araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Carbon Ion Radiotherapy for Atypical Meningiomas

Summary: Treatment standard for patients with atypical or anaplastic meningioma is neurosurgical resection. With this approach, local control ranges between 50 and 70%, depending on resection status. A series or smaller studies has shown that postoperative radiotherapy in this patient population can increase progression-free survival, which translates into increased overall survival. However, meningiomas are known to be radioresistant tumors, and radiation doses of 60 Gy or higher have been shown to be necessary for tumor control.
  Carbon ions offer physical and biological characteristics. Due to their inverted dose profile and the high local dose deposition within the Bragg peak precise dose application and sparing of normal tissue is possible. Moreover, in comparison to photons, carbon ions offer an increased relative biological effectiveness (RBE), which can be calculated between 2 and 5 depending on the cell line as well as the endpoint analyzed.
  First data obtained within the Phase I/II trial performed at GSI in Darmstadt on carbon ion radiotherapy for patients with high-risk meningiomas has shown safety, and treatment results are promising.
  Therefore, in the current Phase II-MARCIE-Study a carbon ion boost will be applied to the macroscopic tumor (gross tumor volume, GTV) in conjunction with photon radiotherapy to the clinical target volume (CTV) in patients with atypical meningiomas after incomplete resection or biopsy.
  Primary endpoint is progression-free survival rate, secondary endpoints are overall survival, safety and toxicity.


Eligibility: Inclusion Criteria:
  -  histologically confirmed atypical meningioma
  -  macroscopic tumor after biopsy or subtotal resection
  -  Simpson Grade 4 or 5
  -  prior photon radiotherapy to the clinical target volume (CTV) of 48-52 Gy
  -  beginning of study treatment no later than 12 weeks after surgery
  -  age ≥ 18 years of age
  -  Karnofsky Performance Score ≥ 60
  -  For women with childbearing potential, adequate contraception
  -  Ability of subject to understand character and individual consequences of the clinical trial
  -  Written informed consent (must be available before enrolment in the trial)
  Exclusion Criteria:
  -  refusal of the patients to take part in the study
  -  previous radiotherapy of the brain
  -  optic nerve sheath meningioma (ONSM)
  -  time interval of > 12 weeks after primary diagnosis (neurosurgical intervention) and beginning of study treatment
  -  Patients who have not yet recovered from acute toxicities of prior therapies
  -  Known carcinoma < 5 years ago (excluding Carcinoma in situ of the cervix, basal cell carcinoma, squamous cell carcinoma of the skin) requiring immediate treatment interfering with study therapy
  -  Pregnant or lactating women
  -  Participation in another clinical study or observation period of competing trials, respectively

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: A Clinical Investigation on Early Visible Effects of Application of K101 During 8 Weeks on Discoloured and Deformed Nails Resulting From Onychomycosis

Summary: The purpose of this study is to further evaluate and document early visible effects on nail appearance of topical K101.


Eligibility: Inclusion Criteria:
  -  Male or female patients aged 18 years or older
  -  25%-75% of the target nail altered as a result of onychomycosis
  -  Signed written informed consent
  Exclusion criteria
  -  Proximal subungual onychomycosis
  -  Patient who has been previously randomized to treatment in the phase III study K70-2 investigating K101
  -  Other conditions known to cause abnormal nail appearance
  -  Use of topical (1 month before screening) and/or systemic (3 months before screening) antifungal medication.
  -  Participation in another clinical study with an investigational drug or device during the previous 4 weeks before enrolment.
  -  Known allergy to any of the tested treatment products

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Safety, Tolerability & Potential Anti-cancer Activity of Increasing Doses of AZD5363 in Different Treatment Schedules

Summary: This study is designed to investigate the safety and tolerability of a new drug, AZD5363, in patients with advanced cancer - and to identify a dose and schedule that can be used in the future. This study will also investigate how the body handles AZD5363 (ie, how quickly the body absorbs and removes the drug). This study will also investigate anti-tumour activity of AZD5363 in patients with advanced / metastatic breast, gynaecological cancers or other solid cancers bearing either AKT1 / PIK3CA or PTEN mutation.

Detailed description: A Phase I, Open-Label, Multicentre Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumour Activity of Ascending Doses of AZD5363 under Adaptable Dosing Schedules in Patients with Advanced Solid Malignancies.

