linjc16/ctgov huggingface dataset:
External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Bowel preparation is closely lined to the quality of colonoscopy, inadequate bowel preparation (IBP) could lead to higher miss rate of adenomas, patients' discomfort and higher health expense. For the patients with possible IBP before the examination, it may be better to cancel the colonoscopy and repeat bowel preparation through modified or enhanced strategies. This study aimed to externally validate the efficiency of a procedure-based model in predicting inadequate bowel preparation

Official Title
-----------------
External Validation of a Predictive Model for Bowel Preparation in Patients Undergoing Colonoscopy

Conditions
-----------------
Bowel Preparation, Colonoscopy

Intervention / Treatment
-----------------
* Other: Questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18 Patient undergoing colonoscopy Exclusion Criteria: Patients with prior colectomy Unable to provide written informed consent

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Questionnaire|Before colonoscopy, the following information was obtained by the colonoscopists through asking patients: the characteristics of last stool, the time of drinking first dose of laxative, the time of first defecation, the time of drinking last dose of laxative. The beginning time of colonoscopy was also recorded. During withdrawal phase, the quality of bowel preparation was evaluated based on BBPS scale.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adequate bowel preparation | Defined by each segmental BBPS≥2 | 1 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The rate of yellow, clear stool in the last defecation | The characteristics of the last stool was self-evaluated by patients based on a picture containing different kind of stool examples. | 1 hour |
A Study of Xeloda (Capecitabine) in Patients With Advanced and/or Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This study will assess the efficacy and safety of continuous oral Xeloda administration in combination with intravenous irinotecan as a first-line treatment in patients with advanced and/or metastatic colorectal cancer. The anticipated time on study treatment is 3-12 months and the target sample size is <100 individuals.

Official Title
-----------------
An Open-label Study of the Effect of Continuous Xeloda Therapy in Combination With Irinotecan on Treatment Response in Patients With Advanced and/or Metastatic Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Drug: Irinotecan
* Drug: capecitabine [Xeloda]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients >=18 years of age; locally advanced and/or metastatic colorectal cancer; >=1 target lesion. Exclusion Criteria: previous treatment with Xeloda or irinotecan; previous systemic therapy for metastatic disease; progressive disease during previous adjuvant therapy or within 6 months of completion.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Irinotecan<br>* 100mg/m2 iv on days 1, 8, 15 and 22 of each 6 week cycle.<br>Drug: capecitabine [Xeloda]<br>* 1000mg po bid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor measurements (RECIST criteria) |  | Event driven | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to progression, time to response, duration of response, time to treatment failure, survival.\n |  | Event driven |
An Observational Study of Pegasys (Peginterferon Alfa-2a) in Patients With HBeAg-Positive or HBeAg-Negative Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This multicenter, prospective, observational study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in routine clinical practice in patients with HBeAg-positive or HBeAg-negative chronic hepatitis B. Eligible patients receiving treatment with Pegasys according to standard of care and the summary od product characteristics/local labelling will be followed for the duration of treatment and up to 2 years of follow-up.

Official Title
-----------------
A Multicenter, Prospective, Non-Interventional Study Evaluating Response Parameters During and After Therapy With PEGASYS (Peginterferon Alfa-2a 40KD) in Subjects With HBeAg Positive or HBeAg Negative Chronic Hepatitis B

Conditions
-----------------
Hepatitis B, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 18 years of age HBeAg-positive or HBeAg-negative serologically proven chronic hepatitis B with or without cirrhosis Elevated serum ALT > ULN (upper limit of normal) but </=10 x ULN according to local label Exclusion Criteria: Contra-indications to Pegasys as detailed in the label Co-infection with hepatitis A, hepatitis B or HIV Concomitant therapy with telbivudine (concomitant peginterferon alfa-2a therapy is contra-indicated according to telbivudine label) Pregnant or breastfeeding women

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HBsAg (IU/ml) levels during therapy (up to 48 weeks) and follow-up |  | from baseline to up to approximately 3 years | 
| Change in HBV DNA (IU/ml) during therapy (up to 48 weeks) and follow-up |  | from baseline to up to approximately 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with sustained immune control (sustained HBV DNA <2000 IU/ml in HBeAg-negative and HBeAg-positive patients or HBeAg seroconversion in HBeAg-positive patients) |  | approximately 4 years | 
| Percentage of patients with normalisation of serum alanine transaminase (ALT) levels |  | approximately 4 years | 
| Percentage of patients with HBsAg clearance/seroconversion |  | approximately 4 years | 
| Safety: Incidence of adverse events |  | approximately 4 years |
Genetic Characterization of Individuals With Limb Girdle Muscular Dystrophy

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to identify and maintain a registry of well-characterized limb-girdle muscular dystrophy (LGMD) patients. Patients seen as part of this study may be candidates for future treatment trials based on their defined genetic classification of LGMD. In the course of this study, the investigators will perform a muscle biopsy and DNA testing in an unlimited number of patients with clinically diagnosed LGMD. The genetic testing will be extended to the family of the study subject in order to better understand true genetic defect.

