araag2/TREC_Precision-Medicine huggingface dataset:
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: A Phase 2 Dose Ranging, Evaluator-Blinded Study to Evaluate the Safety of Topical IDP-118

Summary: Subjects with a clinical diagnosis of plaque psoriasis with 10% to 20% of body surface area affected will be enrolled in the study.

Detailed description: Approximately 60 subjects with a clinical diagnosis of moderate or severe psoriasis (defined as at least of 10 % - 20% treatable Body Surface Area (BSA) and an Investigator's Global Evaluation (IGE) of 3 or 4 at baseline (moderate or severe) will be enrolled in the study.

Eligibility: Inclusion Criteria:
  -  Male or female of any race, 18 to 65 (inclusive) years of age.
  -  Freely given verbal and written informed consent obtained from the subject.
  -  Clinical diagnosis of psoriasis at the Screening and Baseline visits with
  -  At least 10% - 20% of total treatable BSA involvement, and
  -  an Investigator's Global Evaluation score of 3 or 4 ( moderate or severe) on a scale of 0 to 5
  -  Good general health as determined by the Investigator based on the subject's medical history and physical examination, with Screening hematology, serum chemistry, and urinalysis laboratory values within normal range limits.
  Exclusion Criteria:
  -  Presence of psoriasis that was previously treated with prescription medication prior to the Screening visit and is non-responsive to corticosteroid treatment, as determined by the Investigator.
  -  Presence of any concurrent skin condition that could interfere with the evaluation of the study drug, as determined by the Investigator.
  -  History of adrenal disease
  -  Female who is pregnant, nursing an infant, or planning a pregnancy during the study period.

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Pilot Study Testing the Effect of Ivacaftor on Lung Function in Subjects With Cystic Fibrosis and Residual CFTR Function

Summary: This study is a multiple within participant crossover study to evaluate the effect of ivacaftor on lung function in participants aged 12 years and older with cystic fibrosis (CF) who have phenotypic or molecular evidence of residual CF transmembrane conductance regulator (CFTR) function.

Detailed description: CFTR Mutations associated with residual function or defective messenger ribonucleic acid (mRNA) splicing include the following:
  R117H, E56K, P67L, D110E, D110H, R117C, R347H, R352Q, A455E, D579G, S945L, L206W, R1070W, F1074L, D1152H, S1235R, D1270N, 2789+5G->A, 3849+10kbC->T, 3272-26A->G, 711+5G->A, 3120G->A, 1811+1.6kbA->G, 711+3A->G, 1898+3A->G, 1898+1G->A, 1717-1G->A, 1717-8G->A, 1342-2A->C, 405+3A->C, 1716G/A 1811+1G->C, 1898+5G->T, 3850-3T->G, IVS14b+5G->A, 1898+1G->T, 4005+2T->C, 621+3A->G, 621+1G->T.

Eligibility: Inclusion Criteria:
  -  Male or female participants with confirmed diagnosis of CF
  -  Clinical evidence of residual CFTR function based on any 1 of the following: 1) Clinically documented residual exocrine pancreatic function, 2) Sweat chloride value less than equal to (<=) 80 millimole per liter (mmol/L) at screening, or 3) Age of diagnosis greater than equal to (>=) 12 years and at least 1 copy of a CFTR mutation associated with residual CFTR function or defective mRNA splicing
  -  FEV1 >= 40 percent (%)
  -  12 years of age or older
  -  Willing to agree to meet the contraception requirements
  -  Able to swallow tablets
  Exclusion Criteria:
  -  A copy of any of the following CFTR mutations: G551D, G178R, S549N, S549R, G551S, G970R, G1244E, S1251N, S1255P, or G1349D
  -  Unable to perform spirometry
  -  An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy (including antibiotics) for pulmonary disease within 4 weeks before Day 1
  -  Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Evaluation of a Novel Pancreaticojejunostomy Technique for Pancreaticoduodenectomy

Summary: Pancreaticoduodenectomy is a surgical procedure for removing cancer in the pancreas, the bile system or the duodenum that is associated with a high rate of complications. The study wants to investigate whether a new technique to reconstruct the joint between the pancreatic gland and the short bowel can reduce the rate of severe complications after this complex surgical procedure.

