linjc16/ctgov huggingface dataset:
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy of ZD6474 in patients with metastatic breast cancer at 2 dose levels.

Official Title
-----------------
An Open-label, Multicenter Phase II Study to Assess the Response of Subjects With Metastatic Breast Cancer Previously Treated With Anthracycline and Taxane Therapy With or Without Capecitabine to ZD6474 (100-mg or 300-mg Daily Oral Dose).

Conditions
-----------------
Breast Neoplasms, Metastases, Neoplasm

Intervention / Treatment
-----------------
* Drug: ZD6474


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological and/or cytological confirmation of metastatic breast cancer which is refractory to anthracycline, taxane, with or without capecitabine therapies; WHO performance status 0, 1 or 2 on the day of registration; Females, aged >= 18 years; No Gastrointestinal pathology which could affect the bioavailability of ZD6474. Exclusion Criteria: Any evidence of severe or uncontrolled systemic diseases including known cases of Hepatitis B or C or human immunodeficiency virus (HIV). Significant cardiac event (including symptomatic heart failure or unstable angina) within 3 months of entry or any cardiac disease that in the opinion of the investigator increases risk for ventricular arrhythmia; History of clinically significant cardiac arrhythmia (multifocal PVCs, bigeminy, trigeminy, ventricular tachycardia), which is symptomatic or requires treatment (CTC grade 3) or asymptomatic sustained ventricular tachycardia; Chronic atrial fibrillation; Previous history of QT / QTc prolongation with other medication; Congenital long QT syndrome; Systemic anti-cancer therapy or other investigational agent within the last 4 weeks (6 weeks for nitrosoureas, mitomycin C, or suramin); Currently receiving drugs with known significant 3A4 inhibitory (ie, ketoconazole, itraconazole, troleandomycin, erythromycin, diltiazem, verapamil) or stimulatory (ie, phenytoin, carbamazepine, barbiturates, rifampicin) effects; Currently receiving therapeutic doses of warfarin (Coumadin?)

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: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: ZD6474|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
-----------------
Metastatic breast cancer
Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal

Study Overview
=================
Brief Summary
-----------------
To assess the five-year incidence of AMD in a population from the central region of Portugal, previously phenotypically characterized.

Detailed Description
-----------------
Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) between 2009 and 2013 will attend a single visit, after giving informed consent.

Official Title
-----------------
Five-year Incidence of Age-related Macular Degeneration in the Central Region of Portugal

Conditions
-----------------
Age-Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who participated in the Epidemiologic Coimbra Eye Study (NCT01298674) and that were phenotyped; Subjects capable of understanding the information about the study and to give their informed consent to enter the study; Subjects willing and able to comply with the study procedures. Exclusion Criteria: - Not applicable

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- | --- |
| Phenotypic classification of AMD in the five-year clinical visit. Comparison of this classification with the grading of 5 years ago. |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Risk factors: Demographic, Medical history, Ophthalmologic history, Family history of AMD, Systemic comorbidities and medication, Nutritional and Lifestyle habits. Signs of AMD on the multimodal evaluation. |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Age- Related Macular Degeneration; Diabetic Retinopathy; Glaucoma; Cataract
Comparison Between Ultra-narrow Diameter Implants (2,75 mm) Without Bone Regeneration Versus Standard Diameter Implants (4,3 mm) in Combination With Bone Regeneration

Study Overview
=================
Brief Summary
-----------------
The main target of the study is to compare ultra-narrow diameter implants (2.75 mm) without bone regeneration versus standard diameter implants (4.3 mm) in combination with bone regeneration. To do so, patients with missing upper central incisors, canines, first or second premolars with alveolar ridges of 6 - 8 mm of thickness will be restored with dental implants. Cone beam computed tomographic examination and clinical values will be registered before and after the surgical procedure at 6 and 12 months.

Official Title
-----------------
Éxito a Corto Plazo de Los Implantes Ultra-estrechos (2,75 mm) en comparación Con Implantes de Plataforma Regular (4,3 mm) Que Requieren regeneración ósea Vestibular simultánea. Ensayo clínico Aleatorizado

Conditions
-----------------
Implant Fracture, Dental Implant, Narrow Implant, Guided Bone Regeneration

Intervention / Treatment
-----------------
* Procedure: Standard implant
* Procedure: Ultra-narrow implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One missing teeth in position: upper central incisor, canine or premolar alveolar ridge thickness of 6 - 8 mm alveolar ridge height of ≥ 10 mm Exclusion Criteria: Missing data ASA ≥ III

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Implant<br> | Procedure: Standard implant<br>* Arm - Standard Implant: implant placement in combination with guided bone regeneration;<br>|
| Experimental: Ultra-narrow Implant<br> | Procedure: Ultra-narrow implant<br>* Arm - Ultra-narrow implant: implant placement without guided bone regeneration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success | According to criteria described by Albrektsson et al. 1986 | 12 months |
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women

Study Overview
=================
Brief Summary
-----------------
This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in preterm and term pregnant patients.

