linjc16/ctgov huggingface dataset:
Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Polyp detection rate in colonoscopy following oral administration of MMX methylene blue tablets

Detailed Description
-----------------
Polyp detection rate in colonoscopy following oral administration of methylene blue MMX modified release tablets in subjects undergoing colonoscopy as outpatients.

Official Title
-----------------
Polyp Detection Rate After Single Oral Dose of Methylene Blue MMX Modified Release Tablets Administered to Subjects Undergoing Outpatients Colonoscopy

Conditions
-----------------
Polyp and Adenoma Detection During Colonoscopy

Intervention / Treatment
-----------------
* Device: oral tablet dye for detection of polyps during colonoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for screening or surveillance colonoscopy. Written informed consent.Practising reliable contraception or sterile.Ability to understand and comply with the protocol. Exclusion Criteria: Pregnancy or lactation known or suspected hypersensitivity GI obstruction or perforation serious cardiovascular, renal or hepatic disease. reduced prothrombin time,elevated serum creatinine.

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 |
| --- | --- |
| patients undergoing outpatient colonoscopy<br> | Device: oral tablet dye for detection of polyps during colonoscopy<br>* oral tablet dye for improved detection of<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polyp and adenoma detection rate |  | 1 day |
Mass Balance and Metabolism Study of 14C-Z-215

Study Overview
=================
Brief Summary
-----------------
The aim of this Phase I study is to determine the absorption, metabolism, and excretion of 14C-Z-215 in healthy male subjects following a single oral administration at a therapeutically relevant dose level (20 mg).

Official Title
-----------------
A Phase I Mass Balance and Metabolism Study of 14C-Z-215 in Healthy Male Volunteers

Conditions
-----------------
Healthy Male Subjects

Intervention / Treatment
-----------------
* Drug: 14C-Z-215


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any race/ethnic origin Subjects will have a body mass index (BMI) between 18.5 and 30.0 kg/m2 Subjects will have a body weight between 50 and 110 kg Subjects will have given their written informed consent to participate in the study, and to abide by the study restrictions. Exclusion Criteria: Subjects who have a significant history of drug allergy, as determined by the Investigator. Subjects who have serum hepatitis or are carriers of the hepatitis B surface antigen (HBsAg) or the hepatitis C antibody. Subjects who have a positive result for the test for human immunodeficiency virus (HIV) antibodies. Subjects who are exposed to radiation as a result of their occupation. Subjects who, in the opinion of the Investigator, should not participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 14C-Z-215<br> | Drug: 14C-Z-215<br>* Single oral dose of 20mg Z-215 and 14C-Z-215 solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery of total radioactivity concentration in plasma, red blood cells and whole blood |  | Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose | 
| Concentration of Z-215 in plasma |  | Predose,15 and 30 minutes, 1, 1.5, 2, 2.5, 3, 3.5, 4, 6, 8, 12, 14, 24, 36, 48, 72, 96, 120, 144, 168, 192, 216, 240 hours postdose | 
| Mass balance recovery of total radioactivity in urine |  | Predose, 0 to 6, 6 to 12, 12 to 24, 24 to 36, 36 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose) | 
| Mass balance recovery of total radioactivity in faecal |  | Predose, 0 to 24, 24 to 48, 48 to 72, 72 to 96, 96 to 120, 120 to 144, 144 to 168, 168 to 192, 192 to 216, 216 to 240 hours postdose, Day 15 (336 hours postdose), Day 19 (432 hours postdose), Day 23 (528 hours postdose) |
Risk Factor and Outcome of Candidemia

Study Overview
=================
Brief Summary
-----------------
Candidemia is the fourth leading cause of hospital-acquired infection in USA. In CMUH, it caused 9% hospital-acquired bloodstream infection in 2008 and 2009. In addition to increased mortality, candidemia also increased hospital stay and cost. There is a trend of increased cases of candidemia in recent years in CMUH. Early empirical and target treatment can reduce mortality and shortened length of hospital stay. In the past, most prior studies in Taiwan dealt with risk factors for mortality rather than for candidemia and also focused at in vitro susceptibility to antifungal agents. In this study, the investigators hope to analyze the candidemic cases from 2003 to 2009, estimated 1000 cases. There were some rare Candida species. Therefore, the investigators hope to do case study for these diseases to provide the epidemiology of candidemia in CMUH. The result can help clinician in predicting the disease and its outcome. Besides, it also provides the epidemiology of candidemia in mid-Taiwan.

Conditions
-----------------
Candidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient had candidemia from 2002-2010 Exclusion Criteria: no

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Risk, outcome
Effects of Raloxifene on Hormone Levels

Study Overview
=================
Brief Summary
-----------------
Blood levels of the hormones estradiol and progesterone are of interest in evaluating ovarian function. However, because these hormone levels vary from day to day, blood samples must be taken very often or elaborately timed to specific phases of the menstrual cycle. A method has now been developed for measuring estradiol and progesterone levels in saliva. This study will test the accuracy of this method and examine whether salivary levels of these hormones change after treatment with raloxifene. Hormone levels will be measured during 3 menstrual cycles in women currently enrolled in the clinical study, A Phase II Trial of Two Doses of Raloxifene in Women at Risk of Developing Invasive Breast Cancer. Participants will provide a saliva sample every morning for about a month during three collection periods-1 month before beginning raloxifene treatment, and 3 and 12 months after treatment starts. Patients will be given kits for collecting the samples and mailing them to the laboratory at the end of each collection period.