Detailed description: Pancreaticoduodenectomy is a complex surgical procedure for radically resecting tumors in the pancreatic head, distal bile duct or duodenum. Postoperative pancreatic fistula is the main contributor of severe postoperative morbidity after pancreaticoduodenectomy. Characteristics of the pancreatic gland like soft pancreatic consistency and small pancreatic main duct predispose for the postoperative fistula development. In high risk patients, the risk of suffering from associated postoperative morbidity is 50 percent which is considered unacceptable high. The aim of the current trial is to investigate whether a new anastomosing technique for the pancreaticojejunostomy can reduce the incidence of associated postoperative morbidity in patients undergoing pancreaticoduodenectomy.

Eligibility: Inclusion Criteria:
  -  Patients scheduled for elective pancreaticoduodenectomy
  -  Pancreatic gland with high risk criteria for associated postoperative morbidity
  Exclusion Criteria:
  -  Patients do not accept participation
  -  Pancreatic gland with intermediate or low risk criteria for associated postoperative morbidity

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Comparison of Endoscopic Radiofrequency Ablation Versus Photodynamic Therapy for Inoperable Cholangiocarcinoma

Summary: The purpose of this study is to compare endoscopic radiofrequency ablation with photodynamic therapy for inoperable cholangiocarcinoma


Eligibility: Inclusion Criteria:
  -  Age ≥ 18 years old
  -  Pathologically or radiologically confirmed biliary malignant
  -  Inoperability by staging
  Exclusion Criteria:
  -  Cholangiocarcinoma with widespread metastasis
  -  Coagulopathy (INR > 2.0 or prothrombin time > 100 sec or platelet count < 50,000)
  -  Prior SEMS placement
  -  Pregnancy
  -  Eastern Cooperative Oncology Group (ECOG) performance status ≥ 3 )
  -  Life expectancy < 3months

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Correlation Between Clinical and Electrophysiological Phenotypes in a Population of Patients With Neuropathy Charcot-Marie-Tooth Disease Type 1A

Summary: This exploratory cross-sectional study proposes, firstly, to objectify in a population of Charcot-Marie-Tooth disease type 1A (CMT 1A)if there is a correlation between the recording of electrical parameters and upper limb muscle strength of the thigh and in a second step, to seek a relationship between the measured parameters.

Detailed description: Patients suffering from CMT 1A neuropathy will be invited to go through a series of tests such as:
  -  Electromyography
  -  Isokinetic test
  -  Podiatric assessment
  -  Functional evaluations: Hand dexterity, limbs muscles strength
  -  Quality of life assessment with questionnaires

Eligibility: Inclusion Criteria:
  -  Patients older than 18 years
  -  Diagnosis of Charcot Marie Tooth disease, type 1A confirmed by molecular biology (duplication 17.p11.2)
  -  Listening and written French
  -  Agreement after written information, clear and honest about the purpose of the study, the nature of the tests and their possible side effects or bothersome.
  -  Strength of the quadriceps superior to 2/5 MMT MRC
  Exclusion Criteria:
  -  Presence of other neurological comorbidity
  -  Presence of coronary artery disease unstabilized
  -  Peripheral neuropathy of other causes: diabetes, monoclonal gammopathy, malignancy, solid cancer, systemic autoimmune disease (lupus, Sjögren's disease, Wegener sarcoidosis ...), infectious disease (viral hepatitis, HIV ...), drugs known to be responsible for iatrogenic neuropathy.
  -  Gait trouble of other origin
  -  Patients unable to give their consent.
  -  Intellectual deficit that does not allow to comply with tests

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Effect of EECP on Anterior Ischemic Optic Neuropathy

Summary: Enhanced External Counterpulsation(EECP) therapy may promote the recovery of visual function by improving the blood perfusion of eyes. The present study aims to investigate the effect of EECP on Anterior Ischemic Optic Neuropathy.

