linjc16/ctgov huggingface dataset:
Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the incidence rate of the major adverse cardiovascular events (MACE) and safety of fenofibrate (Lipilfen capsule) add-on statin therapy in patients who have history of acute myocardial infarction and are diagnosed with metabolic syndrome.

Official Title
-----------------
Multi-center, Prospective, Observational Study to Assess the Incidence Rate of the Major Adverse Cardiovascular Events (MACE) and Safety of Fenofibrate (Lipilfen Capsule) Add-on to Statin Therapy in Patients Who Have History of Acute Myocardial Infarction and Are Diagnosed With Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: Not applicable-observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients >20 years of age. history of acute myocardial infarction metabolic syndrome diagnosis Exclusion Criteria: current liver disease or AST or ALT greater than 3 times the upper limit of reference range pre-existing gallbladder disease moderate to severe renal disorder (serum creatinine >2.5mg/dL) pancreatitis diagnosis

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| Not applicable-observational study<br>Not applicable-observational study | Other: Not applicable-observational study<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of the major adverse cardiovascular events (MACE) | cardiac death, MI, re-PCI, CABG | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence rate of the major adverse cardiac and cerebrovascular event (MACCE) | non-cardiac death, stroke, hospitalization for acute coronary syndrome | 24 months |
LACE+ and MRS Score Readmission Rate Assessment

Study Overview
=================
Brief Summary
-----------------
A study to demonstrate that the LACE+ score in non-inferior to the medication risk score when predicting 30-day readmission post hospital discharge.

Detailed Description
-----------------
The objective of this study is evaluate a program that provides transition of care services to a local Tucson hospital involving activities designed to reduce 30 day post hospital discharge readmission rates. The organization has had a fee for service contract with this hospital since 2017 to provide pharmacist delivered transition of care services. The organization collects internal tracking outcome data as part of the contract deliverable and is required to report it to the hospital once per month. The investigators look to assess LACE+ and medication risk scores to learn if there is an association with the 30 day post hospital discharge readmission rate post pharmacist intervention. The outcomes will not be generalizable and will be reported back to the hospital client to demonstrate value added.

Official Title
-----------------
Comparing the Predictive Strength of the LACE+ Index With the MedWise Rise Score on Hospital Readmission Rates: a Non-inferiority Observational Study

Conditions
-----------------
Hospitalism

Intervention / Treatment
-----------------
* Other: Pharmacist transition of care consultation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Those referred to receive transition of care services between January 2018 to December 2019 and were discharged on 10 or more medications. Exclusion Criteria: 89 years or older

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 88 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 |
| --- | --- |
| Readmitted<br>Patients that were readmitted within 30 days post hospital discharge | Other: Pharmacist transition of care consultation<br>* Pharmacist-delivered comprehensive medication review<br>|
| Not readmitted<br>Patients that were not readmitted within 30 days post hospital discharge | Other: Pharmacist transition of care consultation<br>* Pharmacist-delivered comprehensive medication review<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Readmission | Readmission within 30-days post hospital discharge | 2018 - 2019 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LACE, medication risk score
Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
The Chinese PAC study (CLDT600ACN03) will evaluate the efficacy and safety of open label telbivudine in 2,200 compensated Chronic Hepatitis B (CHB) adults. The primary objective of the study is the proportion of patients achieving undetectable HBV DNA at week 52.

Official Title
-----------------
An Open-label, Multicenter, Phase IV Study to Evaluate the Efficacy and Safety of Telbivudine 600mg Tablets in Chinese Patients With Chronic Hepatitis B

