linjc16/ctgov huggingface dataset:
Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of the new RJ4 compare with the standard RJ3 biopsy forceps for performing polypectomy for small colorectal polyps.

Official Title
-----------------
Comparison of Two Types of Biopsy Forceps for Obtaining Cold Biopsy Polypectomy for Small Sessile Colorectal Polyps Less Than 6 mm in Diameter

Conditions
-----------------
Colorectal Polyps

Intervention / Treatment
-----------------
* Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colon polyps less than 6 mm Exclusion Criteria: no colon polyps

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: RJ3 Biopsy Forcep<br>use of RJ3 Biopsy forcep for the polypectomy | Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep<br>* Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.<br>|
| Active Comparator: RJ4 Biopsey Forcep<br>Use of RJ$ biopsy forcep for polypectomy | Other: evaluate the effectiveness of the RJ4 biopsy forcep versus the RJ3 biopsy forcep<br>* Use of either the RJ3 or RJ4 biopsy forcep for colon polypectomy. will evaluate the effectiveness of removal of polyps less than 6 mm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete endoscopic (visual) eradication of the polyp with the first forceps bite |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of bites to completely visually eradicate the polyp if the polyp was not fully eradicated with the first forceps bite |  | one year | 
| Complete pathologic eradication of the polyp on the first forceps bite. |  | one year | 
| Correlate endoscopic with pathologic eradication |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
evaluate the effectiveness of one bite polypectomy with the RJ3 biopsy forcep versus the RJ4 biopsy forcep
Amrubicin Study for Elderly Patients With Extensive-disease Small-cell Lung Cancer (ED-SCLC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and toxicity of amrubicin with carboplatin plus etoposide in elderly patients with extensive-disease small-cell lung cancer.

Official Title
-----------------
Randomized Phase III Trial of Amrubicin Versus Carboplatin Plus Etoposide in Elderly Patients With Extensive-disease Small-cell Lung Cancer

Conditions
-----------------
Small-cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Amrubicin Hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Extensive-disease small-cell lung cancer Aged 70 years or older Performance status of 0-2 No prior chemotherapy Exclusion Criteria: Prior therapy for primary lesion Pneumonitis and/or pulmonary fibrosis Active concomitant malignancy

Ages Eligible for Study
-----------------
Minimum Age: 70 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

| Intervention/Treatment |
| --- |
|Drug: Amrubicin Hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression |  |  | 
| Objective tumor response |  |  | 
| Quality of Life (QOL: EuroQOL, FACT-L-LCS) |  |  | 
| Frequency and severity of adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Extensive-disease small-cell lung cancer (ED-SCLC)
Epirubicin and Docetaxel in the Treatment of Patients With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The epirubicin/docetaxel combination is one of the most active and best tolerated taxane/anthracycline combinations. In this phase II trial, we will further evaluate the feasibility, safety and effectiveness of the docetaxel/epirubicin combination, when administered as first-line treatment for metastatic breast cancer.

Detailed Description
-----------------
Upon determination of eligibility, all patients will receive: Docetaxel + Epirubicin Both drugs will be repeated at 21-day intervals

Official Title
-----------------
A Phase II Trial of Epirubicin/Docetaxel in the First-Line Treatment of Patients With Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Docetaxel
* Drug: Epirubicin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be included in this study, you must meet the following criteria: Metastatic breast cancer confirmed by biopsy. Received no previous chemotherapy for metastatic breast cancer. Prior hormonal therapy is acceptable. Measurable or evaluable disease. Able to perform activities of daily living without considerable assistance Adequate bone marrow, liver and kidney function Must be able to understand the nature of this study and give written informed consent. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: Age < 18 years. Cardiac ejection fraction < 45%. Women who are pregnant or lactating. Patients with meningeal metastases are ineligible. Moderate peripheral neuropathy History of hypersensitivity reaction to Taxotere Males with metastatic breast cancer Please note: There are additional inclusion/exclusion criteria. The study center will determine if you meet all of the criteria. If you do not qualify for the trial, study personnel will explain the reasons. If you do qualify, study personnel will explain the trial in detail and answer any questions you may have.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Docetaxel|nan|
|Drug: Epirubicin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response rate of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of the docetaxel/epirubicin combination in the first-line treatment of patients with metastatic breast cancer |  |  |
MR-Guided Laser Ablation of Hepatic Tumors

Study Overview
=================
Brief Summary
-----------------
This is a pilot study to investigate the performance of MR-guided Laser Induced Thermal Therapy (LITT) in the treatment of liver tumors.

