linjc16/ctgov huggingface dataset:
Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to define silent breast cancer prevalence in both sexes and will be held by biopsies performed in imaging suspicious areas of the breast (ecography and mammography) in cadavers without known breast cancer.

Detailed Description
-----------------
Cadavers of both sexes are going to be submitted to bilateral mastectomy. The specimens are going to be examined by palpation, ecography and mammography and all areas with (Breast Imaging Reporting and Data System) BI-RADS classification >= 3 are going to be biopsied. Biopsy specimens are going to be processed by the pathology department and cancers are going to be identified and classified by their molecular type. The investigators intend to know which is the disease reservoir in various ages.

Official Title
-----------------
Silent Breast Cancer A Study of the Disease Prevalence Held by Imaging Guided Biopsies in Autopsy Specimens

Conditions
-----------------
Male Breast Cancer, Female Breast Cancer

Intervention / Treatment
-----------------
* Procedure: Bilateral mastectomy
* Other: Biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female and male cadavers above 40 years Exclusion Criteria: Known breast cancer Breast tissue accidental damage

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: female cadavers<br>female cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy | Procedure: Bilateral mastectomy<br>* Bilateral mastectomy and imaging study of cadaveric breasts<br>Other: Biopsy<br>* Biopsy of BI-RADS 3 and superior lesions<br>|
| Experimental: Male cadavers<br>male cadavers above 40 years without known breast cancer Bilateral mastectomy Biopsy | Procedure: Bilateral mastectomy<br>* Bilateral mastectomy and imaging study of cadaveric breasts<br>Other: Biopsy<br>* Biopsy of BI-RADS 3 and superior lesions<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silent breast cancer prevalence | To define the existing disease that did not caused death in both sexes | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Silent breast cancer prevalent molecular profile | To identify those molecular subgroups of the disease that remain silent | 2 years |
Lymph Node Ratio and Kras Mutation in R Colon Cancer

Study Overview
=================
Brief Summary
-----------------
clinical impact of LN ratio with Kras expression in colon cancer

Detailed Description
-----------------
LNR and K ras were evaluated with correlated with different clinicopathological parameters of the patients, PFS and OS.

Official Title
-----------------
Lymph Node Ratio and Kras Mutation in Risk Stratification of Colon Cancer

Conditions
-----------------
Colon Cancer Stage III

Intervention / Treatment
-----------------
* Device: k ras
* Drug: Panitumumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stage III colon cancer Exclusion Criteria: Stage I, II, IV

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patients<br>LNR measured by (number of metastatic lymph nodes/total number of lymph nodes excised). and K ras (polymerase chain reaction (PCR) and pyrosequencing targeted for KRAS codons 12-13 was performed ) | Device: k ras<br>* K ras<br>Drug: Panitumumab<br>* vectibex in stage iv<br>* Other names: vectibex;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LNR and K ras were evaluated with correlated with different clinicopathological parameters (Gender, CEA, tumor size, tumor grade and response to treatment). | impact on response | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LNR and K ras were evaluated and ASSOCIATION with PFS and OS. | impact on survival | 2 years |
Drug-Drug Interaction Study Of Effect Of PF-03882845 On Simvastatin Pharmacokinetics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to estimate the effect of multiple oral doses of PF-03882845 on the pharmacokinetics of simvastatin and simvastatin acid in healthy, adult subjects.

Official Title
-----------------
A Phase 1, Open-Label, Fixed-Sequence Study To Estimate The Effect Of Repeated Dosing Of PF-03882845 On The Pharmacokinetics Of A Single Dose Of Simvastatin In Healthy Adult Subjects

Conditions
-----------------
Human Volunteers

Intervention / Treatment
-----------------
* Drug: Simvastatin/PF-03882845


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males and/or females of non-childbearing potential between the ages of 18 (or 21 based on country-specific age of consent) and 60 years, inclusive, at Screening. Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12-lead ECG or clinical/safety laboratory tests. Body Mass Index (BMI) of 17.5 to 30.5 kg/m2 inclusive; and a total body weight >50 kg (110 lbs). Exclusion Criteria: Use of CYP3A4 inhibitors (eg, ketoconazole, ciprofloxacin, diltiazem) or inducers (eg, pheytoin, carbamazepine) or substrate (eg, simvastatin, quinidine) within 28 days or 5 half-lives (whichever is longer) prior to Day 1. Known history of hypersensitivity, allergy, severe adverse drug reaction or intolerance to simvastatin or other statins.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment<br> | Drug: Simvastatin/PF-03882845<br>* Single dose 20 mg simvastatin on Day 1, 30 mg PF-03882845 once daily from Days 2 to 13, the single dose 20 mg simvastatin on Day 12.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite (or Profile) of Pharmacokinetics | AUCinf, AUClast, Cmax, Tmax, t1/2 of simvastatin and simvastatin acid | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with adverse events as a measure of safety. |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DDI, pharmacokinetics
Safety, Effectiveness and Manipulability Evaluation of a Domestic PD Machine

