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

Clinical trial: ToleroMune Ragweed Exposure Chamber Study

Summary: It is believe that ragweed is the primary cause of autumn allergies and 87% of patients with ragweed allergy suffer rhinoconjunctivitis. ToleroMune Ragweed is a novel, synthetic, allergen-derived peptide desensitising vaccine, currently being developed for the treatment of ragweed allergy.
  This study will look at the efficacy, safety and tolerability of two doses of ToleroMune Ragweed in ragweed allergic subjects following challenge with ragweed in an EEC.

Detailed description: This study is designed as a randomised, double-blind, placebo-controlled, parallel group study to evaluate the safety and tolerability of ToleroMune Ragweed in ragweed allergic subjects with allergic rhinoconjunctivitis,subjects may also have controlled asthma. The efficacy of ToleroMune Ragweed will be explored in subjects using an(Environmental Exposure Chamber)EEC.
  The study will consist of 3 study periods. In Period 1, Screening will be performed up to a maximum of 12 weeks before randomisation and may consist of one or two visits to the clinic, at the Investigator's discretion. Baseline Challenge will consist of 4 visits to the EEC at least 3 days before randomisation.
  In Period 2, subjects in each cohort complying with the inclusion/exclusion criteria will be randomised to one of five groups and will receive treatment every 2 weeks (±2 days) for 14 weeks.
  In Period 3, Post Treatment Challenge will consist of 4 visits to the EEC 18-22 weeks after the first administration in the treatment period and assessments will be performed identical to those at the baseline challenge. Follow-up will be conducted 3-10 days after PTC.

Eligibility: Inclusion criteria
  -  Male or female, aged 18-65 years.
  -  Minimum 2-year documented history of rhinoconjunctivitis on exposure to ragweed. [Subjects may also have controlled asthma
  -  Positive skin prick test to ragweed allergen.
  -  Minimum qualifying rhinoconjunctivitis symptom scores
  Exclusion criteria
  -  History of asthma.
  -  A history of anaphylaxis to ragweed allergen.
  -  Subjects with an FEV1 <70% of predicted.
  -  Subjects who cannot tolerate baseline challenge in the EEC.
  -  Subjects for whom administration of epinephrine is contra-indicated (e.g. subjects with acute or chronic symptomatic coronary heart disease or severe hypertension).
  -  A history of severe drug allergy, severe angioedema or anaphylactic reaction to food.
  -  A history of any significant disease or disorder (e.g. cardiovascular, pulmonary, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, neoplastic/malignant, psychiatric, major physical impairment).

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

Clinical trial: An East Asian Study of LDE225

Summary: The purpose of this study is to determine Maximum Tolerated Dose (MTD) or recommended phase II dose of LDE225 when administered orally to two adult patient groups of East Asian (i.e., Japanese and Chinese/Taiwanese) with advanced solid tumors that have progressed despite standard therapy or for which no standard therapy exists.


Eligibility: Inclusion Criteria:
  -  confirmed diagnosis of advanced solid tumor (including medulloblastoma and basal cell carcinoma)
  -  blood work criteria
  Exclusion Criteria:
  -  patients with history of brain tumor (except recurrent medulloblastoma) or brain metastases
  -  positive HIV, hepatitis B or C
  -  impaired intestinal function
  -  impaired heart function
  -  pregnant or breast-feeding women
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Treatment of Primary Basal Cell Carcinomas of the Skin With Combination of Topical Imiquimod and Cryosurgery

Summary: The purpose of this study is to evaluate the efficacy of cryosurgery during continuing imiquimod application in the treatment of basal cell carcinoma of the skin.

