linjc16/ctgov huggingface dataset:
Effects of Atorvastatin Versus Probucol on Small Dense LDL

Study Overview
=================
Brief Summary
-----------------
Small dense low-density lipoprotein (LDL) plays an important role in causing glomerular injury through conversion to an oxidatively modified form of LDL. However, few studies evaluated the effects of antilipidemic agents on the LDL particle size and renoprotective actions in hyperlipidemic patients with non-diabetic nephropathy.

Detailed Description
-----------------
The study is a randomized crossover trial comparing the effect of atorvastatin (10 mg/day) and probucol (500 mg/day) for 24 weeks in 30 patients (urinary albumin excretion 0.3-2.0 g/day, and creatinine clearance > 30 ml/min/1.73 m2 or serum creatinine concentration < 2 mg/L). Lipid parameters, mean LDL particle diameter, creatinine clearance, and urinary albumin to creatinine excretion ratio are measured before and during treatment periods. It will be evaluated that, first, whether atorvastatin and probucol significantly reduce serum total cholesterol and LDL cholesterol concentrations, second, whether atorvastatin and probucol significantly increase the LDL particle size, third, whether significant differences in urinary albumin/creatinine excretion ratio and creatinine clearance are observed in both groups during treatment.

Official Title
-----------------
Effects of Atorvastatin Versus Probucol on Low-Density Lipoprotein Subtype Distribution and Renal Function in Hyperlipidemic Patients With Non-Diabetic Nephropathy

Conditions
-----------------
Chronic Nephropathy

Intervention / Treatment
-----------------
* Drug: Effects of atorvastatin versus probucol on small dense LDL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hyperlipidemic patients with non-diabetic nephropathy Exclusion Criteria: Endocrinological, hematological or hepatic disease Cerebral infarction or hemorrhage Homozygous familial hypercholesterolemia Uncontrolled hypertension Myocardial infarction occurring within the previous 6 months Unstable angina Diabetic nephropathy Abnormal thyroid function Receiving steroids or immunosuppressive agents

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Effects of atorvastatin versus probucol on small dense LDL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normalization of serum cholesterol concentrations |  | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
small dense LDL
Prospective Exploratory Study to Describe Hepatitis B Virus (HBV) Kinetics During Treatment With Telbivudine

Study Overview
=================
Brief Summary
-----------------
This study will explore HBV kinetics in CHB patients during the first 24 weeks of treatment with telbivudine

Official Title
-----------------
Prospective Exploratory Study to Describe in CHB naïve and Non-naïve Patients, Hepatitis B Virus (HBV) Kinetics During the First 24 Weeks of Treatment With Telbivudine

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

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, at least 18 years of age. Documented compensated HBeAg negative CHB defined by baseline HBV serology, DNA and ALT criteria. Exclusion Criteria: Co-infection with HCV, HDV, or HIV. Prior therapy with nucleos(t)ides in NAÏVE patient and prior treatment with lamivudine in patients with suboptimal response to adefovir. History of hepatic decompensation History of malignancy Patient has one or more additional known primary or secondary causes of liver disease

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Telbivudine | Drug: Telbivudine<br>* Arm 1: 600 mg/day, oral telbivudina for 24 weeks<br>* Other names: Hepsera;|
| Active Comparator: 2<br>Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks | Drug: oral adefovir<br>* Arm 2: 600 mg/day, oral telbivudina plus 10 mg/day oral adefovir for 24 weeks<br>* Other names: adefovir;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV viral load will be measured by HBV DNA quantification in plasma (log opies/mL) at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks |  | at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver function assessed at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks HBV genotype measured at baseline |  | at baseline, 2, 4, 8, 12, 16, 20 and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B, chronic, Viral kinetics, Telbivudine, Adefovir, Compliance
Accuracy of Continuous and Non-invasive Hemoglobin Monitoring

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this observational study is to investigate the accuracy on the continuous and non-invasive hemoglobin monitoring during laparoscopic gastrectomy.

