linjc16/ctgov huggingface dataset:
A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

Study Overview
=================
Brief Summary
-----------------
People who follow a low-carbohydrate diet typically experience a decrease in triglycerides and increase in HDL-C level, but fail to lower their LDL cholesterol (LDL-C). Such patients may require lipid-lowering therapy. Statins may not be the most effective strategy for patients on this diet, since they typically consume a greater amount of saturated fat and cholesterol. Absorbed cholesterol may contribute more to their circulating plasma LDL-C. We hypothesize that patients following a low carbohydrate diet would experience a significantly greater decrease in LDL-C by taking ezetimibe 10 mg, a drug that blocks cholesterol uptake in the intestine, in addition to simvastatin 20 mg, when compared to taking simvastatin 20 mg alone.

Official Title
-----------------
A Randomized, Double-Blinded Study of Simvastatin 20 mg/Day Versus Vytorin 10/20 in Subjects With Lipid Profiles Not Meeting Current NCEP Guidelines, Following a Low-Carbohydrate Diet

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Drug: simvastatin 20 mg/ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Moderately obese with hyperlipidemia Exclusion Criteria: Recent unstable heart or lung condition Current use of other lipid modifying drugs Hepatic disease Pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 2<br>Low carb diet plus simvastatin 20 mg/ezetimibe 10 mg | Drug: simvastatin 20 mg/ezetimibe<br>* see protocol<br>* Other names: Low carb diet plus simvastatin 20 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL cholesterol |  | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other lipid measures |  | 8 weeks of treatment | 
| Safety and tolerability |  | 8 weeks treatment |
Functional Evaluation of the Total Knee Prostheses:Rising From a Chair

Study Overview
=================
Brief Summary
-----------------
In this study, a functional evaluation of total knee arthroplasty (TKA) patients is performed. The patients are measured prior to surgery and 6 and 12 months after surgery. The measurements consist of questionnaires and rising from a chair. Also, two types of TKA are functionally evaluated. At last, the TKA group will be compared to a THP group.

Official Title
-----------------
Functional Evaluation of Total Knee Arthroplasties,Protocol for Rising From a Chair.

Conditions
-----------------
Osteoarthritis, Knee, Osteoarthritis, Hip

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral TKA Exclusion Criteria: TKA bilateral recent THP movement disorders like Parkinson's disease, insults, that disturb equilibrium and movements
Sexes Eligible for Study
-----------------
All

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

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
-----------------
C05.550.114.606.500, C05.550.114.606.508
Evaluation of an Innovative Speech-enabled Translator in Emergency Settings

Study Overview
=================
Brief Summary
-----------------
Survey-based satisfaction, performance and technical features evaluation of a speech-enabled fixed-phrase translation tool (BabelDR) in an emergency department.

Official Title
-----------------
Evaluation of an Innovative Speech-enabled Translator in Emergency Settings

Conditions
-----------------
Diagnoses Disease

Intervention / Treatment
-----------------
* Device: the translation tool BabelDr


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: As per inclusion criteria, patients were required to have no understanding of French, thus making a diagnostic interview by the doctors impossible. Exclusion Criteria: Exclusion criteria concerned patients who shared a common language with the doctor and/or were not able to read in their native language.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: the translation tool BabelDr|Doctors use a speech-enabled fixed-phrase translation tool to help communicate with an allophone patient.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction evaluation through a 4-point scale survey | Are patients' and doctors' satisfied with the use of BabelDr? | During the consultation | 
| Efficacy evaluation through a 2-point scale survey | Can BabelDr be efficient tool in an emergency context: are doctors' able to reach a diagnostic with the tool? | During the consultation | 
| Technical features evaluation through a 4-point scale survey | Are the technical features appreciated by the doctors'? | During the consultation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Translation tool, Anamnesis
Assess the Effect of Erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of erythromycin on the Rate of Success in Placement of a Self-propelled Feeding Tube.

Conditions
-----------------
Pancreatitis

Intervention / Treatment
-----------------
* Drug: Erythromycin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-80 years Having pancreatitis Require jejunal enteral nutrition Exclusion Criteria: Known impaired peristalsis (critically ill patients, postoperative patients, history of surgery of the stomach/duodenum) Pregnancy Hypersensibility to erythromycin Cardiac arrhythmias with a prolonged QT-time Simultaneous usage of drugs impairing peristalsis

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Erythromycin<br> | Drug: Erythromycin<br>* Subjects receive 4x250mg erythromycin i.v. daily after intubation of a self-propelled feeding tube<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Subjects receive 4x placebo i.v. daily after intubation of a self-propelled feeding tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 48 hours. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The success rate of spontaneous positioning the tubes tip into the jejunum, beyond Treitz ligament, after 24 hours. |  |  | 
| Adverse events using this self-propelled tube |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
erythromycin, prokinetics, nasojejunal tubes, Bengmark feeding tube, post-pyloric feeding, pancreatitis, Non-critically ill patients having pancreatitis who require jejunal enteral nutrition
Validation of 70-gene MammaPrint Profile in Japanese Population

Study Overview
=================
Brief Summary
-----------------
By using gene-expression profiling, Van't Veer and colleagues developed a 70-gene prognosis profile, MammaPrint, to identify breast cancer patients who are at low risk of developing distant metastases and therefore might safely be spared chemotherapy. The aim of this study is to evaluate the prognostic value of the 70-gene Mammaprint profile in Japanese women with node-negative breast cancer.

