linjc16/ctgov huggingface dataset:
Validation of a Multi-gene Test for Lung Cancer Risk

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the validity of a multi-gene Lung Cancer Risk Test (LCRT). In the process, the investigators will establish a bank of NBEC samples and corresponding blood samples from individuals demographically at increased risk for lung cancer.

Detailed Description
-----------------
Because more than 160,000 individuals die of lung cancer/year in the United States alone, it is important to use the best possible methods to determine whether increased surveillance of individuals at highest risk for lung cancer will result in reduced lung cancer mortality. The Lung Cancer Risk Test (LCRT) proposed for evaluation promises to accurately identify the 10-15% of the population that is most susceptible to lung cancer based on genetic predisposition. More than 90 million individuals in the United States alone are demographically at high risk for lung cancer and potential candidates for increased surveillance.

Official Title
-----------------
Validation of a Multi-gene Test for Lung Cancer Risk

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Genetic: Lung Cancer Risk Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20 or more pack year smoking history clinical need for diagnostic bronchoscopy or consent to study driven bronchoscopy Exclusion Criteria: Lung Cancer within 3 months after the date of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Lung Cancer, Heavy Smoker<br>Subjects will be ≥ 50 years of age and have a ≥ 20 pack year smoking history and will be either healthy volunteers or individuals undergoing diagnostic bronchoscopy, with absence of lung cancer documented at the time of enrollment. | Genetic: Lung Cancer Risk Test<br>* Measurement of gene expression in normal bronchial epithelial cells obtained at time of bronchoscopy.<br>* Other names: LCRT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of LCRT to predict incidental lung cancer | Time of diagnosis of incidental lung cancer will be compared to value of the investigational device, the Lung Cancer Risk Test (LCRT). | from time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung Cancer
norUrsodeoxycholic Acid vs Placebo in PSC

Study Overview
=================
Brief Summary
-----------------
Double-blind, randomized, multi-center, placebo-controlled, comparative, phase III trial. The study will be conducted with two treatment groups in the form of a parallel group comparison and will serve to compare oral treatment with either 1500 mg/d norursodeoxycholic acid capsules or placebo capsules for the treatment of Primary Sclerosing Cholangitis.

Official Title
-----------------
Double-blind, Randomized, Placebo-controlled, Phase III Study Comparing norUrsodeoxycholic Acid Capsules With Placebo in the Treatment of Primary Sclerosing Cholangitis

Conditions
-----------------
Primary Sclerosing Cholangitis

Intervention / Treatment
-----------------
* Drug: norUrsodeoxycholic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent verified PSC Liver Biopsy available for Review If pre-treated with UDCA Patient must be on stable dose not exceeding 20mg/kg/bw Patients with or without concomittant IBD Exclusion Criteria: History or presence of other concomitant liver diseases Presence of Cholangiocarcinoma Secondary causes of Sclerosing Cholangitis Small Duct Cholangitis in the absence of large duct disease Any known relevant infectious disease Abnormal renal function Any active malignant disease Known intolerance/hypersensitivity to study drug

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 75 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: norUrsodeoxycholic acid<br>norUrsodeoxycholic acid 250mg capsules, 6 capsules/day for 2 years | Drug: norUrsodeoxycholic Acid<br>* oral treatment<br>* Other names: NUC;|
| Placebo Comparator: Placebo to norUrsodeoxycholic acid<br>norUrsodeoxycholic acid 250mg Placebo-capsules, 6 capsules/day for 2 years | Drug: norUrsodeoxycholic Acid<br>* oral treatment<br>* Other names: NUC;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) | prevention of disease progression assessed by partial normalization of serum Alkaline Phosphatase (s-ALP) levels in patients with PSC | 2 years | 
| Show superiority of norursodeoxycholic acid (norUDCA) compared to placebo in the treatment of Primary Sclerosing Cholangitis (PSC) | prevention of disease progression assessed by liver histology | 2 years |
Dermacyd Femina (Lactic Acid) - Photo Dermatological Evaluation of the Irritation and Sensitivity Potential.

Study Overview
=================
Brief Summary
-----------------
To prove the absence of photo irritation and photo sensitivity potential of the product Dermacyd Femina.

Official Title
-----------------
Dermatological Evaluation of the Photo Irritation and Photo Sensitivity Potential for Dermacyd Femina.

