araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Randomized Trial Between Weekly and 5 Day 3 Weekly Cisplatin for Cervical Cancer

Summary: The primary aim of this research protocol is to compare if there is a difference in progression free survival between weekly versus 5-day 3 weekly cisplatin based chemotherapy regimen in women with locally advanced cervical cancer. The secondary aims are to compare quality of life assessment of patients and their carers as well as toxicity profiles both acute and late.


Eligibility: Inclusion Criteria:
  -  stage IB2-IVA , histological proven cervical carcinoma
  -  no previous diagnosis of carcinoma
  -  no prior history of chemotherapy or radiotherapy
  -  ECOG less than or equal to 2
  -  Above 21 years old
  -  medically fit for radical concurrent Cisplatin based chemotherapy and radiotherapy
  -  Hemoglobin >10g/dL
  -  Adequate hematological, renal and hepatic function according to all of the following laboratory values:
  -  Absolute neutrophil count ≥ 1.5 ×109/l
  -  Platelets ≥ 100 ×109/l
  -  Serum creatinine ≤ 1.5 times upper limit of laboratory normal
  -  Total serum bilirubin ≤ 1.5 times upper limit of laboratory normal
  -  ASAT(AST) or ALAT(ALT) ≤ 2.5 times upper limit of laboratory normal
  -  Alkaline phosphatase of ≤ 2.5 times upper limit of laboratory normal
  Exclusion Criteria:
  -  Age below 21
  -  Presence of known HIV infection, chronic hepatitis B or hepatitis C infection
  -  Psychological, familial, sociological, or geographical condition that would preclude study participation
  -  Prior (within the last 3 years) or simultaneous malignancies (other then cutaneous basal cell carcinoma or non-invasive tumors)
  -  Patients with the following histologies are excluded: small cell, carcinoid, glassy cell, clear cell and adenoid cystic.
  -  Life expectancy < 6 months
  -  Patients with insulin dependent diabetes
  -  Prior tumor-directed surgery
  -  Previous systemic chemotherapy or pelvic radiation therapy
  -  As radiation and cytotoxic agents are contraindicated in pregnancy, pregnant women are ineligible and those of childbearing potential should use contraception

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: External-Beam Radiation Therapy With or Without Indinavir and Ritonavir in Treating Patients With Brain Metastases

Summary: RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Indinavir and ritonavir may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether external-beam radiation therapy is more effective with or without indinavir and ritonavir in treating patients with brain metastases.
  PURPOSE: This randomized phase II trial is studying external-beam radiation therapy alone to see how well it works compared to external-beam radiation therapy given together with indinavir and ritonavir in treating patients with brain metastases.

Detailed description: OBJECTIVES:
  -  Compare the efficacy, in terms of time to treatment failure at CNS level and 4-months treatment failure rate, in patients with brain metastases treated with external-beam radiotherapy in combination with indinavir sulfate and ritonavir versus external-beam radiotherapy alone.
  -  Prospectively investigate the efficacy of a potentially antiangiogenic agent, indinavir sulfate.
  -  Investigate the antineoplastic activity of indinavir sulfate in combination with ionizing radiation in cancer patients with metastatic disease to the brain.
  OUTLINE: Patients are randomized to 1 of 2 treatment arms.
  -  Arm I: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total). Patients also receive oral indinavir sulfate and oral ritonavir twice daily for 35 days beginning at day 1 of radiotherapy.
  -  Arm II: Patients undergo radiotherapy to the brain once daily, 5 days a week for 2 weeks (10 doses total).
  Patients complete quality of life questionnaires, including QOL-30 and the Mini Mental Status Examination, at baseline, 2 weeks after completion of radiotherapy, and at 1 and 3 months after completion of study treatment.
  After completion of study treatment, patients are followed periodically for at least 4 months.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed metastatic cancer with brain metastases
  -  Biopsy of brain metastases is not required
  -  All cancer types allowed, except for the following:
  -  Prostatic adenocarcinoma
  -  Sarcoma
  -  Melanoma
  -  Germ cell carcinoma,
  -  Small-cell lung cancer
  -  Measurable disease by MRI of the brain
  -  Not requiring immediate surgical decompression (may qualify after surgery, if remaining measurable brain lesions)
  PATIENT CHARACTERISTICS:
  -  ECOG performance status 0-2 (corresponds to recursive partitioning analysis groups I or II)
  -  Life expectancy > 4 months
  -  Able to understand the aim of trial and to comply with follow-up
  -  No HIV seropositivity
  PRIOR CONCURRENT THERAPY:
  -  Prior dexamethasone allowed provided it is tapered before initiation of study radiotherapy
  -  Not requiring cytotoxic treatment within 3 months after study radiotherapy
  -  At least 1 week since prior and no concurrent phenytoin