Detailed Description
-----------------
Frozen tumor samples from 140 node-negative, breast cancer patients aged between 29 and 70 years at diagnosis are hybridized on MammaPrint array. Patients were treated with breast conserving therapy or mastectomy with axillary lymph node dissection between December 1998 and August 2001 at Osaka Medical Center for Cancer and Cardiovascular Diseases. Samples are evaluated by gene expression profiling for the 70-gene MammaPrint profile and classified as genomic high risk or genomic low risk.

Official Title
-----------------
Validation 70-gene MammaPrint Profile in Japanese Population

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Breast cancer patients Node-negative Treated with breast conserving therapy or mastectomy with axillary lymph node dissection at Osaka Medical Center for Cancer and Cardiovascular Diseases

Ages Eligible for Study
-----------------
Minimum Age: 29 Years
Maximum Age: 70 Years

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 |
| --- | --- | --- |
| The probability of recurrence free survival (PRFS) |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microarray, gene expression profiling, MammaPrint, breast cancer
Custom-made Ceramic Barrier vs Titanium Mesh

Study Overview
=================
Brief Summary
-----------------
It is a comparative study between custom-made ceramic barrier and titanium mesh for augmentation of atrophic posterior mandible.

Official Title
-----------------
Comparative Study Between Custom-made Ceramic Barrier and Titanium Mesh for Augmentation of Atrophic Posterior Mandible

Conditions
-----------------
Bone Loss

Intervention / Treatment
-----------------
* Device: Ceramic barrier
* Device: Titanium Mesh


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with atrophic posterior mandible Both sexes No intraoral soft and hard tissue pathology No systemic condition that contraindicate implant placement Exclusion Criteria: Untreated gingivitis Periodontitis Insufficient oral hygiene Previous radiation therapy Head and neck neoplasia Systemic disorders Heavy smokers Bone pathology Psychiatric problems Emotional instability Unrealistic aesthetic demands

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ceramic Barrier<br>The use of a ceramic barrier to induce bone formation during GBR | Device: Titanium Mesh<br>* The use of a titanium mesh to induce bone formation during GBR<br>|
| Active Comparator: Titanium mesh<br>The use of a titanium mesh to induce bone formation during GBR | Device: Ceramic barrier<br>* The use of a ceramic barrier to induce bone formation during GBR<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone height | CBCT & Three dimensional planning software to measure the height of bone gained in millimeters. | 6 months | 
| Bone width | CBCT & Three dimensional planning software to measure the width of bone gained in millimeters. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histomorphometric - bone area percent | Histomorphometric analysis of bone area percent | 6 months |
The Effect of Autologous Autovaccine in Patients With Allergy on House-dust-mite

Study Overview
=================
Brief Summary
-----------------
House dust mite allergy is a common problem, resulting in asthma, chronic swelling of the eyes, and running nose. The investigators test a possibility to immunize subjects sensitized against house dust mite with extracts from their own gut bacteria auto-vaccination.

Detailed Description
-----------------
see above

Official Title
-----------------
Frankfurt Investigator-initiated Autovaccine-study

Conditions
-----------------
Allergens, House Dust Mites

Intervention / Treatment
-----------------
* Biological: Injection of autovaccine (Autovaccine Symbiopharm)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent age 18-35 years known allergy on house-dust mite GINA 0-1 Exclusion Criteria: anamnestic incompatibility to parts of autovaccine asthma > GINA I° chronic disease conditions or infections pregnancy inhalative or systemic steroid use any immunosuppressive therapy intake of any other probiotic medication (e.g. E.coli nissle 1917) participation in any other study at the same time substance abuse Incapability of understanding the study's purpose and performance smoker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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 |
| --- | --- |
| Active Comparator: A<br>house dust mite allergics will undergo autovaccine immunization | Biological: Injection of autovaccine (Autovaccine Symbiopharm)<br>* increasing dosage schedule, six different concentrations, application over six weeks, 2 weeks break, another six weeks, 2 weeks break, than challenge with inhalative house dust mite extract<br>* Other names: Autovaccine Symbiopharm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients' clinical parameters and behaviour, laboratory values |  | jul 2006 - august 2008 | 
| laboratory testing reflecting function of bone marrow, liver, kidney |  | jul 2006- august 2008 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung function,exhalative NO |  | jul 2006 - oct 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
house dust mite, asthma, autovaccine, allergy
Compassionate Use of Vorinostat for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma (0683-042)