Eligibility: Inclusion Criteria:
  -  Aged at least 18 years.
  -  Parts A,B: The presence of a solid, malignant tumour, excluding lymphoma, that is resistance to standard therapies or for which no standard therapies exist.
  -  ER+/HER2+ breast, ovarian, cervical, endometrial cancer, or other solid cancers, resistance to standard therapies with a PIK3CA gene mutation (Part C), AKT1 gene mutation (Part D) or a dysregulatory aberration on the PIK/AKT pathway (Part D), advanced or metastatic ER+ positive breast cancer that has an AKT1 gene mutation (Part E) or advanced or metastatic ER+ positive breast cancer that has a PTEN gene mutation (Part F).
  -  The presence of at least one lesion that can be accurately assessed at baseline by CT, MRI or plain X-ray and is suitable for repeated assessment. Estimated life expectancy of more than 12 weeks.
  -  Estimated life expectancy of more than 12 weeks.
  Exclusion Criteria:
  -  Clinically significant abnormalities of glucose metabolism.
  -  Spinal cord compression or brain metastases unless asymptomatic, treated and stable (not requiring steroids).
  -  Evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses or active infections including hepatitis B, C and HIV.
  -  Evidence of clinically significant cardiac abnormalities, uncontrolled hypotension, left ventricular ejection fraction below the lower limit of normal for the site or experience of significant cardiac interventional procedures.
  -  A bad reaction to AZD5363 or any drugs similar to it in structure or class.

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation

Summary: The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.


Eligibility: Inclusion Criteria:
  -  Symptomatic atrial fibrillation for more than 3 hours and less than 7 days (as dated by symptoms).
  -  Atrial fibrillation documented by ECG at the start of study drug infusion.
  Exclusion Criteria:
  -  Previous exposure to K201
  -  QTcF (Fridericia correction) >440 ms
  -  QRS interval > 140 ms
  -  Paced atrial or paced ventricular rhythm on ECG
  -  History of receiving another intravenous Class I or Class III antiarrhythmic drug within 3 days of randomization
  -  History of amiodarone (oral or IV) in the last 3 months.
  -  Clinical evidence or history of acute coronary syndrome (e.g. myocardial infarction, unstable angina) within 30 days prior to randomization
  -  History of failed electrical cardioversion at any time in the past
  -  History of polymorphic ventricular tachycardia (e.g. torsades des pointes)
  -  History or family history of Long QT Syndrome
  -  History of ventricular tachycardia requiring drug or device therapy
  -  Ejection fraction of 40% or less.

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: An Open Label Study To Investigate the Pharmacokinetics and Pharmacodynamics of Repeat Escalating Doses of the Oral AKT Inhibitor GSK2141795 by 18F FDG PET Analysis in Subjects With Ovarian Cancer

Summary: The purpose of this study is to explore the potential dose response relationship between the pharmacokinetics of GSK2141795 and [18F] FDG PET pharmacodynamic markers of glucose metabolism in tumor tissue. Three to six subjects will be enrolled in each cohort and dosed with repeat escalating doses of GSK2141795. [18F] FDG PET imaging and optional tumor biopsies will be done prior to initiation of dosing and sequentially at select time points during the first five weeks of dosing. The maximal dose of a given schedule evaluated in this study will not exceed the maximal tolerated dose established in the first-time-in-human trial PCS112689 for the same schedule.


Eligibility: Inclusion Criteria:
  1. Capable of giving written informed consent
  2. Females of non-childbearing potential, 18 years or older with ovarian cancer
  3. Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent ovarian cancer
  4. Histologically or cytologically confirmed diagnosis of PET-positive recurrent or persistent uterine or gastro-oesophageal tumors (these tumor types will only be included if there is poor enrollment of patients with ovarian cancer)
  5. Disease at least 2 cm suitable for assessment by imaging
  6. Performance Status score of 0, 1 or 2 according to the Eastern Cooperative Oncology Group scale
  7. Adequate organ systems function
  Exclusion Criteria:
  1. Chemotherapy, radiotherapy, or immunotherapy within 28 days prior to the first dose of GSK2141795
  2. Use of an investigational anti-cancer drug within 28 days or five half-lives, whichever is shorter, prior to the first dose of GSK2141795
  3. Current use of a prohibited medication
  4. Anticoagulants at therapeutic doses are permitted only after consultation with the GSK Medical Monitor
  5. Presence of active gastrointestinal disease or other condition that could affect gastrointestinal absorption
  6. Any major surgery within the last four weeks of screening
  7. Unresolved toxicity greater than or equal to Grade 2 from previous anti-cancer therapy
  8. Previously diagnosed diabetes mellitus
  9. Current use of oral corticosteroids, with the exception of inhaled or topical corticosteroids
  10. Any serious or unstable pre-existing medical, psychiatric, or other condition
  11. Symptomatic or untreated CNS metastases or leptomeningeal involvement
  12. Evidence of severe or uncontrolled systemic diseases
  13. QTc interval ≥ 470 msecs
  14. Other clinically significant ECG abnormalities
  15. History of myocardial infarction, acute coronary syndromes
  16. Class III or IV heart failure
  17. Pregnant or Lactating patients
  18. History of hepatitis B or C or HIV

