araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Superficial Basal Cell Cancer's Photodynamic Therapy: Comparing Three Photosensitises: HAL and BF-200 ALA Versus MAL

Summary: This pilot study compares three photosensitisers, hexylaminolevulinate (HAL) and aminolevulinic acid nano emulsion (BF-200 ALA) to methylaminolevulinate (MAL) in photodynamic therapy of superficially growing basal cell carcinomas. Study is conducted using randomised prospective double blinded comparing design. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up before and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.

Detailed description: Study recruits volunteering patients, who are referred to the department of dermatology and allergology, Päijät-Häme Central Hospital, Lahti, with 99 clinically assessed superficial basal cell carcinoma on the body area, not face and scalp. Diagnoses is confirmed histologically by punch biopsies and hyperspectral images are taken before the biopsies. The lesions are randomised in three groups: interventions HAL and BF-200 ALA and comparator MAL. Photodynamic therapy is given by the standard procedure. Fluorescence is measured in A.U. (Arbitrary Unit) with standardised set-up, with Wood's light, digital camera and a yellow lens, before and after the exposure. Pain is measured in VAS-scale before, during and after the exposure. Efficacy is assessed clinically, histologically and by hyperspectral imaging system at 3 months, 12 months and 5 years.

Eligibility: Inclusion Criteria:
  -  superficial basal cell carcinomas on body area
  -  lesions accepted needs to be 10 cm apart from each other
  Exclusion Criteria:
  -  pigmented, morpheaform, infiltrative or nodular basal cell carcinomas
  -  lesions that are in face and scalp area
  -  pregnancy
  -  breast feeding
  -  allergy to photosensitizer

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Observational Study of Vismodegib (Erivedge) in Patients Treated in Argentina

Summary: This observational, noninterventional study is designed to further characterize the effectiveness and safety profile of vismodegib (Erivedge) in Argentine patients. Only patients with locally advanced basal cell carcinoma (laBCC) or metastatic basal cell carcinoma (mBCC) will be considered in the effectiveness analysis. Study duration is estimated to be approximately 12 months.


Eligibility: Inclusion Criteria:
  -  Argetine patients prescribed vismodegib according to standard of care and in line with Summary of Product Characteristics (SPC) and local labeling
  -  Diagnosis of laBCC or mBCC for the effectiveness analysis
  Exclusion Criteria:
  -  None specified

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: A Study of BIND-014 in Patients With Urothelial Carcinoma, Cholangiocarcinoma, Cervical Cancer and Squamous Cell Carcinoma of the Head and Neck

Summary: BIND-014 (docetaxel nanoparticles for injectable suspension) is being studied in patients with advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree and squamous cell carcinoma of the head and neck.
  Ferumoxytol imaging will also be investigated at US sites as an exploratory endpoint.


Eligibility: Inclusion Criteria:
  1. Diagnosis of advanced urothelial carcinoma, cervical cancer, cholangiocarcinoma or carcinomas of the biliary tree or squamous cell carcinoma of the head and neck.
  2. Progressive disease after ≥ 1 prior chemotherapy regimen.
  3. Patients with brain metastases are eligible if asymptomatic and neurologically stable for at least 4 weeks and are not taking any medications contraindicated
  4. Chemotherapy must have been completed at least 4 weeks prior to initiation of study medication
  5. ECOG performance status 0-1
  6. Tumors must have measurable disease as per RECIST (version 1.1);
  7. Female or male, 18 years of age or older
  8. Adequate organ function
  9. Life expectancy of > 3 months
  Exclusion Criteria:
  1. Current treatment on another therapeutic clinical trial
  2. Prior treatment with docetaxel within 6 months of enrollment
  3. Stage II, III or IV cardiac failure
  4. Carcinomatous meningitis
  5. Ongoing cardiac dysrhythmias
  6. Peripheral neuropathy
  7. Serious concomitant conditions
  8. Pregnant or breast feeding
  9. Known sensitivity to ferumoxytol
  10. Hypersensitivity to polysorbate 80

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: A Study of the Efficacy and Safety of ASN-002 in Adult Patients With Low-risk Nodular Basal Cell Carcinoma

Summary: The study evaluates whether ASN-002 is safe and effective in the treatment of nodular basal cell carcinoma (nBCC) in patients aged 18 years or over.
  The participants will receive weekly injections of ASN-002 alone or in combination with 5-FU for 3 weeks and undergo surgical excision of the tumor.