Official Title
-----------------
Accuracy of Continuous and Non-invasive Hemoglobin Monitoring During Laparoscopic Gastrectomy: Observational Study

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

Intervention / Treatment
-----------------
* Other: SpHb monitoring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparoscopic gastrectomy under general anesthesia Exclusion Criteria: atypical hemoglobin disease, infective state, cardiovascular disease, peripheral vascular disease

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 85 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 |
| --- | --- |
| continuous and noninvasive hemoglobin monitoring<br>Group receive the continuous and noninvasive hemoglobin monitoring during laparoscopic gastrectomy. | Other: SpHb monitoring<br>* Subjects receive the continuous and noninvasive hemoglobin monitoring (SpHb monitoring).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference between SpHb value in g/dL and SaHb value in g/dL (SpHb - SaHb) | SpHb value in g/dL is measured by co-oxymetry, and SaHb value in g/dL is measured by blood sampling. | from the start of anesthesia to the end of anesthesia, an average 2 hours |
Effect of Vojta Therapy on Covid-19 Respiratory Disease

Study Overview
=================
Brief Summary
-----------------
Vojta therapy is a physiotherapy intervention with scientific evidence in respiratory pathologies in children and proven in adults. In this pilot study with an RCT design, its effect in adult patients with respiratory pathology caused by the SARS-CoV-2 virus will be studied. The non-invasive and non-painful technique consists of applying tolerable pressure to specific areas of the patient's body. The objective is to activate, in a reflex way, the ventilatory physiology. It is compared with the conventional respiratory physiotherapy approach.

Official Title
-----------------
Effect of Vojta Therapy in Respiratory Disease Caused by SARS-CoV-2. Randomized Controlled Pilot Study

Conditions
-----------------
COVID-19 Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Other: Respiratory physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: respiratory disease by covid-19 Exclusion Criteria: patient older than 75 years

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vojta Therapy<br>Reflex turn first phase: Patient positioned supine with legs flexed 30º-45º. The pectoral area is stimulated for five minutes on each side x 2 consecutive times. Total 20 minutes per session. | Other: Respiratory physiotherapy<br>* Respiratory physiotherapy<br>|
| Active Comparator: Control Group<br>.Inspiratory techniques, mucociliary clearance techniques (expiratory). Use of inspiratory and expiratory incentives. Employment of mechanical assistants | Other: Respiratory physiotherapy<br>* Respiratory physiotherapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SpO2 | Oxygen saturation | 3 weeks | 
| Breathing frequency | frequency of respiratory cycles per minute | 3 weeks | 
| Stay time | Days of stay in the intermediate respiratory care unit | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vojta therapy, Respiratory physiotherapy
A Study to Evaluate the Safety, Tolerability and Pharmacodynamics of DDP733 for IBS-c

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the safety, tolerability and pharmacodynamics of the investigational drug DDP733 in treating subjects with IBS-c. A placebo control will be utilized.

Official Title
-----------------
A Phase 2a, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Multiple Doses and Dose Levels of DDP733 in Patients With Irritable Bowel Syndrome With Constipation

Conditions
-----------------
Irritable Bowel Syndrome With Constipation, Irritable Bowel Syndrome

Intervention / Treatment
-----------------
* Drug: DDP733


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have a history of IBS-c for at least 3 months prior to randomization as assessed using ROME criteria Must have had endoscopic/radiologic bowel evaluation within the past 10 years Must comply with completing a daily diary and be able to comply with GI transit measurements, including swallowing capsules containing small x-ray visible markers Female subjects cannot be pregnant, post-partum for less than 1 year or breastfeeding Exclusion Criteria: Serious underlying diseases, including psychiatric disorders Current history of conditions affecting bowel transit Recent history of biochemical or structural abnormalities of the gastrointestinal tract, gastrointestinal surgery, or gastrointestinal infection Clinically significant abnormal examination findings or laboratory tests Inability to stop taking certain medications, or a planned change in medications (including herbal remedies) which could interfere with study assessments Use of drugs and or ethanol which may interfere with compliance of study procedures or influence study outcome Presence of a medical condition which could interfere with the interpretation of study data Significant use of nicotine or caffeine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: DDP733|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of DDP733 on gastrointestinal transit |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the effect of DDP733 on patient reported outcomes |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IBS, IBS-c
Drug-Drug Interaction Study in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to assess the effects of cyclosporine on the pharmacokinetics of K-877 in healthy adult subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: K-877
* Drug: Cyclosporine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is a healthy adult male or female volunteer between the ages of 18 and 45 years, inclusive, at Screening. Subject has a body mass index of 18 to 30 kg/m2, inclusive, at Screening. Subject has hematology, serum chemistry, and urinalysis test results within the reference ranges or is showing no clinically relevant deviations, as judged by the investigator at Screening. Exclusion Criteria: Subject has clinically relevant abnormalities in the screening or check in assessments. Subject has a blood pressure (as measured at Screening during the collection of vital signs) after resting supine for at least 5 minutes that is higher than 140 mm Hg systolic or 90 mm Hg diastolic, or lower than 90 mm Hg systolic or 60 mm Hg diastolic (for males) and 50 mm Hg diastolic (for females). Subject has a supine pulse rate (as measured at Screening during collection of vital signs) after resting for 5 minutes that is outside the range of 40 to 90 beats per minute.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: K-877<br>K-877 | Drug: K-877<br> <br> |
| Experimental: K-877 with Cyclosporine<br>K-877 with Cyclosporine | Drug: K-877<br> <br> Drug: Cyclosporine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum concentration (Cmax) |  | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under concentration curve (AUC) |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adult Volunteers
Accuracy of Self-estimation of Blood Alcohol Concentration Compared to Object Values