Detailed description: Patients with Anterior Ischemic Optic Neuropathy are randomized into two groups: one group receive standard medical treatment for ischemic optic neuropathy, the other group plus EECP therapy besides standard medical treatment.

Eligibility: Inclusion Criteria:
  -  ischemic optic neuropathy
  -  within 1 month
  Exclusion Criteria:
  -  Hemorrhagic disease
  -  thrombophlebitis or infection lesions
  -  severe hypertensive patients
  -  Atrial fibrillation
  -  Aortic regurgitation

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

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: possibly relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Selective Internal Radiotherapy (SIRT) Versus Transarterial Chemoembolisation (TACE) for the Treatment of Cholangiocellular Carcinoma (CCC).

Summary: Selective Internal Radiotherapy is superior to Transarterial Chemoembolisation for the treatment of intrahepatic cholangiocellular carcinoma (CCC).


Eligibility: Inclusion Criteria:
  -  ≥18 years
  -  Intrahepatic CCC, proven by histology or by typical morphology in cross sectional imaging and elevated tumor markers (CEA or CA 19-9)
  -  Tumor confined to the liver
  -  At least one measurable lesion in magnetic resonance imaging (MRI)
  -  Tumor load ≤ 50%
  -  Preserved liver function (Child Pugh A and B)
  -  ECOG performance status ≤2
  Exclusion Criteria:
  -  Patients feasible for curative treatment (e.g. resection or local ablation)
  -  Previous TACE or SIRT
  -  Prior Chemotherapy
  -  Child Pugh stage C
  -  ECOG Performance Status >1
  -  Tumor involvement >50% of the liver
  -  Extrahepatic tumor
  -  Serum Bilirubin >2.0 mg/dl; Serum Albumin 2.8 g/dl, Serum Creatinine >2 mg/dl; Leukocytes <3000/ml; Thrombocytes <50000/ml
  -  Clinically apparent ascites (ascites only in CT/MRI is no exclusion criteria)
  -  Esophageal bleeding during the last 3 months
  -  Hepatic encephalopathy
  -  Transjugular intrahepatic portosystemic shunt (TIPS)
  -  Infiltration or occlusion of the main portal vein
  -  Hepatofugal blood flow in the portal vein
  -  Hepatopulmonary shunt ≥ 20% in the macroaggregated albumin scan (MAA-scan)
  -  Contraindications against angiography
  -  Pregnancy

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Safety and Efficiency of Photodynamic Therapy for Blie Duct Carcinoma

Summary: This research is a prospective randomized controlled trial.It aimed to determine longterm outcomes and factors associated with increased survival after photodynamic therapy (PDT) through T-tube compared with biliary drainage alone in patients presenting with unresectable bile duct cancer.


Eligibility: Inclusion Criteria:
  -  1.Patients with bile duct cancer 2.Patients are willing to join in this clinical trial.
  Exclusion Criteria:
  -  1.Patients with bile duct carcinoma can not suffer PDT procedure. 2.Allergy to photosensitizer

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Role of Bile Duct Resection in Major Hepatectomy Due to Intrahepatic Cholangiocarcinoma

Summary: To investigate the prognosis due to presence or absence of bile duct resection in intrahepatic cholangiocarcinoma that require hepatic lobectomy.

Detailed description: The bile duct resection in hepatic lobectomy due to cholangiocarcinoma, mass forming type, is still controversial. We retrospectively evaluated the effect of bile duct resection in this surgery.