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, multi-center，crossover study of a domestic FM peritoneal dialysis machine and Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Detailed Description
-----------------
Our study is a randomized, multi-center，crossover study. It compares a domestic FM peritoneal dialysis machine with Baxter HOMECHOICE.It aims to verify safety, effectiveness and manipulability of a domestic peritoneal dialysis machine.

Official Title
-----------------
A Randomized, Multicenter, Crossover Study Comparing the Domestic FM Peritoneal Dialysis Machine With Baxter HOMECHOICE

Conditions
-----------------
Kidney Failure,Chronic

Intervention / Treatment
-----------------
* Device: FM peritoneal dialysis machine
* Device: HOMECHOICE peritoneal dialysis machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18, male or female Dialysis duration:≥30 days Sign the written informed consent Exclusion Criteria: Hemodialysis Exit site infection or tunnel infection Peritonitis ≤30 days before screening Catheter mechanical failure Anti-HIV positive Allergic to components of dialysate Comorbidity:Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure,hypertension Poor compliance Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial Has a history of alcoholism and drug abuse (defined as illegal drugs) Any circumstances when patients are believed unsuitable for this trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FM peritoneal dialysis machine<br>FM peritoneal dialysis machine APD 10L/10h; | Device: FM peritoneal dialysis machine<br>* FM peritoneal dialysis machine APD 10L/10h<br>|
| Active Comparator: HOMECHOICE peritoneal dialysis machine<br>HOMECHOICE peritoneal dialysis machine APD 10L/10h; | Device: HOMECHOICE peritoneal dialysis machine<br>* HOMECHOICE peritoneal dialysis machine APD 10L/10h<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily peritoneal Kt/V |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The accuracy of filling |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Automated PD, Effectiveness, Safety, Manipulability
Exploratory Study to Assess the Pharmacokinetics of AZD5985

Study Overview
=================
Brief Summary
-----------------
The aim of this exploratory study is to assess the pharmacokinetics of increasing oral doses of AZD5985 in healthy male volunteers

Official Title
-----------------
An Exploratory Phase I, Single Centre, Double-Blind, Randomised, Placebo-Controlled, Parallel-Group Study to Assess the Pharmacokinetics of Increasing Oral Doses of AZD5985 in Healthy Male Volunteers

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: AZD5985
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures. Healthy male subjects aged 18 to 45 years (inclusive). Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg. Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start. Exclusion Criteria: History or presence of any clinically significant disease or disorder in the opinion of the investigator. Any clinically relevant abnormal findings in physical examination, clinical chemistry, haematology, urinalysis, vital signs or ECG at baseline in the opinion of the investigator. Participation in another investigational drug study within 3 months before Visit 2 or participation in a method development study (no drug) 1 month prior to Visit 2

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>AZD5985 | Drug: AZD5985<br>* Oral suspension. Single oral doses of AZD5985 starting with 4 mg and subsequently with up to 3 dose escalations will be administered not exceeding AstraZeneca pre-defined upper exposure limits.<br>|
| Experimental: B<br>placebo | Drug: placebo<br>* Oral suspension.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| It is the objective of this exploratory study to assess pharmacokinetics of AZD5985 following administration of single increasing doses. The primary variable is plasma concentration of AZD5985. |  | Frequent sampling occasions during study days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy volunteers
Diabetic Retinopathy and Diabetic Macular Edema Screening by Non-Physicians With Limited Training

Study Overview
=================
Brief Summary
-----------------
The purpose is to assess accuracy of digital retinal image interpretation by technicians and direct ophthalmoscopy by nurses for the determination of diabetic retinopathy severity and the presence of diabetic macular edema for the identification of referrals to ophthalmologists. The results of both screening methods were compared with comprehensive eye examination by ophthalmologists.

Detailed Description
-----------------
Diabetic visual disabilities have increasingly become a global concern since a number of diabetic patients are expected to surge dramatically in the coming decade. Essential means to minimize this problem are detecting vision-threatening diabetic retinopathy early in the course of disease and timely interventions by ophthalmologists. The American Diabetes Association had issued a guideline for the detection and recommended regular comprehensive eye examination as a preferred method. However, it is not likely that there will be ophthalmologists enough to comprehensively examine the surging number of diabetic patients. Other practical screening methods, such as an interpretation of digital retinal images or direct ophthalmoscopy employed by other health care providers, for identifying the retinopathy for referral to ophthalmologists, should minimize this problem.