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Chest Physiotherapy After Bariatric Aurgery - A Comparison Between Incentive Spirometry and Expiratory Positive Airway Pressure (Epap)

Summary: Objective: To compare the effects of the EPAP and the incentive spirometry flow-oriented in the pulmonary function after bariatric surgery.
  Method: Twenty-eight women, non-smokers, with no lung disease and BMI of 35-49,99 kg/m2, undergoing bariatric surgery by laparoscopy, were studied. Before surgery the patients were divided in two groups: Spirometer Group (SG) (n=13) and EPAP Group (EG) (n=15). Pulmonary function was evaluated by spirometry, thoracoabdominal (cirtometry) and diaphragmatic motion, on the preoperative and on the second postoperative day. Physiotherapy started on the day of surgery, each modality (incentive spirometry or EPAP) performed lasting 15 minutes. The deambulation and active exercises of upper and lower limbs were standardized for groups.


Eligibility: Inclusion Criteria:
  -  Obese with body mass index between: 35 e 50 kg/m2
  -  Non-smokers
  -  No lung disease
  Exclusion Criteria:
  -  Unable to perform the evaluation tests
  -  Not signed the consentment term

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Autologous Versus Synthetic Versus Biological Sling for Trans-obturator Correction of Urinary Stress Incontinence

Summary: The treatment of urinary stress incontinence with trans-obturator approach, know as transobturatory tape (TOT), is a largely used sling-adopting procedures. The efficacy and safety of this minimally invasive surgery have been demonstrated, also in comparison with similar procedures, i.e transvaginal tape (TVT).
  To date the results of TOT in terms of efficacy and safety described in literature mainly refer to procedure in which synthetic materials are used, whereas few data regarding the use of biological materials are available. Moreover, despite the well known benefits of the available synthetic and eterologue kit, their use may be limited by the high cost of these materials. At this proposal it can be suggested as alternative option the possibility to perform the procedure using an autologous tissue, i.e. rectus fascia, and reusable introductory needles. Based on these considerations the aim of this trial will be to compare autologous, synthetic and biological mesh for TOT in women with urinary stress incontinence.

Detailed description: Women with genuine stress urinary incontinence will be enrolled and randomized in three groups (arm 1, arm 2, arm 3). All patients will be treated with a transobturatory approach, in patients of arm 1 will be used an autologous tissue and reusable introductory needles, in patients of arm 2 will be used a synthetic kit whereas in arm 3 will be a biological kit .
  All eligible patients will undergo baseline assessment consisting of anthropometric, clinical, hormonal, urodynamic, and ultrasonographic evaluations. During the study, the surgical outcomes, the clinical subjective and objective efficacy data, and the adverse experiences will be evaluated in each patient.
  Data will be analyzed using the intention-to-treat principle and a P value of 0.05 or less will be considered significant.

Eligibility: Inclusion Criteria:
  -  Genuine stress urinary incontinence by self report, examination and test
  -  Urethral hypermobility
  -  Eligible for all three surgical procedures
  -  Ambulatory
  Exclusion Criteria:
  -  Pregnancy
  -  <12 months post-partum
  -  Systemic disease and/or drugs known to affect bladder function
  -  Current chemotherapy or radiation therapy
  -  Urethral diverticulum, augmentation cytoplasty, or artificial sphincter
  -  Recent pelvic surgery
  -  Severe genuine stress incontinence (loss of urine with minimal physical activity) with associated prolapse equal to or more than second degree
  -  Previous pelvic or anti-incontinence surgery
  -  History of severe abdominopelvic infections
  -  Known extensive abdominopelvic adhesions
  -  Detrusor instability and/or intrinsic sphincter dysfunction
  -  Other gynaecologic pathologies (eg, fibroids, ovarian cysts)
  -  BMI >30

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Evaluation of the A1CNow+ Test Kit

Summary: The purpose of this study was to assure that consumers can successfully use the new version of A1CNow+ along with revised instructional materials.