Official Title
-----------------
Genetic Characterization of Individuals With Limb Girdle Muscular Dystrophy

Conditions
-----------------
Limb-Girdle Muscular Dystrophy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any subject with clinical diagnosis of LGMD must visit Columbus Children's Hospital for 2-day study visit muscle biopsy tissue must be available; either from previous biopsy, affected relative, or willing to have biopsy at Columbus Children's Exclusion Criteria: diagnosis of a neuromuscular disorder other than LGMD unable to provide muscle tissue from previous or current biopsy incapable of giving consent and not having a legal guardian willing or able to do so
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 |
| --- | --- | --- |
Efficacy and Safety of Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Prior Metformin Monotherapy (HbA1c 7.0-9.5%)

Study Overview
=================
Brief Summary
-----------------
The present study is designed to evaluate the efficacy and safety of fixed combination therapy of vildagliptin and metformin (25/1000 mg bid) in patients with type 2 diabetes inadequately controlled with prior metformin monotherapy.

Official Title
-----------------
A Multicenter, Double-blind, Randomized Study to Compare the Efficacy of 24 Weeks Treatment With Fixed Combination Therapy of Vildagliptin and Metformin (25/1000 mg Bid) Versus Metformin Monotherapy (1000 mg Bid) in Patients With Type 2 Diabetes Inadequately Controlled With Metformin Monotherapy.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin + metformin
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of T2DM treated with Metformin Exclusion Criteria: FPG >= 260 mg/dL (14.4mmol/L) Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 78 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vildagliptin + metformin<br> | Drug: vildagliptin + metformin<br> <br> |
| Active Comparator: metformin<br> | Drug: metformin<br>* 1000 bid metformin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c reduction after 24 weeks of treatment in patients with T2DM inadequately controlled with metformin monotherapy |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FPG reduction |  | 24 weeks | 
| Safety and tolerability |  | 24 weeks | 
| Body weight change from baseline |  | 24 weeks | 
| Changes in the fasting lipid profile |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients

Study Overview
=================
Brief Summary
-----------------
The main objective of the trial is to confirm safety of a new product - Epipad. The main impact of the device is to provide good environment for the healing of chronic wounds and wounds in the last healing phase (granulation and epithelisation).

Official Title
-----------------
Multi-centre, Open-label, First-in-man Study With Epipad Used in Adult Patients

Conditions
-----------------
Wound

Intervention / Treatment
-----------------
* Device: Sodium Hyaluronate Lyophilizate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffered from superficial wound of different etiology Wounds in terminal phase of healing Wounds without visible sign of infection Max. size of the wound: 10 x 20 cm (i.e. two pieces of the product) Duration of wound treatment of at least 6 weeks Subject willing and able to provide written informed consent Ability to communicate well with the investigator in local language, and to understand and comply with the requirements of the study Exclusion Criteria: Sloughy or necrotic wound bed Severely contaminated or infected wound Age < 18 years Pregnant or lactating woman Subject in terminal stage of living Subject with cancer disease Subject with known hypersensitivity or allergy to any component of the investigational device Subject participating in other interventional clinical trial Alcohol and/or drug abuse

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

| Intervention/Treatment |
| --- |
|Device: Sodium Hyaluronate Lyophilizate|Device is placed directly onto the treated wound. The wound should be cleaned with antiseptic solution prior to the device administration. The device is fixed on the wound by secondary dressing: e.g. plaster, compression.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the wound dimensions (width x length) | Change in the wound dimensions from baseline | Week 3 |
Oral Drug Study In Women With Refractory Metastatic Breast Cancer After First-line or Second-line Herceptin.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy of an oral investigational drug for the treatment of metastatic breast cancer tumors that are known to overexpress HER2/neu.

Official Title
-----------------
An Open-Label, Multicenter, Single Arm Phase II Study of Oral GW572016 as Single Agent Therapy in Subjects With Advanced or Metastatic Breast Cancer Who Have Progressed While Receiving Herceptin Containing Regimens

