linjc16/ctgov huggingface dataset:
The Effect of MK0859 on Lipoprotein Metabolism in Patients With Dyslipidemia (0859-026 AM3)

Study Overview
=================
Brief Summary
-----------------
This study will investigate the effect of MK0859 on lipoprotein metabolism in patients with dyslipidemia already on statin therapy.

Official Title
-----------------
A Multiple Dose Study to Investigate the Effect of MK0859 on Lipoprotein Metabolism When Added to Ongoing Statin Therapy in Dyslipidemic Patients

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: anacetrapib
* Drug: Comparator: atorvastatin
* Drug: Comparator: placebo to MK0859
* Drug: Comparator: placebo to atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient's weight has been stable for at least 6 weeks Patient is in good health based on medical history, physical exam, and laboratory tests Patient has dyslipidemia Exclusion Criteria : Patient has a history of stroke, seizures, or major neurological disorders Patient has a history of cancer Patient is currently taking any lipid-lowering medications or substances except for statins Patient consumes excessive amounts of alcohol or caffeine Patient has multiple and/or severe allergies to food or drugs

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Panel A<br>Period 1: atorvastatin + placebo to MK0859; Period 2: atorvastatin + MK0859 | Drug: anacetrapib<br>* [Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.<br>Drug: Comparator: atorvastatin<br>* Atorvastatin 20 mg tablet once daily for 4 weeks in Period 1 and 8 weeks in Period 2.<br>Drug: Comparator: placebo to MK0859<br>* Placebo to MK0859 once daily for 4 weeks.<br>|
| Experimental: Panel B<br>Period 1: placebo to atorvastatin + placebo to MK0859; Period 2: MK0859 + placebo to atorvastatin | Drug: anacetrapib<br>* [Intervention Name: MK0859] MK0859 100 mg tablet once daily for 8 weeks.<br>Drug: Comparator: placebo to MK0859<br>* Placebo to MK0859 once daily for 4 weeks.<br>Drug: Comparator: placebo to atorvastatin<br>* Placebo to atorvastatin once daily for 4 weeks in Period 1 and 8 weeks in Period 2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in Production Rate (PR) and Fractional Catabolic Rate (FCR) of Low Density Lipoprotein (LDL) apoB100 following treatment with MK0859 and atorvastatin versus atorvastatin alone |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in FCR of LDL apoB100 following treatment with MK0859 versus placebo |  | 12 weeks |
Labetalol to Prevent Hypertension and Tachycardia During Fiberoptic Bronchoscopy

Study Overview
=================
Brief Summary
-----------------
Passing a bronchoscope through the airways frequently causes a stress response even though patients are sedated. This stress response is usually an increase in pulse and blood pressure, which may have undesirable effects on the heart and circulation. We plan to give patients labetalol (a beta blocker which reduces pulse and blood pressure) in addition to normal sedation, to patients undergoing bronchoscopy in our department.

Conditions
-----------------
Bronchoscopy

Intervention / Treatment
-----------------
* Drug: Labetalol 10mg iv


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients over 18 years old undergo fiberoptic bronchoscopy in our unit Exclusion Criteria: inability or refusal to give informed consent bronchoscopy through an artificial airway intolerance or allergy to the study drug bradycardia (HR<60/min) or hypotension (systolic BP <100) at screening pregnancy, concomitant treatment with diltiazem or verapamil intention to use propofol as the sedative agent for bronchoscopy.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Labetalol 10mg iv|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart Rate |  |  | 
| Systolic Blood Pressure |  |  | 
| Diastolic Blood Pressure |  |  | 
| Rate pressure product (HR*SBP/100) |  |  |
Post-Operative Myocardial Incident & Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
To explore predictors of major cardio-vascular events after cardiac surgery and trans-catheter valve implantation with a specific interest in studying mechanisms linking pre-operative leukocyte, fat and myocardial phenotypes with post-intervention outcomes.

Official Title
-----------------
Longitudinal Study of Patients Undergoing Cardiac Surgery or Implantation of a Percutaneous Valve Prosthesis

Conditions
-----------------
Valve Heart Disease, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for cardiac surgery (coronary artery bypass graft surgery and/or valvular surgery) or transcatheter valve implantation Exclusion Criteria: pregnant woman urgent surgery or intervention not able to consent to the protocol

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) | cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention | from the day of intervention to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| peri-operative myocardial injury | Area Under the Curve of blood troponin release during the 3 days following cardiac intervention | 3 days following intervention | 
| post-operative myocardial infarction (type 5 myocardial infarction) | myocardial infarction during the peri-operative time | 10 days following intervention | 
| post-operative atrial fibrillation | atrial fibrillation onset during post-op hospitalisation | 10 days following intervention | 
| major cardio-vascular events after cardiac intervention (surgery or transcatheter valve implantation) | cardiovascular death, hospitalisation for heart failure, stroke, myocardial infarction, re-intervention | from the day of intervention to 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prognosis, translational research
Myfortic Conversion Trial in OLT Recipients With GI Intolerance

