araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Selinexor in Advanced Liposarcoma

Summary: This is a randomized, multicenter, double-blind, placebo-controlled, Phase 2-3 study of patients diagnosed with advanced unresectable dedifferentiated liposarcoma. Approximately 245 total patients will be randomized to study treatment (selinexor or placebo).

Detailed description: In the Phase 2 portion of the study, approximately 50 patients will be randomized to selinexor (60 mg) or placebo at a 1:1 allocation ratio.
  In the Phase 3 portion of the study, approximately 195 patients will be randomized to selinexor (60 mg) or placebo with a 2:1 allocation ratio.
  Patients who progress during the blinded portion of the study will be unblinded and if receiving:
  -  placebo, may cross over to open-label selinexor (60mg twice weekly)
  -  selinexor, will be withdrawn from further treatment and followed for survival
  Study treatment will be given twice weekly on Day 1 and Day 3 during Weeks 1-6 of each six-week (42 day) cycle until disease progression or intolerability.
  Treatment will continue until one or more of the following occurs:
  -  Disease progression, as defined by WHO criteria
  -  Clinical progression, as determined by the treating physician
  -  Unacceptable AEs or failure to tolerate study treatment
  -  Patient withdrawal
  -  Patient discontinuation due to non-compliance

Eligibility: Inclusion Criteria:
  1. Patients ≥12 years of age
  2. Body surface area (BSA) ≥ 1.2 m2
  3. Histologic evidence of DDLS at any time prior to randomization AND current evidence of DDLS requiring treatment
  4. Must have measurable disease by the bidimensional WHO Response Criteria
  5. Radiologic evidence of disease progression within 6 months prior to randomization. If the patient received other intervening therapy after documented disease progression, further disease progression must be documented after the completion of the intervening therapy
  6. Must have had at least one (1) prior line of systemic therapy for liposarcoma (no maximum number)
  7. If patient received any previous systemic therapy, the last dose must have been ≥ 21 days prior to randomization (or ≥ 5 half-lives of that drug - whichever is shorter) with all clinically significant therapy- related toxicities having resolved to less than or equal to Grade 1
  Exclusion Criteria:
  1. Patients with pure WDLS, myxoid/round cell or pleomorphic tumor histologic subtypes.
  2. Known active Hepatitis B (HepB), Hepatitis C (HepC) or human immunodeficiency virus (HIV) infection.
  3. Known central nervous system metastases

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Proton Pump Inhibitor Empirical Treatment in Management of Outpatients With Gastroesophageal Reflux Disease.

Summary: China Survey of Proton Pump Inhibitor Empirical Treatment in Management of Outpatients with Gastroesophageal Reflux Disease

Detailed description: To estimate the overall responder rate after 4 weeks of Proton Pump Inhibitor empirical treatment This will be a multicenter prospective observational study carried out in China. Investigator will collect data in a pre-specified Case Report Form from the outpatient. Informed consents will be needed. Investigator will provide patient diary card to each patient for them to note down the symptom frequency every day. Main data from each outpatient will include demographics, Gerd Q, symptom frequency and Proton Pump Inhibitor empirical treatment. Data from each outpatient will be collected on the screening day, 2 weeks and 4 weeks.

Eligibility: Inclusion Criteria:
  -  Female or male, and any race, Age ≥ 18 years and≤ 65 outpatients.
  -  Gastroenterologists already prescribe PPI standard dose bid as empirical treatment.
  -  GerdQ≥8
  -  The subject will not have endoscopy within 4 weeks after enrolment.
  -  Ability to provide informed consent, adhere to the study visit schedule, and complete all study assessments and complete the patient diary by his/herself.
  Exclusion Criteria:
  -  If participating in any interventional clinical trial.
  -  Patient with alarm symptom of oncology(weight loss, recurrent dysphagia, anemia, hematemesis, melena).
  -  Continuous application of nonsteroidal anti-inflammation drugs or acid suppressive drug within 2 weeks before screening.
  -  The need for H2-receptor antagonists (H2RA) including cimetidine, ranitidine and famotidine or sucralfate, antacids, traditional Chinese medicine and prokinetics during the upcoming 4 weeks (study duration).
  -  Previous gastroesophageal surgery.
  -  Upper gastrointestinal malignancy, achalasia, and esophageal spasm or stricture.
  -  Peptic ulcer
  -  Diabetes
  -  Cerebral vascular disease
  -  Zollinger-Ellison syndrome
  -  Scleroderma
  -  Hiatus hernia women
  -  Pregnant or lactating women
  -  Any other subjects were not suitable to this study in the opinion of the investigator.

