araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Novel Detection System for Lung Cancer Curative Effect Monitoring

Summary: The purpose of this study is to investigate the sensitivity，specificity and concordance rate of EGFR testing results in plasma in comparison of results in matched tumor tissues tested by amplification refractory mutation system(ARMS). Moreover, the investigators correlate our findings in plasma with survival of advanced patients.

Detailed description: Non-small cell lung cancer (NSCLC), accounting for 80% of all lung cancers, is a leading cause of cancer deaths worldwide. Inhibition of epidermal growth factor receptor (EGFR) kinase activity by EGFR tyrosine kinase inhibitors, such as gefitinib and erlotinib, can result in improved response and prolonged progression-free survival (PFS) in selected non-small cell lung cancer (NSCLC) patients harboring sensitizing EGFR mutations, especially the exon 19del and exon 21（L858R） mutations. Unfortunately, about 50%-60% patients who accept EGFR tyrosine kinase inhibitors with sensitizing mutations will receive resistance mutations, the T790M resistance is a target of active pharmaceutical development. So EGFR mutation testing is a step in identifying the right patients for EGFR tyrosine kinase inhibitors treatment. Now tissue samples and tumor cytologic samples are accepted as appropriate sample types for EGFR mutation detection, but these samples are not always available on or after diagnosis, and, even when available, they may be of insufficient quality or quantity for mutation testing. Noninvasive techniques for tumor genotyping may be needed to fully realize, such as plasma sample. Cell-free DNA (cf-DNA) in plasma is a kind of fresh and realtime sample, and has been shown to be promising for the detection of sensitizing EGFR mutations even the resistance mutation（T790M). However, a challenge was also raised about how to detect the low abundance of mutant alleles in plasma. In our study Droplet Digital polymerase chain reaction and Realtime polymerase chain reaction will be used to assess the EGFR mutation in plasma DNA samples from patients with advanced NSCLC before and after EGFR tyrosine kinase inhibitors therapy.

Eligibility: Inclusion Criteria:
  1. Aged 18-85 years old;
  2. The diagnosis of lung cancer by pathological examination;
  3. At least one specific measurable lung cancer lesions (according to RECIST criteria, application of spiral CT, the lesion diameter 10 mm or higher);
  4. People understand and are willing to accept the study, and sign the informed consent
  Exclusion Criteria:
  1. With severe hemorrhagic disease;
  2. Compliance is poor, can't cooperate with the visitor.

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Study Evaluating Intepirdine (RVT-101) in Subjects With Dementia With Lewy Bodies: The HEADWAY-DLB Study

Summary: This study seeks to evaluate the efficacy and safety of intepirdine (RVT-101) in patients with dementia with Lewy bodies.

Detailed description: The efficacy and safety of RVT-101 at doses of 70 mg and 35 mg daily will be evaluated over a 24-week double-blind treatment period in patients with dementia with Lewy bodies.
  The randomization ratio will be 1:1:1 (70 mg RVT-101: 35 mg RVT-101: placebo).
  Subjects completing this study will be eligible to enroll in an extension study of RVT-101 (Study RVT-101-2002).

Eligibility: Inclusion Criteria:
  -  Male or female subject with probable DLB
  -  Mini Mental State Examination (MMSE) score of 14-26 inclusive at Screening and Baseline
  -  Patient has the ability to comply with procedures for cognitive and other testing in the opinion of the investigator
  -  Patient has a reliable caregiver who is willing to report on the subject's status throughout the study
  -  Patients currently receiving therapy for DLB are eligible for enrollment
  Exclusion Criteria:
  -  Atypical clinical features or clinical course that would lead the investigator to conclude primary symptoms are more likely explained by an alternate dementia diagnosis.
  -  Any clinically relevant concomitant disease that, in the opinion of the investigator, makes the patient unsuitable for inclusion in the study.

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Phase 1 Study of DS-6051b in Japanese Subjects With Advanced Solid Malignant Tumors

Summary: This is a Phase 1 study to evaluate the safety, tolerability, and pharmacokinetics of DS-6051b in Japanese subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene.

