linjc16/ctgov huggingface dataset:
Personalized Medicine for Diabetes Prediction and Prevention of Complications

Study Overview
=================
Brief Summary
-----------------
The metabolic syndrome is a collection of related risk factors that predispose to the development of type 2 diabetes Mellitus and cardiovascular disease. The investigators will examine the hypothesis that the metabolic and genomic characteristics of patients with metabolic syndrome and/or diabetes that are at risk for developing complications differ from each other and can be detected using specific biomarkers in blood or in the exhaled breath. Early detection of these individuals will enable personalized treatment to prevent and treat diabetes and its complications

Detailed Description
-----------------
Breath samples will be collected in inert respiratory bag from diabetic and healthy volunteers, and analyzed using a chamber containing nano-chemical sensors. These samples together with blood samples will additionally be characterized using Gas Chromatography-Mass Spectroscopy GC-MS.

Official Title
-----------------
Personalized Medicine in Diabetes Using a Nanotechnology Platform

Conditions
-----------------
Metabolic Syndrome, Diabetes

Intervention / Treatment
-----------------
* Other: Breath analysis and blood analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metabolic Syndrome Type 2 diabetes Healthy volunteers with 20<Body Mass Index<25 Exclusion Criteria: Smoking Chronic or acute lung disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exhaled breath uptake blood test<br>Diabetic patients receiving oral hypoglycemic drug will be tested for biomarkers in their breath and blood samples | Other: Breath analysis and blood analysis<br>* Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.<br>* Other names: nanothecnology platform;|
| No Intervention: Exhaled breath and blood test<br>Breath and blood samples will be collected from healthy volunteers and analyzed using Gas Chromatography-Mass Spectroscopy. The results will be compared to the experimental arm. | Other: Breath analysis and blood analysis<br>* Exhaled breath and blood samples will be collected and further tested using Gas Chromatography-Mass Spectroscopy system.<br>* Other names: nanothecnology platform;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Diabetes or complication |  | 2 years |
Optical Coherence Tomography (OCT) Data Collection Study

Study Overview
=================
Brief Summary
-----------------
Collect OCT data to evaluate the range and age trend of eye measurements.

Official Title
-----------------
Optical Coherence Tomography Data Collection Study

Conditions
-----------------
No Eye Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least 18 years of age Able and willing to provide consent Able and willing to complete the required examininations and visit Refractive error within 8 diopters sphere and within 2 diopters cylinder in each eye Best corrected visual acuity of 20/30 or better in each eye Exclusion Criteria: History of leukemia, AIDS, dementia or multiple sclerosis Concomitant use of hydroxycloroquine or chloroquine Family history of glaucoma among first degree relatives Intraocular pressure of 22mm Hg or greater in either eye Unreliable or abnormal visual field Active ocular disease Previously diagnosed with glaucoma or glaucoma suspect Congenital ocular abnormalities Previous intra-ocular surgery or laser treatment (other than refractive surgery or uncomplicated cataract surgery greater than 6 months previously) Anatomic narrow angle

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Age 18-29<br> | |
| Age 30-39<br> | |
| Age 40-49<br> | |
| Age 50-59<br> | |
| Age 60-69<br> | |
| Age 70+<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| range of eye measurements |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age trend of eye measurements |  | Day 1 |
Safety Study of CDP7657 in Patients With Systemic Lupus Erythematosus

Study Overview
=================
Brief Summary
-----------------
To evaluate safety, tolerability pharmacokinetics and immunogenicity of CDP7657.

Official Title
-----------------
A Multicenter, Investigator- and Subject-Blind, Randomized, Placebo-Controlled, Parallel-Group, Repeat-Dose Study to Evaluate the Effect of CDP7657 in Subjects With Active Systemic Lupus Erythematosus

Conditions
-----------------
Immune System Diseases, Autoimmune Diseases, Lupus Erythematosus, Systemic, Skin and Connective Tissue Diseases, Connective Tissue Disease

Intervention / Treatment
-----------------
* Biological: CDP7657
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Systemic Lupus Erythematosus (SLE) Exclusion Criteria: Severe neuropsychiatric or severe renal Systemic Lupus Erythematosus (SLE) History of chronic, recurrent, or recent severe infection Significant hematologic abnormalities History of cancer, heart failure, renal disease, liver disease or other serious illness