Detailed description: Evaluation of efficacy:
  -  Number of patient: N=50
  -  Inclusion criteria: Basal cell carcinoma of the skin proven with biopsy
  -  Exclusion criteria: (1) Size of the tumors >2cm; (2) Distance from the eyelid <1cm; (3)Number of tumors >5
  Treatment protocol: Patients will apply imiquimod daily for 14 days on the tumor and a rim of 2mm around the tumor. On day 14 a session of mild cryosurgery (2 cycles of 10-15 seconds, with open spray liquid nitrogen) will be applied and the patients will continue application of imiquimod for another 3 weeks before being evaluated again. Persisting erosion will be considered as persistence of the tumor and imiquimod will be continued for another 3 weeks with/or without a cryosurgery session. The patients will be evaluated at 1,3,6,12 months after discontinuation of imiquimod and yearly thereafter for relapse. In case of clinical relapse, it will be confirmed by biopsy.

Eligibility: Inclusion Criteria:
  -  Basal cell carcinoma of the skin
  -  Size < or = 2cm
  -  Number of tumors < or = 5
  -  Distance from eyelids, mouth >1cm
  Exclusion Criteria:
  -  Size >2cm Number of tumors > 5 Distance from eyelids or mouth < or = 1cm

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

Clinical trial: PEP005 Gel - Evaluation of the Safety and Efficacy of Ingenol Mebutate Gel on a Superficial Basal Cell Carcinoma on the Trunk or Extremities

Summary: This study is primarily designed to investigate whether treatment, once daily for up to three consecutive days, with PEP005 (ingenol mebutate) Gel, 0.05% will be safe and tolerable in patients with superficial Basal Cell Carcinoma (sBCC) lesions on the trunk and extremities.


Eligibility: Inclusion Criteria:
  -  Must be male or female and at least 18 years of age
  -  Female patients must be of: non-childbearing potential or if of childbearing potential then have a negative serum and urine pregnancy test and using effective contraception
  -  Ability to provide informed consent
  -  primary diagnosed and histologically confirmed sBCC located on the trunk or extremities which is suitable for excision
  Exclusion Criteria:
  -  location of the sBCC lesion within 10cm of an incompletely healed wound, on the hand or foot, on the breast of women, on the anogenital area.
  -  Undergone cosmetic or therapeutic procedures within 2cm of the selected treatment area in the 2 weeks prior to the screening visit.
  -  Use of acid-containing therapeutic products within 2 cm of the selected treatment area in the 2 weeks prior to the screening visit
  -  Use of topical moisturisers/creams/lotions (non-medicated/non-irritant salves are acceptable), artificial tanners or topical steroids: within 2 cm of the selected treatment area.
  -  Have received treatment with immunomodulators, or interferon/interferon inducers, systematic medications that suppress the immune system or UVB in the last 4 weeks
  -  Have undergone treatment with 5-FU, imiquimod, diclofenac or photodynamic therapy within 2 cm of the selected treatment area within 8 weeks prior to any screening visit.
  -  Use of systemic retinoids.
  -  Those who are currently participating in any other clinical trial
  -  Those known or suspected of not being able to comply with the requirements of the protocol
  -  Females who are pregnant or are breastfeeding

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

Clinical trial: A Phase II Study of Efficacy and Safety in Patients With Locally Advanced or Metastatic Basal Cell Carcinoma

Summary: This study will assess the efficacy and safety of oral treatment with two dose levels of LDE225 in patients with locally advanced or metastatic BCC.


Eligibility: Inclusion Criteria:
  -  Patients with locally advanced BCC and metastatic BCC
  -  Patients with adequate bone marrow, liver, and renal function
  Exclusion Criteria:
  -  Patients who have had major surgery within 4 weeks of initiation of study medication
  -  Patients unable to take oral drugs or with lack of physical integrity of the upper gastrointestinal tract, or known malabsorption syndromes.
  -  Patients with concurrent medical conditions that may interfere or potentially affect the interpretation of the study.
  -  Patients with neuromuscular disorders or are on concurrent treatment with drugs that may cause muscle damage.
  -  Patients who are on concurrent therapy with other anti-neoplastic agents.
  -  Patients who have taken part in an experimental drug within 4 weeks of initiation of study medication.
  -  Pregnant or nursing (lactating) women
  -  Women of child bearing potential unwilling to use 2 forms of highly effective contraception throughout the study and for 3 months after the last treatment
  -  Fertile males not willing to use condoms throughout the study and for 3 months after the last treatment.
  -  Patients who are unwilling or unable to comply with the protocol.
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Expression Levels of RISC and Microprocessor Complex Components in Epithelial Skin Cancer