Detailed description: This study is single arm study with DS-6051b in approximately 9 subjects with advanced solid malignant tumors harboring either a ROS1 or NTRK fusion gene. Safety and tolerability, pharmacokinetics (PK), MTD/RP2D (maximum tolerated dose/recommended phase 2 dose) and preliminary efficacy of DS-6051b will be evaluated.

Eligibility: Inclusion Criteria:
  -  Advanced solid malignant tumors that are refractory to standard therapy or for which no standard therapy is available.
  -  An Eastern Cooperative Oncology Group (ECOG) performance status (PS) 0-1.
  Exclusion Criteria:
  -  Previously had or currently has any of the following diseases:
  Cardiac failure (NYHA Functional Classification ≥ Class III), myocardial infarction, cerebral infarction, unstable angina, arrhythmia requiring treatment, coronary/peripheral artery disease, pulmonary thrombosis, uncontrolled deep vein thrombosis, clinically severe thromboembolic event, or autoimmune disease requiring treatment.
  -  Previously had or currently has clinically severe pulmonary disease (eg, interstitial pneumonia, pneumonitis, pulmonary fibrosis, radiation pneumonia).
  -  Severe or uncontrolled concomitant disease.
  -  Clinically active brain metastases or central nervous system tumor requiring steroid or anticonvulsant treatment.

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Prevalence of Sleep Disordered Breathing in a Lung Cancer Screening Cohort

Summary: Prospective study of sleep disordered breathing in a lung cancer screening cohort.

Detailed description: The proposed study is a prospective single arm study evaluating the prevalence of sleep disordered breathing in a cohort of lung cancer screening patients.

Eligibility: Inclusion Criteria:
  -  Age 55-75.
  -  > 30 pack years tobacco exposure.
  -  Enrolled in lung cancer screening program.
  Exclusion Criteria:
  -  Inability or unwillingness to undergo a home sleep study.

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Hypofractionated vs. Conventionally Fractionated Concurrent CRT for LD-SCLC

Summary: The purpose of this study is to determine whether hypofractionated concurrent chemo-radiotherapy has the same efficiency as conventionally fractionated concurrent chemo-radiotherapy in Limited Disease Small Cell Lung Cancer.

Detailed description: For patients with Limited Disease Small Cell Lung Cancer, 45Gy/15F of radiotherapy with concurrent chemotherapy will be used in experimental arm. While 60Gy/30F of radiotherapy with concurrent chemotherapy will be used in the control arm. Both survival and toxicity of the two arms will be observed and compared.

Eligibility: Inclusion Criteria:
  -  18~70 years old, ECOG 0-2
  -  patients with histologically or cytologically proved small cell lung cancer
  -  Limited disease (LD), was characterized by tumors confined to one hemithorax. It may include ipsilateral hilar, both mediastinum and both supraclavicular nodes. Metastatic lymph nodes were defined as lymph nodes with short diameter of more than 1cm or FDG uptake in PET. The thickness of pleural effusion was less than 1cm unless malignant pleural effusion was cytologically proved. In a word, stage I-IIIB excluding the patients with lung metastases should be defined as LD according to AJCC cancer staging 7th edition.
  -  No progression after 2 cycles of chemotherapy with EP.
  -  No prior history of anti-tumor treatment.
  -  No severe internal diseases and no organ dysfunction
  -  Written informed consent provided and
  Exclusion Criteria:
  -  Malignant tumors of other sites. Non melanoma skin cancer and Cervical carcinoma in situ were not included if curable.
  -  Active heart disease or acute myocardial infarction happen in six months.
  -  Psychiatric history.
  -  Pregnant woman or woman need to breast feed or woman with positive chorionic gonadotrophin (HCG)
  -  Uncontrolled diabetes or hypertension
  -  Interstitial pneumonia or Active pulmonary fibrosis
  -  Acute bacterial or fungal infection
  -  Oral or intravenous use of steroids