Detailed description: The primary purpose of this study is to determine whether ASN-002 alone or in combination with 5-FU is safe and effective in the treatment of nodular basal cell carcinoma (nBCC).
  Patients aged 18 or over, who have been diagnosed with nodular Basal Cell Carcinoma (nBCC), may be eligible to join this study.
  Study details:
  ASN-002 is an immunotherapeutic product that is injected into the BCC spot to be treated. It is made from modified adenovirus serotype 5 (also called Ad5). Adenoviruses are common in nature worldwide and can cause mild colds and respiratory infections from which people usually recover without treatment. The Ad5 used in this study has been modified so that it cannot grow in the body or cause an infection. The modified Ad5 in this study will deliver artificially made genetic material into the cancerous and surrounding cells. This genetic material will produce human interferon which is normally produced by the body to stimulate the immune system. It is hoped that injected ASN-002 will cause the body's own cells to produce interferon and stimulate the immune system to attack the cancerous cells and reduce the size of or eliminate the nBCC. Participants will attend the study centre weekly for an injection of ASN-002 alone of in combination with 5-FU into the nBCC. The participants recruited will have 3 injections over 3 weeks, and then undergo surgical excision of the tumor.
  Patient outcomes will then be assessed using a tumour sample collected during surgery and by the incidence of adverse events which occur throughout the study.
  It is hoped that the findings of this trial will provide information on the safety and efficacy of using ASN-002 alone or in combination with 5-FU for nBCC, particularly for patients in whom the standard treatment of surgery is not possible or not recommended.

Eligibility: Inclusion Criteria:
  1. Low risk nodular basal cell carcinoma
  2. Biopsy of any other skin tumor
  3. Willingness to have injection therapy followed by surgery
  4. Written informed consent
  Exclusion Criteria:
  1. No or only minimal symptoms
  2. Known or suspected metastatic disease.
  3. Pregnant or Lactating females
  4. Clinically active or uncontrolled skin disease
  5. Immunocompromised or receiving immunomodulating agent
  6. treatment with psoralen plus Ultraviolet A or Ultraviolet B light therapy within 6 months
  7. Any serious or active medical or psychiatric illness
  8. Recreational or therapeutic drug or alcohol use
  9. Taking any investigational product within 1 month of first dose of ASN- 002.

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Head and Neck Cancer in Children: A Retrospective Study

Summary: The aim of the study is to identify demographic characteristics, various histopathologies, and site preferences for each disease entity of malignant head and neck tumors in pediatric oncology patients & treatment outcomes in these patients, according to experience at South Egypt Cancer Institute which is the largest referral site in Upper Egypt.

Detailed description: Background:
  Although head and neck masses represent a common entity in children, malignancy is uncommon. Only very limited data are available in the literature on the incidence of childhood cancer of the head and neck worldwide.
  Data from the United States National Cancer Institute database suggest that the head and neck are involved in 12 % of all childhood malignancies. The most common pediatric head and neck malignancies include Non Hodgkin lymphomas, Hodgkin lymphomas, rhabdomyosarcomas, thyroid malignancies, nasopharyngeal carcinomas (NPCs), salivary gland malignancies, and neuroblastomas.
  Patients & Methods:
  A hospital-based study, involving Pediatric cancer patients, those diagnosed with malignant tumors of the head & neck, in the period from 2001 January till 2015 December, and received treatment at the pediatric oncology department, their medical records will be retrospectively reviewed for data collection.
  Clinico-laboratory data for each hisopathologic disease entity of various head & neck malignancies will be gathered. The demographic distribution for each disease entity in accordance with gender & age, and site preferences in these disease entities will be recorded. Treatment received & treatment outcomes will be verified and absolute frequencies & relative incidence of these disease entities will be calculated.