Detailed Description
-----------------
The SureCALL® Labor Monitor® (SureCALL®) is a transabdominal electromyography monitor intended to measure uterine activity. It is intended for use on pregnant women, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting. This measurement study was designed to evaluate the performance of SureCALL® Labor Monitor® (SureCALL®) compared to the predicate Tocodynamometer device (TOCO) in pregnant laboring preterm patients, nonlaboring preterm patients, and nonlaboring term patients. This study involved 25 women at a Gestational Age of 36 weeks or less and 5 women at a Gestation Age of greater than 36 at five clinical sites. Each study subject was instrumented with two technologies for measuring uterine activity: Standard tocodynamometer attached to the maternal abdomen, SureCALL® with a set of abdominal surface electrodes for uterine electromyography attached to the maternal abdomen Subjects did not recieve any interventions as a part of this study.

Official Title
-----------------
Comparison of SureCALL® Labor Monitor® and Tocodynamometer Measurement in Preterm and Term Pregnant Women

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton Pregnancy Informed Consent Required Exclusion Criteria: Multifetal Pregnancy Informed Consent Not Given

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant, Preterm, In Labor<br>Gestation Age at or less than 36 weeks, clinically determined to be in labor | |
| Pregnant, Preterm, Nonlaboring<br>Gestation Age at or less than 36 weeks, clinically determined to not be in labor | |
| Pregnant, Term, Nonlaboring<br>Gestation Age more than 36 weeks, clinically determined to not be in labor | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of SureCALL® and Tocodynamometer Detection of Contraction Event Timing | Time Stamps of the Peaks of Corresponding Contractions | 9 - 41 Minutes |
A Thorough ECG Study in Subjects With Acne Vulgaris Treated With SB204

Study Overview
=================
Brief Summary
-----------------
A Double-Blind, Double-Dummy, Randomized, 4-Period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Detailed Description
-----------------
A Double-Blind, Double-Dummy, Randomized, 4-Period, Crossover Study to Define the ECG Effects of SB204 Using a Clinical and a Supratherapeutic Dose Compared with Placebo and Moxifloxacin (a Positive Control) in Subjects with Acne Vulgaris: A Thorough ECG Study

Official Title
-----------------
A Double-blind, Double-dummy, Randomized, 4-period Crossover Study to Define the ECG Effects of SB204 Using a Clinical and Supratherapeutic Dose Compared With Placebo and Moxifloxacin in Subjects With Acne Vulgaris: A Thorough ECG STudy

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Drug: SB204 4%
* Drug: SB204 8% or 12%
* Drug: Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate to severe acne 20 inflammatory and 25 non-inflammatory acne lesions Exclusion Criteria: Pregnant, trying to become pregnant, or nursing Known allergy to any component of the topical SB204 formulation

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SB204 4%<br>SB204 4% once | Drug: SB204 4%<br>* Applied topically once<br>* Other names: NVN1000;|
| Experimental: SB204 8% or 12 %<br>SB204 8 or 12 % (supratherapeutic) once | Drug: SB204 8% or 12%<br>* Applied once topically<br>* Other names: NVN1000;|
| No Intervention: Moxifloxacillin<br>Moxifloxacillin 400 mg orally | |
| Placebo Comparator: Vehicle Gel<br>Placebo | Drug: Vehicle<br>* Applied topically once<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Define ECG effect of SB204 at therapeutic and supratherapeutic dose concentrations as measured by the difference between time-matched baseline adjusted QTcF interval for the groups recieving SB204 and placebo. |  | 15 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Categorical analysis of the QTc interval to determine number and percentage of time points and subjects by dose group with absolute QT/QTc > 450, 480, and 500 ms. |  | 15 days |
Phase 2 Study of the Safety and Efficacy of UK-500,001 in Adult Patients With COPD

Study Overview
=================
Brief Summary
-----------------
This initial proof of concept, phase II study aims to assess the safety and efficacy of UK-500,001 for the chronic maintenance treatment of adults with Chronic Obstructive Pulmonary Disease.

Official Title
-----------------
A Phase II Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study To Evaluate The Efficacy And Safety Of UK-500,001 Dry Powder For Inhalation (DPI) In Adults With Moderate To Severe Chronic Obstructive Pulmonary Disease (COPD).