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CDP7657<br>CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks | Biological: CDP7657<br>* CDP7657 100 mg/ ml solution 30 mg/ kg initial dose 15 mg/ kg every other week 10 weeks<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Placebo<br>* Placebo comparator<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with at least one Treatment-emergent Adverse Event (TEAE) during the study |  | 0 - 28 Weeks | 
| Percentage of subjects who withdrew due to an Treatment-emergent Adverse Event (TEAE) during the study |  | 0 - 28 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | 0 - 28 Weeks | 
| Predose plasma concentration (Ctrough) |  | 0 - 28 Weeks | 
| Area under the concentration-time curve over the dosing interval (AUCτ) |  | 0 - 28 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lupus, SLE
Levetiracetam in the Treatment of Neuroleptic-induced Tardive Dyskinesia

Study Overview
=================
Brief Summary
-----------------
An 8-week study to examine safety and efficacy of levetiracetam in patients with neuroleptic-induced tardive dyskinesia

Official Title
-----------------
An 8-week Exploratory, Double-blind, Placebo Controlled, Randomized Trial: Evaluation of the Efficacy and Safety of Levetiracetam up to 3000 mg/Day (250-500 mg Oral Tablets in b.i.d. Administration) on Neuroleptic-induced Tardive Dyskinesia in Subjects With Stable Axis I Psychiatric Disorder, Aged From at Least 18 Years to 80 Years.

Conditions
-----------------
Dyskinesia, Medication-induced

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects between ages 18 and 80 years Subjects must have a diagnosis of stable axis I psychiatric disorder at least 6 months prior to screening Subjects must have a stable neuroleptic-induced tardive dyskinesia at least 1 month prior to screening and meet tardive dyskinesia severity criteria Subjects must have used antipsychotics for at least 6 cumulative months, and, be on a stable dose for 1 month prior to screening Exclusion Criteria: Presence of any axis II condition within 6 months prior to screening Huntington´s disease, idiopathic dystonia, Wilson´s disease, Sydenham´s chorea, thyroid dysfunction, spontaneous dyskinesia Start of drugs-other than neuroleptics- that can cause dyskinesia Presence of additional major disease such as cardiac, renal or hepatic dysfunction or terminal illness

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in neuroleptic-induced tardive dyskinesia over an 8 week treatment period |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuroleptic-induced akathisia and other extrapyramidal symptoms , |  |  | 
| Effect on the primary psychiatric disorder |  |  | 
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuroleptic-induced tardive dyskinesia, Keppra, Levetiracetam
Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients

Study Overview
=================
Brief Summary
-----------------
The infectious endocarditis is a grave infection the incidence of which is at present esteemed at 30-100 episodes by million inhabitants a year. This infection is marked with a heavy morbi-mortality.Preliminary studies seem to show an abnormally high death rate at the patients presenting an infectious endocarditis to streptococci with an inhibitive minimal concentration raised to the amoxicilline. The aim of the study is to describe the epidemiology and the clinical presentations of the patients presenting an endocarditis to streptococci

Official Title
-----------------
Characterization of Endocarditis to Streptococci and Impact of the CMI on the Future of the Patients

Conditions
-----------------
Endocarditis, Bacterial

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years endocartitis with steptococci with Duke's criteria Exclusion Criteria: age < 18 years suspiscious endocarditis without Duke's criteria

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 |
| --- | --- | --- |
| Evaluation of factors associated to the mortality in the patients presenting an endocarditis to streptococci. |  | an average of one year |
Evaluation of Cardiac Variability After a Vitamine D Protocol and Whole Body Vibration

Study Overview
=================
Brief Summary
-----------------
Evaluation of heart rate variability in time and frequency domains, in Chronic Obstructive Pulmonary Disease (COPD) after 03 months of vitamine D supplementation and whole body vibration (WBV) training

Official Title
-----------------
Heart Rate Variability in Healthy Older and Older COPD After Vitamine D Use and Whole Body Vibration Protocol

Conditions
-----------------
Copd, Aging

Intervention / Treatment
-----------------
* Dietary Supplement: vitamine D
* Other: whole body vibration (WBV)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD or healthy elderly sedentary according to International Physical Activity Questionnaire BMI between 22.9 and 28 kg/m2 COPD with clinical-functional diagnosis of the disease according to Gold ex-smokers Exclusion Criteria: Older patients with COPD who had episodes of exacerbation in the last three months Who participate in pulmonary rehabilitation programs in the last year Who used home oxygen therapy Patients with COPD-associated comorbidities Who were taking vitamin D