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

Intervention / Treatment
-----------------
* Drug: Telbivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female 16 to 65 year of age Documented CHB defined by detectable serum HBsAg and serum HBV DNA level Willing and able to comply with the study drug regimen Written informed consent before any assessment Exclusion Criteria: Patient has a history of/or clinical signs/symptoms of hepatic decompensation Patient has a history of HCC or findings suggestive of possible HCC Patient has received treatment of nucleoside or nucleotide drugs whether approved or investigational at any time History of hypersensitivity to any of the drugs (telbivudine) or to drugs of similar clinical classes Patient has received IFN or other immunomodulatory treatment with 12 months before screening Previous treatment history with NRTIs Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Telbivudine<br>* 600 mg/day, oral tablets, once daily, 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA PCR negativity rate |  | at 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV DNA PCR negativity rate |  | at week 24 | 
| DNA reduction |  | from baseline to Weeks 12, 24, 36, 52 | 
| HBeAg loss rate |  | at week 52 | 
| HBeAg seroconversion rate |  | at week 52 | 
| ALT normalization rate |  | at weeks 24 and 52 | 
| Incidence of AE (SAE,etc), Graded lab abnormalities |  | at week 52 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic hepatitis B, Adult, HBV DNA suppression, Telbivudine
Oxygen Therapy in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Due to intense ATP-consuming processes in the brain, a high level of brain energy supply is required. A popular hypothesis regarding the pathogenesis and pathophysiology of schizophrenia postulates hypofunction of neuronal circuits in the prefrontal and limbic-temporal areas. An emerging body of data suggests that impaired energy metabolism due to mitochondrial dysfunction plays a role in the pathophysiology of schizophrenia. Under normal conditions cellular metabolic rate, i.e. oxygen and glucose consumption, increases proportionally with any increase in neuronal activity. The impaired energy metabolism due to mitochondrial dysfunction and frontal lobe hypofunction might be improved by increasing O2 supply to the brain. Oxygen-enriched air inhalation has been shown to increase brain oxygen supply. Hyperoxia therapy is a useful tool in the treatment of neurological and neurotrauma deficits. We therefore suggest a randomized double blind cross-over study of enriched inspired O2 partial pressure in schizophrenia. It is surprising given the numerous findings on reduced energy metabolism in schizophrenia that simple treatment with inspired enriched oxygen has not been studied.

Official Title
-----------------
Oxygen Therapy in Schizophrenia

Conditions
-----------------
Chronic Schizophrenia

Intervention / Treatment
-----------------
* Drug: oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-45 years old 2 years of illness PANSS more than 60 Exclusion Criteria: unstable or serious physical illness suicidality drug abuse BMI above 30 taking anti-hypertension medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: oxygen|Patients will be treated with oxygen for 1 month and then for 1 month with regular air with the same flow rate and procedure or randomly in the opposite order. We propose to enrich the inspired oxygen partial pressure from 21 kPA to  40 kPa in a double blind cross-over design. Ninety percent oxygen or regular air will be supplied from oxygen concentrators, through standard plastic nasal prongs, at a flow rate of 5 liters/minute, for 7 hours/day, throughout the night.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PANSS |  | every two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impressions |  | every two weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
schizophrenia, oxygen therapy
Clinical Course of Cirrhotic Patients With Portal Vein Thrombosis Treated With TIPS

Study Overview
=================
Brief Summary
-----------------
Portal vein thrombosis (PVT) is defined as an obstruction of the portal vein. The prevalence of PVT is 10-25% and incidence is about 16% in cirrhotic patients. PVT leads to increased intrahepatic resistance, decreased portal velocities, splanchnic vasodilatation, and stagnant flow. Portal vein recanalization (PVR) with transjugular intrahepatic portosystemic shunt (TIPS) is aimed at restoring main portal vein (PV) flow in chronic PVT. In this study, we will review the safety and outcomes of this approach.

Detailed Description
-----------------
Portal vein thrombosis (PVT) is a fairly common complication of liver cirrhosis. Importantly, occlusive PVT might influence the prognosis of patients with cirrhosis. Transjugular intrahepatic portosystemic shunt (TIPS) has been reported to be an effective treatment of PVT in cirrhosis, with the advantage of avoiding the risk of bleeding linked to anticoagulation. In this study, we will evaluate the outcome of TIPS for PVT in patients with and without cirrhosis and determinate survival.

Official Title
-----------------
Follow-up and Survival of Cirrhotic and Non Cirrhotic Patients With Portal Vein Thrombosis Treated With Transjugular Intrahepatic Portosystemic Shunt

Conditions
-----------------
Portal Vein Thrombosis

Intervention / Treatment
-----------------
* Procedure: Transjugular intrahepatic portosystemic shunt


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Liver cirrosis or non-cirrhotic patients Portal vein thrombosis (degree of vessel obstruction > 50%) Exclusion Criteria: Active variceal bleeding Prior history of TIPS placement or shunt surgery Concomitant renal insufficiency Severe cardiopulmonary diseases Uncontrolled sepsis Serious medical conditions which may reduce the life expectancy Contraindications for TIPS

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Transjugular intrahepatic portosystemic shunt|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome of TIPS for PVT in patients with and without cirrhosis | Clinical evolution after placement of TIPS | 5 years |
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Study Overview
=================
Brief Summary
-----------------
Tegaserod (HTF919) is an aminoguanidine indole compound and a member of a new class of subgroup-selective 5-hydroxytryptamine (5-HT) agonists. The aim of this study is to investigate the efficacy, safety and tolerability of tegaserod on bowel habits in patients with CC.

