araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: An Analysis of the Response of Human Tumor Microvascular Endothelium to Ionizing Radiation

Summary: Doctors will take some tissue from the tissue removed during surgery in order to study how the blood vessels of the tumor respond to radiation therapy. The tissue obtained will be used to determine how these tumor blood vessels respond to radiation therapy delivered to the tumor, after it has been removed. This radiation is delivered in the research lab. This research is being conducted in order to develop new methods to treat tumors by radiation therapy. No additional surgery will be performed to obtain these samples, and only materials that remain after all diagnostic testing has been completed will be used.

Detailed description: The goal of this study is to determine if concepts established in mouse models of the tumor microvascular response to ionizing radiation (IR) therapy are applicable to human tumors in order to begin to establish that the engagement of the endothelial response is a valid target for IR in human tumors. A portion of tumor will be isolated from individuals who have signed informed consent for this protocol and are undergoing surgery on the Neurosurgery, Colorectal, and Gynecology, Head and Neck, Urology, and Hepatobiliary Services at Memorial Sloan-Kettering Cancer Center. Tumor tissue will be obtained from the surgical sample in pathology after adequate specimens have been obtained for diagnostic purposes. Tumor tissue will be irradiated ex vivo and the microvascular endothelial response will be determined. From specimens of adequate size, a pure tumor endothelial cell population will be isolated and the response to IR will be determined.
  Primary Outcomes:
  -  To determine if human tumor microvascular endothelium displays similar dose parameters as mouse tumor endothelium.
  Secondary Outcomes:
  -  To determine if tumor endothelium isolated to near homogeneity demonstrates dose parameters similar to those used in single dose radiotherapy of brain tumors.
  -  To determine if the microvascular endothelium of tumors of different types behaves in a similar fashion in its response to IR.

Eligibility: Inclusion Criteria:
  -  Patients who are felt to have adequate tumor volume for these studies, at least a 2 x 2 x 2 cm3 tumor by physical exam, imaging studies or colonoscopy reports
  -  Primary or recurrent tumors are eligible
  -  Patients must be suitable candidates for surgery
  -  Patients who have signed the informed consent
  Exclusion Criteria:
  -  Patients who are not considered suitable candidates for surgery
  -  Patients who have received prior radiation therapy to the tumor being removed
  -  Patients who have received chemotherapy within 6 months of tumor removal
  -  Patients who are pregnant
  -  Patients may choose to be excluded at any time
  -  Minors are excluded from this study because there are expected to be very few minors with the tumor types which the investigators are evaluating in this study

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: A Study Of Oral Palbociclib (PD-0332991), A Cyclin-Dependent Kinase Inhibitor, In Patients With Advanced Cancer

Summary: PD-0332991 may work in cancer by stopping cancer cells from multiplying. PD-0332991 is in a new class of drugs called cyclin-dependent kinase (CDK inhibitors). This research study is the first time that PD-0332991 will be given to people. PD-0332991 is taken by mouth daily.


Eligibility: Inclusion Criteria:
  -  Advanced solid tumors (excluding SCLC and retinoblastoma) or follicular of diffuse large cell non-Hodgkin's lymphoma, histologically or cytologically proven at diagnosis which is refractory to or intolerant of established therapy know to provide clinical benefit for their condition; tumors must express Rb
  -  Adequate blood cell counts, kidney function and liver function and and ECOG score of 0, 1, or 2.
  -  Patients may have to have tumor biopsy before and after treatment.
  Exclusion Criteria:
  -  Prior stem cell or bone marrow transplant
  -  Uncontrolled infection, unstable or sever intercurrent medical condition, or current drug or alcohol abuse
  -  Active or unstable cardiac disease or history of heart attack within 6 months

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Gatekeeper European 005

Summary: Evaluation of the Gatekeeper System in the treatment of patients with Gastroesophageal Reflux Disease (GERD) who already have been treated under study protocols Endo 2000-03 and Endo 2000-04


Eligibility: Inclusion Criteria:
  -  Subjects must have been part of the Endo 2000-03 or Endo 2000-04 clinical study
  -  Subjects who have been informed of the nature of the long-term follow-up study and have agreed to its participation and provided Informed Consent
  Exclusion Criteria:
  -  Underwent another endoscopic or surgical treatment for GERD (except re-intervention with Gatekeeper)
  -  Developed other medical illness that may cause the subject to be non-compliant
  -  Extensive Barrett's Esophagus (>2 cm)
  -  Unable or unwilling to cooperate with the study procedures

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: An Open-Label Study of Once-Daily Oral Administration of Esomeprazole 40 mg in Patients With Symptoms of Gastroesophageal Reflux Disease (GERD)

Summary: The purpose of this study is to evaluate whether there is a difference in proportion of patients with resolution of heartburn and other symptoms related to gastroesophageal reflux disease (GERD) after four weeks of treatment with esomeprazole (NEXIUM®) in those subjects with Erosive Esophagitis (EE) and those without EE.


