linjc16/ctgov huggingface dataset:
Study of Atorvastatin Dose Dependent Reduction of Proteinuria

Study Overview
=================
Brief Summary
-----------------
Randomized controlled double blind study of parallel groups to evaluate the comparative effects of low-dose of atorvastatin on proteinuria in patients with stage 3 or 4 chronic kidney disease.

Official Title
-----------------
The Renal Protective Effects of Low-dose and High-dose Atorvastatin in Patients With Glomerular Disease and Proteinuria: a Randomized Controlled Double Blinded Study

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: Atorvastatin
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 and over Stage 3 or 4 chronic kidney disease (modified MDRD) proteinuria of > 1g/d on ACEi and/or ARB, or proteinuria of > 1g/d with intolerance or contraindication to ACEi and/or ARB blood pressure < 130/80 mmHg or < 140/90 mmHg in patients with five or more antihypertensive drugs stable renal function Exclusion Criteria: rapid progression of renal failure immunosuppressive therapy within the past 3 months need a renal replacement therapy within 8 months definite history of chronic liver disease, or abnormal liver function evidence of active inflammatory muscle disease definite previous adverse reaction to a statin concurrent treatment with a contraindicated drug (fibrate, macrolide antibiotic, systemic use of imidazole or triazole antifungals, protease-inhibitors, ciclosporin) child bearing potential known to be poorly compliant with clinic visits or prescribed medication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Atorvastatin 10mg<br> | Drug: Atorvastatin<br>* Atorvastatin 10mg 1co id (10mg active) Placebo 40mg 1co id (40mg inactive)<br>* Other names: lipitor 10mg;|
| Active Comparator: Atorvastatin 40mg<br> | Drug: Atorvastatin<br>* Atorvastatin 40mg 1co id (40mg active) Placebo 10mg 1co id (10mg inactive)<br>* Other names: lipitor 40mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proteinuria |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease
Processing and Effects of Cannabis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the processing of cannabis, and to investigate the occurrence of effects of cannabis on the cardiovascular system and the central nervous system; at higher levels of exposure.

Detailed Description
-----------------
In Europe, cannabis is the most illicit used drug, mainly for its psychoactive properties (becoming high or stoned). The active compound in cannabis is THC (tetrahydrocannabinol). In recent years the strength of cannabis (marihuana) available on the market in the Netherland has increased (especially netherweed). The THC-content has increased from on average 8.6% in 2000 to on average 20.3% in 2004. Experienced users adapt their habit of smoking to the strength of the cannabis sigaret (joint). However, there is also a group of people, mainly young ones, who intent to smoke the joint entirely, and can therefore be exposed to higher levels of THC. Information is lacking about the effects of cannabis at higher levels of exposure. Because of this, the Ministry of Health, Welfare, and Sports of the Netherlands ordered the investigators to perform a study to gain more insight in this issue.

Official Title
-----------------
A Double-Blind, Randomised, Placebo-Controlled, Cross-Over Study on the Pharmacokinetics and Effects of Cannabis

Conditions
-----------------
Tachycardia, Hypotension

Intervention / Treatment
-----------------
* Drug: Smoking of cannabis cigarettes (different strength)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cannabis users (2-9 joints per month) Exclusion Criteria: Psychiatric illness Evidence of excessive alcohol abuse Use of other drugs

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

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Smoking of cannabis cigarettes (different strength)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum concentration over time |  |  | 
| Physical parameters (heart rate, blood pressure) |  |  | 
| Psychomotor tests (such continuous attention) |  |  | 
| Event related potentials |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reporting questionnaires |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cannabis, Tetrahydrocannabinol, Pharmacokinetics, Psychomotor tests, Event related potentials
Study Of The Safety And Pharmacokinetics Of CE-326,597 In Patients With Asymptomatic Gallstones

Study Overview
=================
Brief Summary
-----------------
The study is designed to assess whether repeated dosing with CE-326,597 will cause patients with asymptomatic gallstones (as detected on screening abdominal ultrasound) to become symptomatic. In addition, the study will characterize the pharmacokinetics of CE-326,597.