Summary: MicroRNAs (miRNAs) are very small endogenous RNA molecules about 22-25 nucleotides in length, capable of post-transcriptional gene regulation. miRNAs bind to their target messenger RNAs (mRNAs), leading to cleavage or suppression of target mRNA translation based on the degree of complementarity. miRNAs have recently been shown to play pivotal roles in diverse developmental and cellular processes and linked to a variety of skin diseases and cancers. In the present study, the investigators examines the expression profiles of the microprocessor complex subunit DGCR8 and the RISC components TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT in epithelial skin cancer and its premalignant stage.

Detailed description: Patients with premalignant actinic keratoses, basal cell carcinomas and squamous cell carcinomas were included in the study. Punch biopsies were harvested from the center of the tumors, from sites of healthy skin and a healthy control group. DGCR8, TARBP1, TARBP2, argonaute-1, argonaute-2 and PACT mRNA expression levels were detected by quantitative real-time reverse transcriptase polymerase chain reaction.

Eligibility: Inclusion Criteria:
  -  epithelial skin cancer
  Exclusion Criteria:
  -  other known previous malignancies

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

Clinical trial: Efficacy, Safety and Pharmacokinetics of Oral LDE225 in Treatment of Patients With Nevoid Basal Cell Carcinoma Syndrome (NBCCS)

Summary: This was a phase II, double-blind, randomized, proof-of-concept, dose-ranging trial evaluating the efficacy, safety and pharmacokinetics of oral LDE225 in treatment of adult patients with NBCCS. This was an exploratory study designed to demonstrate preliminary efficacy of LDE225 in this indication. This study included a Screening period of approximately 4 weeks, treatment period duration of 12 weeks with initial follow-up of approximately 6-8 weeks followed by a long-term follow-up period.


Eligibility: Inclusion Criteria:
  -  Patients with multiple basal cell carcinomas (at least two) and typical presentation of NBCCS.
  -  Female patients must be women of non-childbearing potential (WONCBP).
  Exclusion Criteria:
  -  Use of any topical treatment to treat BCCs, including prescription and over the counter in the 4 weeks prior to first dose of study drug.
  -  Use of photodynamic therapy (PDT), radiation or systemic treatment known to affect BCCs or neoplasm in the 12 weeks prior to first dose of study drug.
  -  Patients receiving medications that are recognized to cause rhabdomyolysis or patients with a prior history of rhabdomyolysis.
  -  Patients with a histologically confirmed diagnosis of locally advanced or metastatic BCC.
  Other protocol-defined inclusion/exclusion criteria may apply

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

Clinical trial: Rates of Positive Basal Cell Carcinomas (BCCs) in Re-excisions

Summary: Basal Cell Carcinoma (BCC) is the most common malignant growth in the world. Treatment is primarily surgical with the goal of excising the growth in its entirety. When pathology results show that this has not been achieved, a re-excision is routinely performed. This study examines retrospectively the percentage of re-excisions of BCC that actually proved to be positive (exhibited growth) among those re-excisions performed at Rambam Healthcare Campus and Zvulun Community Medical Center during the years 2008-10.


Eligibility: Inclusion Criteria:
  All patients that underwent an incomplete BCC excision during the years 2008-2010.
  Exclusion Criteria:
  Patients that underwent an incomplete BCC excision and were subsequently referred to undergo a MOHS procedure.