Detailed description: The purpose of this study was to assure that consumers could successfully use the new version of A1CNow+ Test Kit along with revised instructional materials. The primary objective was to establish accuracy and secondary objectives were to establish precision, comprehension of instructional materials, and user feedback about the overall testing experience.

Eligibility: Inclusion Criteria:
  1. Adults (age 18 and older) approximately 80% being ≤55 years old
  2. Persons with:
  -  known diabetes (type 1 or type 2) and pre-diabetes - approximately 85% of subject population per site
  -  no known diagnosis of diabetes - approximately 15% of subject population per site
  3. Individuals who are interested in performing a test using the kit at home
  4. Individuals willing to complete all study procedures (including venous draw and allowing site staff to perform finger punctures)
  5. Individuals who are able to speak, read, and understand English
  6. Individuals able to read out loud the first 5 lines of the A1C Test Kit instructional materials to demonstrate ability to read the print (may use glasses, if needed)
  Exclusion Criteria:
  1. Individuals taking prescription anticoagulants (such as Warfarin or heparin) or have clotting problems that may prolong bleeding. (Taking Plavix or aspirin daily is not excluded)
  2. Individuals with known Rheumatoid Arthritis or other condition causing significant impairment of manual dexterity
  3. Individuals with a known hemoglobin variant such as HbS or HbC
  4. Individuals with any known disorder of the blood or blood-forming organs (such as recovery from blood loss, hemolytic anemia, or iron deficiency anemia)
  5. Individuals who have received a blood transfusion within the 4 months prior to the study.
  6. Persons with known infection with a bloodborne pathogen (e.g. HIV, hepatitis)
  7. Individuals working for a competitive medical device company
  8. Individuals who have participated in previous studies on the A1CNow+ product
  9. Persons missing a digit or partial digits on the hand
  10. Individuals with the following impairments which, in the opinion of the investigator, would seriously compromise the integrity of the study:
  -  Significant visual impairment
  -  Significant hearing impairment
  -  Cognitive disorder
  -  Any other condition as per investigator's discretion

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: PET Scans in Patients With Head And Neck Cancer Who Are Undergoing 3-Dimensional Conformal Radiation Therapy And Intensity-Modulated Radiation Therapy

Summary: RATIONALE: Imaging procedures, such as PET scans, may determine the extent of cancer and help doctors plan radiation therapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving radiation therapy that uses a 3-dimensional image of the tumor to help focus thin beams of radiation directly on the tumor, and giving radiation therapy in higher doses over a shorter period of time, may kill more tumor cells and have fewer side effects. Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue.
  PURPOSE: This clinical trial is studying PET scans to see how well they work in patients with head and neck cancer who are undergoing 3-dimensional conformal radiation therapy and intensity-modulated radiation therapy.

Detailed description: OBJECTIVES:
  Primary
  -  To assess the value of pre-treatment PET in determining the target volume in patients with head and neck cancer undergoing three-dimensional conformational radiotherapy and intensity-modulated radiotherapy.
  Secondary
  -  To evaluate variations in weekly fludeoxyglucose F 18 PET imaging during the first 5 weeks of treatment.
  -  To determine the relationship between changes in tumor metabolism during radiotherapy and control tumor at 3 months and at 1 year post-treatment.
  OUTLINE: This is a multicenter study.
  Patients undergo fludeoxyglucose F18 PET (FDG-PET) in addition to conventional imaging at baseline. Patients undergo standard three-dimensional conformational radiotherapy and intensity-modulated radiation therapy 5 days a week for 5 weeks.
  Some patients also undergo weekly FDG-PET during treatment.

