure in the Emergency Department Setting

Summary: The purpose of this study is evaluate if K3, a novel biomarker, sampled at arrival to the emergency department can be used to predict the development of organ failure measured as SOFA score. K3 consists of lactate dehydrogenase, albumin and magnesium combined.


Eligibility: Inclusion Criteria:
  -  Age ≥18 years
  -  Admitted to emergency department, Karlstad Central Hospital, Sweden
  Exclusion Criteria:
  -  Not in need of venous blood sample

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

Clinical trial: Translational Study for BRAFV600 Serum and Plasma Determination in Patients With BRAFV600 Metastatic Melanoma

Summary: This is a multi-centric translational study with biological samples collection. The aim of this study is to validate a method to detect BRAFV600 in blood samples.
  Samples: Blood from patients with BRAFV600 metastatic melanoma collected following standard medical practice.
  The treatment is not the aim of the study. Patients can be treated either with specific or no-specific drug.


Eligibility: Inclusion Criteria:
  -  Confirmed diagnosis of melanoma and BRAFV600
  -  Signed Informed Consent Form
  -  Unresectable phase III or phase IV melanoma
  -  The patients should be starting a treatment for melanoma (either first line or subsequent lines)

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

Clinical trial: Efficacy of Propranolol Treatment to Prevent Melanoma Progression

Summary: Melanoma's incidence is increasing worldwide. The efforts made in melanoma screening led to an earlier detection of the primary tumour and a better prognosis, but melanoma remains an aggressive cancer when it comes to its metastatic stage. Three recent retrospective studies compared groups of patients diagnosed with primary melanoma and treated with betablockers for another indication to patients who never received betablockers. In these three studies, the outcome of the disease is significantly better for people under betablocker treatment with a decreased rate of recurrence and a better 5 years survival rate. Here we want to investigate the efficacy and the tolerability of an adjuvant treatment with propranolol for patients suffering from a primary melanoma with a high risk of recurrence.


Eligibility: Inclusion Criteria:
  -  patient over 18 y.o
  -  Breslow index > 1mm or any Breslow index with ulcerated primary lesion
  -  Melanoma stage AJCC Ib, IIa, IIb, IIc, IIIa, IIIb or IIIc
  -  Able to undergo outpatient treatment
  Exclusion Criteria:
  -  No contra indication for betablockers as defined by the compendium
  -  No clinical evidence of coagulopathy
  -  No unstable angina pectoris
  -  No AV-block II or III without pacemaker
  -  No severe congestive heart failure
  -  No untreated phaeochromocytoma
  -  No severe bradycardia
  -  No severe hypotension
  -  No severe impairment of peripheral arterial circulation
  -  No uncontrolled cardiac arrhythmia
  -  No severe asthma or COPD
  -  No uncontrolled diabetes mellitus
  -  No Angioneurotic edema
  -  No severe Aortic valve stenosis
  -  No severe hypertrophic cardiomyopathy
  -  No severe renal dysfunction
  -  No patients on beta blockers by inclusion
  -  No known adverse reaction to betablockers
  -  No pregnant or lactating patients can be included
  -  No melanoma stage AJCC IV by inclusion
  -  No patients requiring a specific oncological treatment

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

Clinical trial: Impact of Excision Margins on Survival and Recurrence Rate in Patients With Thick Melanoma (>2mm)

Summary: Objective: To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.
  Background: Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.
  Methods: The investigators will conduct a retrospective population-based survey in patients with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins in the investigators center. For both groups, the patients' charts reviewed for data including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness, tumor type, presence of ulceration, findings of sentinel nodes, local recurrences, locoregional metastases, disease free survival and overall survival were calculated for both groups.

Detailed description: Background
  Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.
  Objective
  To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.
  Methods
  The investigators will conduct a retrospective population-based survey in patients with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins in the investigators center. For both groups, the patients' charts reviewed for data including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness, tumor type, presence of ulceration, findings of sentinel nodes, local recurrences, locoregional metastases, disease free survival and overall survival were calculated for both groups.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed melanoma
  -  Safety margin 1 cm or 2 cm
  -  Tumor thickness according to Breslow >2mm
  Exclusion Criteria
  -  Safety margin less 1 cm
  -  Unclear safety margins

Relevance to patient case: not relevant