Eligibility: Inclusion Criteria:
  -  Symptoms of GERD as defined in this protocol: Heartburn (severity of mild, moderate or severe) 2 or more times in the 7 days prior to the Screening visit (Visit 1) and, on average, at least 2 times per week over the past 3 months.
  -  Male or female, 18 to 70 years old, inclusive.
  -  Non-pregnant, non-lactating female patients. Female patients must be postmenopausal, surgically sterile, or using a medically acceptable form of birth control, as determined by the investigator. Females of childbearing potential must agree to continue using an acceptable form of birth control throughout the conduct of the study.
  -  Negative urine pregnancy test for females of childbearing potential.
  -  Willingness to adhere to all protocol requirements.
  Exclusion Criteria:
  -  Previous enrollment in the present study.
  -  Significant clinical illness within 2 weeks prior to the first dose of study medication or a significant illness during the study.
  -  Use of a PPI, including PRILOSEC OTC®, within 21 days of Screening (Visit 1) or at anytime during the study (Visit 1 through Visit 4).
  -  Daily therapy with an H2 RA within 14 days of Screening (Visit 1): eg, ranitidine (ZANTAC®), cimetidine (TAGAMET®), nizatidine (AXID®), famotidine (PEPCID®) (occasional use; ie, less than daily, is permitted).
  -  Use of H2 RAs at any frequency are prohibited throughout the entire study (Visit 1 through Visit 4).
  -  A history of gastric or esophageal surgery (including, but not limited to, Nissen fundoplication and bariatric surgery), except for simple closure of a perforated ulcer or procedures that would not affect the study as determined by the Clinical Study Team physician at AstraZeneca.
  -  Clinically significant gastrointestinal (GI) bleeding (eg, melena, frank hematochezia) within 3 days of Screening (Visit 1) or noted at the time of baseline EGD.
  -  Non-acid related etiologies of esophagitis (eg, pill-induced, caustic ingestion or eosinophilic esophagitis).
  Generalized bleeding disorders resulting from hemorrhagic diathesis (such as abnormalities in clotting factors or platelets).

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Study Evaluating Pantoprazole Sodium Enteric-Coated Spheroid Suspension In Infants With Presumed GERD

Summary: The purpose of this study is to characterize the pharmacokinetic (PK) and pharmacodynamic (PD) profiles to determine the safety and tolerability of single and multiple doses of pantoprazole in infants aged 1 through 11 months.


Eligibility: Inclusion Criteria:
  -  Greater than 44 weeks beyond neonatal period but less than 12 months
  -  Presumptive diagnosis of GERD
  -  Weight greater than 2.5 kg but less than 15 kg
  Exclusion Criteria:
  -  History of gastrointestinal (GI) disorders, ie, unrepaired tracheal esophageal fistula, GI malabsorption
  -  Clinically significant medical or surgical abnormalities

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Symptom Assessment in Adult Patients With Erosive GERD (Gastroesophageal Reflux Disease) or enGERD (Endoscopic-negative GERD) After Treatment With Pantoprazole (BY1023/M3-343)

Summary: The aim of this study is to compare investigator and patient-assessed gastroesophageal reflux disease symptoms in patients with erosive GERD or endoscopic-negative GERD (enGERD). An endoscopy will be performed at study start and study end. During the study, the patients will complete a patient-orientated, self-assessed reflux questionnaire (ReQuest™ questionnaire). The study duration consists of a baseline period (8 days) and treatment period (28 days). Pantoprazole (tablet) will be administered once daily at one dose level. The study will provide further data on safety and tolerability of pantoprazole.