Eligibility: DISEASE CHARACTERISTICS:
  -  Histologically confirmed head and neck cancer
  -  No nasopharyngeal or paranasal sinus cancer
  -  Locally advanced disease (T3 or T4)
  -  Not in complete remission
  -  Planning to undergo curative radiotherapy (minimum dose of 66 Gy), with or without standard treatment (i.e., platinum-based chemotherapy or biological therapy/rituximab)
  -  Measurable tumor according to RECIST criteria
  PATIENT CHARACTERISTICS:
  -  WHO performance status 0-2
  -  Not pregnant or nursing
  -  Able to lie still for 1 hour
  -  No history of progressive neoplastic disease
  -  No known hypersensitivity to fludeoxyglucose F18 or any of its excipients
  -  No severe or uncontrolled systemic disease, including any of the following:
  -  Kidney disease
  -  Liver disease
  -  Cardiac disease
  -  Unstable or uncompensated respiration
  -  Uncontrolled diabetes (i.e., glucose ≥ 1.5 g/L)
  -  No geographical, social, or psychological conditions that make follow-up impossible
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics
  -  No prior surgery
  -  No concurrent experimental agents

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Immunoreactivity to Cetuximab in Cancer Patients

Summary: RATIONALE: Studying samples of blood in the laboratory may help doctors predict which patients will develop hypersensitivity to cetuximab.
  PURPOSE: This research study is looking at hypersensitivity to cetuximab in patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab.

Detailed description: OBJECTIVES:
  -  To examine serum samples from patients with head and neck cancer or advanced colorectal cancer previously treated with cetuximab for the presence of antibodies against cetuximab.
  OUTLINE: Serum samples are examined by immunoreactivity screening of IgE, IgG, IgA, and IgM antibodies and complement reaction.

Eligibility: DISEASE CHARACTERISTICS:
  -  Diagnosis of one of the following:
  -  Head and neck cancer
  -  Advanced colorectal cancer
  -  Previously treated with cetuximab
  -  Serum samples available from patients enrolled in one of the following clinical trials:
  -  VU-VICC-GI-0410 (colorectal cancer)
  -  VU-VICC-GI-0622 (colorectal cancer)
  -  VU-VICC-HN-0356 (head and neck cancer)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Growth Factor Levels in the Blood of Patients Undergoing Radiation Therapy for Epithelial Cancer

Summary: RATIONALE: Measuring levels of transforming growth factor-beta (TGF-beta) in the blood of patients with epithelial cancers (head and neck, lung, breast, colorectal, and prostate) may help doctors predict how patients will respond to treatment with radiation therapy.
  PURPOSE: This research study is measuring levels of TGF-beta in patients with epithelial cancers who are undergoing radiation therapy.

Detailed description: OBJECTIVES:
  -  To determine whether there is a dose-dependent increase in TGF-beta following radiotherapy in patients with epithelial cancers.
  OUTLINE: Patients undergo blood sample collection prior to treatment, 24-72 hours after the first fraction of radiotherapy, and at the end of radiotherapy. Patients will also be asked for a weekly blood sample, but this is optional. Samples are analyzed to compare pre- and post-treatment TGF-beta levels.

Eligibility: DISEASE CHARACTERISTICS:
  -  Known diagnosis of an epithelial cancer, including any of the following:
  -  Head and neck
  -  Lung
  -  Breast
  -  Colorectal
  -  Prostate
  -  Radiotherapy must be a component of planned treatment therapy
  PATIENT CHARACTERISTICS:
  -  No serious medical or psychiatric illnesses which would prevent informed consent

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Biomarkers in Predicting Response to Treatment in Patients With Newly Diagnosed Stage III or Stage IV Head and Neck Cancer Treated With Carboplatin, Paclitaxel, and Radiation Therapy

Summary: RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.
  PURPOSE: This research study is looking at biomarkers in predicting response to treatment in patients with newly diagnosed stage III or stage IV head and neck cancer treated with carboplatin, paclitaxel, and radiation therapy.