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Efficacy and Safety of TRK-700 in Patient With Post-Herpetic Neuralgia

Summary: In Post-Herpetic Neuralgia(PHN) patients:
  -  To conduct an explorative investigation of the efficacy and safety of repeated oral doses of TRK-700 via a randomized double blind comparative study
  -  To measure the plasma concentration of TRK-700 and its metabolites


Eligibility: Inclusion Criteria:
  -  Patients with pain persisting for at least 3 months after the onset of herpes zoster
  -  Patients whose average pain score on the Numerical Rating Scale (NRS) over the past 24 hours at preliminary enrollment is at least 4
  Exclusion Criteria:
  -  Patients with another skin disease that may affect the evaluation of the pain at the site of PHN
  -  Patients with pain other than PHN that may affect the evaluation of pain
  -  Patients with pain that is suspected to be mainly psychogenic
  -  Patients who have received neurolytic or neurosurgical therapy for PHN

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Combination of Cetuximab With Afatinib for Patient With EGFR Mutated Lung Cancer

Summary: Until recently, the first line treatment of metastatic Non Small Cell Lung Cancer (NSCLC) was a platine-based chemotherapy. It has been changed by the discovery of EGFR (Epidermal Growth Factor Receptor) mutations and associated treatment with Tyrosine Kinase Inhibitor (TKI) of EGFR. The superiority of EGFR TKI over chemotherapy for EGFR mutated patients has been proved in several phase III trials with gefitinib, erlotinib or afatinib.
  Nevertheless, all patients will progress after 9 to 12 months of treatment due to the appearance of a treatment resistance.
  Afatinib is an irreversible EGFR TKI. It binds to its receptor permanently.Contrary to erlotinib and gefitinb which inhibits only EGFR, afatinib inhibits the kinase activity of all HER family (Human Epidermal growth factor Receptor). Nevertheless, there is no proof that afatinib delay the appearance of resistance.
  Cetuximab is a monoclonal antibody which binds specifically with EGFR. The double inhibition of EGFR by afatinib and cetuximab has demonstrated its efficacy in pre-clinical models. The hypothesis of this study is that the combination between cetuximab and afatinib will permit to delay or decrease the appearance of resistances.


Eligibility: Principal Inclusion Criteria:
  -  Stage III or IV NSCLC, non irradiable non operable
  -  Non squamous NSCLC histologically or cytologically confirmed
  -  No previous treatment of NSCLC
  -  EGFR mutation (exon 19 deletion, L858R mutation, G719X , L861Q or S768I mutations or exon 19 insertion)
  -  Presence of at least one lesion that can be measured
  -  PS 0 or 1
  Principal Exclusion Criteria:
  -  Symptomatic brain metastasis or requiring immediate radiotherapy
  -  T790M mutation or exon 20 insertion
  -  Radiotherapy less than 2 weeks prior randomization including symptomatic radiotherapy
  -  Interstitial pneumopathy

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: The Efficacy and Safety of Apatinib Combined With Etoposide in Heavily Pretreated Advanced Non-small Cell Lung Cancer

Summary: The development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. Apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (VEGFR-2). Etoposide is an oral preparation for lung cancer which is recommended by NCCN guideline. The investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments. Thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.