Eligibility: Main Inclusion Criteria:
  -  Written informed consent
  -  Outpatients
  -  History of GERD-related symptoms for at least 6 months prior to study inclusion
  -  Endoscopically confirmed erosive GERD or non-erosive GERD
  Main Exclusion Criteria:
  -  Acute peptic ulcer and/or ulcer complications
  -  PPIs during last 7 days prior to study start
  -  Systemic glucocorticoids or non-steroidal anti-inflammatory drugs including COX-2 inhibitors during the last 28 days prior to study start; except regular intake of acetylsalicylic acid up to a daily dose of 163 mg/day
  -  Intake of PPIs in combination with antibiotics for eradication of H. pylori

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Genetic Analysis of Familial Melanoma

Summary: In collaboration with members of The International Melanoma Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2 or p16) gene, or the cyclin-dependant kinase 4 (CDK4). CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

Detailed description: In collaboration with members of The International Melanoma Genetics Consortium, we propose to study melanoma in families lacking mutations in the cyclin-dependent kinase inhibitor 2 (CDKN2A), or the cyclin-dependant kinase 4 (CDK4) genes. CDKN2 and CDK4 are both genes that encode presumed tumor suppressor genes, mutant forms of which are known to cause increased susceptibility to melanoma. The purpose of the present study then is to confirm the existence of and to identify additional gene(s) involved in heritable melanoma (cutaneous and ocular) and their precursor lesions (atypical nevi) by linkage analysis and gene mapping strategies. It is clear that the risk to develop atypical nevi and/or melanoma is strongly influenced by genetic and environmental factors (e.g. sun exposure). Characterization of such genes could provide important insights into the inheritance, pathogenesis, and treatment of this increasingly important disease.

Eligibility: -  INCLUSION CRITERIA:
  Inclusion into this study was restricted to families containing at least three CMM cases with DNA available for genotyping, and CDKN2A and CDK4 involvement and had been excluded.
  All families must be mutation negative for both CDKN2A and CDK4.
  This study will also include families with at least one case of ocular and two cases of other cutaneous melanomas, or at least 2 ocular melanomas (except where they occur in parent and child).
  EXCLUSION CRITERIA:
  Any family showing evidence of haplotype sharing in the 9p21-p22 region, where CDKN2A is located, was also excluded.

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Studying Genes to Identify Melanoma in Patients in Iceland and Their Family Members

Summary: RATIONALE: Studying the genes expressed in samples of blood from patients with cancer and their family members may help doctors identify biomarkers related to cancer.
  PURPOSE: This clinical trial is studying genes to identify melanoma in patients in Iceland and their family members.

Detailed description: OBJECTIVES:
  -  Assess the feasibility of Iceland Genomics Corporation (UVS) to identify melanoma in multiple-case families, individuals with multiple tumors, and selected additional family members in Iceland.
  -  Assess the feasibility of mutation detection using sequencing and HPLC.
  -  Determine UVS' ability to create datasets with demographic, epidemiologic and molecular data.
  OUTLINE: Participants and patients undergo blood collection and complete lifestyle questionnaires. All patients and population-based controls have DNA samples sequenced for MC1R. Demographic and epidemiologic data on all study participants is collected. Sequencing of the major melanoma susceptibility genes CFDKN2A, CDK4, and MC1R is also performed.

Eligibility: DISEASE CHARACTERISTICS:
  -  Patients diagnosed with melanoma and selected family members are eligible to participate
  -  Must live in Iceland
  PATIENT CHARACTERISTICS:
  -  Not specified
  PRIOR CONCURRENT THERAPY:
  -  Not specified

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Study Evaluating Pantoprazole in Neonates and Preterm Infants With GERD

Summary: The purpose of this study is to determine whether or not consistent drug levels can be achieved in infants with presumed Gastroesophageal Reflux Disease.


Eligibility: Inclusion Criteria:
  -  Hospitalized patients
  -  Presumed diagnosis of GERD
  -  Term or post-term infants within the neonatal period less than 28 days or preterm infants with a corrected gestational age of less than 44 weeks
  Exclusion Criteria:
  -  cardiovascular instability
  -  clinically significant laboratory abnormalities
  -  use of warfarin, carbamazepine, phenytoin, or rifampin

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Study Evaluating the Efficacy and Safety of Pantoprazole in Infants With Symptomatic Gastroesophageal Reflux Disease (GERD)

Summary: To assess the efficacy of pantoprazole for the treatment of infants with symptomatic Gastroesophageal Reflux Disease (GERD).


Eligibility: Inclusion Criteria:
  -  term or post term infants beyond the neonatal period of an age greater than 28 days but less than or equal to 11 months
  -  clinical diagnosis of GERD
  -  weight greater than 2.5 kg and less than or equal to 15 kg
  Exclusion Criteria:
  -  known history of upper GI anatomic disorders
  -  history of acute life-threatening medical conditions
  -  clinically significant medical conditions or laboratory abnormalities

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Study Evaluating Pantoprazole in Adolescents With GERD

Summary: The purpose of this study is characterize the PK profile of single and multiple doses of pantoprazole in adolescents aged 12 to 16 years with Gastroesophageal Reflux Disease (GERD).


