araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: PAK4 and NAMPT in Patients With Solid Malignancies or NHL (PANAMA)

Summary: This study will evaluate the safety, tolerability, and efficacy of oral KPT-9274 for the treatment of patients with advanced solid malignancies or non-Hodgkin's lymphoma (NHL).

Detailed description: This is a first-in-human, multi-center, open-label clinical study with separate Dose Escalation and Expansion Phases to assess preliminary safety, tolerability, and efficacy of KPT-9274, a dual inhibitor of PAK4 and NAMPT, in patients with advanced solid malignancies (including sarcoma, colon, lung, etc.) or NHL for which all standard therapeutic options considered useful by the investigator have been exhausted.

Eligibility: Inclusion Criteria:
  -  Advanced solid malignancies or NHL for which all standard therapeutic options considered useful have been exhausted.
  -  Must have objective evidence of progressive disease on study entry.
  -  Advanced solid malignancies: Measureable disease as defined by RECIST 1.1.
  -  NHL: Measureable disease including target lesion(s) as defined by the Lugano Classification for initial evaluation and staging.
  -  Must have a site of disease amenable to biopsy and be a candidate for biopsy.
  -  Eastern Cooperative Oncology Group (ECOG) performance status of ≤1.
  -  Dose Expansion Phase (KPT-9274 + niacin ER cohort only): Patient tumors NAPRT1 and IDH1 tumor status must be determined at the central laboratory prior to enrollment.
  -  Life expectancy of ≥3 months.
  Exclusion Criteria:
  -  Known central nervous system (CNS) disease or leptomeningeal involvement, regardless of response to prior therapy.
  -  Major surgery within 4 weeks before C1D1.
  -  Active infection with completion of therapeutic antibiotics, antivirals, or antifungals within one week prior to C1D1. Prophylactic antibiotics, antivirals or antifungals are permitted.
  -  Known history of Human Immunodeficiency Virus (HIV); HIV testing is not required as part of this study.
  -  Known, active hepatitis A, B, or C infection; or known to be positive for HCV RNA or HBsAg (HBV surface antigen).
  -  Significant diseased or obstructed gastrointestinal tract or uncontrolled vomiting or diarrhea that could interfere with the absorption of KPT-9274.
  -  Active peptic ulcer disease or other active gastrointestinal bleeds.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Dose-Escalation Study of FT-2102 as a Single Agent and in Combination With Azacitidine in Patients With AML or MDS With an IDH1 Mutation

Summary: This Phase 1/1b study will utilize a multicenter, open-label dose-escalation design to evaluate the safety, PK, and PD of FT-2102 (single agent) and FT-2102 + azacitidine (combination agent) administered via one or more intermittent dosing schedules. Approximately 48 patients will be enrolled in the dose-escalation portion of this study in one or more schedules followed by approximately 14 patients in expansion cohorts


Eligibility: Inclusion Criteria:
  -  Pathologically proven acute myeloid leukemia or high risk or very high risk MDS as defined by the World Health Organization (WHO) criteria or Revised International Prognostic Scoring System (IPSS-R) that is either relapsed or refractory to standard therapy, or for whom standard treatments are contraindicated.
  -  Patients must have documented IDH1-R132 gene-mutated disease as evaluated by the site
  -  Good kidney and liver function
  -  No prior organ allograft
  -  For fertile men and women, agreement to use effective contraceptive methods duration of study participation and 90 days after
  Exclusion Criteria:
  -  Previously treated with any prior IDH1 targeted therapy
  -  History of prior malignancy unless disease free for > 2 years.
  -  Patients with symptomatic central nervous system (CNS) metastases or other tumor location (such as spinal cord compression, other compressive mass, uncontrolled painful lesion, bone fracture, etc.) necessitating an urgent therapeutic intervention, palliative care, surgery or radiation therapy
  -  Treatment with major surgery (requiring general anesthesia) within one month prior to study entry
  -  Patients unable to swallow oral medications, or patients with gastrointestinal conditions (e.g. malabsorption, gastric or small bowel resection, etc.) deemed to jeopardize intestinal absorption
  -  Congestive heart failure (New York Heart Association Class III or IV) or unstable angina pectoris. Previous history of myocardial infarction within 1 year prior to study entry, uncontrolled hypertension or uncontrolled arrhythmias
  -  Pulmonary disease (e.g. COPD, asthma, etc) that is not controlled (moderate to severe symptoms) with current medication
  -  Known HIV positivity
  -  Active, uncontrolled bacterial, viral, or fungal infections, requiring systemic therapy

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Photodynamic Therapy in Locally Advanced Hilar Cholangiocarcinoma

Summary: To determine the safety and efficacy of photodynamic therapy with a novel photosensitizer and a flexible laser probe in locally advanced hilar cholangiocarcinoma.