Study Overview
=================
Brief Summary
-----------------
Liver transplant patients often require multimodal immunosuppressive therapy to minimize their risk for rejection. In our regimen, MMF (mycophenolate mofetil) is often added to lower the side effects of the calcineurin inhibitors. Unfortunately the literature reports 20% up to as many as 40% of patients have GI intolerance to MMF. At our Center, approximately 30% of patients have intolerance to MMF, thereby mitigating our ability to use this agent. The primary objective of this study is to assess the tolerability of myfortic in combination with Neoral or Tacrolimus as determined by the GSRS (Gastrointestinal Symptom Rating Scale) after conversion from MMF in maintenance liver transplant patients with GI intolerance within 3 months.

Official Title
-----------------
A Three-Month, Open-Label, Two Cohort Study to Investigate the Safety and Tolerability of Myfortic in Combination With Neoral (Cyclosporin) or Prograf (Tacrolimus) in Liver Transplant Recipients With GI Intolerance

Conditions
-----------------
GI Disturbance

Intervention / Treatment
-----------------
* Drug: Mycophenolic Acid (Myfortic)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Recipients of orthotopic liver transplant at least 8 weeks post transplant Mild and/or moderate GI complaints directly related to MMF Exclusion Criteria: Multi-organ transplant recipients Evidence of graft rejection within 14 days prior to Baseline visit

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Mycophenolic Acid (Myfortic)|Equimolar conversion from mycophenolate mofetil to mycophenolic acid|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of GI symptoms using GSRS, GIQLi, and SF-12 after conversion to Myfortic |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Orthotopic Liver Transplant Recipients with GI disturbance
Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
Evaluation of the diagnostic performance of artificial intelligence-based software for the detection of liver nodules on scanner in patients at risk of liver metastases of colorectal cancer

Detailed Description
-----------------
The aim of this study is to evaluate the performance of a software for liver nodule detection in patients with colorectal cancer compared to the consensus of two radiologists analysis. 300 hepatic scanners will be analysed.

Official Title
-----------------
Detection and Automatic Segmentation of Liver Nodules in Patients With Colorectal

Conditions
-----------------
Detection of Liver Metastases

Intervention / Treatment
-----------------
* Other: retrospectives analysis on hepatic scanner


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients consecutively treated for colorectal cancer a Availability of imaging by injected abdominal scanner including at least one portal phase Age over 18 Exclusion Criteria: Patients with treatment of the hepatic nodule by ablation or previous hepatic surgery Imaging follow-up <12 months Non-interpretable scanner (artefact, injection quality, etc.) Patients with more than 10 liver metastases

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 without hepatic metastases<br>hepatic scanner of 100 patients with colorectal cancer without hepatic metastases will be analysed | Other: retrospectives analysis on hepatic scanner<br>* hepatic scanner will be analysed by two radiologist and by the software<br>|
| patients with synchronous hepatic metastases<br>hepatic scanner of 100 patients with colorectal cancer with synchronous hepatic metastases will be analysed | Other: retrospectives analysis on hepatic scanner<br>* hepatic scanner will be analysed by two radiologist and by the software<br>|
| patients with metachronous hepatic metastases<br>hepatic scanner of 100 patients with colorectal cancer with metachronous hepatic metastases will be analysed | Other: retrospectives analysis on hepatic scanner<br>* hepatic scanner will be analysed by two radiologist and by the software<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the performance of the software for detection of hepatic nodules on CT scan of patients with colorectal cancer compared to a reference constituted by the evaluation established by two radiologists in consensus. | Number of nodules detected by the software compared to the reference method | 1 month |
Assessment Of Safety And Efficacy Of SU11248 In Patients With Metastatic Colorectal Cancer Who Have Failed Selected Previous Treatments.

Study Overview
=================
Brief Summary
-----------------
Assessment of safety and efficacy of SU11248 in patients with metastatic colorectal cancer who have failed selected previous treatments.

Official Title
-----------------
A Phase II Study Of SU011248 In Patients With Metastatic Colorectal Cancer Who Have Previously Failed Treatment With Irinotecan, Oxaliplatin, And A Fluoropyrimidine, With And Without Bevacizumab

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Drug: SU011248


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metastatic colorectal cancer Failed selected cancer therapies in the past. Exclusion Criteria: Prior treatment with tyrosine kinase inhibitors or VEGF inhibitors other than bevacizumab.

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

| Intervention/Treatment |
| --- |
|Drug: SU011248|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-tumor efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor control survival safety |  |  |
The Effect of Tang Ning Tongluo Formula in Type 2 Diabetics Clinical Analysis

Study Overview
=================
Brief Summary
-----------------
The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule.

