araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Ursodeoxycholic Acid in the Treatment of Duodenal Adenomas in Familial Adenomatous Polyposis (FAP) Patients

Summary: Malignant transformation of adenomas of the duodenum is now the leading cause of death in familial adenomatous polyposis (FAP) patients who had a restorative proctocolectomy. Ursodeoxycholic acid (UDCA) modifies the biliary acid profile and could reduce the severity of duodenal adenomas and prevent such transformation.

Detailed description: We designed a randomized double blinded study to evaluate the efficiency of UDCA in the treatment of duodenal adenomas. One hundred patients are planned to be included. Fifty will receive UDCA and fifty a placebo. Three duodenoscopies are planned: one before inclusion, one at the end of the first year of follow-up and one after two years of follow-up at the end of the protocol. These duodenoscopies are associated to endoscopies of the ileal reservoir performed at the time of restorative proctocolectomy and are recorded numerically. Severity of the duodenal adenomas are evaluated according to the SPIGELMAN score. Patients are seen every 6 months. Before each endoscopy, blood samples are collected for biliary acid profile analysis. Moreover, during endoscopies, duodenal fluid and ileal fluid are collected for biliary acid profile analysis, also.
  At the end of the follow-up of the last patients included (nov 2008), biliary acid profile analysis will be performed and statistical analysis of the results will be performed.

Eligibility: Inclusion Criteria:
  -  Male or female patients between 18 and 65 years of age
  -  Weight less than or equal to 100 kg
  -  Restorative proctocolectomy
  -  Activated protein C (APC) mutation identified or more than 100 polyps on the colectomy specimen
  -  SPIGELMAN score of duodenal adenoma greater than or equal to 1
  -  Efficient contraceptive treatment for pre-menopausal women
  -  Cooperative patient
  -  Signed consent
  -  Social security insurance
  Exclusion Criteria:
  -  SPIGELMAN score of duodenal adenoma equal to 4 with severe dysplasia
  -  Hepatic disease
  -  Intermesenteric desmoid tumour
  -  Any severe disease
  -  Daily use during the last 3 months of:
  -  aspirin;
  -  non-steroid anti-inflammatory drugs;
  -  tamoxifen;
  -  cholestyramine.
  -  Pregnancy
  -  Breast-feeding

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Adoptive Cell Transfer Combined With Peptide Vaccination in Transiently Immunosuppressed Melanoma Patients

Summary: Patients with advanced stage melanoma who underwent vaccination with the Melan-A/MART-1 peptide and who display detectable levels of Melan-A specific CD8+ T cells in peripheral blood are eligible for this trial. After collecting and freezing of these tumor specific T cells via apheresis, patients undergo a single cycle of immunosuppressive chemotherapy. 3 days after, cells are reinfused and peptide vaccination continued. The aim of this immunotherapy protocol is to boost tumor specific T cells during the immune recovery period in order to reinforce the patients' immune response against the tumor.

Detailed description: Patients who have previously been vaccinated with Melan-A/MART-1 peptide are eligible. Whole PBMC's containing Melan-A specific CD8+ lymphocytes are collected via lymphocytapheresis and freezed. Lymphodepleting chemotherapy consists of 2 days of Busulfan 2mg/kg at days -7,-6, followed by Fludarabine 30mg/m2 at days -5,-4,-3. At day 0, whole untreated PBMC's are reinfused to the patient and vaccination with Melan-A analog peptide is restarted and repeated every 4 weeks. Immunomonitoring with detailed FACS analysis using tetramers is performed at day 0,8,15,30, and then monthly. The aim is to boost Melan-A specific CD8 T cells in vivo during homeostatic proliferation after lymphodepletion and antigen driven proliferation due to peptide vaccination.

Eligibility: Inclusion Criteria:
  -  Stage IV melanoma
  -  tumor expressing Melan-A
  -  patient of HLA-A2 subtype
  -  Detectable immune response after peptide vaccination with Melan-A
  -  Disease progression during peptide vaccination
  Exclusion Criteria:
  -  Cerebral metastases
  -  rapidly progressive disease, that necessitates systemic chemotherapy

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Limb Loss Self-Management Program

Summary: The goal of the project is to develop and test the efficacy of a community-based self-management intervention for reducing pain, depression, and improving self-efficacy and function in person with limb loss

Detailed description: Approximately 1.2 million Americans are living with the loss of a limb and the incidence is increasing due to increases in the prevalence of diabetes. Pain, emotional distress, reduced functional abilities are common conditions following limb loss and reduce quality of life. Self-management interventions have been found to be effective in reducing the secondary conditions associated with arthritis and diabetes. Self management uses the principles of cognitive-behavioral therapy including education, self monitoring, problem solving, and skill acquisition.
  The goal of the project is to develop and test the efficacy of a community based self management intervention for reducing pain, depression, and improving self efficacy and function in persons with limb loss using a randomized controlled design.
  50 groups of 8-10 persons will be randomized to either a control group or a treatment group.