Detailed description: Photodynamic therapy (PDT) is a way of producing tissue necrosis with light after prior administration of a photosensitizing agent. The most important advantages include the possibility of combining PDT with other target therapies and repeat the process as needed with a favorable outcomes. The combination of diverse therapeutic modalities is one of the new strategies to enhance oncologic treatments for pancreatic cancer. In order to overcome the limitations of each treatment modalities and to prevent the development of resistance, the application of PDT combined with target therapies, without increasing the toxicity for the patient, is being widely investigated.
  PDT has been only extensively studied for the treatment of various superficial skin cancers in the Europe but not available in the United States and Japan due to the overlapping treatment fields. In Korea, the use of first-generation and second-generation photosensitizers are part of the study of Gastroenterology, Dermatology, Otolaryngology, and Gynecology.
  Recently, although the investigators have introduced PDT using novel photosensitizers has not yet been used for the treatment of pancreatic cancers. This study aim to determine the safety and efficacy of photodynamic therapy with a novel photosensitizer in locally advanced hilar cholangiocarcinoma.

Eligibility: Inclusion Criteria:
  1. Locally advanced cholangiocarcinoma confirmed to be unsuitable for surgical resection
  2. Exhibiting disease progression without distant metastasis after conventional chemoradiation therapy at multidisciplinary team discussion in Asan Medical Center
  3. Pathologically proven cholangiocarcinoma
  4. have a negative pregnancy test if appropriate
  5. ECOG(Eastern Cooperative Oncology Group) Score 0-2
  6. patients to give informed consent and age more than >19 years
  Exclusion Criteria:
  1. age less than 18 years
  2. previous history of PDT
  3. uncorrectable coagulopathy
  4. refuse to participate
  5. pregnancy
  6. recent participation in another clinical research trial within 30 days
  7. presence of porphyria or hypersensitivity to photosensitizer
  8. Creatinine clearance < 45ml

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: A Study of LY3039478 in Participants With Advanced or Metastatic Solid Tumors

Summary: The main purpose of this study is to evaluate the safety of the study drug known as LY3039478 in combination with other anticancer agents in participants with advanced or metastatic solid tumors.


Eligibility: Inclusion Criteria:
  -  For all parts: The participant must be, in the judgment of the investigator, an appropriate candidate for experimental therapy after available standard therapies have failed to provide clinical benefit for their advanced or metastatic cancer.
  -  For dose escalation for all combinations: The participant must have histological or cytological evidence of cancer, either a solid tumor or a lymphoma, which is advanced or metastatic.
  -  For Part A dose confirmation: All participants must have histological evidence of advanced or metastatic soft tissue sarcoma or breast cancer. Breast cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part B dose confirmation: All participants must have histological evidence of advanced or metastatic colon cancer or soft tissue sarcoma. Colon cancer participants must have prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part C dose confirmation: All participants must have histological evidence of advanced or metastatic breast cancer and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway.
  -  For Part D dose confirmation: All participants must have histological evidence of cholangiocarcinoma and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >1 line of prior systemic therapy for metastatic or resectable disease (that is, participants may have received adjuvant gemcitabine and then later gemcitabine/cisplatin for recurrent metastatic disease).
  -  For Part E dose confirmation: All participants must have histological evidence of locally advanced or metastatic triple negative breast cancer (TNBC) and prescreened mutations, amplification, or gene/protein expression alterations related to Notch pathway. Participants must not have received >2 lines of systemic treatment for advanced or metastatic TNBC.
  -  Have adequate organ function.
  -  Have a performance status of ≤1 on the Eastern Cooperative Oncology Group (ECOG) scale.
  -  Have discontinued all previous therapies for cancer.
  Exclusion Criteria:
  -  Have current acute leukemia.
  -  Have current or recent (within 3 months of study drug administration) gastrointestinal disease with chronic or intermittent diarrhea, or disorders that increase the risk of diarrhea, such as inflammatory bowel disease.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Identification of Molecular Defects in Idiopathic Cytopenia of Undetermined Significance

Summary: The project's objective is to identify and characterize somatic mutations in cases of idiopathic cytopenia of undetermined significance (ICUS) on the basis of molecular defects found in myelodysplastic syndrome (MDS), in order to validate the hypothesis whereby ICUS may be a precursor of MDS. To this end, high-throughput exon sequencing (using next-generation sequencing (NGS)) will be used to target the genes known to be mutated in MDS. This study is important for two reasons. Firstly, it will help to optimise the clinical monitoring of patients with molecular defects and considered to be at risk of progression. Secondly, it will provide a better understanding of the fundamental molecular mechanisms underlying the progression of ICUS to MDS.


