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: The Effectiveness of the Manual Therapy on Infant Colic (MT-IF)

Summary: The main goal of this study is to get to know if applying manual therapy will reduce the infant colic symptoms for to improve quality of life of babies and parents.

Detailed description: Background:
  Infant colic is one of the most common disorders in the first year of baby´s life. It is estimated to affect between 10 to 40 % of healthy born children in their first year of life. To determine the effectiveness of a protocol manual therapy in the treatment of colic, using the Infant Colic Severity Questionnaire, we analyzed two intervention groups: experimental in which children received the protocol manual therapy and counseling to parents and the Control group, in which parents received advice only.
  Objectives:
  To assess the effectiveness of visceral manual therapy to improve the symptoms on infant colic.

Eligibility: Inclusion Criteria:
  -  Infants with medical diagnostic of colic following Wessel criteria.
  Exclusion Criteria:
  -  Infant's parents without full capacity to answer the survey questions, such as the existence of intellectual disability.
  -  Babies with neurological disorders such epilepsy, meningitis, encephalitis, cerebral palsy, spina bifida, hydrocephalus, encephalopathy, Arnold Chiari malformation, syringomyelia and Huntington's disease.
  -  Babies with digestive disorders, such Crohn's disease, irritable bowel syndrome, peritonitis, intestinal malabsorption, hepatitis, diverticular bowel disease, esophagitis, Intussusception and Ulcerative Colitis.
  -  Babies with congenital diseases such Angelmen syndrome, Down syndrome, cystic fibrosis, haemophilia, Klinefelter syndrome, Neurofibromatosis, Patau syndrome and Tay Sachs syndrome.
  -  Babies with traumatology - orthopedic pathologies such idiopathic scoliosis, spondylolisthesis, Perthes disease, Meyer dysplasia, Marfan syndrome, Morquio syndrome and congenital hip dislocation.
  -  Babies with dermatological diseases such Atopic dermatitis, staphylococcal scalded skin syndrome, psoriasis, urticaria and disorders of skin pigmentation.
  -  Babies who are subjected to drug treatments that are not specific to the treatment of colic.

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: Resiliency Training for Patients With NF2 Via Videoconferencing With Skype

Summary: The aim of this study is to determine, whether the 3RP is feasible, accepted and efficacious and durable when delivered via Skype to patients with neurofibromatosis type 2 (NF2) who are deaf or have severe hearing loss using Communication Access Realtime Translation (CART) and/or American Sign Language (ASL).
  This will be a substudy of the IRB-approved protocol #2013P002605. It is the same study except it is looking at a particular sub-population: patients with NF2 who are hard of hearing.


Eligibility: Inclusion Criteria:
  1. Age 18 or older
  2. Can read and speak English at or above the 6th grade level
  3. Patients with NF2 who are deaf or have severe hearing loss.
  Exclusion Criteria:
  1. Severe active or untreated major mental illness that would interfere with study participation, to be determined at the discretion of the study investigator (e.g. untreated psychosis or suicidality)
  2. Recent (within past 3 months) change in antidepressant medication
  3. Use of formal relaxation training (including past participation in a mind-body program), currently or in the past 6 months.
  4. Unable or unwilling to sign the informed consent documents
  5. Unable or unwilling to complete psychological assessments online via the REDCap system.
  6. Unable or unwilling to participate in an intervention delivered via videoconferencing with Skype.
  7. Unwilling to use either CART or ASL for communication during the Skype groups.

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: Prognostic Factors Affecting Outcomes in Multivisceral en Bloc Resection for Colorectal Cancer

Summary: Determine clinical and pathological factors associated with perioperative morbidity and mortality, and oncological outcomes after multivisceral en bloc resection in patients with colorectal cancer.

Detailed description: Between January/2009 and February/2014, 105 patients with primary colorectal cancer selected for multivisceral resection were selected from a prospective database. Clinical and pathological factors, perioperative morbidity and mortality and outcome were verified from medical records. Estimated local recurrence, and overall survival were compared using the log rank method, and Cox regression analysis was used to determine the independence of the studied parameters.

Eligibility: Inclusion Criteria:
  -  T4 Colorectal cancer -
  Exclusion Criteria:
  -  Non primary Colorectal cancer -

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: Cavernous Sinus Dissection and Bleeding in Meningiomas

Summary: The blood loss will be compared in middle fossa meningiomas which will receive pealing of the outer layer of the lateral wall of the cavernous sinus and those which will not revive pealing before the dura is opened

Detailed description: Cases with middle fossa meningiomas will be randomised to one of two surgical techniques. The first technique will involve pealing of the outer layer of the lateral wall of the cavernous sinus before the dura is opened and the tumour attacked, and the second group of cases will be operated by a standard technique, where the tumour will be directly attacked with out pealing of the outer layer of the lateral wall of the cavernous sinus. Blood loss will be monitored in each case by calculating the amount of blood in the suction container and subtracting it from the amount of fluids used for irrigation during surgery. The number of cotton patties and dressings will be also counted with each case as well as the number of gauzes used. The pre-operative complete blood picture will be documented particularly the haemoglobin , hematocrits and others. The same lab data will be also monitored after surgery. The amount of blood transfusion required will also be calculated in each case.