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

Clinical trial: Development of a Nanosecond Pulsed Electric Field System to Treat Skin Cancer

Summary: Human Basal Cell Carcinomas (BCCs) can be ablated by treating them with nanosecond pulsed electric fields (nsPEF)

Detailed description: The purpose of this study is to determine if low energy, non-thermal, 100 ns pulses can ablate BCCs. The investigators consider this a non-significant risk study because our PulseCure system only applies 0.4 watts to the skin compared to the 40 watts applied by the currently used electrosurgical unit to remove skin lesions, the Hyfrecator. Since the PulseCure applies 1/100 of the energy and does not even heat the skin significantly, it represents a non-significant risk to the patient. Our study will provide the first data on the response of BCCs to these 100 ns pulses. The investigators will first treat three BCCs on BCNS patients with different pulse numbers to determine the pulse number needed to ablate. Once the investigators have the optimal pulse number, the investigators will use it to treat 20 normal patients with sporadic BCCs on their trunks. This should provide sufficient data to conclude whether or not nsPEF can ablate BCCs on normal individuals.

Eligibility: Inclusion Criteria:
  1. Study subjects must have had diagnosed at least one BCCon their trunk
  2. The subject is from 18-75 years of age, inclusive.
  3. The subject must sign and date all informed consent statements.
  Exclusion Criteria:
  1. The subject is exhibiting signs of a bacterial or viral infection, including fever.
  2. The subject is unwilling to allow a biopsy of a malignant lesion for histological analysis.
  3. The subject has a pace maker or other electronic device implanted

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

Clinical trial: New Versus Approved Methyl-aminolevulinate Photodynamic Therapy (MAL-PDT) Regime in Basal Cell Carcinoma (BCC)

Summary: Basal cell carcinoma (BCC) is the most common malignant skin lesion in white adults. It is a slow-growing tumour which despite low metastatic potential may cause significant local tissue destruction and patient morbidity. Methyl aminolevulinate cream plus photodynamic therapy (MAL-PDT) for BCC is currently approved for a procedure using 2 treatment sessions 1 week apart. This procedure is considered quite time- and resource-consuming. Introducing a single treatment session, with a new PDT session for treatment failures after 3 months, might represent an attractive simplification.
  This randomised controlled single-blinded multi-centre study primarily aims to compare BCC lesion response rate of two treatment schedules: (a) 1 single treatment of Metvix-PDT with re-treatment of non-complete responders by 3 months, and (b) the usual schedule of 2 standard Metvix(R) PDT treatments 1 week apart.
  Secondary objectives are to investigate the treatment response in relation to clinical and histological tumour characteristics such as tumour thickness, subtype and immunohistochemical markers.


Eligibility: Inclusion Criteria:
  -  male/female above 18 years of age
  -  written informed consent
  -  1 or more primary histologically verified BCC, clinically assessed as of either superficial of nodular type
  Exclusion Criteria:
  -  pregnancy
  -  breastfeeding
  -  Gorlin's syndrome
  -  porphyria
  -  xeroderma pigmentosum
  -  history of arsenic exposure
  -  known allergy to MAL
  -  concomitant treatment with immunosuppressive medication
  -  physical or mental conditions that most likely will prevent patients attending follow-up sessions

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

Clinical trial: Microarray Analysis of microRNA Expression in Basal Cell Carcinoma

Summary: Perturbations in microRNA (miRNA) expression profiles has been reported for a variety of cancers. This study will be an exploratory analysis of miRNA expression in basal cell carcinoma by miRNA expression profiling using microarrays.

Detailed description: Perturbations in the expression profiles of microRNAs (miRNAs) have been reported for a variety of different cancers. Basal cell carcinoma (BCC) of the skin has not been systematically evaluated regarding differentially expressed miRNAs. Patients with BCC are included in the study to perform an exploratory analysis by miRNA expression profiling using microarrays. Expression levels of miRNA candidates will be validated by TaqMan real-time quantitative polymerase chain reaction (RT-PCR).

Eligibility: Inclusion Criteria:
  -  Basal Cell Carcinoma
  Exclusion Criteria:
  -  Other Skin Cancer than Basal Cell Carcinoma

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

Clinical trial: An Observational Study of Treatment Patterns and Effectiveness and Safety Outcomes in Advanced Basal Cell Carcinoma and Basal Cell Carcinoma Nevus Syndrome Patients(RegiSONIC)

Summary: This multi-center, prospective, observational cohort study will evaluate the effectiveness, safety and utilization of treatments in patients with advanced basal cell carcinoma and basal cell carcinoma nevus syndrome. The total study duration is anticipated to be a maximum of 8 years, including 3 years for patient recruitment and 5 years follow-up.