Official Title
-----------------
Technical Success, Safety, and Short-term Efficacy for MR-Guided Laser Ablation of Hepatic Tumors

Conditions
-----------------
Soft Tissue Tumors

Intervention / Treatment
-----------------
* Procedure: Laser ablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with soft tissue tumor metastases to the liver who are referred to Interventional Radiology for treatment. Surgery is not a viable or desirable alternative therapy at the time of enrollment Radiation therapy has failed or not indicated or can be safely postponed Tumor size ≤ 5 cm at its largest diameter Tumor position is not in the central liver hilum Performance status is ECOG 2 or better in adults Patient is able to undergo MRI Exclusion Criteria: Patients with pacemaker or defibrillator Patients with metallic surgical clips close to the site of the intended ablation Pregnant women Patients with hilar liver lesions

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Visualise Thermal Therapy System<br> | Procedure: Laser ablation<br>* Laser ablation of hepatic tumors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MR Images |  | 6 months |
A Pilot Evaluation of Adhesives and How They Are Impacted by Out-put

Study Overview
=================
Brief Summary
-----------------
The study investigates the impact real output (subjects own) and simulated output have on the adhesion of adhesives.

Conditions
-----------------
Ileostomy

Intervention / Treatment
-----------------
* Other: Buffer
* Other: Own output
* Other: simulated output


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have given written informed consent Be at least 18 years of age and have full legal capacity Have had an ileostomy for more than one year Have intact skin on the area used in the evaluation Has an ileostomy with a diameter up to (≤) 35 mm Have a peristomal area accessible for application of patches/adhesive strips (assessed by investigating scientist) Exclusion Criteria: Currently receiving or have within the past 2 month received radio- and/or chemotherapy Currently receiving or have within the past month received topical steroid treatment in the peristomal skin area or systemic steroid (tablet/injection) treatment. Are pregnant or breastfeeding Having dermatological problems in the peristomal- or abdominal area (assessed by investigating scientist) Participating in other interventional clinical investigations or have previously participated in this evaluation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 01a<br>This is a sub-study testing three patches consisting of an adhesive patch and a sleeve. The sleeve can contain one of three solutions: Buffer Own output Simulated output (digestive enzymes) All subjects will test the three solutions at the same time, hence the three patches with different solutions will be placed on the peristomal skin simultanously. | Other: Buffer<br>* The sleeve contains phosphate buffered saline buffer<br>Other: Own output<br>* The sleeve contains the subject own ileal effluent<br>Other: simulated output<br>* The sleeve contains simulated output<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Remaining adhesive area of adhesive | The remaining adherent area of the adhesive is assessed by subtracting the area of output and swelling from the total adhesive area. | 30 hours |
Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study. No additional treatment or intervention will be conducted except for blood sampling that will be limited to one time only. Blood samples (10 cc in volume) will be collected from all study participants once they provided written informed consent form. DNA will be extracted from peripheral blood samples using DNA isolation kit.

Official Title
-----------------
Genome-wide Association Study to Predict Treatment Response for Molecular Targeted Therapy in Hepatocellular Carcinoma and Renal Cell Carcinoma

Conditions
-----------------
Hepatocellular Carcinoma, Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Hepatocellular carcinoma and Renal cell carcinoma patients who receive molecular targeted therapy will be candidates for the study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Renal cell carcinoma<br> | |
| Hepatocellular carcinoma patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genotypes | To define genotypes of HCC and RCC patients who will likely to response to molecular targeted therapy. To define genotypes associated with adverse events from molecular targeted. To identify genotypes which will predict survival or disease-free survival following molecular targeted therapy. | 36months |
IN CONTROL--Hypertension Reduction in Inner City Seattle

Study Overview
=================
Brief Summary
-----------------
To implement and evaluate with a randomized, controlled trial interventions to improve control of hypertension among inner city low- income and minority residents of Seattle.

Detailed Description
-----------------
BACKGROUND: Low income residents of inner city Seattle especially African Americans, have significantly higher rates of cardiovascular mortality and morbidity than other Seattle residents. Hypertension is a major risk factor for these excess deaths. The prevalence of both hypertension and uncontrolled hypertension is also higher among low income and minority residents, especially young men. The study was in response to a demonstration and education initiative, Improving Hypertensive Care for Inner City Minorities, which was reviewed and approved by the Clinical Applications and Prevention Advisory Committee in April 1992 and by the National Heart, Lung, and Blood Advisory Council in May 1992. The Request for Applications was released in October 1992. DESIGN NARRATIVE: Two interventions were studied, both of which improved upon existing activities and strengthened the relationship between community and clinic-based hypertension control activities. The first intervention improved the identification and entry into care of new and uncontrolled hypertensives in the community with an emphasis on bringing more young males (especially African American) through: (a) screening and education activities (b) a microcomputer-based client tracking system to follow persons with elevated blood pressure (c) an outreach system to improve follow-up into clinical care. The second intervention enhanced access to and compliance with hypertension care among patients using the participating clinics (both currently registered patients and new patients referred through community screening activities) through: (a) microcomputer-based patient tracking system at each clinic to identify nonadherent and other high risk patients (b) placing a hypertension patient care coordinator at each clinic who created an individualized care plan for each patient and coordinated a wide range of services, including specific strategies to enhance compliance (c) making available outreach workers to assist in efforts to keep patients in care. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
Study of KP-1461 for the Treatment of HIV Positive Patients Who Have Failed Multiple HAART Regimens