Study Overview
=================
Brief Summary
-----------------
In an effort to allow patients continued access to vorinostat outside of the base study, patients that are actively receiving study medication will discontinue from this study and receive vorinostat via another method supported by the SPONSOR (e.g. Named Patient Program (NPP)). For those institutions that do not allow receipt of an investigational therapy outside of a clinical trial, patients that are actively receiving study medication and continue to meet eligibility will transition to an extension phase of the study and the base study will be closed. The extension phase will begin as soon as the protocol amendment is implemented.

Official Title
-----------------
Compassionate Use of Vorinostat (MK0683) for the Treatment of Patients With Advanced Cutaneous T-Cell Lymphoma

Conditions
-----------------
Lymphoma, T-Cell, Cutaneous

Intervention / Treatment
-----------------
* Drug: Comparator: vorinostat


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Advanced cutaneous T-cell lymphoma on or following two systemic therapies Female participants must have a negative serum pregnancy test within 3 days of the first dose of vorinostat Female participants must have finished menopause, or are surgically sterilized, or agree to use 2 adequate barrier methods of contraception Male participants must agree to use 2 adequate barrier methods of contraception To be treated on extension phase of study participant must have been treated on the base study for Protocol 042 Exclusion Criteria: Currently receiving any potential histone deacetylase (HDAC) inhibitor (e.g. valproic acid) Currently receiving any other systemic therapy for CTCL. Corticosteroids that are similar in strength to 20 mg of prednisone daily are permitted Pregnant or lactating Known allergy to any component of the study drug Eligible for any other study of vorinostat in CTCL patients

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

| Intervention/Treatment |
| --- |
|Drug: Comparator: vorinostat|Each patient will receive open-label vorinostat 400 mg q.d. capsules. Treatment will continue until disease progression, intolerable toxicity, withdrawal of consent, or physician determines it is in best interest of patient to withdrawal.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Combined Vitrectomy and Triamcinolone in Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether pars plana vitrectomy in combination with triamcinolone acetate is effective in the treatment of macular edema due to branch retinal vein occlusion.

Official Title
-----------------
A Randomized Study Comparing Combined Vitrectomy and Triamcinolone to Laser Grid in Patients With Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO)

Conditions
-----------------
Branch Retinal Vein Occlusion, Macular Edema

Intervention / Treatment
-----------------
* Procedure: Grid Laser
* Procedure: Vitrectomy and 20 mg triamcinolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Macular edema secondary to BRVO Best Corrected Visual Acuity of ≤ 20/40 on ETDRS chart Duration no shorter than 3 months Duration no longer than 12 months Exclusion Criteria: Proliferations in study eye Blod in vitreous cavity Previous fundus laser treatment BRVO with over 180˚ of ischemia on FA Age under 18 Other eye condition which contribute to relevant loss of visual acuity

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Grid Laser | Procedure: Grid Laser<br>* ETDRS Grid Laser<br>* Other names: Laser photocoagulation of macular edema;|
| Experimental: 2<br>Vitrectomy in combination with 20 mg triamcinolone | Procedure: Vitrectomy and 20 mg triamcinolone<br>* Pars plana vitrectomy is followed by an injection of 20 mg purified triamcinolone acetate<br>* Other names: PPV with induction of posterior vitreous detachment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity (ETDRS) |  | 12 and 36 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal thickening measured on OCT. |  | 12 and 36 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Branch Retinal Vein Occlusion, BRVO, Macular Edema, Triamcinolone, Vitrectomy
Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine

Study Overview
=================
Brief Summary
-----------------
Comparison Study of CoaguChek XS PT and Laboratory Innovin PT by NTUH Lab Medicine

Detailed Description
-----------------
This trial is going to proceed in two phases: Familiarization Phase and Evaluation Phase. The Preliminary Comparison Study consists of ten (10) patients being tested with the CoaguChek system and the laboratory reference method. This preliminary study is intended to help familiarize the operator with the dosing of the CoaguChek XS PT strips and to serve as an indicator as to whether some of the variables. Evaluation Phase consists of testing seventy (70) patient samples with the CoaguChek XS system and with the laboratory method.

Official Title
-----------------
Comparison Study of CoaguChek XS Prothrombin Time and Laboratory Innovin PT by NTUH Lab Medicine

Conditions
-----------------
Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Warfarin continuously treated patients Exclusion Criteria: Warfarin recently discontinuous treatment

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the PTINR measured by Coaguchek and laboratory CA1500 |  | 2 Months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PT, DVT