Eligibility: Inclusion Criteria:
  -  Patients whose age less than or equal to 18 years.
  -  Patients diagnosed with a primary malignant tumor of the head & neck.
  Exclusion Criteria:
  -  Patients whose age more than 18 years.
  -  Patients diagnosed with a malignant disease primarily arising from the bone marrow.
  -  Patients diagnosed with tumors of the central nervous system.
  -  Patients diagnosed with retinoblastoma.

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Study to Analyze Mutations in V600 BRAF Oncogen in Participants With Metastatic Melanoma

Summary: This is a national, multicenter, cross-sectional epidemiological study in adult Spanish participants diagnosed with advanced or metastatic melanoma.


Eligibility: Inclusion Criteria:
  -  Valid tumor samples from participants diagnosed with Stage IIIc or IV melanoma
  -  Written informed consent granted
  Exclusion Criteria:
  - Do not fulfill one or more inclusion criteria

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Early Detection of Skin Cancer With Sensor Technology

Summary: Skin cancer represents a large problem in today's healthcare setting. The majority of cancer diagnoses are attributed to malignant skin diseases including its major types: basal cell carcinoma, squamous cell carcinoma and melanoma. Early diagnoses is critical given early detection of malignant lesions largely increases chances of successful treatment. The current gold standard of diagnosis is histopathological examination of biopsied skin. Biopsies are not only invasive and expensive, they have variable positive predictive value, meaning they may often be preformed unnecessarily. As such, we have developed a skin scanner, which is less bulky and expensive that existing similar technologies, as a tool to evaluate skin lesions prior to determining the need for a biopsy. Our objective is to obtain information in order to validate this skin scanner in the context of its ability to accurately identify basal cell carcinoma skin lesions.


Eligibility: Inclusion Criteria: Patient requiring skin biopsy for suspected basal cell carcinoma skin lesion, 18 years of age or older -
  Exclusion Criteria: Poor english fluency, Pregnancy

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Topical Itraconazole in Treating Patients With Basal Cell Cancer

Summary: This phase 0 trial studies how well itraconazole gel works in treating patients with basal cell cancer. Itraconazole gel may help to treat basal cell tumors in patients.

Detailed description: PRIMARY OBJECTIVES:
  I. To determine if 12 weeks of topical itraconazole gel reduces basal cell carcinoma (BCC) biomarkers (Gli1, the target gene of the Hedgehog pathway).
  SECONDARY OBJECTIVES:
  I. To determine if topical itraconazole gel will decrease BCC size.
  OUTLINE:
  Patients apply itraconazole topically twice daily (BID) and placebo topically BID for 12 weeks.
  After completion of study treatment, patients are followed up for up to 14 weeks.

Eligibility: Inclusion Criteria:
  -  The subject must sign and date all informed consent statements; children will sign the assent form and their guardian will sign the consent form
  -  The subject must be willing to apply the medications twice daily for 1 month
  -  The subjects must have at least four BCCs in non-cosmetically sensitive sites
  -  For women of child-bearing potential, a negative urine pregnancy test
  -  Women of child-bearing potential are expected to use an effective method of birth control to prevent exposing a fetus to potentially dangerous agent with unknown risk
  -  For male patients with female partners of childbearing potential, agreement to use adequate contraception while you are participating in the study and 1 month after applying your last dose
  Exclusion Criteria:
  -  Pregnancy or breast-feeding
  -  History of congestive heart failure or other findings of ventricular dysfunction
  -  History of current evidence of malabsorption or liver disease
  -  Current immunosuppression or taking immunosuppressive drugs
  -  Taking oral itraconazole
  -  Taking any medication known to affect hedgehog (HH) signaling pathway
  -  The subject has used topical or systemic therapies that might interfere with the evaluation of the study medication during the study; specifically these include the topical use to the study tumors of: glucocorticoids (ii) retinoids (e.g., etretinate, isotretinoin, tazarotene, tretinoin, adapalene) systemically or topically (iii) alpha-hydroxy acids (e.g., glycolic acid, lactic acid) to more than 5% of the skin during the six months prior to study entry (iv) 5-fluorouracil or imiquimod; also - treatment with systemic chemotherapy or agents known to be inhibitors of HH signaling within 60 days to starting study medication