Detailed Description
-----------------
Deviations from normal levels of serum E(2) and P are of interest in evaluating ovarian function. However, the day-to-day variations in these levels necessitates serial blood sampling or elaborate efforts to time blood draws within specific phases of the menstrual cycle. A noninvasive method for assessment of the levels of sex steroids on a daily basis using saliva has been developed. This study will assess the levels of estradiol and progesterone during 3 menstrual cycles (pre-drug and after 3 and 12 months of raloxifene therapy) in pre-menopausal women participating in a pilot chemoprevention trial of raloxifene.

Official Title
-----------------
Assessment of the Effects of Raloxifene on Salivary Estradiol and Progesterone Levels

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

Intervention / Treatment
-----------------
* Procedure: measuring estradiol and progesterone levels in saliva


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients must be enrolled on protocol 98-C-0123 (MB #402) or this same protocol at the National Naval Medical Center.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: measuring estradiol and progesterone levels in saliva|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
-----------------
Breast, Hormones, Prevention, Saliva, Serum
A Prospective, Non-Interventional Study of RoActemra/Actemra (Tocilizumab) in Patients With Moderate to Severe Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This prospective, observational study will evaluate the efficacy, safety and tolerability of RoActemra/Actemra (tocilizumab) in patients with moderate to severe active rheumatoid arthritis who have had an inadequate response or are intolerant to one or more conventional disease-modifying anti-rheumatic drugs. Data will be collected from patients initiated on RoActemra/Actemra treatment according to the local label at baseline, Weeks 4, 12 and 24, and at 3 and 6 months after the last dose of study drug.

Official Title
-----------------
A Prospective, Non-interventional Multi-center Observational Study to Evaluate the Safety and Efficacy of Tocilizumab in Patients With Moderate to Severe Active Rheumatoid Arthritis in Routine Practice

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 21 years of age Moderate to severe active rheumatoid arthritis (DAS28 >/= 3.2) Inadequate response to one or more conventional disease-modifying anti-rheumatic drugs (DMARDs) Initiated on RoActemra/Actemra treatment in accordance with the prescribing information Exclusion Criteria: Pregnant or lactating women Contra-indication to RoActemra/Actemra treatment according to the local labelling Previous treatment with tocilizumab Treatment with any investigational agent within 4 weeks (or 5 half-lives of the investigational agent, whichever is longer) before starting treatment with RoActemra/Actemra Women of childbearing potential not using effective methods of contraception as defined by protocol

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: Incidence of adverse events |  | approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients achieving a clinically meaningful improvement in disease activity: DAS28 reduction of at least 1.2 units, low disease activity (DAS28 </= 3.2) or remission (DAS28 <2.6) |  | approximately 3 years | 
| Clinical/demographic patient characteristics at initiation of RoActemra/Actemra treatment |  | approximately 3 years | 
| Treatment regimens: Concomitant medications |  | approximately 3 years |
Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients?

Study Overview
=================
Brief Summary
-----------------
This study evaluates whether sustaining inspiratory pressure for 10 seconds at a time can open collapsed lung areas in non-dependant regions of the lung in mechanically ventilated patients.

Detailed Description
-----------------
Collapse of lung volume, atelectasis, is a common complication in sedated and mechanically ventilated patients. In adults the atelectasis occur mainly in the dependant areas of the lung. In this study the investigators examine whether these atelectasis can be opened by repeatedly sustaining the inspiratory pressure for 10 seconds when the patient has been positioned so that the atelectasis is located in a non-dependant position. Furthermore, the investigators examine how many times the inspiratory pressure needs to be sustained before the atelectasis is opened and at what pressure.

Official Title
-----------------
Can 10 Seconds Inspiratory Hold Open Atelectasis in Mechanically Ventilated Patients? A Pilot Study.

Conditions
-----------------
Atelectasis

Intervention / Treatment
-----------------
* Other: Inspiratory hold


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Continuously or intermittently mechanically ventilated with artificial airway (endotracheal tube or tracheostomy tube) Pressure controlled or pressure supported ventilator mode PEEP ≤ 12 cm H2O, registered peak pressure ≤ 32 cm H2O Non-ventilated lung regions according to E.I.T. measurements Richmond Agitation Score 0 -(-5) Circulatory stable or stabilized Exclusion Criteria: Pregnancy BMI > 50 Pacemaker or other electrically active implants Skin lesions, wounds or bandages on chest area where E.I.T. belt needs to be placed Undrained pneumothorax Pulsating air-mattress Unstable skeletal injury to spinal column Recent brain injury or spinal chord injury Recent injury to heart, to major blood vessels in chest, to major airways or to the oesophagus.

