linjc16/ctgov huggingface dataset:
Surveillance Study for HCC by Combining Biomarkers With Imaging (ALDUS)

Study Overview
=================
Brief Summary
-----------------
This study is intended to be a prospective observational study at multiple sites, not a randomized controlled trial (RCT). The uses of the biomarkers has been approved by government regulations and adopted for surveillance programs in some countries, thus an RCT which compares patients followed by US alone with patients followed by both US and the biomarkers would raise an ethical conflict, especially in countries where the biomarkers have been routinely used. For this study, enrolled patients will be followed by US and the biomarkers at regular intervals and classified after completing the study to evaluate the clinical effectiveness of the biomarkers. The comparisons of sensitivity, specificity, and other parameters with respect to tumor characteristics will be made among US alone, the biomarkers, and combined use of US and the biomarkers. Also economical effectiveness of using the biomarkers will be investigated in this study. Requirement status is monitored every month.

Detailed Description
-----------------
Data are being stored in the electric data capture (EDC) server.

Official Title
-----------------
Study for Clinical Significance of Use of Alphafetoprotein (AFP), AFP-L3 and Des-gamma-carboxy Prothrombin (DCP) Versus US Alone in Surveillance for HCC

Conditions
-----------------
Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with compensated cirrhosis. No discrimination by underlying causes will done. Patients aged 18 years and older Patients agree to the informed consent Exclusion Criteria: Patients with liver cancer at the time of enrollment Patients who have experienced HCC or other malignant tumor with in five (5) years Women with pregnancies Patients who are likely to be transplanted within one (1) year Patients with ≥ 3 mg/dL of total bilirubin Patients with uncontrollable ascites Patients with ≥ Grade II of hepatic encephalopathy

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 |
| --- | --- | --- |
| Hepatocellular carcinoma | Tumor marker measurement and ultrasonography are conducted at an interval of 13 weeks, until total events (HCC occurrence) reach to 120 cases. | Expected time frame; 2.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 2 and 5 year after patient enrollment |
Comparison of Bowel Cleansing Regimens Prior to Colonoscopy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to to compare two bowel preparation regimens of patients who will undergo colonoscopy, in terms of quality of bowel preparation and in terms of patient satisfaction.

Official Title
-----------------
PRECOL2011-1: Sodium Picophosphate and Magnesium Citrate Versus Polyethylene Glycol as Evacuating Treatment Prior to Colonoscopy: Phase IV Randomized Trial.

Conditions
-----------------
Patients Undergoing Elective Colonoscopy

Intervention / Treatment
-----------------
* Drug: polyethylene glycole (PEG) solution
* Drug: sodium picosulphate and magnesium citrate solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • Subjects who are candidate to undergo colonoscopy: Diagnosis Screening Follow-up after previous polypectomy Informed consent Age > 18 years Exclusion Criteria: Previous colonic resection Severe inflammatory bowel disease (IBD)

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEG<br>polyethylene glycol solution 2 liters | Drug: polyethylene glycole (PEG) solution<br> <br> |
| Active Comparator: NapP<br>Sodium picosulphate and magnesium citrate solution 300 ml | Drug: sodium picosulphate and magnesium citrate solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Boston Bowel Preparation Scale value | evaluated by two endoscopists who are blinded to treatment assigned at randomization | at time of colonscopy | 
| patient reported acceptability score | using visual analog scale | just prior to colonscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of bowel cleansing regimen dose assumed as reported by patient |  | just prior to colonoscopy |
Comparison of Early Caries Detection in Children Utilizing an Electrical Conductance Device and the Gold Standard of Visual-tactile Technique.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a methodology for detecting early forming cavities in children that is more accurate and reliable than the gold standard used by dentists around the world. The new method uses an electrical current device to detect early enamel mineral loss before it can develop into a cavity. The manual gold standard is for a dentist to probe the surfaces of the teeth with a fine pick, searching for areas of defect.