Eligibility: Inclusion Criteria:
  -  12-16 years old
  -  clinical diagnosis of GERD
  -  ability to swallow tablets
  Exclusion Criteria:
  -  GI or malabsorption disorders
  -  chronic use of warfarin
  -  positive pregnancy test

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Evaluation of 24-Hour Intragastric pH Using Esomeprazole, Lansoprazole, and Pantoprazole in Hispanic Patients With GERD

Summary: This study will be conducted in order to determine safety and efficacy esomeprazole, lansoprazole and pantoprazole control stomach acid by measuring the stomach acid in men and women of Hispanic origin who have GERD.


Eligibility: Inclusion Criteria:
  -  Signed informed consent
  -  Males and females ages 18-69 who are of Hispanic origin
  -  Symptoms of GERD, defined as heartburn at least 2 times a week on average over the last 3 months
  Exclusion Criteria:
  -  Female patients who are pregnant or breastfeeding
  -  Known intolerance or lack of response to Proton Pump Inhibitors (PPIs) such as Nexium, Prevacid, or Protonix
  -  Current or relevant history of non-healed ulcers, stomach surgery, or esophageal surgery

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Deoxycholic Acid Injection for the Treatment of Superficial Lipomas

Summary: The purpose of this research is to compare the safety and effectiveness of 4 different concentrations of deoxycholic acid injection against a placebo in the treatment of superficial lipomas.

Detailed description: A lipoma is a fatty lump typically located on the trunk, shoulder, arms or legs. For the purposes of this study, only lipomas on the trunk, arms, legs, or neck were treated. (Lipomas on the face, wrists, hands, lower portion of the spine, genitals, ankles, or feet were not treated.)

Eligibility: Inclusion Criteria:
  -  One or more lipomas, based on clinical diagnosis, which are accessible for treatment and assessment, are quantifiable along at least 2 perpendicular diameters, and have the following characteristics:
  -  History of slow growth followed by dormancy, and stable for at least 6 months.
  -  Greatest length by greatest perpendicular width between 1 and 16 square centimeters, inclusive
  -  Discrete, oval to rounded in shape, not hard or attached to underlying tissue
  -  Located on the trunk, arms, legs, or neck
  -  Stable body weight with a body mass index of less than 30 kg/m²
  -  Signed informed consent
  Exclusion Criteria:
  -  Absence of significant medical conditions that could affect safety
  -  History of surgical treatment for lipomas
  -  Treatment with an investigational agent within 30 days before ATX-101 treatment

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Efficacy and Safety of Esomeprazole Once Daily for the Treatment of GERD in Neonatal Patients

Summary: The purpose of this study is to assess the difference between esomeprazole and placebo in the treatment of signs and symptoms as observed by 8-hour video and cardiorespiratory monitoring in neonatal patients.


Eligibility: Inclusion Criteria:
  -  Full-term or gestational age >/= 28 to 44 weeks
  -  In-patient in Neonatal Intensive Care Unit, special care nursery, or equivalent
  -  Patient must be on a stable mode of feeding or with minimal variations for at least 2 days prior to randomization
  Exclusion Criteria:
  -  Patients with a need for resectional or reconstructive surgery of the gastrointestinal tract
  -  Patients with any condition that may require surgery during the course of the study
  -  Patients with acute respiratory distress within 72 hours prior to enrollment

Relevance to patient case: not relevant
Patient case: 38-year-old male with Liposarcoma. Genetic variant: CDK4 Amplification. Other conditions: GERD.

Clinical trial: Nexium (Esomeprazole) in Symptom Adapted Therapy in GERD Patients

Summary: To compare the efficacy of three different long-term treatment strategies of reflux disease in primary care setting.


Eligibility: Inclusion Criteria:
  -  Subjects who seek medical advice in primary care for symptoms thought to be GERD related (GERD is a condition which develops when the reflux of stomach content causes troublesome symptoms and / or complications).
  Exclusion Criteria:
  -  Subjects with any clinical GERD treatment (PPI, H2-receptor antagonists) within the last 3 months prior to Visit 1.
  -  A history of severe esophagitis or known other complications, with alarm symptoms

Relevance to patient case: not relevant