Eligibility: Inclusion Criteria:
  -  Age 18 or over.
  -  Haemoglobin <11 g/dl and/or a polynuclear neutrophil count <1.5.109/L and/or a platelet count <100.109/L
  -  Full clinical biochemistry/haematological profiling: complete blood count, blood smear, reticulocyte count, iron status, folates, B12, TSH, creatinine, liver enzymes, ANAs, rheumatoid factor, anticardiolipin antibodies, Coombs test, EPO assay, serological tests for HIV, HVB and HVC.
  -  Availability of a bone marrow differential cell count and an evaluation of myelopoiesis disorders (number of lineages, percentage of cells affected, etc.) plus Perls staining.
  -  Availability of a cytogenetic analysis.
  -  Voluntary provision of written, informed consent
  -  Life expectancy >6 months
  -  Social security coverage
  Exclusion Criteria:
  -  An obvious cause of anaemia (if isolated): iron deficiency, chronic kidney failure (clearance <60 ml/min), regenerative anaemia (reticulocytes >150G/L)
  -  Vitamin B12 or B9 deficiency
  -  Hepatomegaly, or clinical and/or ultrasound signs of portal hypertension
  -  Clinical and/or ultrasound signs of splenomegaly
  -  Abnormal liver enzyme levels: total bilirubin, alkaline phosphatases or transaminases > 1.5N; gammaGT > 2N. A history of (or diagnostic criteria during screening) auto-immune diseases such as systemic erythematous lupus, antiphospholipid syndrome or Evans syndrome.
  -  An abnormal bone marrow differential cell count
  -  A bone marrow karyotype revealing MDS
  -  Medical, psychological or social conditions that prevent the participant from correctly understanding the study procedures.
  -  Legal guardianship and incarceration.

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: A Dose Finding Study of IDH305 With Standard of Care in IDH1 Mutant Acute Myeloid Leukemia

Summary: The purpose of this study is to evaluate the safety, tolerability and potential efficacy of IDH305 with standard treatments for newly diagnosed IDH1R132 mutant acute myeloid leukemia (AML).


Eligibility: Inclusion Criteria:
  -- Previously untreated AML. Patients with untreated, high or very high risk MDS (according to rIPSS or equivalent) are also permitted in Arm 2.
  -  Documentation of IDH1R132 mutation of tumor
  -  ECOG performance status ≤ 2
  -  Clinically fit for standard of care medication per protocol.
  Exclusion Criteria:
  -  Prior treatment for AML or MDS
  -  Any severe or uncontrolled medical conditions that would prevent the patient's participation in the clinical study due to safety concerns or compliance with clinical study procedures such as the presence of other clinically significant cardiac, respiratory, gastrointestinal, renal, hepatic or neurological disease.
  -  Acute Promyelocytic Leukemia
  -  Women who are pregnant or lactating
  Other protocol-defined Inclusion/Exclusion may apply

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Accelerated Aging in Middle-Aged Men With Sleep-disordered Breathing.

Summary: Obstructive Sleep Apnea Syndrome (OSAS) regardless of any other associated risk factor can lead to accelerated aging. The study of aging-related Obstructive Sleep Apnea (OSA) is difficult because of associated risk factors (diabetes, hypertension, dyslipidemia, obesity), promoting themselves aging. The investigators propose to compare a group of OSAS patients free of any associated pathology, to subjects matched for age, sex, smoking and body mass index (BMI)


Eligibility: Inclusion Criteria
  Patient:
  -  Men aged 20 to 65 years
  -  Having polysomnography in the Functional Explorations department, Sleep Laboratory, Hospital Henri Mondor, Creteil
  -  With an AHI > 5 / h
  Healthy volunteers:
  -  Men aged 20 to 65 years
  -  With an AHI ≤ 5 / h
  Exclusion Criteria
  All subjects:
  -  Known cardiovascular risk: hypertension treated, diabetes treated, dyslipidemia treated,
  -  Known cardiovascular disease associated (heart failure, rhythm disorder ...)
  -  Known respiratory diseases
  -  Known neoplastic pathology, known chronic inflammatory disease
  -  Psychiatric pathology treated
  -  Medication
  -  Not affiliated to the French social health care system
  -  Major protected person
  -  Private person of liberty
  -  People in emergency situation
  -  Patient refusing to participate in the study

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: HOPE Social Media Intervention for HIV Testing and Studying Social Networks

Summary: This study [HOPE: Harnessing Online Peer Education] seeks to determine the efficacy of using online social networks to scale peer community leader models to increase HIV prevention within African-American and Latino men who have sex with men. The peer community leader model, which teaches community popular opinion leaders about how to disseminate behavior changes messages throughout the community, has been proven to increase HIV prevention behaviors. Social networks such as Facebook.com may be a cost-effective platform for scaling these models. Primarily upper middle-class White populations used the Internet in its early years, however, Internet use within African-American and Latino households has recently increased dramatically, especially on online social networks such as Facebook.com. People using the Internet may be at the highest risk for contracting HIV and are using novel Internet approaches to find sex partners, such as through online social networks. This is the first study to examine the effectiveness of the HOPE social media intervention to increase HIV testing among at-risk groups in the United States.