Eligibility: Inclusion Criteria:
  -  Obtain of informed consent.
  -  Histologically or cytologically confirmed non-small cell lung cancer.
  -  World Health Organization (WHO) performance status (PS) of 0 to 2.
  -  Measurable lesions as defined by RECIST criteria.
  -  Second-line or more treatments.
  -  Wild type of epidermal-growth-factor receptor (EGFR).
  -  Life expectancy ≥12 weeks.
  -  Organ functions normal, as defined below, within two weeks of randomization:
  • Hb≥90g/L Absolute neutrophils count(ANC)≥1.5×109/L Platelets≥80×109/L Serum bilirubin≤2×ULN; Aspartate transaminase(AST) and alanine transaminase (ALT)≤2.5×ULN(≤5×ULN if liver metastases) Creatinine clearance≥45ml/min or Cr≤1.25×ULN.
  -  Females of child-bearing potential must have negative serum pregnancy test.
  -  Sexually active males and females (of childbearing potential) willing to practice contraception during the study.
  Exclusion Criteria:
  -  Small cell lung cancer.
  -  Newly diagnosed Central Nervous System (CNS) metastases that have not yet been definitively treated with surgery and/or radiation.
  -  Uncontrolled hypertension.
  -  Myocardial ischemia or infarction more than stage II, cardiac insufficiency.
  -  Abnormal coagulation (INR>1.5 or PT>ULN+4, or APTT>1.5 ULN), bleeding tendency or receiving coagulation therapy.
  -  Difficulties in taking pills (inability to swallow tablets,GI tract resection, chronic bacillary diarrhea and intestinal obstruction).
  -  Hemoptysis, more than 2.5ml daily.
  -  Thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis.
  -  Unhealed bone fracture or wound for long time.
  -  Received big surgery, had bone fracture or ulcer in 4 weeks.
  -  Urine protein≥++, or urine protein in 24 hours≥1.0g.
  -  Pregnant or lactating woman.

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Can Epidermal Growth Factor Receptor Improve the Postoperative Survivorship for Inoperable Non-small Cell Lung Cancer With Spinal Metastasis ?

Summary: Not significantly increased survival in T/T


Eligibility: Inclusion Criteria:
  -  NSCLC with spinal metastasis
  Exclusion Criteria:
  -  brain metastasis and expected survival < 3 months

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: A Study to Assess the Efficacy and Safety of AXS-05 in Subjects With Treatment Resistant Major Depressive Disorder

Summary: To evaluate the efficacy and safety of AXS-05 relative to bupropion in subjects with treatment resistant major depressive disorder (MDD).
  This is a randomized, double-blind, active-controlled, 12-week, two-period study consisting of an open-label, bupropion lead-in period, and a double-blind treatment period. The trial is being conducted in subjects with treatment resistant MDD.
  Subjects will be considered to have treatment resistant MDD if they have had a historical inadequate response to 1 or 2 antidepressant treatments and a prospective inadequate response to treatment with bupropion during the open-label, lead-in period.


Eligibility: Key Inclusion Criteria:
  -  Currently meets DSM-V criteria for MDD
  -  History of inadequate response to 1 or 2 adequate antidepressant treatments
  -  Body mass index (BMI) between 18 and 40 kg/m2, inclusive
  -  Agree to use adequate method of contraception for the duration of the study
  -  Additional criteria may apply
  Key Exclusion Criteria:
  -  Suicide risk
  -  Treatment with any investigational drug within 6 months
  -  History of electroconvulsive therapy (ECT), vagus nerve stimulation, transcranial magnetic stimulation, or any experimental central nervous system treatment during the current episode or in the past 6 months
  -  Pregnant, breastfeeding, or planning to become pregnant or breastfeed during the study
  -  Additional criteria may apply

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Liraglutide for HIV-associated Neurocognitive Disorder

Summary: This study will test the effect of liraglutide on cognitive function in HIV-infected overweight or obese subjects with type 2 diabetes.

Detailed description: HIV, insulin resistance and type 2 diabetes mellitus (DM) are independently associated with cognitive impairment. Considering the synergistic effects of HIV and DM on cognition, these subjects are at increased risk of cognitive impairment. glucagon-like peptide 1 (GLP-1) receptors have wide tissue distribution including the central nervous system. The study hypothesis is that GLP-1 could potentially ameliorate the impairments in cognition in this population. This study will assess the impact of liraglutide on neurocognitive performance and peripheral inflammatory markers. It will also evaluate the effects of liraglutide on glycemic control and metabolic risk factors in HIV infected subjects with type 2 diabetes.