Official Title
-----------------
A Phase 1, 2-Part, Randomized, Subject And Investigator Blinded, Placebo-Controlled, Cross-Over Trial To Evaluate The Safety, Tolerability And Pharmacokinetics Of CE-326,597 In Obese, Adult Subjects With Asymptomatic Cholelithiasis

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Drug: CE-326,597
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index between 30-40 kg/m2, inclusive Evidence of asymptomatic cholelithiasis on screening abdominal ultrasound Exclusion Criteria: Patients with unstable medical conditions, such as diabetes, stroke, heart attack. Females of childbearing potential or those who may be pregnant or breast feeding. Patients with inflammed gallbladder, evidence of stones in bile ducts on screening abdominal ultrasound, history of symptoms indicating active gallbladder disease or gallbladder removal.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CE-326,597<br> | Drug: CE-326,597<br>* CE-326,597 administered orally, once daily for 14-days at 1 to 2 doses (25 mg QD, 100 mg QD) with the morning meal.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* CE-326,597 matching placebo administered orally, once daily for 14-days with the morning meal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability assessed via AEs/SAEs, plus where applicable gastrointestinal symptoms checklist, clinical laboratory tests, vital signs (blood pressure and pulse rate) |  | Day 1 to 14 | 
| CE-326,597 pharmacokinetics by estimating AUC0-24, Cmax and Tmax |  | Day 7 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety in patients with Asymptomatic cholelithiasis/gallstones.
Observational Study on Patients With Hepatocellular Carcinoma (HCC)

Study Overview
=================
Brief Summary
-----------------
This is an ongoing, longitudinal, single centre, observational, retro-prospective clinical cohort study of patients with HCC in usual clinical practice. All the HCC patients diagnosed and treated in Liver Cancer Center, Nanfang Hospital are consecutively collected and followed up.

Official Title
-----------------
Observational Study on Patients With Hepatocellular Carcinoma (HCC)

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Other: No intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HCC; Age ≥ 16 years; Received treatment targeting for HCC at least once, including operation, ablation, TACE, sorafenib, radiotherapy, chemotherapy, etc; Good compliance with clinical treatment. Exclusion Criteria: Diagnosed as other pathological types such as cholangiocarcinoma, or mixed liver cancer; Received only traditional Chinese medicine or symptomatic supportive treatment; (3) survival time ≤ 7 days; HCC diagnosed after liver transplantation; Poor compliance or important data deficient.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the overall survival rate of all HCC patients | In order to identify the potential influence factors of HCC patients survival | 10 years | 
| Evaluate the recurrence free survival rate of HCC patients after curative treatments | In order to identify the potential influence factors of tumor recurrence | 10 years |
Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the degree of indirect benefits to family members and classmates resulting from administration of influenza vaccine to children.

Official Title
-----------------
Direct and Indirect Benefits of Influenza Vaccination in Schools and Households

Conditions
-----------------
Influenza Virus Infection, Influenza-like Illness, Acute Respiratory Infection

Intervention / Treatment
-----------------
* Biological: Trivalent live attenuated seasonal influenza vaccine
* Biological: Monovalent live attenuated pandemic influenza vaccine
* Biological: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hong Kong residents aged between 7 and 11 and their family members. Exclusion Criteria: Children with history of hypersensitivity to eggs, egg proteins, gentamicin, gelatin, or arginine or with life-threatening reactions to previous influenza vaccinations. Children receiving aspirin therapy or aspirin-containing therapy. Children with asthma or active wheezing. Children or family members with underlying immunocompromised condition or receiving immunosuppressive agents.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Influenza vaccination<br>Live attenuated influenza vaccine (seasonal and pandemic strains) by nasal spray | Biological: Trivalent live attenuated seasonal influenza vaccine<br>* One dose<br>* Other names: FluMist, MedImmune Vaccines, Inc.;Biological: Monovalent live attenuated pandemic influenza vaccine<br>* One dose<br>* Other names: FluMist Novel H1N1, MedImmune Vaccines, Inc.;|
| Placebo Comparator: Saline placebo<br>Saline nasal spray | Biological: Saline<br>* One dose<br>* Other names: Saline nasal spray;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical influenza by self-reported symptoms, specifically defined as at least two of fever ≥37.8ºC, cough, headache, sore throat, aches or pains in muscles or joints |  | One year | 
| Influenza virus infection confirmed by RT-PCR |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Influenza virus infection during the follow-up period assessed by four-fold or greater rise in paired serology. |  | One year | 
| Adverse events following vaccination |  | 7 days |
Intensive Sequential Chemotherapy With Adriamycin Taxol and Cytoxan in the Treatment of Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Intensive sequential chemotherapy with Adriamycin Taxol and Cytoxan in the treatment of locally advanced breast cancer

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

Intervention / Treatment
-----------------
* Drug: Adriamycin, Taxol and Cytoxan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with locally advanced breast cancer
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 |
| --- |
|Drug: Adriamycin, Taxol and Cytoxan|Chemotherapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effectiveness |  | overall |
Treatment Strategy of Ankle Fracture Combined With Deltoid Ligament Rupture

Study Overview
=================
Brief Summary
-----------------
Ankle fracture is very common which is often combined with deltoid ligament injury. Although the incidence of deltoid ligament injury is high, but there is no unified and effective diagnosis method. Even whether the ankle fracture with deltoid ligament rupture needs surgical repair is still controversial. There is no high-level, multi-center, large sample, long-term follow-up clinical evidence to prove whether the repair of deltoid ligament is necessary or not. The main content of the project: 1 Achieve accurate classification of deltoid ligament rupture with intraoperative exploration. 2 Study the surgical indications and treatment guidelines by comparative study.