Eligibility: Inclusion Criteria:
  -  18 years of age or older
  -  Male
  -  Sexually active with another man in the last 12 months
  -  Willing and capable of understanding and assenting to an online informed consent form
  -  Has (or willing to create) a social media page.
  Exclusion Criteria:
  -  Does not satisfy inclusion criteria

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Effectiveness of Prophylactic Antibiotics to Prevent Post Endoscopic Retrograde Cholangio Pancreatography Bacteremia in Biliary Obstruction Patient

Summary: Endoscopic retrograde cholangio-pancreatography (ERCP) is advanced endoscopic technique that allows minimally invasive management of biliary and pancreatic disorders. However, the incidence of infectious complication of ERCP is considerable. Transient blood stream infection after ERCP has been reported in a high ratio, up to 27% and post-ERCP infection accounts for about 10% of the major complications associated with mortality.
  Although prophylactic use of antibiotics is generally not recommend in all cases, debates about the prophylactic use of antibiotics continues and prophylactic use of antibiotics is recommend in case of ERCP that incomplete biliary drainage is expected.
  In this study, researchers will use prophylactic antibiotics in patients with biliary obstruction who have high-risk of post-ERCP bacteremia. Antibiotics regimen is selected based on the data of our institution, and administered to patients before ERCP procedure.


Eligibility: Inclusion Criteria:
  -  Patients with biliary obstructive disease (Benign or Malignant)
  -  19 year-old and older than 19 year-old
  Exclusion Criteria:
  -  Younger than 19 year-old
  -  Patients with leukocytosis (WBC ≥ 11,000/mm3)
  -  Body temperature ≥ 38 °C within 72 hours before ERCP
  -  History of antibiotics administration due to cholangitis, cholecystitis or sepsis within 72 hours before ERCP
  -  Pregnancy women
  -  Patients with allergy to beta-lactam

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Italian Registry on the Prevalence of IDH1/IDH2 Mutations in Patients With Acute Myeloid Leukemia

Summary: This is a study where there are no interventions planned. Investigators will only collect data already in the patient's history and analyze it. Particularly, we are interested in molecular data from AML patients.
  This means that patients will follow their regular diagnostic and clinical practice. The analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

Detailed description: The study will be conducted as follows:
  1. Retrospective phase clinical and molecular data of patients analyzed for IDH1/2 mutations will be retrospectively collected in the centers that have already introduced IDH1/2 mutational screening in their practice from cases collected according to standard procedure (Ficoll and lysis in RLT buffer).
  2. Prospective phase: each participating center already performing IDH1/2 mutational status on samples of their AML patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using Ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Eligibility: Inclusion criteria:
  -  Signed written informed consent according to ICH/EU/GCP and national local laws (if applicable);
  -  AML patients;
  -  Age ≥18;
  -  IDH mutation test performed at diagnosis or relapse until January 31st, 2019.
  Exclusion criteria:
  -  AML M3 subtype according to the FAB classification;

Relevance to patient case: not relevant
Patient case: 50-year-old male with cholangiocarcinoma; genetic feature: IDH1

Clinical trial: Study of DS-1001b in Patients With Gene IDH1-Mutated Gliomas

Summary: This is a study to assess the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and anti-tumor activity of DS-1001b in patients with gliomas that harbor IDH1-R132 mutations.


Eligibility: Inclusion Criteria:
  1. Has histologically confirmed glioma with an IDH1-R132 mutation
  2. Has disease that has recurred or progressed following standard treatment including radiotherapy
  3. Has measurable lesion(s) as per RANO criteria
  4. Has Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2
  Exclusion Criteria:
  1. Has significant symptoms of increased intracranial pressure
  2. Has another active neoplasm
  3. Has active infection requiring systemic treatment
  4. Has a history of severe cardiac disease
  5. Has had prior treatment with any inhibitor targeting mutant IDH1
  6. Has had investigational drug treatment within 4 weeks prior to the first dose of study treatment
  7. Is a pregnant or lactating female

Relevance to patient case: not relevant