Eligibility: Inclusion Criteria:
  -  Cases of major hepatectomy due to intrahepatic cholangiocarcinoma
  Exclusion Criteria:

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Efficacy,Safety and Quality of Life After TOOKAD® Soluble VTP for Localized Prostate Cancer

Summary: The aim of this study is to confirm the Efficacy,the Safety and the Quality of Life after TOOKAD® Soluble VTP in localized prostate cancer patients.

Detailed description: The study is designed as a multicenter, single-arm, open label, 12 months follow-up clinical trial. Men with localized prostate cancer will be treated with TOOKAD® Soluble VTP under general anesthesia.
  Patients will be followed-up for 12 months with patient questionnaires on QoL, erectile and urinary functions, clinical evaluation with study visits at 1, 3, 6 and 12 months , Prostate Specific Antigen(PSA) testing at 3, 6 and 12 months. In addition, they will have biopsy at 6 months (± 2) and 12 months.

Eligibility: Inclusion Criteria:
  -  Histologically proven localized prostate carcinoma diagnosed using prostate biopsy showing:
  -  Gleason 3+3 prostate
  -  Gleason 3+4 prostate adenocarcinoma is acceptable provided it is not present in more than 2 cores and no more than 50% cancer in any core.
  -  Clinical stage up to cT2a - N0/Nx - M0/Mx.
  -  Serum prostate-specific antigen (PSA) ˂ 20ng/ml
  -  Prostate volume ≥ 25 cc and ≤ 70 cc.
  -  Male subjects aged 18 years or older.
  -  Signed Informed Consent Form by the patient.
  Exclusion Criteria:
  -  Unwillingness to accept the treatment.
  -  Any prior or current treatment for prostate cancer, including surgery, radiation therapy (external or brachytherapy)or chemotherapy.
  -  Any surgical intervention for benign prostatic hypertrophy.
  -  Any condition or history of illness or surgery that may pose an additional risk to men undergoing the VTP procedure.
  -  Life expectancy less than 10 years.
  -  Participation in another clinical study involving an investigational product within 1 month before study entry.
  -  Subject unable to understand the patient's informed consent document, to give consent voluntarily or to complete the study tasks, especially unable to understand and fulfill the health-related QoL questionnaire.
  -  Subject in custody and or in residence in a nursing home or rehabilitation facility.
  -  Any condition or history of active rectal inflammatory bowel disease or other factors which may increase the risk of fistula formation;
  -  Any hormonal manipulation (excluding 5-alpha-reductase inhibitors) that alters androgen production or use of androgen supplements within the previous 6 months;
  -  Any history of urethral stricture disease;
  -  Any history of acute urinary retention within 6 months of study entry

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Efficacy Study of Intra-hepatic Administration of Therasphere® in Association With Intravenous Chemotherapy to Treat Cholangiocarcinoma

Summary: The purpose of this study is to assess efficacy and tolerance of intra-hepatic administration of Yttrium 90-labelled microsphere (Theraspheres®, Nordion) in association with intravenous chemotherapy with Gemcitabin and Cisplatin for the treatment of intra-hepatic cholangiocarcinoma.