Eligibility: Inclusion Criteria:
  -  Meningiomas of the middle cranial fossa
  Exclusion Criteria:
  -  Meningiomas outside the middle cranial fossa

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: Immunotherapy of CD8+NKG2D+ AKT Cell With Chemotherapy to Pancreatic Cancer

Summary: A Prospective Study on the Efficacy and Safety of CD8+NKG2D+ AKT cell immunotherapy to the pancreatic cancer patients treated with adjuvant chemotherapy.


Eligibility: Inclusion Criteria:
  -  1. Diagnosed as stage II-III pancreatic ductal adenocarcinoma patients by pathologic histology;
  -  2. Pancreatic cancer after radical resection;
  -  3. Eastern Cooperative Oncology Group Performance Status less than 2;
  -  4. Without radiotherapy or neoadjuvant chemotherapy;
  -  5. The man or the gestation and lactation women Age between 18 to 80 years old;
  -  6. Bone marrow functioned well: ANC more than 1.5*10^9/ L, PLT more than 100*10^9/LHgb more than 9 g/dL;
  -  7. Blood biochemical indicators: AST（SGOT）less than 1.5 ULNALT（SGPT）less than 1.5 ULN, TBIL less than 1.5 ULN;
  -  8. PT and PPT are in normal ranges;
  -  9. Three months prior to clinical research did not receive any other clinical research trials;
  -  10. patients are voluntary, and willing to sign informed consent.
  Exclusion Criteria:
  -  1. Patients with other malignant tumors in the past five years;
  -  2. Active viral or bacterial infection and cannot be controlled with appropriate anti-infection treatment;
  -  3. Known as HIV infection, active hepatitis B virus or hepatitis C virus infection;
  -  4. Known allergy to any kind of component of study drugs;
  -  5. History of connective tissue disease(Such as lupus, scleroderma, nodular arteritis);
  -  6. Patients with a history of interstitial pneumoniaSlowly progressive difficulty in breathing and hoose Sarcoidosissilicosis Fibrose pulmonaire idiopathiquehylactic pneumonia or A variety of allergy;
  -  7. Suffering from mental illness or other illness, such as heart or lung disease, diabetes, etc. that can not be controlled, and can not cope with study treatment and monitoring requirements;
  -  8. At the same time Patients participate in any other use of interventional medicine clinical research or checkers.

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: Proton/Photon Rt - Benign Meningiomas(P92-13)

Summary: The purpose of this study is to determine the best radiation dose for participants with meningioma that has grown back after previous surgery, or which the surgeon has been unable to remove completely. This research study is designed to determine whether a higher dose of radiation will decrease the likelihood that the tumor will grow back, compared to the probability of re-growth that occurs after standard radiation doses.

Detailed description: -  After initial interview and physical examination, an immobilization device (head mask, neck support, back support, etc.) will be made for the participant. A treatment planning CT will be performed and a radiation treatment plan will be based on this CT scan.
  -  The radiation dose will usually be given once a day, five days per week. The radiation treatment will take between 7 and 8 1/2 weeks, including treatment planning.
  -  Treatment doses will vary, and the dose each participant will receive will be made on the basis of random assignment. Participants will either receive the usual dose of 55.8 CGE in 31 treatments or 1.8 CGE, or 63 CGE in 35 treatments of 1.8 CGE.

Eligibility: Inclusion Criteria:
  -  Age 18 or over
  -  Histological documentation of benign meningioma
  -  Documentation by imaging studies (CT and/ or MRI) or residual or recurrent intracranial tumor
  -  Karnofsky performance status of ≥ 70
  -  Study specific informed consent
  Exclusion Criteria:
  -  Malignant meningiomas
  -  Prior cranial irradiation, except treatment of localized skin cancer of the face or scalp
  -  Patients having a concurrent primary cancer (except skin)
  -  Patients having another cancer controlled < 3 years
  -  Pregnant patients

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: Multisession Radiosurgery in Large Meningiomas

Summary: This is a prospective observational trial consisting of robotic multisession radiosurgery (CyberKnife ®) for large and medium size and/or located at critical site benign intracranial meningiomas.