Eligibility: Inclusion Criteria:
  -  age 18 or older congenital or acquired limb loss
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Use of 852A in Metastatic Cutaneous Melanoma.

Summary: Pilot study to test the efficacy of 852A administered intravenously up to 3 times per week for 12 weeks in subjects with inoperable metastatic cutaneous melanoma.


Eligibility: Inclusion Criteria:
  -  Advanced melanoma not responding to 1st line chemotherapy
  -  Histological evidence of melanoma
  -  Measurable disease according to RECIST criteria
  -  ECOG performance status less than or equal to 2
  -  Life expectancy 6 months or more
  -  Normal organ and bone marrow function as defined by hematological and serum chemistry limits
  -  Adequate contraception for females of childbearing potential
  Exclusion Criteria:
  -  Stage IV disease which has previously progressed during interferon treatment.
  -  Restriction of some therapies/medications for a certain timeframe prior to enrollment and during the study including: investigational drugs, high dose corticosteroids, immunotherapy, immunosuppressive medications, radiotherapy and drugs known to prolong QT interval and/or induce Torsades De Pointes
  -  History of uncontrolled seizure disorders
  -  Uncontrolled coagulation disorders.
  -  History or evidence of myocardial ischemia, congestive heart failure or arrythmias requiring treatment in the past 6 months
  -  History of uncontrolled intercurrent or chronic illness
  -  Concurrent malignancies.
  -  Brain metastases.
  -  HIV positive.
  -  Prolonged QTc interval
  -  Uncontrolled intercurrent or chronic illnesses.
  -  Pregnant or lactating women

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: A Randomised Single Centre Study to Compare the Long-term Performance of 4 Designs of the DePuy Ultima LX Stem in Primary Total Hip Replacement

Summary: The purpose of this study is to compare the performance of 4 designs of the DePuy Ultima LX hip stem in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to one of the 4 designs of the DePuy Ultima LX hip stem and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments.


Eligibility: Inclusion Criteria:
  Current indications for primary total hip arthroplasty utilising a cemented femoral component. These include pain, deformity and loss of function which are not responsive to medical treatment
  Exclusion Criteria:
  i) Revision Total Hip Arthroplasty ii) Rheumatoid arthritis iii) Age greater than 80 years at time of surgery iv) Age less than 60 years at time of surgery v) Previous hip joint sepsis vi) Obesity vii) Patient likely to remain housebound once rehabilitation is complete

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Effect of Platelet Concentrate in Treatment of Diabetic Ulcers

Summary: Autologous platelet concentrate will enhance the rate of healing of chronic diabetic wounds

Detailed description: The treatment of a diabetic wound with APC and thrombinhas the potential to accelerate the re-epithial process when compared with usual care. The study is a prospective, randomized, blinded, multicenter clinical evaluation.

Eligibility: Inclusion Criteria:chronic diabetic ulcer -
  Exclusion Criteria:steroids, dialysis, vascular disease

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Genetic Characterisation of High-grade Paediatric Osteosarcomas

Summary: At present, the only recognised prognostic factor for primary high-grade osteosarcoma is the histological response to preoperative chemotherapy. Our study was designed to identify new diagnostic markers that could eventually have a prognostic value and therapeutic consequences. 80 patients under 20 years of age with primary osteosarcomas were studied while under treatment by the French Society of Paediatric Oncology OS 94 protocol. Paired normal and biopsy samples were collected. In addition, surgical resection specimens, following preoperative chemotherapy, were obtained in many cases. After genomic DNA extraction, an allelotyping analysis targeting microsatellites was planned. The studied DNA regions contained mainly Rb, p53, APC, p16, c-met, TWIST, c-kit, erbB2 and topoisomerases genes. The techniques used in this molecular analysis comprised mainly allelotyping study, quantitative real-time PCR, gene sequencing , immunohistochemistry. The first results showed the prognostic value of 7q31 region containing c-met and 5q21 containing APC (Br J Cancer, 2003, Entz-Werlé et al.), 7p21 containing TWIST (Int J Cancer, 2005, Entz-Werlé et al.) and 4q21 targeting c-kit gene (J Clin Oncol, 2005, Entz-Werlé et al.).


Eligibility: Inclusion Criteria:
  -  Patients under 20 years of age with primary osteosarcomas
  -  Under treatment by the French Society of Paediatric Oncology OS 94 protocol

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Effect of APC and Epo on the Inflammatory Response During Sepsis

Summary: An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis.