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacyd Femina)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Phototype Skin II and III; Integral skin test in the region; Exclusion Criteria: Lactation or gestation; Use of Anti-inflammatory and/or immuno-suppression drugs 15 days before the selection; Diseases which can cause immunity decrease, such as HIV, diabetes; Use of drug photosensitizer; History of sensitivity or irritation for topic products; Active cutaneous disease which can change the study results; History or photodermatosis active; Family or personal antecedent of cutaneous photoinduced neoplasias; Presence of a precursor lesion of cutaneous neoplasia, such as nevus melanocyte and keratoses actinium; Intense solar exposure in the study area; Use of new drugs or cosmetics during the study; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Drug: Lactic acid (Dermacyd Femina)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The photo irritation test and the photosensitivity will be measured using UVA irradiation and evaluated according International Contact Dermatitis Research Group (ICDRG) scale |  | 5 weeks | 
| The sensibility will be evaluated according to the skin type. |  | 5 weeks |
Optimal Site for Rapid Urease Test in the Stomach

Study Overview
=================
Brief Summary
-----------------
The accurate diagnosis of H. pylori infection is an important step for establishing the strategy for gastric cancer prevention. During endoscopy, rapid urease test (RUT) is the first of biopsy-based H. pylori tests. Despite indirect test for H. pylori detection, RUT shows rapid result with good sensitivity and specificity. Several study reported that H. pylori density was related to positive reaction time of RUT. However, there was no study comparing the positive reaction times of RUT according to biopsy site, degree of gastric atrophy, and intestinal metaplasia.

Detailed Description
-----------------
The aims of this study were to: (1) assess the positive reaction times of RUT in the body and antrum, (2) investigate the association between the difference of RUT results (body and antrum) and gastric atrophy, and intestinal metaplasia, and (3) evaluate the optimal biopsy site for RUT according to degree of gastric atrophy in Korean population.

Official Title
-----------------
Comparison of Rapid Urease Test Between the Gastric Body and Antrum in Helicobacter Pylori-Infected Stomach

Conditions
-----------------
Helicobacter Pylori Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who underwent upper endoscopy and rapid urease test Exclusion Criteria: : age < 20 or > 70 years; anemia (serum hemoglobin level < 10 g/dL); severe systemic disease or advanced chronic liver disease; use of certain medications, including proton pump inhibitors, H2-receptor antagonists, or antibiotics; a history of H. pylori eradication; a history of gastric surgery; a recent history of upper gastrointestinal bleeding.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive reaction time of urease test | Color change to red or pink means positivity | within 24 hours |
Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or m

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics (e.g. smoking status, sex, histology, etc). In particular, the study will aim to determine the frequency of EGFR M+ lung cancers in patients with clinico-pathological characteristics that are not commonly associated with EGFR mutation positivity (i.e., smokers, men, and non-adenocarcinoma).

Detailed Description
-----------------
An NIS Registry for the Epidemiological and Scientific evaluation of EGFR mutation status in patients with newly diagnosed locally advanced or metastatic NSCLC (stage IIIB/IV non-small cell lung cancer)

Official Title
-----------------
An NIS Registry for the Epidemiological and Scientific Evaluation of EGFR Mutation Status in Patients With Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer (Stage IIIB/IV Non-small Cell Lung Cancer)

Conditions
-----------------
Newly Diagnosed Locally Advanced or Metastatic Non-small Cell Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Histologically confirmed locally advanced or metastatic NSCLC (stage IIIB/IV). Mixed histology of small cell and non-small cell lung cancer

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of the study is to collect epidemiological data on EGFR mutation status (M+, M-) in a population of predominantly Caucasian ethnicity and to correlate EGFR mutation status with clinico-pathological characteristics |  | Days 1-10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To collect real-life clinical outcome data in all EGFR M+ patients up to and including progression.To collect real-life pharmacoeconomic data (resource use) associated with the diagnosis and treatment of EGFR M+ patients. |  | Study Days 21-30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EGFR mutation ,newly diagnosed NSCLC, locally advanced or metastatic NSCLC
Prevention of Bacteremia Induced by Debridement of Pressure Ulcer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analyse bacteremia induced by debridement of pressure ulcers in patients in the complex nursing department.