Eligibility: Inclusion Criteria:
  -  HIV controlled on therapy for at least 12 weeks
  -  Viral load < 200 copies
  -  BMI >27 to 45
  -  Diagnosis of DM type 2 with A1-C >7 to 12
  -  Participants must be willing to comply with all study related procedures
  Exclusion Criteria:
  -  Personal or family history of pancreatitis
  -  Medullary thyroid carcinoma (MTC) or Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
  -  Gastroparesis
  -  Allergy to liraglutide or any of the active ingredients in liraglutide or other GLP-1 analogue
  -  Weight loss drugs other than metformin
  -  Type 1 diabetes mellitus or diabetic ketoacidosis
  -  Known major cognitive deficit dementia, history of head trauma with loss of consciousness >30 min, history of stroke, current central nervous system (CNS) disorder such as seizures or opportunistic CNS infection
  -  Renal insufficiency defined as creatinine clearance < 60 mL/min
  -  Active opportunistic infections
  -  Pregnancy or breastfeeding
  -  Unstable cardiovascular disease with hospitalization within 1 year for acute coronary syndrome
  -  Decompensated heart failure
  -  Substance abuse
  -  Active alcohol or opioid substitution therapy
  -  Serious or unstable medical or psychological conditions that would compromise the subject's safety for successful participation

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Gilotrif (Afatinib) in Advanced Non-Small Cell Lung Cancer Patients Pre-treated With Erlotinib or Gefitinib

Summary: The program will provide early access to the investigational drug gilotrif in patients with advanced non-small cell lung cancer who have failed at least 6 months on erlotinib or gefitinib.
  The Compassionate Use Programme will also provide additional safety information on gilotrif use.


Eligibility: Inclusion Criteria:
  1. Patients with pathologically confirmed diagnosis of adenocarcinoma of the lung Stage IV with progressive disease following at least one line of platinum-based cytotoxic chemotherapy
  2. Patients progressing after clinical benefit on erlotinib or gefitinib: clinical benefit is defined as stable disease for at least 6 months, or a complete or partial response, or the presence of an activating mutation of the epidermal growth factor (EGF) receptor family.
  3. No further treatment option is available.
  4. Male and female patients age ≥18 years.
  5. Written informed consent that is consistent with International Conference on Harmonisation-Good Clinical Practice (ICH-GCP) guidelines and local law.
  Exclusion Criteria:
  1. Significant or recent acute gastrointestinal disorders with diarrhoea as a major symptom.
  2. Patients who have any other life-threatening illness or organ system dysfunction, which in the opinion of the investigator, would compromise patient safety.
  3. History of cardiac disease that is clinically significant, as judged by the investigator or uncontrolled cardiac disease (including congestive heart failure, angina, myocardial infarction, arrhythmia, including New York Heart Association (NYHA) functional classification of 3).
  4. Aspartate amino transferase (AST) or alanine amino transferase (ALT) ≥ three times the upper limit of normal (if related to liver metastases ≥ five times the upper limit of normal).
  5. Bilirubin ≥1.5 mg/dl
  6. Serum creatinine ≥ 1.5 times of the upper normal limit or calculated/measured creatine clearance ≤ 45ml/min
  7. Women of child-bearing potential or men who are able to father a child unwilling to use a medically acceptable method of contraception during the treatment.
  8. Pregnancy or breast feeding.
  9. Pre-existing Interstitial Lung Disease (ILD).
  10. Patients suitable to be included into afatinib clinical trials

Relevance to patient case: not relevant
Patient case: 58-year-old female with Lung cancer. Genetic variant: NTRK1. Other conditions: Depression, Hypertension, Diabetes.

Clinical trial: Perfusion CT Imaging in Lung Cancer With SBRT

Summary: The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility: Inclusion Criteria:
  -  Gender: male or female
  -  CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
  -  Patient will sign a consent form prior to study entry
  -  Lung cancer and lung metastases are biopsy proven
  Exclusion Criteria:
  -  Patients who are unable to give valid informed consent
  -  Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.

Relevance to patient case: not relevant