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: Inspiratory hold<br>Mechanical inspiratory pressure held for 10 seconds at a time. | Other: Inspiratory hold<br>* Sustainment of the ventilators inspiratory pressure for 10 seconds at a time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventilation in previously non-ventilated lung tissue | Registered using electrical impedance tomography, E.I.T., via PulmoVista500 by Dräger Medical | During intervention and for 30 minutes after ended intervention |
Upper GI Handling of Branded vs. Generic Alendronate

Study Overview
=================
Brief Summary
-----------------
To compare upper GI handling of fosamax and generic, because the main AE profile of alendronate is before systemic absorption in the esophagus; differences could be relevant to the side effect profile.

Official Title
-----------------
A Randomized, Single-Blind Study to Evaluate Upper Gastrointestinal Handling of Branded Versus Generic Alendronate Tablets

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

Intervention / Treatment
-----------------
* Drug: MK0217, alendronate sodium / Duration of Treatment: 1 Month
* Drug: Comparator: Alendronate-Teva / Duration of Treatment: 1 Month


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal females aged greater 55 years Prescribed alendronate 70 mg tablets for a therapeutic indication throughout the previous 3 months and expected to continue on this treatment for the duration of the study Willing to abstain from alcohol for 24 hours before each dose and until the end of each study day Willing to abstain from smoking for 24 hours before each dose and until the end of each study day Exclusion Criteria: History of drug hypersensitivity Suffers from dysphagia, achalasia, or other conditions or medications affecting upper gastrointestinal motility

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: MK0217, alendronate sodium / Duration of Treatment: 1 Month|nan|
|Drug: Comparator: Alendronate-Teva / Duration of Treatment: 1 Month|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gamma camera imaging of tablet dissolution in oesophagus |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gamma camera dissolution of tablets in stomach |  |  |
Phase II Iressa + Irradiation Followed by Chemo in NSCLC

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to determine wether the ZD1839 associated with a radiotherapy, before the beginning of chemotherapy is effective in the treatment of your disease and to evaluate the tolerance of these treatments.

Official Title
-----------------
A Phase II Open-Label Multicentre Study Of The Efficacy Of ZD1839 (IRESSA™) In Combination With Irradiation Followed By Chemotherapy In Patients With Inoperable Stage III Non Small Cell Lung Cancer

Conditions
-----------------
Non-Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Gefitinib
* Procedure: Radiation therapy
* Drug: Cisplatin
* Drug: Vinorelbine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed informed consent. 18 to 75 years inclusive. At least one measurable lesions histologically confirmed inoperable stage III NSCLC. WHO performance status of 0 to 2 inclusive. Adequate pulmonary function, pulmonary dose volume histogram less than or equal to 40 %. Life expectancy of at least 6 months. Using secure contraceptives precautions. Exclusion Criteria: Any previous anti cancer therapy for NSCLC. Known severe hypersensitivity to these products Any evidence of clinically active interstitial lung disease Other co-existing malignancies, symptomatic metastases. Abnormal blood test Weight loss of over 15% in the 3 months before the start of the study. Treatment with a non-approved or investigational drug within 30 days before Day 1 of study treatment.

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Gefitinib|nan|
|Procedure: Radiation therapy|nan|
|Drug: Cisplatin|nan|
|Drug: Vinorelbine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To estimate the objective response rate in patients treated with this drug |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine the safety and toxicity of this drug in these patients |  |  |
Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

Study Overview
=================
Brief Summary
-----------------
In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases (IBD).

Detailed Description
-----------------
In this study the investigators aim to evaluate the ability of i-scan OE together with magnification endoscopy to detect and assess microscopic inflammation in patients with inflammator bowel diseases. For this purpose, IBD patients will be prospectively enrolled and inflammatory changes will be assessed using optical magnification endoscopy in conjunction with optical chromoendoscopy. Endoscopic scoring of inflammatory changes in IBD patients will be done on a newly developed magnification score resulting as a consensus from experts in optical diagnosis and endoscopy in IBD patients. Results will be correlated against histopathology.

Official Title
-----------------
Magnification Endoscopy and Electronic Chromoendoscopy in Patients With Inflammatory Bowel Disease

Conditions
-----------------
Inflammatory Bowel Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Magnification endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with established diagnosis of Inflammatory Bowel Diseases Ability to provide written informed consent Age 18 years and older Exclusion Criteria: poor bowel preparation inability to provide written informed consent minors

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Magnification endoscopy|All IBD patients will undergo magnification endoscopy with 136-fold optical magnification in conjunction with optical chromoendoscopy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of endoscopic Inflammation | Endoscopic Inflammation will be determined and scored by assessement of the vascular and mucosal pattern under magnification endoscopy. | 12 months | 
| Assessment of histopathological Inflammation | Histopathologic Inflammation will be assessed by grading inflammation of intestinal biopsies routinely obtained during colonoscopy on established pathological scores. | 12 months |