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Study of RAD001 for Treatment of NF2-related Vestibular Schwannoma

Summary: The purpose of the study is to determine if RAD001 treatment will shrink or slow the growth of the vestibular schwannoma(s) in Neurofibromatosis 2 (NF2) patients. Secondary objectives include determining if RAD001 treatment will improve hearing ability in NF2 patients.
  RAD001 is an oral drug that is approved by Food and Drug Administration (FDA) for other types of tumors, it is not approved by the FDA for treatment of NF2 related tumors.

Detailed description: This protocol is a Phase II, open-label, efficacy and safety study of single-agent RAD001 in patients with NF2. During the study, subjects will receive continuous daily oral treatment with RAD001 for up to 1 year or until tumor progression.
  Primary Objective: To determine whether RAD001 has an effect on the VS growth in patients with NF2 at a rate sufficient to submit the drug for further testing.
  Secondary Objectives: To determine whether RAD001 has an effect on the volume of other intracranial tumors, and to assess the effect of RAD001 on hearing function in patients with NF2 (when applicable).

Eligibility: Inclusion Criteria:
  -  Diagnosis of NF2 by National Institutes of Health (NIH) criteria
  -  Age ≥ 16 years
  -  Progressive VS growth during the previous 12 months.
  -  WHO performance status > or = 2
  -  Adequate bone marrow, liver and renal function.
  -  For women of childbearing potential, no pregnancy or breast-feeding
  -  Willingness and ability to comply with scheduled visits, drug administration plan, laboratory tests, other study procedures, and study restrictions.
  -  Willingness to provide informed consent
  Exclusion Criteria:
  -  Inability to tolerate periodic MRI scans or gadolinium contrast.
  -  Inability to tolerate periodic audiologic testing or to understand a language with established scoring for word recognition testing.
  -  Inability to adequately perform volumetric measurement of at least 1 target lesionNote: Patients with cochlear or auditory brainstem implants may participate if a target lesion can be accurately assessed.
  -  Radiation therapy for the target lesion in the 60 months preceding inclusion in the study.
  -  Patients currently receiving anticancer therapies or who have received anticancer therapies within 4 weeks of the start of study drug.
  -  Immunization with attenuated live vaccines within one week of study entry or during study period.
  -  Presence of a fungal infection requiring systemic antifungal treatment at enrollment
  -  Other malignancies within the past 3 years except for adequately treated carcinoma of the cervix or basal or squamous cell carcinomas of the skin.
  -  Patients who have any severe and/or uncontrolled medical conditions.
  -  Patients with a known hypersensitivity to everolimus or other types of rapamycin or to its excipients.
  -  Patients unwilling to or unable to comply with the protocol

Relevance to patient case: possibly relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Open Label Phase 1 Study in Japan for Patient With Advanced Solid Malignancies

Summary: The purpose of this study is to assess the safety, tolerability, pharmacokinetics and preliminary anti-tumour activity of ascending doses of AZD5363 under adaptable dosing schedules in Japanese patients with advanced solid malignancies.


Eligibility: Inclusion Criteria:
  -  Aged at least 20 years
  -  Histological or cytological confirmation of a solid malignant tumour, excluding lymphoma, that is refractory to standard therapies or for which no standard therapies exist
  -  At least one lesion (measurable and/or non-measurable) that can be accurately assessed according to RECIST
  -  World Health Organisation (WHO) performance status 0-1 with no deterioration over the previous 2 weeks and minimum life expectancy of 12 weeks
  -  Patients should be willing to remain in hospital until the completion of the first cycle including cycle 0, cycle 1, and cycle 2 Day1 (as cycle 1 Day 21)
  Exclusion Criteria:
  -  Clinically significant abnormalities of glucose metabolism as defined by any of the following:
  -  Diagnosis of diabetes mellitus type I or II (irrespective of management)
  -  Baseline fasting glucose value of ≥7 mmol/l (126mg/dL)
  -  Glycosylated haemoglobin (HbA1C) >6.5%
  -  Spinal cord compression or brain metastases unless asymptomatic, treated and stable and not requiring steroids for at least 4 weeks prior to start of study treatment
  -  Inadequate bone marrow reserve or organ function
  -  Any evidence of severe or uncontrolled systemic diseases, including active bleeding diatheses, or active infection
  -  With the exception of alopecia, any unresolved toxicities from prior therapy greater than CTCAE grade 1 at the time of starting study treatment

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Prevention of Photoparoxysmal Abnormalities by Mozart K448

Summary: The purpose of this clinical trial is to examine the effect of non-invasive cortical activation by specific patterned auditory stimulation (Mozart K448- Piano Sonata for Two Hands in D Major), in altering or eliminating photoparoxysmal abnormalities. Recent work has indicated that such evoked activity (i.e. by specific music) can result in significant reductions, or even complete termination of epileptiform activity and/or seizures across a broad range of individuals with epilepsy. A hypothesis is generated that specific music activation would beneficially effect photoparoxysmal based epileptiform abnormalities.