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: The ED50 of DEX for Providing Sedation in Different Female Age Group

Summary: Dexmedetomidine(DEX) could provide dose-dependent sedation , analgesia , anti-anxiety and inhibition of sympathetic nerves and other effects. Because of its minimal impact on the respiratory , currently it was more and more widely used to sedate patients undergoing regional anesthesia.Many anesthetic pharmacokinetics and pharmacodynamics are often affected by age, and current studies with regard to the effects of age on dexmedetomidine pharmacodynamic are rare. This study was designed to explore the right DEX dose of different female Age of patients to produce suitable sedation.Dexmedetomidine be used in patients with combined spinal and epidural anesthesia for sedation,which is monitored by the Narcotrend,during the operation.The relation between Narcotrend index (NTI) and the depth of sedation for patients is also investigated.

Detailed description: 90 patients scheduled for combined spinal epidural spinal anesthesia were included in one of three groups. In each group,determination of median effective (ED50) doses was performed by the Dixon up-and-down method, an initial dose of 1.0 μg/kg dexmedetomidine, with dose adjustment intervals of 0.1 μg/kg in first three turning points and 0.05μg/kg in the last three turning points.Initial doses was 1.4μg/kg, .Sedative efficacy was defined as an OAA/S of ≤3,30 min after the beginning of drug administration.

Eligibility: Inclusion Criteria:
  1. ASA Ⅰ ~ Ⅱ patient undergoing lower extremity surgery
  2. Written informed consent from the patient or the relatives of the participating patient.
  3. BMI:18.0～25.0kg/m2
  Exclusion Criteria:
  1. Mental illness can not match
  2. epidural anesthesia contraindicated
  3. People who have Slow-type arrhythmias
  4. People who were language or hearing impaired
  5. Sensory block reached to T8 or higher.
  6. People who had lung infection or sleep apnea syndrome.
  7. Pregnancy
  8. Chronic renal failure
  9. Alcohol or drug abuse
  10. Already taking gabapentin, pregabalin, benzodiazepin or antidepression drug

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Postoperative Concurrent Chemoradiotherapy With Docetaxel for High-Risk Squamous Cell Carcinoma of Head and Neck

Summary: This is a non-randomized, phase II, open label study of postoperative concurrent chemoradiotherapy with docetaxel for high-risk squamous cell carcinoma of the head and neck(HNSCC).The primary purpose of this study is to evaluate the efficacy and safety of concurrent chemoradiotherapy with docetaxel in HNSCC patients.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed squamous cell carcinoma of the head and neck.Site of tumor origin in the oral cavity, oropharynx, larynx, or hypopharynx (excluding nasopharynx, or sinuses)
  2. Gross total resection, with pathology demonstrating one or more of the following risk factors:
  1. Histologic extracapsular nodal extension
  2. Histologic involvement of ≥ 2 regional lymph nodes
  3. Invasive cancer seen on microscopic evaluation of the resection margin, with no evidence of gross tumor residual
  3. No evidence of distant metastases
  4. No synchronous or concurrent head and neck primary tumors
  5. Karnofsky score over 60
  6. Adequate organ function including the following:
  1. Absolute neutrophil count (ANC) >= 1.5 * 10^9/l
  2. Platelets count >= 100 * 10^9/l
  3. Hemoglobin >= 10 g/dl
  4. AST and ALT <= 2.5 times institutional upper limit of normal (ULN)
  5. Total bilirubin <= 1.5 times institutional ULN
  6. Creatinine clearance >= 50 ml/min
  7. Serum creatine <= 1 times ULN
  7. Signed written informed consent
  Exclusion Criteria:
  1. Evidence of distant metastasis
  2. Prior chemotherapy or anti-cancer biologic therapy for any type of cancer, or prior radiotherapy to the head and neck region
  3. Other previous cancer, except for in situ cervical cancer and cutaneous basal cell carcinoma
  4. Pregnant or breast-feeding females, or females and males of childbearing potential not taking adequate contraceptive measures
  5. Presence of an uncontrolled concomitant illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, or cardiac arrhythmia