Official Title
-----------------
Efficacy, Safety and Tolerability of Tegaserod in Patients With Chronic Constipation

Conditions
-----------------
Chronic Constipation

Intervention / Treatment
-----------------
* Drug: Tegaserod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and females of at least 18 years of age A 12-month history of constipation (defined as < three spontaneous bowel movements per week and ≥1 of the following symptoms >25% of the time: hard stools, sensation of incomplete evacuation and straining) Exclusion Criteria: Patients with cancer, inflammatory bowel disease or other structural bowel disease Patients who participated in a prior tegaserod study Evidence of cathartic colon or laxative abuse, pelvic floor dysfunction or neurological disorders Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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: Tegaserod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of complete spontaneous bowel movement (csbm) during the first 4 weeks of treatment. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of csbm during 8 weeks of treatment. |  |  | 
| Daily assessment of bowel habits:frequency, form, straining, feeling of complete evacuation. |  |  | 
| Daily patients' assessment: bowel habits, constipation, distention/bloating, abdominal discomfort pain. |  |  | 
| Laxative use. |  |  | 
| Safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic constipation, tegaserod
Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain

Study Overview
=================
Brief Summary
-----------------
To assess the association of the number of medical nutrition therapy (MNT) consultations and eating behavior (cognitive restraint, uncontrolled eating, and emotional eating) with GWG in women with type 2 diabetes mellitus (T2DM) and gestational diabetes mellitus (GDM).

Detailed Description
-----------------
Women in puerperium with known T2DM or GDM diagnosed at the hospital were invited to participate in the study. Gestational diabetes was diagnosed with a 75-g oral glucose tolerance test. Weight (kg) and height (m) were measured using a mechanical column scale (SECA). The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18 (TFEQ-18). The Medical Nutrition Therapy (MNT) was offered every 2-4 weeks. This therapy consists of providing a food plan with the following recommendations: limiting carbohydrate intake to 35-45% of total calories calculated as 30 kcal/kg based on pregestational BMI for an ideal weight . We evaluated the effect of MNT on GWG using a multiple linear regression model

Official Title
-----------------
Influence of Medical Nutrition Therapy and Eating Behavior on Gestational Weight Gain in Women With Diabetes

Conditions
-----------------
Weight Gain, Eating Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women in puerperium with known T2DM or GDM diagnosed at the hospital. Exclusion Criteria: Women with a twin or other multiple pregnancy, type 1 diabetes mellitus (T1DM), or intolerance to carbohydrates, and those with additional diseases (hypertensive disorders of pregnancy, hyper- or hypothyroidism, lupus, kidney or liver disease).
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Gestational Weight Gain (GWG). | GWG was calculated by subtracting the prepregnancy weight from the weight at the end of third trimester (kg). | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eating behavior | The specific dimensions of eating behavior were measured through the 18-item Three-Factor Eating Questionnaire-18. | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gestational diabetes, Type2 Diabetes
Safe Colorectal Surgery in the Elderly

Study Overview
=================
Brief Summary
-----------------
The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed.

Detailed Description
-----------------
The objective was to evaluate the use and outcomes of robotic proctectomy compared to open and laparoscopic approaches for rectal cancer in the elderly. A retrospective cross-sectional cohort study utilizing the Nationwide Inpatient Sample (NIS; 2006-2013) was performed. All cases were restricted to age 70 years old or greater. The incidence of robotic proctectomy from 2006 - 2013 both as a whole as well as divided into approach was analyzed. Each approach was compared for both primary and secondary outcomes.

Official Title
-----------------
Safe Surgery in the Elderly: A Review of Outcomes Following Robotic Proctectomy From the Nationwide Inpatient Sample, a Retrospective Cross Sectional Cohort Study. Cross-Sectional Study

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Procedure: Proctectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 70 years of age or older underwent proctectomy Exclusion Criteria: emergent admissions abdominoperineal resections

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Open Proctectomy Patients<br>Patients who underwent Proctectomy through an open approach | Procedure: Proctectomy<br>* Resection of the rectum<br>|
| Laparoscopic Proctectomy Patients<br>Patients who underwent Proctectomy through a Laparoscopic approach | Procedure: Proctectomy<br>* Resection of the rectum<br>|
| Robotic Proctectomy Patients<br>Patients who underwent Proctectomy through a Robotic approach | Procedure: Proctectomy<br>* Resection of the rectum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital Complications | Complications to include mechanical wound, infections, urinary, pulmonary, gastrointestinal, cardiovascular, systemic, surgical, and any complication | through study completion, an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In-hospital mortality | Death during admission | through study completion, an average of 5 days | 
| Length of Stay | Length of in hospital stay | through study completion, an average of 5 days | 
| Costs and Charges | Hospital charges refer to the total amount billed by the hospital. Hospital cost refers to the amount paid by the insurance provider | through study completion, an average of 5 days |