Conditions
-----------------
Pressure Ulcers, Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient in the complex nursing department With contaminated pressure ulcers Going to have a debridement procedure Exclusion Criteria: Penicillin sensitivity Bacteremia that does not react to the antibiotic treatment
Sexes Eligible for Study
-----------------
All

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Debridement
Augmenting Flortaucipir Dosimetry Estimates

Study Overview
=================
Brief Summary
-----------------
This study will obtain data from urine in subjects administered flortaucipir in an Avid-sponsored study to augment the calculation of radiation dosimetry estimates.

Official Title
-----------------
A Multicenter Study to Obtain Data to Assist in Radiation Dosimetry Calculations From Subjects Enrolled in Human Studies Employing 18F-AV-1451

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: Flortaucipir F18


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who passed screening in an Avid-sponsored study in which flortaucipir will be administered Exclusion Criteria: Subjects who have withdrawn informed consent Investigator or sponsor believes it is in the best interest of the subject to be removed from the trials
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urine Analysis<br>Urine will be collected from subjects administered flortaucipir in an Avid-sponsored study to determine the amount of radioactivity excreted in urine. | Drug: Flortaucipir F18<br>* No flortaucipir administered in this study. Subjects received flortaucipir in an Avid-sponsored study.<br>* Other names: Tauvid;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine Analysis - Total Integrated Radioactivity Excreted in Urine | Total integrated radioactivity excreted in urine over time will be determined to augment previous radiation dosimetry calculations. | 0-360 minutes post injection |
Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis

Study Overview
=================
Brief Summary
-----------------
This study will try to determine whether fetuses to mothers having clinical chorioamnionitis have changes in blood flow in middle cerebral artery.

Detailed Description
-----------------
This study will try to determine whether fetuses to mothers having clinical chorioamnionitis have changes in blood flow in middle cerebral artery. MCA flow parameters will be evaluated during labor of women with and wthout chorioamnionitis

Official Title
-----------------
Changes in Blood Flow in MCA of Fetuses to Mothers Having Clinical Chorioamnionitis During Labor Comparing to Fetuses to Healthy Mothers.

Conditions
-----------------
Chorioamnionitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women giving birth week 37-42 healthy one fetus Exclusion Criteria: more than one fetus IUGR illness or damage to fetus

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Study of RO5045337 in Patients With Solid Tumors

Study Overview
=================
Brief Summary
-----------------
This open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.

Official Title
-----------------
An Open-Label, Randomized 3-Way Crossover, Study to Examine the Food-Effect on Pharmacokinetics of the Current Formulation and Relative Bioavailability of Two New Formulations for RO5045337 in Patients With Solid Tumors Including Lymphoma

Conditions
-----------------
Neoplasms

Intervention / Treatment
-----------------
* Drug: RO5045337


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/=18 years of age Histologically confirmed solid tumor Life expectancy of >/=12 weeks ECOG performance status of 0 or 1 Adequate bone marrow, renal and hepatic function Exclusion Criteria: Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start Patients with pre-existing gastro-intestinal disorder Patients with uncontrolled intercurrent illness

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 |
| --- | --- |
| Active Comparator: A<br> | Drug: RO5045337<br>* single oral dose<br>|
| Experimental: B<br> | Drug: RO5045337<br>* single oral dose<br>|
| Experimental: C<br> | Drug: RO5045337<br>* single oral dose<br>|
| Experimental: D<br> | Drug: RO5045337<br>* single oral dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Examination of potential food-effect on pharmacokinetics of RO5045337 |  | 3 weeks | 
| Evaluation of relative bioavailability of RO5045337 |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of safety and tolerability of RO5045337 |  | 3 weeks | 
| Evaluation of pharmacodynamics and biomarkers |  | 3 weeks |
Neuroimaging Changes in Hereditary Ataxia

Study Overview
=================
Brief Summary
-----------------
This study aim to investigate the neuroimaging changes of hereditary ataxia patients, especially in the SCA3 patients in preclinical or mild stage.

Official Title
-----------------
Neuroimaging Changes in Hereditary Ataxia

Conditions
-----------------
Hereditary Ataxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: genetically diagnosed as Spinocerebellar ataxia Exclusion Criteria: deny to follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| neuroimaging information | neuroimaging information approached by MRI, including 3D-T1, T2, DTI, rsfMRI, SWI, ASL were collected | from 2021 to 2025 |