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: UK-500,001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderate-severe COPD (Global inititiative for chronic Obstructive Lung Disease, GOLD, 2003 definition) Smoking history of at least 10 pack-years Exclusion Criteria: Any significant co-morbid disease Use of any maintenance therapy except short acting bronchodilators

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: UK-500,001|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in forced expiratory volume in 1 second (FEV1) compared to placebo |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in other lung function parameters, dyspnea, quality of life compared to placebo |  |  |
Web-Mediated Risk Assessment for Endoscopic Screening of Colorectal Polyps

Study Overview
=================
Brief Summary
-----------------
Colorectal polyps are risk factors for cancer. Early detection of polyps is critical for colorectal cancer management. However, the diagnosis rate of patients with colorectal polyps is still low. Therefore, we design this study to access whether pre-endoscopic screening risk assessment of genetic and environmental risk factors could improve diagnosis rate of colorectal polyps.

Official Title
-----------------
Randomized Trial Comparing Gastroscopy Following Web-Mediated Risk Assessment With Routine Endoscopy Screening of Colorectal Polyps

Conditions
-----------------
Colorectal Polyp

Intervention / Treatment
-----------------
* Diagnostic Test: pre-endoscopic screening risk assessment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-65. Signed informed consent Exclusion Criteria: Severe back ground disease including malignancy. State after gastric surgery. COPD, CHF, CRF and any disease with respiratory disturbances. Deviation of the nasal septum, lack of venous access at the dorsum of the hand or any other technical problem prevents gastric acid collection or base excess evaluation.

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?
-----------------

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: pre-endoscopic screening risk assessment<br> | Diagnostic Test: pre-endoscopic screening risk assessment<br>* pre-endoscopic screening risk assessment<br>|
| No Intervention: routine screening<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic rate of patients with polyps | Diagnostic rate of patients with polyps | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and characteristics of polyps detected | Characterization of types of polyps | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colorectal Polyp, Screening, Risk assessment
Comparison of the Effects of Continuous Epidural Analgesia and Continuous Intravenous Analgesia on Postoperative Bowel Movement in Patients Undergoing Laparoscopic Gastrectomy

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that sympatholytic effect of epidural analgesia would attenuate the hemodynamic instability and decrease in the splanchnic blood flow caused by pneumoperitoneum during laparoscopic surgery. This study is to compare the effect of epidural analgesia and intravenous analgesia on postoperative bowel movement in patients undergoing laparoscopic gastrectomy.

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Other: continuous epidural analgesia
* Other: continuous intravenous analgesia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient between 20 and 70 of age with ASA physical status Ⅰ-Ⅲ gastric cancer patient undergoing laparoscopic gastrectomy Exclusion Criteria: ASA physical status Ⅳ bradycardia (< 60 bpm), arrhythmia uncompensated heart failure hepatic failure (Child-Pugh score B) renal failure (eGFR MDRD < 60 ml/min/1.73m2)

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?
-----------------

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: continuous epidural analgesia group<br> | Other: continuous epidural analgesia<br>* the continuous epidural analgesia group: epidural analgesia started from induction of anesthesia and continued for 48 h.<br>|
| Active Comparator: continuous intravenous analgesia group<br> | Other: continuous intravenous analgesia<br>* the continuous intravenous analgesia group: intravenous analgesia started from induction of anesthesia and continued for 48 h.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time to first gas passing after surgery | Outcome will be assessed by a investigator blinded to the study group. | within 5days after surgery | 
| the time to resume water intake after surgery | Outcome will be assessed by a investigator blinded to the study group. | within 5days after surgery | 
| soft diet intake after surgery | Outcome will be assessed by a investigator blinded to the study group. | within 5days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain | numerical rating scale 0 (no pain) to 10 (worst pain) | immediately after surgery to 48 hours |
Effect of Hydration With Sodium Bicarbonate for Long-Term Clinical Outcomes in Patients With Chronic Kidney Disease Undergoing an Emergent Coronary Procedure

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy of sodium bicarbonate plus N-acetylcysteine for the prevention of contrast-induced nephropathy.

Conditions
-----------------
Chronic Renal Failure

Intervention / Treatment
-----------------
* Drug: N-acetylcysteine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic renal failure(serum creatinine >1.1mg/dl) undergoing elective percutaneous coronary intervention Exclusion Criteria: administered with sodium bicarbonate and/or N-acetylcysteine and/or contrast media within 72 hours. pregnancy congestive heart failure allergy to sodium bicarbonate and/or N-acetylcysteine hemodialysis

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: NAC<br> | Drug: N-acetylcysteine<br> <br> |
| Placebo Comparator: nonNAC<br> | Drug: N-acetylcysteine<br> <br> |

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
-----------------
patients with chronic renal failure undergoing elective percutaneous coronary intervention