Detailed description: An observational study to determine the effect of APC and Epo in reducing the systemic inflammatory response during severe sepsis. Patients already prescribed either drug will be enrolled. The microcirculation of the sublingual vascular bed will be observed with a microscope to detect the alterations in the inflammatory response.

Eligibility: Inclusion Criteria:
  -  patients in the ICU in severe septic shock undergoing APC and/or Epo treatment
  Exclusion Criteria:
  -  any severe comorbid conditions

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Intratumoural Administration of Coxsackievirus A21 for the Control of Malignant Melanoma

Summary: The purpose of this study is to determine the safety of an injection of coxsackievirus A21 into a melanoma tumour, and also to see if there is a tumour response.

Detailed description: Coxsackievirus A21, a naturally occurring enterovirus, has shown that in vivo it can infect and lyse melanoma. This study is to assess safety of a single intratumoural injection of the virus into an accessible subcutaneous melanoma metastasis.

Eligibility: Inclusion Criteria:
  -  stage IV melanoma (AJCC classification)
  -  minimum of 2 sc metastases
  -  failure or refusal of standard chemotherapy
  -  ECOG score of 0 or 1
  -  other
  Exclusion Criteria:
  -  metastatic CNS disease
  -  ocular or mucosal melanoma
  -  immunodeficiency
  -  splenectomy
  -  other

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Peptide-pulsed vs. RNA-transfected Dendritic Cell Vaccines in Melanoma Patients

Summary: Dendritic cells (DCs)are the most potent antigen-presenting cells of the immune system, as such they are able to direct the immune system specifically against cancer cells. Currently DCs are used in clinical vaccination studies and immunological and clinical responses have been observed. For inducing anti-tumor immunity, the DCs have to be loaded with tumor antigen (i.e. molecular structures that are presented by the tumor, that are recognized by the immune system). Currently most studies use tumor peptides (small protein fragments) for this purpose. This approach has several disadvantages: only patients with a certain HLA-type can be treated and the immune response that is induced by the vaccine is limited to the used peptides. These disadvantages do not exist when the DCs present antigen which is endogenously processed, for example after RNA transfection. For this reason we investigate the immunogenicity of DCs that are pulsed with peptides or transfected with mRNA encoding melanoma associated antigens in stage III and IV melanoma patients.


Eligibility: Inclusion Criteria:
  For both stage III and IV
  -  Histological proof of cutaneous melanoma
  -  Melanoma expressing both gp100 and tyrosinase, each in approximately 20% or more of cells by immunohistochemistry staining,
  -  HLA type A2 and/or A3, with known HLA-DR4 expression,
  -  WBC > 3.0 x 109/l, lymphocytes > 0.8 x 109/l, platelets > 100 x 109/l, serum creatinine < 150 μmol/l, serum bilirubin < 25 μmol/l.
  -  Expected adequacy of follow-up,
  -  Written informed consent.
  For Stage III only
  -  Stage III melanoma according to the 2001 AJCC criteria.
  -  Start of treatment within 2 months of lymph node dissection for melanoma stage III
  For stage IV only
  -Stage IV melanoma according to the 2001 AJCC criteria. Limited tumor burden; LDH < 2x upper limit of normal
  Exclusion Criteria:
  For both stage III and IV
  -  No autoimmune disorders, no concomitant use of immunosuppressive drugs,
  -  no serious concomitant disease, no serious active infections, no 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,
  -  No known allergy to shell fish (contains KLH) are excluded.
  -  No pregnancy or lactation,
  For stage III only:
  -  No signs or symptoms of distant metastases as defined by normal history, physical examination, chest X-ray and serum LDH.
  -  No concomitant or previous systemic treatment for melanoma
  For stage IV only:
  -  No 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.
  -  No prior chemotherapy, immunotherapy, or radiotherapy within three months before planned vaccination is allowed.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Study of CP-675,206 in Refractory Melanoma

Summary: CP-675,206 is a fully human monoclonal antibody (mAb). It binds to the CTLA4 molecule, which is expressed on the surface of activated T lymphocytes. CP-675,206 is thought to stimulate patients' immune systems to attack their tumors. CP-675,206 is not expected to have a direct effect on tumor cells. CP-675,206 been shown to induce durable tumor responses in patients with metastatic melanoma in Phase 1 and Phase 2 clinical studies.