Conditions
-----------------
Dental Caries in Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children whose parents authorize participation by signing a consent form. Children who attend public school only. Children in good health. Children between 6 and 9 years of age. Children with all first permanent molars erupted. All permanent first molars must not have any signs of cavitation but only one molar can have some mineral loss(e.g. white spots). Children must show some caries in the primary molars as a sign of caries susceptibility. - Exclusion Criteria: Children of parents or a guardian who do not agree to participate in the study. Children registered in private schools. Children not in good health. Children undergoing antimicrobial or antibiotic treatment. Children outside the range of age selected for the study. Children with one or more first permanent molars unerupted. Children with any cavitation in the occlusal surface of any first permanent molar. Children who do not have a sign of dental caries in the primary molars as a sign of caries susceptibility. Children who do not allow themselves to be examined. -

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 9 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the detection of occlusal caries lesions in the first permanent molars of Venezuelan children by electrical conductance and visual-tactile means. |  | 14 months from baseline assessment |
Vitamin D Supplementation in Obesity and Weight Loss (3DD Study)

Study Overview
=================
Brief Summary
-----------------
In this study, we will provide supplemental vitamin D in postmenopausal overweight/obese women, and hypothesize that it will not affect areal BMD, but will alter bone compartments (trabecular and cortical bone). In addition, higher vitamin D intake will increase serum 25OHD and suppress serum PTH and bone turnover during weight reduction. Secondary outcomes include the influence of vitamin D and weight loss on markers of insulin resistance and on cognitive tests of attention, learning, and memory.

Official Title
-----------------
A Pilot Dose Response Study to Vitamin D in Obesity and Weight Loss: Effect on Bone

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Dietary Supplement: 600 IU Vitamin D3
* Dietary Supplement: 2000 IU Vitamin D3
* Dietary Supplement: 4000 IU Vitamin D3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index of 25-40 kg/m2 Postmenopausal Age 50-72 years Exclusion Criteria: Women who are taking any medication known to influence Calcium or bone metabolism, Evidence of diseases known to influence Calcium metabolism (i.e. metabolic bone disease) hyperparathyroidism untreated thyroid disease significant immune disease hepatic disease renal disease or a kidney stone in the last 5 years significant cardiac disease active malignancy or cancer therapy within the past year

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 72 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 600 IU D3<br> | Dietary Supplement: 600 IU Vitamin D3<br>* Once daily<br>|
| Active Comparator: 2000 IU D3<br> | Dietary Supplement: 2000 IU Vitamin D3<br>* Once daily<br>|
| Active Comparator: 4000 IU D3<br> | Dietary Supplement: 4000 IU Vitamin D3<br>* Once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density (BMD) | BMD | 1 year | 
| Bone quality | thickness (mm) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone turnover markers | osteocalcin (others include PINP and CTX) | Baseline, 6 months, 12 months | 
| Glycemic indices | glucose and insulin | Baseline, 6 months and 12 months | 
| Cognition and biochemical markers | Cognitive measures and serum biochemical markers | One year | 
| cholesterol absorption | Serum levels | baseline and one year | 
| serum vitamin D | 25(OH)D | Baseline, 6 months and 12 months | 
| Bone regulating hormones | PTH | Baseline, 6 months and 12 months |
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)

Study Overview
=================
Brief Summary
-----------------
An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.

Detailed Description
-----------------
Main objectives are: Description of the clinical and histological characteristics, treatment and evolution of these NHL. Study their physiopathology by immunological, virologic and molecular studies. The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments. The enrolment period is 6 years and the total study lasts 8 years. Prospective patients are followed every 6 months during one year, and all the years during 2 or 5 years. Retropective patients are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies. The enrollment is estimated at 140 patients.

Official Title
-----------------
Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus

Conditions
-----------------
Chronic Hepatitis C

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with evolving NHL whatever its histological type At diagnosis or relapse or failure previous treatments stopped over 3 months Patients with HCV infection with positive quantitative viral load 18 years or more of age Life expectancy greater than 6 months Signed and informed consent Benefit from social security Exclusion Criteria: Active uncontrolled infection (out hepatitis C) HIV (Human immunodeficiency virus) infection Severe psychiatric history

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 |
| --- | --- | --- |
| presentation of NHL and HCV infection, and treatments of NHL and HCV infection | the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics | at the first visit (Day 0) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of intercurrents biological and clinical events |  | Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60 | 
| virological response | HCV quantitative viral load | Month 60 | 
| haematological response | to evaluate the correlation between hematological and virological response | Month 60 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
B-Cell Non Hodgkin Lymphomas, Hepatitis C
Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study the effect of fingolimod on cardiac autonomic regulation in patients with relapse-remitting multiple sclerosis. This will be done by measuring heart rate variability from the 24-hour Holter recording and myocardial ventricular repolarisation patterns from the 12-lead electrocardiogram tracings. The fingolimod treatment is prescribed according to the accepted drug label.