Conditions
-----------------
Metastatic Breast Cancer, Neoplasms, Breast

Intervention / Treatment
-----------------
* Drug: Investigational Cancer Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (The patient must meet the following criteria in order to be eligible for this study.) Signed informed consent No more than two prior regimens for metastatic breast cancer. Each regimen must have contained Herceptin. Refractory Stage IIIb or IV breast cancer HER2/neu tumor overexpression Disease progression while receiving a prior chemotherapy regimen with Herceptin alone or in combination with other chemotherapy. Tumor tissue available for testing. 2 weeks since treatment with Herceptin (alone or in combination). Able to swallow and retain oral medication Cardiac ejection fraction within the institutional range of normal as measured by MUGA (Multiple Gated Acquisition Scan). Adequate kidney and liver function Adequate bone marrow function Exclusion Criteria: (The patient cannot meet any of the following criteria in order to be eligible for this study.) Prior regimens did not include Herceptin. Pregnant or lactating. Conditions that would affect absorption of an oral drug Serious medical or psychiatric disorder that would interfere with the patient's safety or informed consent. Severe cardiovascular disease or cardiac disease requiring a device. Active infection. Brain metastases. Concurrent cancer therapy or investigational therapy. Use of oral or IV steroids. Unresolved or unstable serious toxicity from prior therapy. Treatment with EGFR (Endothelial Growth Factor Receptor) inhibitor other than Herceptin.

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: Investigational Cancer Drug|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
-----------------
Refractory
Effects of Neighborhood SES on Coronary Heart Disease Burden in Communities - Ancillary to ARIC

Study Overview
=================
Brief Summary
-----------------
To investigate the role of racial and socioeconomic disparities in coronary heart disease (CHD) mortality in the United States.

Detailed Description
-----------------
BACKGROUND: Despite strong decreases in coronary heart disease (CHD) mortality over past decades, there is evidence that racial and socioeconomic disparities in CHD mortality are increasing. CHD surveillance efforts that examine trends within these population subgroups are an important first step in quantifying and reducing disparities. The Atherosclerosis Risk in Communities (ARIC) Study has monitored rates and trends in validated hospitalized myocardial infarction and fatal CHD among black and white adults aged 35 to 74 years in four U.S. communities since 1989. DESIGN NARRATIVE: The study will expand the scope of ARIC surveillance by examining variations in the rates and temporal trends in CHD by socioeconomic status (SES), measured at the level of census tract. For CHD events already included in ARIC surveillance (1992-2002), addresses will be obtained from medical records and death certificates and geocoded so that they can be matched with identifiers for census based geographical areas. The ARIC study will contribute yearly updates of abstracted CHD events and addresses for subsequent years (2003-2005). Each event will be linked with census tract level SES indicators available from the 1990 and 2000 censuses. This novel effort will permit an examination of disparities by SES in rates and trends in fatal CHD, hospitalized myocardial infarction, case fatality, use of invasive cardiac procedures and prescription of efficacious medication at time of hospital discharge. In addition, the extent to which racial disparities in CHD and associated treatments are explained by SES will also be explored.

Official Title
-----------------
Effects of Neighborhood SES on Coronary Heart Disease Burden in Communities - Ancillary to ARIC

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
hospitalized and fatal coronary heart disease cases eligibility: within 4 defined geographic areas and ages 35 to 74 years of age

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 74 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
-----------------
Surveillance, coronary heart disease, neighborhood SES
Monitoring Anticoagulant Therapy in Antiphospholipid Syndrome

Study Overview
=================
Brief Summary
-----------------
To Assess the Influence of Antiphospholipid Antibodies on INR Test Results in Patients with the Antiphospholipid Syndrome Anticoagulated with Vitamin-K Antagonists.

Detailed Description
-----------------
Patients with an antiphospholipid syndrome receiving Vitamin-K antagonists for secondary prevention after a first thrombotic complication are known to be at higher risk of recurrent thrombotic events despite INR values in the therapeutic range. It ist also known that antiphospholipid antibodies can interfere with phospholipid-dependent tests (e.g. prothrombin time and INR). The primary objective of this study is to determine the prevalence of interfering antiphospholipid antibodies. The intensity of anticoagulant therapy was assessed by measuring the INR using different thromboplastins and the CoaguChek system for INR self-assessment. Test results were compared to measurements of the phospholipid-independent chromogenic factor X. The second objective of this study is to evaluate the incidence of recurrent thrombotic events during 1-year follow-up.

Official Title
-----------------
Monitoring Anticoagulant Therapy With Vitamin-K Antagonists in Patients With Antiphospholipid Syndrome

Conditions
-----------------
Antiphospholipid Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 18-90 years Exclusion Criteria: none

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| APS patients<br>Patients with antiphospholipid syndrome requiring long-term anticoagulant therapy with vitamin-K antagonists | |
| Controls<br>Patients without antiphospholipid antibodies requiring anticoagulant therapy with vitamin-K antagonists | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference between INR and CFX correlate >20% |  | 0, 1, 2, 3, 6 and 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Arterial or venous thrombosis | Any arterial of venous thrombosis occurring under anticoagulant treatment with vitamin-K antagonists during 1-year follow-up | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antiphospholipid syndrome, Antiphospholipid antibodies, Vitamin-K antagonists, International normalized ratio, Chromogenic factor X