Detailed description: OBJECTIVES:
  -  Determine if gene expression patterns that correlate with treatment response and survival can be identified using DNA microarrays in patients with newly diagnosed head and neck squamous cell carcinoma (HNSCC) treated with carboplatin, paclitaxel, and radiotherapy.
  -  Determine if protein expression patterns that correlate with treatment response and survival in HNSCC can be identified using matrix-assisted laser desorption ionization-time-of-flight mass spectrometry (MALDI-TOFMS).
  -  Determine if the molecular signature of human papilloma virus-16 infection can be determined using DNA microarray and MALDI-TOFMS and correlate with gene and protein expression, treatment response, and survival.
  OUTLINE: Tumor tissue samples are analyzed by DNA microarray analysis and validated by quantitative reverse transcription-polymerase chain reaction (PCR). Protein and gene expression patterns are analyzed by laser desorption ionization-time-of-flight mass spectrometry, high performance liquid chromatography, liquid chromatography-tandem mass spectrometry, and PCR. Samples are also analyzed by tissue microarray and immunohistochemistry.

Eligibility: DISEASE CHARACTERISTICS:
  -  Newly diagnosed head and neck squamous cell carcinoma
  -  Stage III-IV disease
  -  Scheduled for pan-endoscopy
  -  Tumor tissue available from patients treated with carboplatin, paclitaxel, and radiotherapy on protocol VU-VICC-HN-0356
  PATIENT CHARACTERISTICS:
  -  Able to speak English
  PRIOR CONCURRENT THERAPY:
  -  See Disease Characteristics

Relevance to patient case: not relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: DNA Analysis of Tissue Samples From Patients With Head and Neck Cancer

Summary: RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at DNA in tissue samples from patients with head and neck cancer.

Detailed description: OBJECTIVES:
  -  Assess common genetic mutations in tumor and germline DNA samples from patients with head and neck squamous cell carcinoma (HNSCC).
  -  Search for viral DNAs and relate this information to demographics, tumor characteristics, and patient prognosis.
  -  Search for novel viral sequences and cancer-associated gene mutations in young nonsmoking HNSCC patients and in other distinct head and neck cancers.
  -  Determine tumor suppressor gene mutations in HNSCC patients and relate this information to gene expression data.
  -  Validate gene expression information using independent techniques such as real-time PCR on expressed sequences and immunohistochemistry.
  OUTLINE: Genetic mutation analysis and gene expression studies are performed on tissue samples from patients with head and neck squamous cell carcinoma. Techniques used include real time-PCR and immunohistochemistry.

Eligibility: Inclusion Criteria:
  -  Patient with head and neck squamous cell carcinoma (HNSCC) enrolled in the Head and Neck Tissue Repository
  -  Sufficient biological material collected to perform study tests
  -  Historical material available from excess tissues at the Vanderbilt Pathology Department
  Exclusion Criteria:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: possibly relevant
Patient case: 58-year-old female with adenoid cystic carcinoma; genetic feature: KIT

Clinical trial: Biomarkers in Patients With Head and Neck Cancer and in Healthy Volunteers

Summary: RATIONALE: Studying samples of blood, tissue, and saliva in the laboratory from patients with cancer and from healthy volunteers may help doctors identify and learn more about biomarkers related to cancer.
  PURPOSE: This laboratory study is looking at biomarkers in patients with head and neck cancer and in healthy volunteers.

Detailed description: OBJECTIVES:
  -  Correlate the differences in serum protein profiles with the differences in the number of peptide matches in patients with squamous cell carcinoma of the head and neck and in healthy volunteers.
  -  Correlate protein levels with the largest difference in peptide matches in sera in these participants.
  OUTLINE: This is a prospective study.
  Participants undergo blood, tissue, and saliva collection for biological studies. Samples are analyzed for albumin-bound and non-albumin-bound proteins or IgG via liquid chromatography and tandem mass spectrometry (LC-MS-MS), ELISA, proteomic profiling, and protein expression.
  PROJECTED ACCRUAL: A total of 50 patients and 50 healthy volunteers will be accrued for this study.

Eligibility: DISEASE CHARACTERISTICS:
  -  Meets one of the following criteria:
  -  Diagnosis of squamous cell carcinoma of the head and neck
  -  Healthy volunteer matched by sex, race, birth decade, or smoking status (e.g., current smoker, former smoker, or nonsmoker)
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant