araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Study of the KineSpring® System to Evaluate Symptom Relief in Patients With Medial Knee Osteoarthritis

Summary: The purpose of this pilot study is to collect data on the safety and effectiveness of the KineSpring System in patients with primarily unicompartmental medial knee osteoarthritis.

Detailed description: The KineSpring System is indicated to treat symptoms of pain and loss of knee function in patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee. The KineSpring System is indicated for patients with osteoarthritis of severity that does not require knee joint replacement.

Eligibility: Inclusion Criteria (Significant criteria only. Others also apply):
  -  Patients with symptoms of knee pain and loss of knee function.
  -  Patients with a diagnosis of osteoarthritis or post-traumatic osteoarthritis in the medial compartment of the knee.
  -  Radiographic confirmation of mild to moderate medial compartment knee OA
  Exclusion Criteria (Significant criteria only. Others also apply):
  -  Patients that that require knee joint replacement.
  -  Symptomatic OA in lateral compartment or patellofemoral compartment.
  -  Known sensitivity to metals including cobalt, chromium, iron, or nickel
  -  Rheumatoid arthritis, other forms of inflammatory joint disease

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Vitamin D Supplementation in Cutaneous Malignant Melanoma Outcome

Summary: To assess whether vitamin D supplementation after surgery of a first cutaneous malignant melanoma protects against relapse of the disease.

Detailed description: To assess whether vitamin D supplementation, in the follow up period after diagnosis and surgery of a first cutaneous malignant melanoma, has a protective effect on relapse of cutaneous malignant melanoma and whether this protective effect correlates with vitamin D levels in serum and vitamin D receptor (VDR) immunoreactivity in the primary tumor.

Eligibility: Inclusion Criteria:
  1. Older than 18 years and younger than 80 years of age.
  2. Histologically proven malignant melanoma, stage one B (IB) to three (III) Not participating in other clinical trial.
  3. The only treatment for melanoma is surgical treatment.
  4. Complete resection of melanoma.
  5. Single primary invasive cutaneous melanoma
  6. Signed ethical committee approved informed consent
  7. Serum phosphate, serum calcium at the entry of the study within normal limits of laboratory reference
  Exclusion criteria
  1. Pregnant/lactating women or planning on becoming pregnant during the study
  2. Known hypersensitivity to vitamin D or its components.
  3. Pre-existing renal stone disease, chronic renal disease with glomerular filtration rate (eGFR) < 30 mL/min/1.73 m2 or renal dialysis.
  4. Liver failure or chronic liver disease with liver enzymes > 2 fold upper limit of normal (ULN).
  5. History of parathyroid disease or granulomatous disease (TBC and sarcoidosis)
  6. History of malabsorption syndrome or any medical condition that might interfere with vitamin D absorption.
  7. History of small intestine resection.
  8. History of other malignancy within the last 5 years except for carcinoma in situ of the cervix or basal cell carcinoma or squamous cell carcinoma of the skin or in situ malignant melanoma.
  9. Chronic alcohol abuse.
  10. Medical or logistic problems likely to preclude completion of the study.
  11. Taking medication that predisposes to hypercalcemia (digoxin, lithium, thiazide diuretics) or taking medication that would affect metabolism of vitamin D (anticonvulsants, corticosteroids, H2-receptor antagonists)
  12. Intake of vitamin D supplements within 6 months prior to entry of the study.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Clinical and Histopathologic Characteristics of BAP1 Mutations

Summary: The goal of this protocol is to determine the prevalence of somatic and germline mutations in BAP1 (BRCA associated protein-1) among patients with mesothelioma , choroidal nevus, primary uveal melanoma (UM), or metastatic UM seen at our institution.


Eligibility: Inclusion Criteria:
  All consents:
  -  > or = to 18 years of age
  -  Ability to provide informed consent
  Consent 1:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  Consent 2:
  Mesothelioma
  -  Histologically proven diagnosis of Mesothelioma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Age<50 at diagnosis
  -  No history of asbestos exposure
  -  Personal history of choroidal nevus, uveal melanoma, melanoma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Choroidal nevus
  -  Diagnosis of choroidal nevus by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography AND one of the following:
  -  More than one clinical risk factor, which may include: orange pigment, thickness > 1 < 2.5mm
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma OR Primary uveal melanoma
  -  Diagnosis of uveal melanoma by direct examination and/or ultrasound/optical coherence tomography and possibly fluorescein angiography
  AND one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma, renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives OR Metastatic uveal melanoma
  -  Histologically proven diagnosis of metastatic uveal melanoma AND
  -  BAP1 mutation or loss of expression identified in tumor sample
  OR one of the following:
  -  Personal history of uveal melanoma, skin melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  Family history of choroidal nevus, uveal melanoma, mesothelioma renal cell carcinoma, or cholangiocarcinoma
  -  History of malignancy in more than two first-degree relatives
  Consent 3:
  -  Relative of patient with germline BAP1 mutation identified through identified testing
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Differential Plasma MicroRNA Profiles in ED and Normal Erectile Function in Older Males

Summary: Erectile dysfunction (ED) is strongly associated with aging. With the rapidly expanding aging population and the increase in life expectancy, an increase in the prevalence of ED is expected in the years to come. Currently, the mechanism of ED is not fully understood. MicroRNAs (MiRNA) are endogenous small RNA molecules that control gene expression post-transcriptionally. It has been included in many in vitro physiology and pathophysiology processes, which also involved in the process of ED. This research was designed to investigate the differential plasma MiRNA profiles in ED and normal erectile function in older males. The results might tell us which MiRNA and how did it involved in the process of ED in aging.


Eligibility: Inclusion Criteria:
  -  older males with erectile dysfunction
  Exclusion Criteria:
  -  have some other general diseases, e.g. hypertension, vascular diseases, depression, chronic kidney disease, diabetes.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Prognostic Value of CTC in HNSCC Patients

Summary: We hypothesized that the number of circulating tumor cells (CTCs) and molecular markers on CTCs could be a prognostic factor or predictive factor to patients with head neck cancer.

Detailed description: 1. Histologically or cytopathologically proven head and neck squamous cell carcinoma (HNSCC)
  2. Disease status: locally advanced or recurrent/metastasized at initial presentation
  3. Age >=20 years old
  4. Could understand and signed the informed consents of this study
  5. Enrolled patients were classified into three distinct subgroups:
  1. Patients underwent curative surgery followed by adjuvant chemoradiotherapy (CRT) because of some pathologic features such as positive margin, pathologic N2, and extracapsular spread (ECS) of involved lymph nodes indicating early relapse according to recommendation from National Comprehensive Cancer Network(NCCN) guidelines;
  2. Patients with advanced disease directly underwent definitive concurrent chemoradiotherapy(CCRT);
  3. Patients were to have palliative chemotherapy for existence of distant metastasis or poor general condition for definitive CCRT.
  6. Blood samples were collected within 7 days before the first dose of chemotherapy.

Eligibility: Inclusion Criteria:
  -  histologically or cytopathologically proven head and neck squamous cell carcinoma Age ≥ 20 years. Measurable or evaluable disease according to Response Evaluation Criteria In Solid Tumors(RECIST) criteria.
  Ability to sign informed consent.
  Exclusion Criteria:
  -  Prior cancers within 5 years, except for non-melanoma skin cancers, and in situ cervical cancers.
  Inability to comply with study and/or follow-up procedures.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: The Effect of Postpartum Pelvic Floor Rehabilitation in Prevention and Treatment of Pelvic Floor Dysfunction

Summary: Pregnancy and childbirth are considered as risk periods for injuries to the pelvic floor and development of pelvic floor dysfunction. This may leed to devastating loss of function and quality of life.The aim of this study is to evaluate the effect of postpartum pelvic floor muscle training with the device "PHENIX Neuromuscular Stimulation Therapy Systems" on the recovery of pelvic floor function for primiparous women.


Eligibility: Inclusion Criteria:
  -  primiparous delivery
  -  term delivery
  -  single childbirth
  -  aged from 18-50yrs
  Exclusion Criteria:
  -  urinary incontinence before pregnancy
  -  fecal incontinence before pregnancy
  -  organ prolapse before pregnancy
  -  history of childbirth or induced labor with pregnancy more than 28 weeks
  -  multiparity
  -  newborn weight less than 2500 grams or more than 4000 grams
  -  precipitate labor
  -  complication of pregnancy
  -  asthma
  -  long-term abdominal pressure(chronic cough>1 month,chronic constipation)
  -  diabetes
  -  sciatica
  -  history of pelvic operation

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Vascular Response to Brachytherapy Using Functional OCT

Summary: The purpose of this study is to learn how blood flows to tumors in patients treated with I-125 plaque brachytherapy for uveal melanoma.

Detailed description: Despite having excellent local tumor control rates, uveal melanoma remains a life-threatening cancer, and even eye-sparing therapy with radiation treatment often leads to significant loss of vision. Major challenges to providing care to patients with uveal melanoma include the inability to accurately predict long-term vision in an eye treated with radiation, due to a poor understanding of the nature of radiation retinopathy and optic neuropathy. Optical coherence tomography (OCT) is a commonly used ophthalmic imaging modality that provides precise, real-time data in vivo in a non-invasive manner. Our research group has recently developed two novel functional OCT technologies: (1) Doppler OCT to quantitatively measure total retinal flow and (2) OCT angiography technology to map optic nerve head, retinal, and choroidal blood flow with unprecedented accuracy. The investigators believe this technology can be utilized to improve understanding of radiation-induced vascular changes in the optic nerve and retina that cause vision loss in patients treated with radiation, as well as provide a tool to monitor tumor response to treatment.
  In this study, the investigators intend to utilize these novel functional OCT technologies to describe the changes over time in optic nerve head and retinal blood flow after I-125 radiation therapy, and to evaluate the relationship between changes in flow and decreased vision. The investigators will also study the association between changes in flow and the total radiation doses received by the optic nerve head and macula, which varies based upon tumor location and size.

Eligibility: Inclusion Criteria:
  -  Adults age 18 and older with uveal melanomas involving the ciliary body and/or the choroid undergoing I-125 plaque brachytherapy.
  Exclusion Criteria:
  -  Inability to give informed consent.
  -  Inability to maintain stable fixation for OCT imaging
  -  Significant renal disease, defined as a history of chronic renal failure requiring dialysis or kidney transplant
  -  A condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).
  -  Blood pressure > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, subject can become eligible.
  -  Women who are pregnant or lactating at the time of enrollment due to unknown safety of fluorescein angiography. Women that become pregnant during the course of the study may remain enrolled; however, flurorescein and ICG angiography will not be performed until they are no longer pregnant or nursing an infant.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: French Digestive Polyposis Cohorte Family Adenomatous Polyposis With APC and MYH Gene Mutations , Cowden's Disease With PTEN Gene Mutation, Peutz Jeghers Disease With STK 11 Gene Mutation ,juvénil Polyposis With SMAD 4 Gene Mutation , Serrated and Hyperplastic Polyposis

Summary: French cohorte about polyposis digestive diseases

Detailed description: Family Adenomatous Polyposis APC and MYH Genes Peutz Jeghers Disease Cowden Disease Festooned polyposis Juvenile polyposis Hyperplastic polyposis

Eligibility: Inclusion Criteria:
  -  APC Gene mutation
  -  MYH Homozygote mutation
  -  COWDEN Disease with PTEN gene mutation
  -  Peutz Jeghers Disease with STK 11 gene mutation
  -  Juvenile polyposis with SMAD 4 gene mutation
  Exclusion Criteria:
  -  heterozygote MYH Gene Mutation

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: A Pharmacodynamic Study to Evaluate Neutrophil Distribution Kinetics and Function Following Single-Dose RoActemra/Actemra (Tocilizumab) in Healthy Volunteers

Summary: This Phase IV, single-blind , randomized, two-arm study will explore the pharmacodynamics effects of RoActemra/Actemra (tocilizumab) on neutrophil redistribution, function and survival in healthy subjects. Subjects will receive either a single dose of intravenous (IV) RoActemra/Actemra at a dose of 8 mg/kg over one hour on study Day 0 or placebo. Neutrophil kinetics data will be collected for all subjects up to Day 10 of the study. Following the last study visit on Day 10, all subjects will attend two further safety follow-up visits on Day 28 and Day 56.


Eligibility: Inclusion Criteria:
  -  Male aged between 18 and 65 years inclusive
  -  Healthy as determined by screening assessments
  -  Body mass index (BMI) 18 to 30 kg/m2 inclusive
  -  Non-smoker
  -  Must agree to use a barrier method of contraception supplemented with spermicide during the treatment period and for at least 150 days after the last dose of study drug
  Exclusion Criteria:
  -  Participation in a clinical study with an investigational drug within 3 months or at least 5 half-lives (whichever is longer) prior to dosing
  -  Current or past history of smoking within 6 months
  -  Previous exposure to therapeutic monoclonal antibodies in the past 6 months prior to screening
  -  Current or clinically significant history of any condition that, in the opinion of the investigator, would: place the subject at undue risk; invalidate the giving of informed consent; interfere with PK or PD data; or interfere with the ability of the subject to complete the study
  -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  -  Any recurrent infections; infection requiring antibiotic treatment in the 6 weeks prior to dosing; mononucleosis in the 6 months prior to dosing; known HIV, Hepatitis B, or Hepatitis C; or active infection at the time of screening
  -  Active tuberculosis (TB) requiring treatment within the previous 3 years.
  -  Evidence of active malignant disease, malignancies diagnosed within the previous 10 years (except basal cell carcinoma of the skin that has been excised and cured), or breast cancer diagnosed within the previous 20 years
  -  Primary or secondary immunodeficiency
  -  Autoimmune disease
  -  Use or dependence on substance of abuse
  -  Alcohol abuse or average weekly intake greater than 2 units per day
  -  Screening or baseline resting heart rate < 45 or >90 beats per minute
  -  Major surgery within 8 weeks prior to screening
  -  Major illness in the 3 months prior to dosing
  -  Biliary obstruction
  -  Current or past history of diverticulitis

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: The Clinical Feature of Ulcer Base Over Time After Prophylactic Argon Plasma Coagulation in Colonic EMR

Summary: The prophylactic APC right after colonic EMR doesn't mean the complete coagulation of visible vessel because of injection material.
  The aim of this study was to evaluate the clinical feature of the visible vessels in ulcer base over time after prophylactic APC in colonic EMR.

Detailed description: The prophylactic Argon plasma coagulation (APC) of non-bleeding visible vessels seems not to have an additional advantage in the prevention of delayed post polypectomy bleeding in recently studies. However, immediate APC after endoscopic mucosal resection (EMR) may not mean the complete coagulation of exposed vessels because of injection material. The aim of this study was to evaluate the clinical feature of the exposed vessels in ulcer base over time after prophylactic APC in colonic EMR. Methods: This study was designed as a prospective study. Investigators excluded diminutive polyp, large polyp (> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR. Between August 2013 and May 2014, patients who were enrolled underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection. After checking the complete coagulation of visible vessels, the numbers of visible vessel group were counted by lap of time such as 1, 3, 5, and 7 min in ulcer base.

Eligibility: Inclusion Criteria:
  -  Underwent prophylactic APC for non-bleeding visible vessels after colonic endoscopic mucosal resection.
  Exclusion Criteria:
  -  Diminutive polyp, large polyp (> 2cm), long stalk pedunculated polyp, and clear ulcer base after EMR.

Relevance to patient case: not relevant
Patient case: 47-year-old male with melanoma; genetic feature: APC loss of function

Clinical trial: Impact of Excision Margins on Survival and Recurrence Rate in Patients With Thick Melanoma (>2mm)

Summary: Objective: To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.
  Background: Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.
  Methods: The investigators will conduct a retrospective population-based survey in patients with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins in the investigators center. For both groups, the patients' charts reviewed for data including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness, tumor type, presence of ulceration, findings of sentinel nodes, local recurrences, locoregional metastases, disease free survival and overall survival were calculated for both groups.

Detailed description: Background
  Early recognition and appropriate excision play a crucial role in management of malignant melanoma, while the size of surrounding normal skin that should be excised is area of controversies.
  Objective
  To investigated the impact of the excision of melanoma 2mm≤ in thickness with 1cm surgical margins on survival of the patients compared with 2 cm surgical margins.
  Methods
  The investigators will conduct a retrospective population-based survey in patients with primary melanoma 2 mm≤ in thickness undergoing tumor excision with 1 cm and 2 cm margins in the investigators center. For both groups, the patients' charts reviewed for data including patient gender, age, tumor location, tumor type, Clark's level, Breslow thickness, tumor type, presence of ulceration, findings of sentinel nodes, local recurrences, locoregional metastases, disease free survival and overall survival were calculated for both groups.

Eligibility: Inclusion Criteria:
  -  Histologically confirmed melanoma
  -  Safety margin 1 cm or 2 cm
  -  Tumor thickness according to Breslow >2mm
  Exclusion Criteria
  -  Safety margin less 1 cm
  -  Unclear safety margins

Relevance to patient case: not relevant