Detailed description: To date, the treatment of choice for intracranial meningiomas is surgical removal.
  Radiotherapy, especially the radiosurgery (SRS), in exclusive, adjuvant or salvage setting represents an alternative or complementary viable treatment to the neurosurgery. Despite being a well-established treatment for intracranial meningiomas, SRS might be associated with significant morbidity when large volumes or critical sites are treated. Hypofractionated stereotactic radiotherapy has the potential to deliver sharply focused high doses per fraction without increasing the risk of toxicity.
  The aims of our study are toxicity and symptom control evaluation of radiosurgery treatment delivered in multisession, for large or medium size intracranial meningiomas and/or for intracranial meningioma located at the critical sites (perichiasmatic area, perioptic area, PCA). We will evaluate also the efficacy of the treatment by volumetric analysis of treated meningiomas carrying out a volumetric comparison between pre- and post-radiosurgery treatment (every 6 month after treatment).
  The neurological and clinical assessment before and after s-SRS will be based on CTCAE v4.0 and BPN BSN House-Brackman and sensorineural internation scale assessment.

Eligibility: Inclusion Criteria:
  -  either histologically confirmed or imaging-defined benign meningioma diagnosis;
  -  large or medium lesion size and/or in critical area (e.i. perichiasmatic area);
  -  signed specific informed consent;
  -  age ≥ 18 years;
  -  for female patients, execution of pregnancy blood test;
  -  Karnofsky Performance Status (KPS) ≥ 70.
  Exclusion Criteria:
  -  histologically confirmed diagnosis of atypical or malignant meningiomas;
  -  patients who had received prior radiotherapy in the same site;
  -  pregnancy;
  -  allergy for contrast medium;
  -  neurofibromatosis diagnosis.

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: K-BASKET, TAS-117, PI3K/AKT Gene Aberration

Summary: The phosphatidylinositol 3-kinase (PI3K)-v-akt murine thymoma viral oncogene homolog (AKT)-mammalian target of rapamycin (mTOR) signaling pathway is one of the most frequently aberrantly regulated pathways in human tumors. TAS-117 is a highly potent and selective oral allosteric AKT inhibitor. It has high affinity for AKT1, 2, and 3 and shows potent anti-proliferative activity against multiple tumor cell lines in vivo. Therefore, we propose to conduct a phase II trial of TAS-117, potent and selective AKT inhibitor, in patients with advanced solid tumor with PI3K/AKT genetic aberrancy by NGS focusing panel in part of K-BASKET trial.


Eligibility: Inclusion Criteria:
  1. Histologically or cytologically confirmed recurrent or advanced solid cancers with PI3K/ATK aberration
  2. Progressive disease who failed to previous standard treatment.
  3. At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors version 1.1 criteria
  4. Eastern Cooperative Oncology Group performance status 0 or 1
  5. Able to take medications orally
  6. Adequate organ function
  7. A life expectancy of at least 60 days
  Exclusion Criteria:
  1. Previous treatment with anti-PI3K or AKT directed therapies
  2. Known hypersensitivity to any drugs similar to TAS-117 in structure or class.
  3. History or current evidence of type 1 or type 2 diabetes mellitus that requires insulin and/or oral antidiabetic therapy.
  4. Current evidence of retinopathy that requires ophthalmological therapy.
  5. History or current evidence of cardiac arrhythmia and/or conduction abnormality.
  6. Treatment with any of the following within the specified time frame prior to study drug administration:
  -  Major surgery within prior 4 weeks
  -  Radiation therapy for extended field within 4 weeks prior to study drug administration or limited field radiation therapy within 2 weeks prior to study drug administration.
  -  Any anticancer treatment within 3 weeks prior to study drug administration (mitomycin within prior 5 weeks).
  7. A serious illness or medical condition(s)
  8. Unresolved toxicity of Grade >1 attributed to any prior therapies (excluding alopecia, skin pigmentation and anemia).
  9. Patients with the risk of hypokalemia
  10. Receiving oral steroid medication.
  11. Pregnant or lactating female

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: Study of Aspirin in Patients With Vestibular Schwannoma

Summary: This is a phase II prospective, randomized, double-blind, longitudinal study evaluating whether the administration of aspirin can delay or slow tumor growth and maintain or improve hearing in VS patients.