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the study is to assess the safety and pharmacokinetics of KP-1461 given every 12 hours for 14 days when administered to HIV+ patients who have failed multiple highly active antiretroviral therapy (HAART) regimens. Patients currently on HAART will be required to discontinue all HAART medications for up to 6 weeks after screening eligibility has been determined.

Detailed Description
-----------------
KP-1461 is a carbamate prodrug of the active nucleoside, KP-1212. KP-1212 is incorporated into the proviral DNA. After multiple rounds of replication, KP-1212 increases the high inherent mutation rate of HIV beyond the threshold of viability, a process called viral decay acceleration. KP-1212 is unique from conventional nucleoside reverse transcriptase inhibitors in that it inserts mutations randomly across the entire 10,000 nucleotide HIV genome and does not exert selective pressure by targeting a specific viral or cellular process, thus potentially avoiding drug resistance.

Official Title
-----------------
A Double-Blind, Placebo-Controlled, Dose Escalation Study of the Safety, Tolerability, and Pharmacokinetics of Multiple Oral Doses of KP-1461 in HIV+ Adults Who Have Failed Two or More Highly Active Antiretroviral Regimens (HAART)

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: KP-1461


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CD4 > 100 cells/mm3 Viral load 2,500 - 200,000 copies/mL Exposure to at least 2 different HAART regimens containing NRTI(s), NNRTI(s), and 2 PI(s), excluding Ritonavir, for a minimum of 4 months or documented resistance to at least 3 of the 4 classes of approved antiretroviral drugs. Few, if any, effective treatment options available Exclusion Criteria: HBsAb (hepatitis B) positive serology

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: KP-1461|nan|

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
-----------------
HIV, Treatment Experienced
Study of Freefol-MCT PKPD in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to analysis PKPD of Freefol-MCT and to investigate relationship between the concentration of Freefol-MCT and the index which signaly analyzes those: EEG, EEG approximate entropy, systolic BP, saturation wave form and invasive BP wave form.

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

Intervention / Treatment
-----------------
* Other: Age: 20-40years
* Other: Age: 41-64years
* Other: Age: ≥65years


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults males/Females aged over 20years Health screening examination within 60 days of the start (Interview, vital signs , 12-lead ECG, blood tests, urinalysis) . The applicant who agreed in writing by told an explanation enough about the characteristics of the study drug, the purpose of the test and the details. Exclusion Criteria: Subjects with clinically significant disease or history such as Liver, kidney, gastrointestinal, respiratory, musculoskeletal, endocrine, nervous psychiatric, blood tumor system and cardiovascular. (In particular, bronchial asthma, severe hepatic, renal failure, severe blood disorders, severe myasthenia gravis, cardiac dysfunction, peptic ulcer, etc.) Who had acute disease or organ dysfunction within four weeks of the start of the test. Who had significant hematologic disorders or donate whole blood within two months of the start of the test. Significant neuropsychiatric or more. Continued drug abuse. Who has a history of drug and other hypersensitivity reactions. Positive at Type B / C hepatitis , syphilis tests (VDRL), if in AIDS antibody test Who took other clinical medicine within two months of the start of the test. Who smokes or drinks within two weeks after dosing. Who takes drugs regularly other than the mineral claim or vitamin. However, it depends on judgment of the researchers.

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| A<br>Gender: 10 Males, 10 Females | Other: Age: 20-40years<br> <br> |
| B<br>Gender: 10 Males, 10 Females | Other: Age: 41-64years<br> <br> |
| C<br>Gender: 10 Males, 10 Females | Other: Age: ≥65years<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non- compartment pharmacokinetic parameters |  | 1200 minutes | 
| Compartment pharmacokinetic parameters |  | 1200 minutes | 
| BIS |  | 1200 minutes | 
| SBP |  | 1200 minutes | 
| E0 |  | 1200 minutes | 
| Emax |  | 1200 minutes | 
| Ce50 |  | 1200 minutes | 
| ke0 |  | 1200 minutes |