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: A Randomized, Double-blind, Placebo-controlled,Trial of IW-3718 for 8 Weeks in Patient With Symptomatic GERD

Summary: The objectives of this study are to evaluate the safety, efficacy, and dose-response relationship of IW-3718 administered orally to patients who have GERD and continue to experience GERD symptoms while receiving once-daily (QD), standard-dose PPIs

Detailed description: This study is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, 8-week study, consisting of 3 distinct periods: a screening period, pretreatment period, and treatment period. The study will enroll patients who have GERD and continue to experience GERD symptoms while receiving QD, standard-dose PPI therapy. Eligible patients will continue to take their PPI and will be randomized to placebo or to one of three doses of study drug.

Eligibility: Inclusion Criteria:
  -  Patient is an ambulatory, community-dwelling male or nonpregnant female and is at least 18 years old at the Screening Visit. Lactating females must agree not to breastfeed.
  -  Patient has a diagnosis of GERD and reports experiencing GERD symptoms (heartburn or regurgitation) on ≥ 4 days per week during the 8 weeks before the Screening Visit while taking standard QD PPI therapy.
  Exclusion Criteria:
  -  Patient may not meet any of the excluded conditions specified in the protocol
  -  Patient has any alarm symptoms including but not limited to GI bleeding, anemia, vomiting, dysphagia, or unexpected weight loss any time during the Screening or Pretreatment Periods
  -  Patient has a history of clinically significant hypersensitivity or allergies to any of the excipients contained in the study medication (active or placebo).

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: KOREA Study (Korea Osimertinib Real World Evidence Study to Assess Safety and Efficacy)

Summary: The objectives of this study are to assess the safety and efficacy of single agent Tagrisso (Osimertinib, hereinafter "the study drug") in a real world setting in adult patients with advanced or metastatic, epidermal growth factor receptor (EGFR) T790M mutation-positive Non-Small Cell Lung Cancer (NSCLC), Who Have Progressed on or after EGFR tyrosine kinase receptor (TKI) therapy.


Eligibility: Inclusion Criteria:
  -  1. Eligible for, or on active study drug treatment according to the approved label; patients with locally advanced or metastatic, EGFR T790M mutation-positive NSCLC, who have progressed on or after EGFR tyrosine kinase receptor (TKI) therapy
  -  2. Provision of signed and dated written informed consent by the patient or legally acceptable representative
  Exclusion Criteria:
  -  1. History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug
  -  2. Pregnancy and/or breast feeding
  -  3. Current participation in any interventional trial

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

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: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Eribulin [Halaven] Use For the Treatment of Advanced Breast Cancer

Summary: The purpose of this study was to evaluate the efficacy and safety of eribulin in standard clinical practice in patients with locally recurrent or metastatic advanced breast cancer.

Detailed description: This was an observational, cross-sectional, retrospective, multicenter study conducted in Spain. During the year after authorization of the drug by the European Medicines Agency (EMA), patients in the compassionate use program (public sites) and patients treated in private sites (no purchase restrictions) who received at least 1 dose of treatment with eribulin per approved label at any of the 17 Spanish sites with the highest numbers of treated cases during that period (minimum 3 patients/site) were enrolled in this observational study. Approximately 112 patients will be enrolled in the study.