Detailed Description
-----------------
The study will include 30 relapse-remitting multiple sclerosis patients. Assessments of heart rate variability and myocardial ventricular repolarisation pattern will be done 1) before fingolimod, 2) first day of fingolimod 3) after 3 months use and 4) after 12 months use of fingolimod.

Official Title
-----------------
Effect of Fingolimod on the Cardiac Autonomic Regulation in Patients With Multiple Sclerosis

Conditions
-----------------
Relapse-remitting Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 65 years Understands the proposed research and actions to be taken The written informed consent has given clinical indication to fingolimod-treatment Exclusion Criteria: Patient refuses Patient takes or has taken part in other clinical drug trial during the last month No clinical indication to the use of fingolimod Contraindication to the use of fingolimod

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| change in heart rate variability |  | prior medication vs initiation vs 3 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
relapse-remitting multiple sclerosis, heart rate variability, fingolimod, cardiac autonomic regulation
Safety Improvement and Checklist Application

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact of the introduction of a surgical checklist on the incidence of complications and mortality within 30 days after surgery in patients scheduled for elective non-cardiac surgery. Patients scheduled for elective surgical procedures lasting longer than 20 minutes at are eligible. Surgery is performed in a single tertiary care center. Study design is an open trial before and after intervention (implementation of the checklist safe surgery saves lifes).

Official Title
-----------------
Safety Analysis in Regard to the Introduction of Surgical Checklists in the Operation Rooms in a Tertiary Care Center

Conditions
-----------------
Outcome, Complications

Intervention / Treatment
-----------------
* Procedure: implementation surgical checklist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery in general or regional anesthesia lasting > 15 min Exclusion Criteria: urgent surgery
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: before surgical checklist<br> | |
| Active Comparator: after implementation surgical checklist<br> | Procedure: implementation surgical checklist<br>* a checklist according to the suggestions raised by the WHO is implementated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of complications after elective surgery | comparison of number of complications in the two study arms before and after introduction of the checklist | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | evaluation of 30-days mortality | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, team, team performance, surgery, outcome
Dent Disease Mutation Genotyping

Study Overview
=================
Brief Summary
-----------------
This study will help the investigator determine whether certain genetic mutations, more than others, are a cause of more severe disease in Dent Disease.

Detailed Description
-----------------
During this study visit, the investigator will draw one tube, about two teaspoonfuls (1 to 1 ½ teaspoons for children), of blood from the subject's arm to obtain white blood cells. These white blood cells will be used as a source of DNA for genetic testing. The investigator will use the isolated DNA to try to identify the gene that is defective in Dent Disease by comparing it with the structure of genes in normal individuals, patients with Dent Disease, and family members for Dent Disease.

Official Title
-----------------
Screening for Dent Disease Mutations in Patients With Proteinuria

Conditions
-----------------
Dent Disease

Intervention / Treatment
-----------------
* Other: Genetic Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has been diagnosed, or in the process of being diagnosed with Dent Disease. The patient has a family member diagnosed with Dent Disease. Exclusion Criteria: - None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Genetic Analysis<br>Genetic Analysis | Other: Genetic Analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with genetic mutations in either the CLCN5 or ORCL1 gene |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dent, Dents, Dent Disease, Dent genetic testing, CLCN5, OCRL1, Genetic testing for Dent Disease, Hereditary study for Dent Disease
Observational Study of Pertuzumab Safety in Participants With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their metastatic disease with HER2 positivity in Korea. Participants who are administered with pertuzumab according to medical opinions of the doctor in charge of surveillance will be registered for this study and treated with pertuzumab under the approval conditions of the product in Korea.

Official Title
-----------------
Post-Marketing Surveillance of Perjeta in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Pertuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity HER2-positive, locally advanced, inflammatory, or early stage breast cancer (greater than [>]2 centimeters [cm] in diameter) participants who have never received chemotherapy and surgery for breast cancer Exclusion Criteria: Hypersensitivity for pertuzumab (Perjeta) or any of its excipients Contraindications to Perjeta according to SmPC Pregnancy and lactation

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pertuzumab<br>Participants for whom the treating physician has decided to administer pertuzumab according to standard of care and in line with the current summary of product characteristics (SmPC)/local labeling, will be observed. | Drug: Pertuzumab<br>* Study protocol does not specify/enforce any particular dosage regimen. Pertuzumab will be administered according to standard of care and in line with current SmPC/local labelling.<br>* Other names: Perjeta;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) |  | Baseline up to approximately 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST) |  | Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years) |