Eligibility: Inclusion Criteria:
  -  Surgically incurable Stage III or IV melanoma
  -  One prior systemic treatment for metastatic melanoma
  -  Measurable disease
  -  Eastern Cooperative Oncology Group (ECOG) PS = 0 or 1
  Exclusion Criteria:
  -  Melanoma of ocular origin
  -  Received prior vaccine
  -  Received prior CTLA4-inhibiting agent
  -  History of, or significant risk for, chronic inflammatory or autoimmune disease
  -  Potential requirement for systemic corticosteroids

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: CP-675,206 Versus Either Dacarbazine Or Temozolomide In Patients Without Prior Therapy

Summary: This is a Phase 3, multi-national, open-label, 2-arm randomized study in patients with surgically incurable metastatic melanoma who have received no prior chemotherapy, or biochemotherapy for the treatment of metastatic disease. The primary objective of this trial is to compare overall survival for patients with advanced melanoma who are randomized to receive CP-675,206 with that of patients who are randomized to receive either dacarbazine or temozolomide (investigator choice)


Eligibility: Inclusion Criteria:
  -  Surgically incurable melanoma, either Stage IV or IIIC with N3 status for regional lymph nodes and in-transit or satellite lesions.
  -  Serum lactic acid dehydrogenase (LDH) <= 2 x ULN
  -  ECOG performance status of 0 or 1
  Exclusion Criteria:
  -  Received any systemic therapy for metastatic melanoma except post-surgical adjuvant treatment with cytokines (eg, alpha-interferon or GM-CSF) or with vaccines after complete resection of melanoma.
  -  History of brain metastases

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Testosterone Replacement in Middle-Aged Hypogonadal Men With Dysthymia: Parallel Group, Double Blind Randomized Trial

Summary: Growing evidence supports the notion that Late-onset Dysthymic disorder in middle aged men may be associated with age-related HPG hypofunctioning. In this study we seek to examine the efficacy of Testosterone replacement for this condition.
  Hypothesis:
  Testosterone replacement will be more effective than placebo, in treating men with late onset Dysthymic Disorder and hypo-gonadism.


Eligibility: Inclusion Criteria:
  1. Male, age 40-80 years.
  2. Diagnosed with hypogonadism (total T level below 350 ng/dl), but not previously treated.
  3. Diagnosis of Dysthymic disorder with onset after age 40.
  4. PSA < 4.0.
  5. Normal digital exam of the prostate in the preceding 1 year.
  6. For subjects currently taking an antidepressant: Current antidepressant treatment last 6 weeks or longer, with decent dose and with no remission (or with partial remission only HAM-D > 12).
  7. Able to give informed consent.
  Exclusion Criteria:
  1. Acute, severe, or unstable prostatitis, symptomatic prostatic hypertrophy, polycythemia, severe acne, breast cancer, prostate cancer, or hypopituitarism.
  2. Currently being treated with testosterone.
  3. Meets lifetime criteria for schizophrenia, schizoaffective disorder, any bipolar disorder (i.e., BP-I, BP-II, or BP NOS); or a major depressive episode in the preceding 5 years.
  4. Current suicidal risk.
  5. Current (past year) substance abuse or dependence.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Efficacy of Chemotherapy Combined With Regional Hypothermia in Advanced Malignant Melanoma Patients With Progressive Soft Tissue Metastases

Summary: The incidence of malignant melanoma continues to rise throughout the world. Approximately 12 in 100,000 Germans are diagnosed with malignant melanoma per year. Malignant melanoma is often very aggressive since it may spread both through the lymphatic system and the bloodstream at an early stage of disease.
  While treatment of localized disease is mostly surgical, in patients with extensive disease, prognosis remains poor; the primary standard therapy of metastastic disease comprises dacarbazine (DTIC) eventually combined with other chemotherapeutic agents e.g., cisplatin or BCNU. The duration of response to systemic chemotherapy is generally short and so far, no standard second-line treatment has been established.
  To study the potential additional therapeutic effects of regional hyperthermia in advanced malignant melanoma patients with progressive chemotherapy refractory soft tissue metastases, in the present trial, we sought to compine local hyperthermia with concomitant systemic second-line chemotherapy.


Eligibility: Inclusion Criteria:
  -  age between 18 and 70
  -  histologically proven malignant melanoma with advanced inoperable soft tissue metastases
  -  progressive disease upon systemic first-line chemotherapy
  -  2 or more bidimensionally measurable soft tisue lesions
  -  WHO performance status (ECOG) of 2 or more
  -  life expectancy of 8 weeks and more
  -  prior informed consent
  Exclusion Criteria:
  -  participation in other therapy studies
  -  pregnancy or breast feeding
  -  concomitant clinically significant infection
  -  cardiac pacemaker or other medical implants, or implants within the hyperthermia treated region (including a safe distance of 5 cm)
  -  lack of physiological heat sensitivity within the hyperthermia treated region (including a safe distance of 5 cm)

Relevance to patient case: not relevant