Eligibility: Inclusion Criteria:
  -  Radiographic diagnosis of vestibular schwannoma (NF2-associated or sporadic).
  -  Age≥12 years.
  -  Ability to provide informed consent.Pediatric patients must provide assent in addition to their parents'/guardians' consent. Adult patients who cannot consent for themselves will not be eligible to participate in this study.
  -  Ability to swallow tablets.
  Exclusion Criteria:
  -  Inability to perform volumetric measurements of vestibular schwannoma(s).
  -  Inability to tolerate MRI with contrast.
  -  Daily use of aspirin within the last two months. Occasional use of aspirin for pain relief is not exclusionary.
  -  Known allergy to aspirin.
  -  Impairment of gastrointestinal function or gastrointestinal disease that may significantly alter the absorption of aspirin.
  -  Pregnant or lactating women.
  -  Patients with serious medical illnesses (e.g. severe asthma) that in the option of the investigator could prevent participation in the trial.
  -  Active bleeding diathesis.
  -  Hydrocephalus from brainstem compression.
  -  Febrile illness or flu-like illness in children and adolescents less than 18 years of age.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Enhancing Recovery in Coronary Heart Disease (ENRICHD) Patients

Summary: To evaluate the effect of psychosocial intervention on mortality and reinfarction in coronary heart disease patients at high psychosocial risk.

Detailed description: BACKGROUND:
  As medical treatments for coronary heart disease have become more sophisticated, they have also become more costly. Evidence concerning the effects of medical and rehabilitative therapies on post-myocardial infarction patients' quality of life, including return to work and to normal levels of functioning, has been mixed. At the same time. recent data suggest that psychosocial factors, such as social isolation and depression, are important predictors of morbidity and mortality in coronary heart disease patients. These studies suggest that interventions which provide psychological support to myocardial infarction patients may enhance both the psychosocial and physical recovery of these patients. To the extent that supportive interventions can be shown to impact favorably on survival and health-related quality of life in myocardial infarction patients, the human and financial costs associated with coronary heart disease can be reduced. The initiative originated in the Working Group on Psychosocial Interventions which met in June 1992.
  The initiative was given concept clearance by the October 1993 National Heart, Lung, and Blood Advisory Council. The Request for Proposals was released in September 1994.
  DESIGN NARRATIVE:
  The study design compared a psychosocial intervention group, in which patients were provided with social and psychological treatment designed to decrease social isolation and depression, with a standard medical care group. The combined endpoint was death and reinfarction, measured for up to 4.5 years following hospital discharge. Secondary endpoints included assessment of health quality of life (HQL).
  The protocol was approved in May 1996. Recruitment began in October 1996 and ended on October 31, 1999 with 2,481 patients enrolled.

Eligibility: Men and women coronary heart disease/myocardial infarction patients, hospitalized for enzyme-documented MI and who are depressed and/or have low social support. Patients must be enrolled with 28 days of the index MI.

Relevance to patient case: not relevant
Patient case: 67-year-old female with Breast cancer. Genetic variant: FGFR1 Amplification, PTEN (Q171). Other conditions: Depression, Hypertension, Heart Disease.

Clinical trial: Prolonged Tamoxifen Compared With Shorter Tamoxifen in Treating Patients Who Have Breast Cancer

Summary: RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using tamoxifen may fight breast cancer by reducing the production of estrogen. It is not yet known if prolonged tamoxifen is more effective than shorter tamoxifen therapy following curative treatment for breast cancer.
  PURPOSE: This randomized phase III trial is studying giving tamoxifen over a prolonged period of time to see how well it works compared to giving tamoxifen over a shorter period of time in treating patients who have had a breast tumor removed.

Detailed description: OBJECTIVES:
  -  Assess the balance of risks and benefits in prolonging the duration of adjuvant tamoxifen by at least 5 years in patients with curatively treated breast cancer who have already had about 5 years of adjuvant tamoxifen.
  OUTLINE: This is a randomized study. After about 5 years of adjuvant tamoxifen, recurrence-free patients are randomized to stop tamoxifen treatment immediately or to continue tamoxifen treatment for at least 5 more years.
  Patients are followed annually.
  PROJECTED ACCRUAL: Approximately 20,000 patients will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Curatively treated carcinoma of the breast
  -  Currently taking adjuvant tamoxifen
  -  Must be substantial uncertainty as to whether or not to continue tamoxifen (i.e., no clear indication or definite contraindication to further treatment with tamoxifen)
  PATIENT CHARACTERISTICS:
  Age:
  -  Any age
  Performance status:
  -  Not specified
  Life expectancy:
  -  Not specified
  Hematopoietic:
  -  Not specified
  Hepatic:
  -  Not specified
  Renal:
  -  Not specified
  Other:
  -  Not pregnant or nursing
  -  No contraindications to receiving tamoxifen
  -  No other serious medical problems
  PRIOR CONCURRENT THERAPY:
  Biologic therapy:
  -  Prior biologic therapy allowed
  Chemotherapy:
  -  Prior chemotherapy allowed
  Endocrine therapy:
  -  See Disease Characteristics
  Radiotherapy:
  -  Prior radiotherapy allowed
  Surgery:
  -  Prior surgery allowed

Relevance to patient case: not relevant