Eligibility: Inclusion Criteria:
  1. Histologically confirmed intra-hepatic cholangiocarcinoma.
  2. Measurable target of at least 2 cm diameter.
  3. Healthy liver or cirrhosis CHILD < B8.
  4. WHO-PS: 0-1.
  5. Age ≥ 18 years.
  6. Non-Metastatic disease in extra-hepatic (are permitted: local lymph nodes < 3 cm, less than 5 lung nodes < 11 mm).
  7. Creatinine clearance (calculated with Cockcroft and Gault formula) ≥ 55 ml/min, polymorphonuclear neutrophils ≥ 1500 G/L, platelets ≥ 80 G/L, prothrombin ≥ 40% (INR ≤ 2.3), serum albumin ≥ 28 g/l, serum bilirubin ≤ 3 x LSN.
  8. Pregnancy test: negative for women of childbearing potential.
  9. Reliable contraception for a childbearing couple, men and woman must have an reliable contraception during the treatment and until 6 months following the end of the treatment by chemotherapy
  10. Signed informed consent form.
  11. Patient with national health insurance.
  Exclusion Criteria:
  1. Pancreas cancer or duodenum cancer invading the bile duct or ampullary cancer. Cholangiocarcinoma of the bile ducts: hilar, main duct, gallbladder.
  2. Extra-hepatic metastasis (including local lymph nodes measuring > 30 mm).
  3. Primary sclerosing cholangitis.
  4. History of chemoembolization or radioembolization.
  5. Cirrhose CHILD > B7
  6. Portal vein trunk tumoral thrombosis
  7. History of hepato-biliary neo adjuvant or palliative chemotherapy and/or radiotherapy.
  8. Contra indication of Gemcitabine and/or Cisplatin.
  9. Other invasive active cancer, excepting in situ cervical cancer and basocellular or spino cellular skin cancer treated adequately. Any history of cancer not considered as completely cured for at least one year.
  10. Technical failure of the diagnostic arteriography.
  11. Extra hepatic uptake on the pre-therapeutic scintigraphy not manageable with an arteriography.
  12. Dosimetry study predicting lung exposure > 30 Gy.
  13. Any unstable medical history (diabetes, hypertension …).
  14. History of organ transplant.
  15. Symptomatic grade 1 angina pectoris or grade ≥ 2 angina pectoris.
  16. An evolutive neuropathy.
  17. Patient who already has been involved in a clinical trial with drug intake, whether this drug was experimental or not, within 30 days before.
  18. Pregnant patient or patient with breastfeeding.
  19. Patient under administrative supervision.
  20. Regular follow-up impossible for various reasons (psychological, familial, economical, and social).

Relevance to patient case: not relevant
Patient case: 64-year-old male with Cholangiocarcinoma. Genetic variant: IDH1 (R132H). Other conditions: Neuropathy.

Clinical trial: Prognosis of Resection and Radiotherapy in the Treatment of Intrahepatic Cholangiocarcinoma Patients

Summary: The purpose of this study is to confirm that prognosis of Intrahepatic Cholangiocarcinoma (ICC) with resection and radiotherapy ,to find which is safe and effective treatment.

Detailed description: Intrahepatic Cholangiocarcinoma (ICC), the second most common primary liver cancer and constitutes 10% of primary liver malignancies.
  Current therapies for the treatment of ICC are ineffective and the role of liver transplantation is not well defined.
  This study reviews our experience with this tumor and looks for preoperative and pathologic indices that may help determine long term prognosis

Eligibility: Inclusion Criteria:
  -  Male or female patients > 17 years and <=60 years of age. confirmed case (patients with ICC) Tumors can be radical removed and resection volume was ≤50%. Criteria of liver function: Child A level, serum bilirubin ≤ 1.5 times the upper limit of normal value,alanine aminotransferase and aspartate aminotransferase ≤ 2 times the upper limit of normal value.
  No dysfunction in major organs; Blood routine, kidney function, cardiac function and lung function are basically normal. Hbg ≥ 90g/L, WBC ≥ 3.000 cells/mm³,platelets ≥ 80.000 cells/mm³.
  Karnofsky Performance Score performance over 60. Patients who can understand this trial and have signed information consent.
  Exclusion Criteria:
  -  Patients who have undergone previous treatment by Resection or Radiotherapy. Patients with apparent cardiac, pulmonary, cerebronic and renal dysfunction, which may affect the treatment of liver cancer.
  Patients with other diseases which may affect the treatment mentioned here. Patients with medical history of other malignant tumors. Subjects participating in other clinical trials. Extrahepatic metastasis, portal vein or other major vascular involvement. liver function: Child B C.
  Patients would not sign the consent to the trial.

Relevance to patient case: not relevant