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: A Study of Continued Treatment Among Participants Who Have Responded to Peginterferon Alfa-2a (Pegasys®) or Recombinant Interferon Alfa-2a (Roferon-A®) in Prior Clinical Studies

Summary: This open label extension study will give an opportunity to the participants that have responded to the treatment with Pegylated-Interferon Alfa-2a (Pegasys) or Recombinant Interferon Alfa-2a (Roferon-A®) in prior clinical studies NO15753 (NCT00003542) for Renal Cell Carcinoma (RCC), NO15764 (NCT number not available) and NO16006 (NCT02736721) for Chronic Myelogenous Leukemia (CML), and NO16007 (NCT number not available) for Malignant Melanoma (MM).


Eligibility: Inclusion Criteria:
  -  Participants must have completed protocol NO15753, NO15764, NO16006 or NO16007 and responded to treatment at the end of the trial as defined in the parent protocol
  -  CML participants must have a confirmed cytogenetic complete response within 2 months of entering the extension study. MM and RCC participants must have tumour assessments verifying stable or better response within 2 months of entering the extension study
  Exclusion Criteria:
  -  Pregnant or lactating women
  -  Refusal to use adequate contraceptive measures among men and women of childbearing potential

Relevance to patient case: not relevant
Patient case: 56-year-old female with basal cell carcinoma; genetic feature: PTCH1

Clinical trial: Serum Squamous Cell Carcinoma Antigen Level and Tumor Volume in Head and Neck Cancer

Summary: Correlation between serum squamous cell carcinoma antigen level and tumor volume in Head and Neck Cancer is to determine a correlation between level of serum squamous cell carcinoma antigen and tumor volume in Head and Neck Caner measured by cross-sectional imaging.

Detailed description: The study is a cross-sectional study. A single measurement of serum squamous cell carcinoma antigen level is performed in the eligible Head and Neck squamous cell carcinoma patients.
  The study tool measuring serum squamous cell carcinoma antigen level is ARCHITECT SCC (Abbott).
  The gross tumor volume in the cross sectional imaging obtained within 2 weeks of each patient is calculated with the typical ellipsoid formula.
  Correlation between both parameters will be determined.

Eligibility: Inclusion Criteria:
  -  Histologically proven squamous cell carcinoma in Head and Neck
  -  Getting a cross-sectional imaging of Head and Neck within 2 weeks of collecting serum squamous cell carcinoma antigen
  Exclusion Criteria:
  -  Metastatic disease
  -  Accompanied Non-Head and Neck squamous cell carcinoma
  -  Nasopharyngeal, thyroid, salivary, nose and paranasal sinus carcinoma
  -  Skin disease: eczema, erythrodermic epidermitis, pemphigus, and psoriasis
  -  Pulmonary disease: tuberculosis, adult respiratory distress syndrome, pulmonary infiltration with eosinophilia, sarcoidosis, and bronchogenic cyst
  -  Renal failure
  -  Using antihistamine eye drops

Relevance to patient case: not relevant