Study Overview
=================
Brief Summary
-----------------
This will be a prospective survey study. The participants will all be volunteers of legal drinking age. Each participant will consume one alcoholic beverage (beer) at a time and then will be asked to verbally estimate their current blood alcohol concentration and if the subject feels they are able to drive. At that time, their BAC level will be measured objectively using a breath alcohol test (BAT) device. The participant will not be told their objective value. This will continue with a verbal estimate and actual BAT reading after every drink until the participant reaches a minimum BAC of 0.10. At this time, participants will continue to be monitored until their BAC falls to 0.08 and they are clinically sober. As their blood alcohol level decreases, the investigators will ask the participant to estimate their level every hour along with an actual reading until reaching 0.08. Statistical analyses will be used to determine how accurate self estimation is in regards to blood alcohol content.

Conditions
-----------------
Alcohol Intoxication

Intervention / Treatment
-----------------
* Behavioral: self estimation of breath alcohol content
* Device: breath alcohol content as measured by Alco Sensor IV device
* Other: drink a beer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over the legal age (21years old) to drink alcohol. Exclusion Criteria: Volunteers will be excluded from the study if they suffer from any of the following conditions: Alcoholism, Diabetes, Kidney/bladder stones, Kidney disease, Liver disease, Stomach ulcer, Organ transplant patients, Dialysis patients, and patients with alcohol allergies.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: all study participants<br>subject will self estimate breath alcohol content and their actual BrAC will be recorded as measured by the Alco Sensor IV after each beer ingested. | Behavioral: self estimation of breath alcohol content<br> <br> Device: breath alcohol content as measured by Alco Sensor IV device<br> <br> Other: drink a beer<br>* drink a beer, repeat until breath alcohol content 0.1<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Breath Alcohol Content Between the Estimated Level and the Actual Level as Measured by an Alco Sensor IV Device | The change was measured both when participants' breath alcohol content was ascending to 0.1 and descending to 0.08. | 1 day |
Aprepitant for Post-operative Nausea

Study Overview
=================
Brief Summary
-----------------
Anesthesia, especially for laparoscopic surgery, can cause post-operative nausea and vomiting. Most patients are given two drugs, decadron and ondansetron, to try to minimize this. This study is to determine if a new drug, aprepitant, would add any benefit in terms of post-op nausea prevention. All laparoscopic cholecystectomy study patients will receive decadron and ondansetron. Half the patients will receive aprepitant in addition. The other half will receive placebo. The study will be randomized and double-blind.

Official Title
-----------------
Aprepitant vs. Placebo for the Prevention of Postoperative Nausea and Vomiting: a Randomized, Double-blind Study in Patients Undergoing Laparoscopic Cholecystectomy

Conditions
-----------------
Postoperative Nausea

Intervention / Treatment
-----------------
* Procedure: Aprepitant
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Laparoscopic cholecystectomy patients. Must be able to swallow a pill. Exclusion Criteria: Liver failure, Age less than 18. Pregnancy, breast-feeding. Pre-op vomiting. Allergy to aprepitant. Need for post-op gastric drainage. Use of drugs that interact with aprepitant.

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Aprepitant<br> | Procedure: Aprepitant<br>* 40 mg po pre-op<br>* Other names: Emend;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Orally, pre-op<br>* Other names: Sugar pill;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative Nausea and Vomiting | Records for this study are no longer available to the sponsor to update this study record as they were destroyed in Hurricane Sandy in October 2012. This information was provided to FDA and OHRP when the event occurred in 2012. Thus, we do not have any information to use to update the records. In addition, the PI for this study is no longer with the institution and no contact information is available. | 1 year |