Conditions
-----------------
Diabetic Retinopathy

Intervention / Treatment
-----------------
* Device: Digital retina image
* Device: direct ophthalmoscopy
* Procedure: comprehensive eye exam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diabetic patients defined by WHO criteria lived in the geographic area of participated hospitals Exclusion Criteria: have contraindications for receiving mydriatic medications have ocular media not clear enough for making diagnosis by any of the screening equipment have other retina diseases precluded the diagnosis of diabetic retinopathy

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Digital retina image|nan|
|Device: direct ophthalmoscopy|nan|
|Procedure: comprehensive eye exam|nan|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity, specificity, kappa coefficient |  | cross-sectional |
Effects of Pitavastatin on Monocyte, Endothelial Dysfunction and HDL-C in Subjects With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine in detail the acute and chronic effects of pitavastatin on plasma lipid transport and atheroma biomarkers in patients at elevated risk for the premature development of atherosclerosis (CAPITAIN).

Official Title
-----------------
An Open Label Study of the Chronic and Acute Effects of Pitavastatin on Monocyte Phenotype, Endothelial Dysfunction and HDL Atheroprotective Function in Subjects With Metabolic Syndrome (CAPITAIN)

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Drug: Pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with metabolic syndrome Patients with LDL-C > 130mg/dL Eligible, able to participate and have given informed consent Exclusion Criteria: Body Mass Index >35 kg/m2 LDL-C > 190mg/dL Fasting triglycerides > 400 mg/dL Diabetes mellitus (fasting glucose >7 mmol/L) or taking diabetic therapy Uncontrolled hypertension (Systolic Blood Pressure >= 140 mmHg or Diastolic Blood Pressure >= 90mmHg) Any conditions that cause secondary dyslipidaemia or increase the risk of statin therapy ALAT and ASAT >3 x ULRR Impaired renal function (Serum Creatinine >1.5 x ULRR or eGFR <60 mL/min) History of any muscle disease or unexplained elevation (>3 x ULRR) of serum creatine kinase Evidence of symptomatic heart failure (NYHA class III or IV) Current or recent user of supplements or medications known to alter lipid metabolism

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pitavastatin 4mg daily<br>4 mg tablets of pitavastatin by oral route for a period of 6 months | Drug: Pitavastatin<br> <br> |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to Day 180 in plasma biomarkers of inflammation and atherosclerosis, including monocytes, lymphocytes, endothelial adhesion proteins, atherogenic lipoproteins and cardioprotective HDL |  | 180 days |
Efficacy of Everolimus-containing Chemotherapy in HER2- mBC Patients With PI3K/AKT/mTOR Mutations Study

Study Overview
=================
Brief Summary
-----------------
The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.14 cases of HER2- metastatic breast cancer patients with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

Detailed Description
-----------------
The PI3K/AKT/mTOR pathway is frequently altered in breast cancer. Everolimus is a selective inhibitor of mammalian target of Rapamycin (mTOR).The benefit of everolimus in metastatic breast cancer patients with PI3K/AKT/mTOR mutations remains unclear, especially in TNBC patients. The study aimed to investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations. 14 cases of HER2- metastatic breast cancer participants with PI3K/AKT/mTOR mutations treated with everolimus-containing chemotherapy were retrospectively analyzed.The genetic profile in PI3K/AKT/mTOR pathway was studied.

Official Title
-----------------
Efficacy of Everolimus-containing Chemotherapy in HER2 Negative Metastatic Breast Cancer Patients With PI3K/AKT/mTOR Mutations: A Retrospective Study

Conditions
-----------------
Everolimus, Breast Cancer, PI3K/AKT/mTOR Pathway Mutation

Intervention / Treatment
-----------------
* Other: No intervention, it was a retrospective study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HER2- metastatic breast cancer Patients with PI3K/AKT/mTOR mutation Exclusion Criteria: Patients treated with endocrinotherapy and everolimus. The efficacy evaluation could not be available.

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 66 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention, it was a retrospective study.|This study aimed to retrospectively investigate the efficacy of the everolimus-containing chemotherapy in metastatic breast cancer patients with PI3K/AKT/mTOR mutations.There was no intervention.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | The PFS was defined as the interval from the date of taking the everolimus-containing chemotherapy to the date of the first occurrence of disease progression or death from any cause,whichever came first, assessed up to 24 months. |