Eligibility: Inclusion criteria:
  1. Patients diagnosed with locally recurrent or metastatic advanced breast cancer, previously treated with taxanes and anthracyclines, unless these were not indicated.
  2. Clinical and/or radiological documentation of location and extension of the disease at the time of starting treatment with eribulin. Patients with measurable diseases and those patients who only have non-measurable lesions are eligible.
  3. Medical history documentation including analytical control data (blood count and serum chemistry including hepatic and renal functions) carried out at least one week before starting treatment with eribulin. (Determining the CA15-3 tumor marker is not indispensable).
  4. Eribulin monotherapy (at least 1 dose) between April 2011 and March 2012, both inclusive.
  5. Availability of a medical history allowing monitoring of clinical progression of the patients during and after treatment with eribulin.
  Exclusion criteria:
  1. Diagnosis of any type of cancer in the last 5 years, except for non-melanoma skin cancer, cervical intraepithelial neoplasia or contralateral breast cancer.
  2. Patients having received any other anti-tumor treatment, whether conventional or experimental, during the week prior to starting treatment with eribulin. Treatment with bisphosphonate and corticoids is allowed if they are clinically indicated and started 28 days before treatment with eribulin.
  3. Lack of clinical status documentation after completing treatment with eribulin or, at least, after having been administered 3 initial cycles. This can arise in any of the following cases (they are not excluding):
  1. Patients whose Medical History does not state the reason and date for interruption of treatment with eribulin and their subsequent clinical progression.
  2. Patients still undergoing treatment with eribulin on March 31, 2012, for whom there is no data for at least the first 3 cycles.

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Utilizing a Multi-gene Testing Approach to Identify Hereditary Pancreatic Cancer

Summary: The primary objective of the study will be to estimate the prevalence of germline mutations in patients who present consecutively within 12 weeks of a confirmed diagnosis of pancreatic ductal adenocarcinoma.

Detailed description: The proposed research is a multi-site prospective and observational plan to investigate the prevalence of germline mutations in patients diagnosed with pancreatic cancer. Thirty two genes will be analyzed, all of which have been associated with an increased risk for cancer. The genes are included on CancerNextTM a multi-gene next generation sequencing and array CGH test. The 32 genes include: APC, ATM, BARD1, BRCA1, BRCA2, BRIP1, BMPR1A, CDH1, CDK4, CDKN2A, CHEK2, EPCAM, GREM1, MLH1, MRE11A, MSH2, MSH6, MUTYH, NBN, NF1, PALB2, PMS2, POLD1, POLE, PTEN, RAD50, RAD51C, RAD51D, SMAD4, SMARCA4, STK11, and TP53 .

Eligibility: Inclusion Criteria:
  -  Male and female patients between the ages of 18 and 89 years of age.
  -  Diagnosed within the previous 12 weeks with histologically or cytologically confirmed PDAC Stage I to IV.
  -  Ability of participant to understand and the willingness to sign a written informed consent document.
  -  Participant must agree to sample collection and genetic testing using the 32 gene test, CancerNextTM and allow the test result to be part of their medical record.
  Exclusion Criteria:
  -  Diagnosed with intraductal papillary mucinous neoplasms, mucinous cystic neoplasms, pancreatic neuroendocrine tumors or dysplasia without PDAC.
  -  Diagnosed with PDAC more than 12 weeks before presenting to the clinical site.
  -  Patients meeting the above enrollment criteria who have had CancerNext performed previously.

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: A Multi-center Prospective Observational Biomarker Study on EGFRm+ Non-small Cell Lung Cancer Patients With Leptomeningeal Metastasis

Summary: Leptomeningeal metastasis (LM) is one of the disastrous events when managing advanced Non-small cell lung cancer (NSCLC) due to a grave prognosis. Although intrathecal (IT) chemotherapy and brain and/or spinal axis irradiation show some effects for LM in advanced NSCLC, the prognosis is still poor with median survival less than 12-14 weeks. Epidermal growth factor (EGFR) tyrosine kinase inhibitors (TKIs) showed to be effective for LM in selected NSCLC patients in some retrospective research. Our single-center prospective research indicated that the incidence of EGFR sensitive mutations (EGFRm+) in NSCLC-LM patients was high and EGFR-TKIs showed a survival benefit for LM in EGFRm+ NSCLC patients. A multi-center prospective observational biomarker study will be started in 11 lung cancer center based on our single-center prospective research result. The aims of the study are to find predictive biomarkers for LM in advanced NSCLC, to establish EGFR-TKIs based comprehensive treatment for appropriate EGFRm+ LM cases, and to establish effective clinical assessment criteria for NSCLC-LM EGFR-TKIs treatment.


Eligibility: Inclusion Criteria:
  1. The cytological identification of malignant cells within cerebrospinal fluid (CSF).
  2. Non-small cell lung cancer patients.
  3. Tumor specimens or cytology specimens can be used for the EGFR gene mutation detection.
  4. The entails examining cerebrospinal fluid could be obtained by lumbar puncture.
  5. Expected survival time is greater than 1 month.
  Exclusion Criteria:
  Patients with radiologic evidence of LM not confirmed by positive CSF cytology.