Eligibility: Inclusion Criteria:
  -  Adult patients, >/= 18 years of age
  -  Patients with basal cell carcinoma (BCC) who meet either of the following definitions:
  -  Patients who were determined with advanced disease (aBCC) within 90 days prior to study enrollment, have not been diagnosed with basal cell carcinoma nevus syndrome (BCCNS) and have not been treated with an investigational or approved hedgehog pathway inhibitor
  -  Patients with aBCC who have not been diagnosed with BCCNS and who were previously treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)
  -  Patients with BCCNS who either have aBCC or multiple BCCs of any stage as defined by protocol (may include patients previously enrolled in Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP))
  Exclusion Criteria:
  -  Participation in a clinical trial within 90 days prior to study enrollment that has either involved treatment of aBCC or involved treatment with an investigational or approved hedgehog pathway inhibitor, except for patients treated with vismodegib as part of Genentech study SHH4476g, SHH4437g, or SHH4811g (EAP)

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

Clinical trial: Concurrent Treatment of Squamous Cell Carcinoma or Adenocarcinoma of the Cervix With CIGB-300 for Local Application

Summary: They include patients who are candidates to complete concurrent treatment with endocavitary brachytherapy External radiation therapy + more QT based weekly cisplatin.


Eligibility: Inclusion Criteria:
  -  Stages IIA and IIB FIGO classification.
  -  Age between 21 to 70 years.
  -  ECOG performance status 0-1.
  -  No history of another neoplastic disease.
  -  Value of Hemoglobin ≥ 9 g / l.
  -  Total leukocyte count ≥ 3.0 x 109 / L.
  -  Absolute neutrophil count ≥ 1.5 x 109 / L.
  -  Platelets ≥ 100,000 x mm3.
  -  Total bilirubin ≤ 1.5 times ULN, SGOT and SGPT ≤ 2.5 times upper limit of normal.
  -  Creatinine ≤ 2 mg / dL and creatinine clearance calculated ≥ 60 ml / min(according to Cockcroft-Gault formula)
  -  Patients of childbearing age who are using an adequate contraception method during treatment to prevent pregnancy.
  -  Life expectancy ≥ 12 months
  -  Measurable disease
  -  Informed consent signed by the patient
  Exclusion Criteria:
  -  Pregnancy and lactation period.
  -  Presence of lymph node metastases or hematogenous extrapelvic known.
  -  Uncontrolled intercurrent diseases, including active infection, symptomatic congestive heart failure, unstable angina or cardiac arrhythmia and psychiatric illness involving incompetence of the patient.
  -  Other malignancies, with the exception of basal cell carcinoma or other tumor that appropriate treatment is received showing a disease-free period ≥ 5 years.
  -  Hepatitis B or C active, positive serology for HIV.
  -  Atopy history of severe / severe asthma.
  -  A history of autoimmune disease.
  -  Presence of significant abnormalities in ECG performed within 14 days prior to admission.
  -  Diseases that prevent the patient give informed consent or their ability to collaborate in the trial.
  -  Participating in another clinical trial "

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

Clinical trial: Leptin Levels in Papillary Thyroid Cancer

Summary: The purpose of this study is to evaluate Leptin levels in females, in the setting of papillary thyroid cancer, benign thyroid nodules, and in normal females without thyroid disease.

Detailed description: There will be three groups in this study, but 2 of the groups are part of another study so will only recruit normal controls.

Eligibility: Inclusion Criteria:
  -  Female
  -  Age>/- 19
  -  Not currently pregnant or lactating
  -  Normal thyroid gland by history
  Exclusion Criteria:
  -  Male Gender
  -  Pregnancy
  -  Lactation
  -  Age below 19
  -  Abnormal thyroid gland by history
  -  Abnormal thyroid gland by structure using ultrasound
  -  Abnormal thyroid gland by function using TSH, Free T4

Relevance to patient case: not relevant