Detailed Description
-----------------
The aim of this retrospective study is to review and describe safety and efficacy of Tang Ning Tong Luo capsule,a traditional Chinese Miao medicine, in Type 2 Diabetics.

Official Title
-----------------
The Effect of Tang Ning Tongluo Formula, a Traditional Chinese Miao Medicine, in Type 2 Diabetics: A Retrospective Clinical Analysis

Conditions
-----------------
General Disorders and Administration Site Conditions

Intervention / Treatment
-----------------
* Drug: Tangning Tongluo Capsule


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: diagnosis of type 2 diabetes for more than one year. the sustained follow-up time >3 month. TNTL single or combined treatment time >3 month. Chinese ethnicity. Exclusion criteria: the medical record information is not original and available. lactating or pregnant. diagnosis of heart failure, acute myocardial infarction, stroke, or serious injuries. any other conditions not suitable for trial as evaluated by the physician in charge.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tangning Tongluo Capsule<br>Type 2 diabetes | Drug: Tangning Tongluo Capsule<br>* Taken drugs 3 times a day, with each time 3 grains<br>* Other names: TNTL Capsule;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Changing (%) of Blood Glucose Level and Glycosylated Hemoglobin Level from Baseline | The Changing (%) of Blood Glucose Level (mmol/L) and Glycosylated Hemoglobin Level (%) from Baseline (start using Tang Ning Tong Luo capsule) in recruited Type 2 diabetes patients. | At least 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants with Adverse Events Using Tangning Tongluo Capsule | The Number of Participants with Adverse Events Using Tangning Tongluo Capsule in the Treatment ofType II Diabetes | At least 3 months |
Specificity Study of Diagnostic for Chagas Disease

Study Overview
=================
Brief Summary
-----------------
This study assesses the specificity of Chagas Detect™ Plus (CDP) rapid test versus standard reference tests (e.g. RIPA or IFA) for Chagas diagnosis in the US. The Chagas Detect™ Plus Rapid Test is a rapid immunochromotagraphic strip assay for the qualitative detection of antibodies to Trypanosoma cruzi (T. cruzi) in human serum or whole blood samples. Reactive assay results are presumptive evidence of Chagas infection. This study will enroll males and females 18-70 years of age from areas non-endemic for Chagas infection. A fingerprick blood sample and a venous blood sample (for processing to serum) will be collected from each subject. Subject age, gender, and symptoms will be recorded. For this study, samples will have no personally identifiable information. CDP and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.

Official Title
-----------------
Determination of Estimated Specificity of Chagas Detect Plus Rapid Tests

Conditions
-----------------
Infectious Diseases

Intervention / Treatment
-----------------
* Other: Chagas Detect Plus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects 18 to 70 years of age Subjects must be able to answer questions concerning: Clinical symptoms Blood transfusions Organ transplants Travel or residence in Chagas endemic areas Exclusion Criteria: Any subject who knows that they have positive serology for Chagas disease Subjects who are unable to understand verbal of written or oral language of the consent, or require a legal authorized representative for consent.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Chagas Detect Plus|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of subjects with negative result |  | one day |
Efficacy of Chlorexidine as Intracanal Medicament in Primary Teeth

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the action of the chlorexidine as intracanal medicament in the reduction of the levels of bacteria inside root canals of primary molar teeth with pulpal necrosis.

Official Title
-----------------
Efficacy of 1% Chlorexidine Gel as Intracanal Medicament in Primary Molar Teeth - a Clinical and Microbiological Study

Conditions
-----------------
Dental Pulp Necrosis

Intervention / Treatment
-----------------
* Drug: chlorexidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy children of both gender; Without history of reactions or alergical diseases; With situated age between 04 and 08 years of age With normal standard of growth and development Patients with necessity of radical endodontic treatment (pulpectomy) in, at least, two primary molar teeth in different hemi-arches. Exclusion Criteria: Patients with history of alergical diseases Patients with allergy to any type of medicine and/or foods Patients with comprometimento of its general state of health Healthy patients with risk to develop bacterial endocardite or patients that their general state of health can be aggravated had the transitory bacteremies, as for example children with congenital cardiac illnesses Patients who are making use of sistemis antibiotics, or that they have made use of sistemic antibiotic in the period of 3 (three) months before the beginning of the endodontic treatment With periapical x-ray evidencing less than 2/3 of remaining root of the primary tooth to be treated Patients whose tooth with endodontic necessity to meet in advanced state of root pathological reabsortion Patients whose legal responsible or parents to refuse to sign the term of free and clarified assent

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 8 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: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: chlorexidine|Chlorexidine gel 1% during 7 days inside root canals|

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
-----------------
primary teeth, chlorexidine, root canal therapy, Pulpectomy