Detailed Description
-----------------
Comparative study for ankle fracture combined with deltoid ligament rupture: with & without repair of ligament

Official Title
-----------------
Comparative Study for Ankle Fracture Combined With Deltoid Ligament Rupture

Conditions
-----------------
Ankle Fractures

Intervention / Treatment
-----------------
* Procedure: repair of deltoid ligament


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ankle fracture with deltoid ligament rupture Exclusion Criteria: ankle fracture without deltoid ligament rupture
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: with repair of deltoid ligament<br>open reduction and internal fixation with repair of deltoid ligament | Procedure: repair of deltoid ligament<br>* intraoperative repair of deltoid ligament combined with ORIF<br>|
| No Intervention: without repair of deltoid ligament<br>open reduction and internal fixation without repair of deltoid ligament | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AOFAS score |  | 12 months after surgery |
Retrospective Review of CT and MR in Pediatric Patients With Cholestasis

Study Overview
=================
Brief Summary
-----------------
The investigators will try to predict the risk of esophageal varices (EVs) in long-term BA survivors using noninvasive computed tomography (CT) or magnetic resonance (MR) indices and the measurement of transverse diameters of paraesophageal and gastroesophageal veins.

Detailed Description
-----------------
We intend to review retrospectively 80 pediatric patients on an average of 2 years, who underwent 64-slice CT or MR examinations between January 2005 and Oct 2010 and had EVs on esophagogastroduodenoscopy. Splenic diameters (mm) and hepatic diameters of all patients were measured. Splenic and hepatic volume indices also calculated. The transverse diameters of paraesophageal varices (PVs) and perigastric varices (PGVs) were measured adjacent to the lower thoracic esophagus and within the lesser sac, respectively. We will try to find out the possible splenic, hepatic or vascular predicting factors useful to evaluate the risk of clinically evident esophageal varices.

Official Title
-----------------
Retrospective Review of Computed Tomography and Magnetic Resonance Images in Pediatric Patients With Cholestasis

Conditions
-----------------
Cholestasis, Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all cholestatic children with CT, MR and complete medical record Exclusion Criteria: all cholestatic children without either CT, MR or complete medical record

Ages Eligible for Study
-----------------
Maximum 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>cholestatic children without esophageal variceal bleeding | |
| study<br>cholestatic children with esophageal variceal bleeding | |
| cholestatic children without EV<br>cholestatic children without esophageal variceal bleeding | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| esophageal variceal bleeding |  | retrospective review | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cholestasis, children
Vascular Function in Adolescent, Diabetic Children

Study Overview
=================
Brief Summary
-----------------
The objectives of this investigator initiated study are to: Determine if and when vascular abnormalities occur during early adolescence Determine if poor diabetic control is related to vascular abnormalities. The development of vascular plaques and vascular contractility will be assessed through the use of the SyphmgnoCor equipment.

Detailed Description
-----------------
Up to 85 Type 1 diabetic and healthy controls, 12-14 years of age, will be recruited for the study. Once the Permission/Assent form has been completed, a cuff will be applied to the arm and the pressure tonometer will be used on various vessels. Cardiovascular data will be recorded. The procedure is non-invasive, will last approximately 10 minutes and will be performed during a routine clinic visit. Onset of diabetes and level of diabetic control as measured by the most recent Hbg A1c (relative to the study visit) will be obtained from the medical record. Microalbumin levels covering the prior 12 months will be collected from the medical record of diabetic subjects.

Official Title
-----------------
Vascular Function in Adolescent, Diabetic Children

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Procedure: Measurement of vascular function per SphymgnoCor equipment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Boys and girls ages 12-14 years who have Type 1 diabetes or are healthy controls Exclusion Criteria: Children and adolescents who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Measurement of vascular function per SphymgnoCor equipment|Pressure tonometer will be used on various vessels, non-invasive.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular abnormalities as measured by the SyphmgnoCor equipment |  | End of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular abnormalities, Type 1 diabetes, Healthy control subjects