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Sirolimus and Cyclophosphamide in Metastatic or Unresectable Myxoid Liposarcoma and Chondrosarcoma

Summary: Chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. Current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. New treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mTOR) inhibition can prevent tumour growth. mTOR is an kinase that is present in two complexes and thereby activates multiple pathways. Aberrant mTOR signalling is known to be involved in cancer cell survival. Several clinical studies for patients with bone or soft tissue sarcoma treated with mTOR inhibitors have been conducted and they show promising results. From these studies the investigators can conclude that the combination of an mTOR inhibitor with cyclophosphamide shows promising results in chondrosarcoma. With the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the Eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.


Eligibility: Inclusion Criteria:
  -  Pathologically proven conventional chondrosarcoma
  -  Or pathologically proven myxoid liposarcoma with PIK3CA mutation or Phosphatase and tensin homolog (PTEN) loss
  -  Or pathologically proven mesenchymal or dedifferentiated chondrosarcoma
  -  Patient is 18 years and up
  -  Documented radiographic progression of disease according to RECIST 1.1 criteria in last 6 months
  -  Written signed informed consent
  -  Adequate bone marrow function (Hb ≥ 6.0 mmol/L, absolute neutrophil count ≥ 1.5 x 109/L, platelets ≥ 80 x 109/L)
  -  Availability of archival tumor material for central review or be able to perform a 3 core fresh biopsy
  -  Ability to adhere to the study visits and all protocol requirements
  Exclusion Criteria:
  -  Previously treated with an mTOR inhibitor
  -  Known to be allergic to cyclophosphamide
  -  Life expectancy of less than 3 months
  -  No measurable lesions according to RECIST 1.1
  -  Eastern cooperative oncology group (ECOG) Performance status >2
  -  Major surgery less than 4 weeks prior to start of treatment
  -  Known human immunodeficiency virus (HIV) positivity
  -  A decreased renal function with calculated glomerular filtration rate (GFR) < 30ml/min
  -  Systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to a target lesion within 21 days prior to the first dose of study drug
  -  Pregnant or lactating women
  -  Other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Efficacy of the Use of Refrigerant Helmet to Prevent Alopecia in Patients Treated With Eribulin for Breast Cancer

Summary: HALACAP-1406 is a prospective single-centre non-interventional study assessing the refrigerant helmet use as medical device to prevent alopecia induced by eribulin (Halaven®) in the conditions of use specified in its marketing authorization. Eribulin will be used alone for the treatment of the patients having a locally advanced or metastatic breast cancer which have progressed after at least 1 chemotherapy regimen for their advanced stage.

Detailed description: A nurse will meet the patient and present the study, then the patient will be invited to participate. If the patient is interested, an information note will be given and the non-opposition of the patient will be collected.
  Patients will be registered via a registration form and an inclusion number will be attributed at each patient.
  Eribulin will be used within the framework of its marketing authorization, per cycle of 21 days, at day 1 and day 8.
  Modalities of refrigerant helmet use will be set according to the habits of the Oscar Lambret center with the following rules :
  -  Placement of a single-use non-woven hygiene cap on the scalp
  -  T-15 minutes: placement of the refrigerant helmet
  -  T0: begin of eribulin infusion (duration: 2-5 minutes)
  -  T+15 minutes: rinse of the line
  -  T+30 minutes: withdrawal of the helmet
  Efficacy will be evaluated before treatment and at each eribulin cycle.

Eligibility: Inclusion Criteria:
  -  Female patient who has a locally advanced or metastatic breast cancer
  -  Indication of Halaven treatment :
  patient pretreated with anthracyclines or taxanes, patient who has received at least 1 chemotherapy regimen for their advanced or metastatic stage
  -  Patient who has had enough time to have retrieved her hair or whose last chemotherapy regimen didn't induce alopecia.
  -  Aged ≥ 18 years
  -  Non-opposition of the patient must have been collected
  Exclusion Criteria:
  -  Skin metastasis of the scalp
  -  Sensitivity to cold, cold agglutinin disease or cryoglobulinemia
  -  Impossibility to submit at the study procedures due to geographic, social or mental reasons

Relevance to patient case: not relevant