Detailed description: Non-pharmacologic, non-surgical treatments for seizures and epilepsy are of increasing importance, given the potential side effects as well as lack of complete seizure control with such treatments. Based on previous studies demonstrating an anti-convulsant and anti-epileptiform effect achieved in subjects by music exposure, it is proposed that specific musical stimuli may causally result in widely distributed cortical activation in such a fashion as to effectively prevent or terminate epileptiform abnormalities in subjects with photosensitive epilepsy. We will investigate the effect of specific musical stimulation (Mozart K448) to reduce or prevent photoparoxysmal abnormalities in subjects.
  Primary outcome will be evaluated in 3 groups, assessing alteration/cessation of photic-induced abnormalities during:
  1. Treatment: music exposure to Mozart K448, vs.
  2. Placebo: music exposure to Beethoven's Für Elise for piano, vs.
  3. Control: no music exposure.

Eligibility: Inclusion Criteria:
  -  Age 5-17 years, inclusive
  -  Female or male with photoparoxysmal epilepsy clinical history, and at least one seizure, as defined by the International League Against Epilepsy (International Classification of Epilepsies and Epileptic Syndromes; Commission on Classification and Terminology of the International League Against Epilepsy 1989)
  -  Abnormal EEG consistent with features of photoparoxysmal epilepsy: occipital based epileptiform abnormalities with otherwise normal background interictal EEG;
  -  On < or equal to 2 anti-seizure medications [range 0-2 AEDs]
  Exclusion Criteria:
  -  History of a generalized convulsion provoked by photic stimulation;
  -  Inability to complete and/or comply with study protocol

Relevance to patient case: not relevant
Patient case: 45-year-old female with Meningioma. Genetic variant: NF2 (K322), AKT1(E17K). Other conditions: None.

Clinical trial: Tissue Procurement for Gastric Cancer, Gastrointestinal Stromal Tumors (GIST), Esophageal Cancer, Pancreas Cancer, Hepatocellular Cancer, Biliary Cancer, Neuroendocrine, Peritoneal Mesothelioma, Anal Cancer and Colorectal Cancer in Patients Undergoing Surgery or Biopsy

Summary: The purpose of this study is to collect and store normal and malignant tissue from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, an estimated 50 to 100 of each tumor type. To collect and store blood samples from patients with gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer. To create a database for the collected tissue and allow access to relevant clinical information for current and future protocols. To create tissue microarrays for each gastrointestinal cancer subtype, namely, gastric cancer, GIST, esophageal cancer, pancreas cancer, hepatocellular cancer, biliary cancer, neuroendocrine, peritoneal mesothelioma, anal cancer and colorectal cancer, to facilitate future molecular studies. To grant access to Dr Kindler, Dr. Salgia, and Dr. Catenacci to this database (as it is being acquired) of the coupled patient tissue samples (normal and malignant) and relevant clinical information for the investigation of tyrosine kinases, such as Met and Ron, receptor tyrosine kinase family members, STATs, paxillin, focal adhesion proteins, cell motility/migration proteins, tyrosine/serine/threonine kinase family members, related molecules, and downstream targets implicated in the pathogenesis of GI cancers. Examples of molecular testing include evaluation of DNA mutation, alternative splice variants, protein expression and phosphorylation, and immunohistochemistry on samples. These studies will be correlated with clinical information as stated above.


Eligibility: Inclusion Criteria:
  -  any patient diagnosed with Gastric (stomach) Cancer, Esophageal (foodpipe) Cancer, Pancreas Cancer, Liver Cancer, Biliary (gallbladder) Cancer, Gastrointestinal Stromal Tumor, Peritoneal Mesothelioma (cancer in the lining of the abdomen), Neuroendocrine (of or relating to the cells that release a hormone into the blood in response to a neural stimulus) Tumor, Anal Cancer or Colorectal Cancer cancer that requires you to undergo a surgical or diagnostic procedure.

Relevance to patient case: not relevant