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: vitamine D<br>a dose once a week | Dietary Supplement: vitamine D<br>* a dose once a week<br>Other: whole body vibration (WBV)<br>* 03 months of WBV training three times per week<br>|
| Placebo Comparator: vitamine D placebo<br>a dose once a week | Other: whole body vibration (WBV)<br>* 03 months of WBV training three times per week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| heart rate variability | evaluation of time and frequency domains | before and immediately after the chronic intervention |
Statins for Prevention of Contrast Induced Nephropathy

Study Overview
=================
Brief Summary
-----------------
In this randomized study the investigators wish to explore the role of pre-procedural statin therapy for the prevention of contrast induced nephropathy in patients with moderate-to-severe renal dysfunction, submitted to elective coronary or angioplasty.

Official Title
-----------------
Usefulness of Atorvastatin (80 mg) in Prevention of Contrast-Induced Nephropathy in Patients With Chronic Renal Disease

Conditions
-----------------
Contrast Induced Nephropathy

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with pre-angiographic estimated creatinine clearance < 60 ml/min Exclusion Criteria: contrast medium administration within the previous 10 days end-stage renal failure requiring dialysis refusal to give informed consent previous therapy with statin
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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>placebo | Drug: Placebo<br> <br> |
| Active Comparator: Atorvastatin<br>80 mg die of Atorvastatin given at least two days before elective angiography or angioplasty and continued for two days after. | Drug: Atorvastatin<br>* 80 mg die<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast-induced nephropathy was defined as an absolute increase of at least 0.5 mg/dl from the baseline value in serum creatinine concentration within the first 24 hours after contrast exposure and peaking up to 5 days afterwards |  | within 5 days after contrast exposure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative increase ≥ 25% over baseline serum creatinine within 5 days after contrast agent administration |  | within 5 days after contrast agent administration | 
| Adverse clinical events within 1 month, including in-hospital death and need for dialysis or hemofiltration |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast induced nephropathy
Efficacy Study of Kissing Drug-Eluting Balloons in Coronary Bifurcation Lesions

Study Overview
=================
Brief Summary
-----------------
KISSING DEBBIE's aim at assessing angiographic and clinical outcomes of provisional treatment of coronary bifurca6on lesions according to TAP sten6ng with BMS and final kissing DEB

Official Title
-----------------
Kissing Drug-Eluting Balloons After Bare Metal Stenting of Coronary Bifurcation Lesions.

Conditions
-----------------
Coronary Artery Disease, Bifurcation Lesions

Intervention / Treatment
-----------------
* Procedure: Kissing DEB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years De novo major bifurca6on lesion of the left coronary artery (LAD-D; LCX-OM) RVD 2.25-4.0 mm Exclusion Criteria: LMCA AMI within 48 hours Limited compliance with 3-month dual antiplatelet therapy

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 |
| --- | --- |
| Coronary bifurcation lesions<br> | Procedure: Kissing DEB<br>* Provisional bare metal stenting followed by kissing drug-eluting balloons<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss on both MV and SB |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedural success (residual stenosis <20% on MV and <50% on SB with TIMI flow 3 for both) |  | immediate | 
| Binary restenosis rate |  | 9 months | 
| Major adverse cardiac events |  | 3 months | 
| Major adverse cardiac events |  | 6 months | 
| Major adverse cardiac events |  | 9 months | 
| Major adverse cardiac events |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary bifurcation lesions
Study to Assess Safety and Quality of Life of Patients Using Biojector Versus Needles for Fuzeon Administration

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Patients using enfuvirtide with the Biojector have an improved quality of life, greater satisfaction, and fewer adverse events compared with using the standard needle.

Detailed Description
-----------------
This study is a N of one trial where the patient is their own control. We will provide the quality of life questionnaire, the MOS-HIV questionnaire; ISR questionnaire and a satisfaction questionnaire to patients that have used a standard need to inject enfuvirtide for at least one month. As well, demographics and laboratory data will be collected. The same procedures will be given 1 month after the use of Biojector in a follow-up visit.

Official Title
-----------------
Prospective Study to Assess Patient Satisfaction, Quality of Life and Adverse Events of Patients Using the Biojector Versus Standard Needles for Enfuvirtide Administration

Conditions
-----------------
Human Immunodeficiency Virus

Intervention / Treatment
-----------------
* Device: Biojector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have taken enfuvirtide for at least one month Exclusion Criteria: Patients with hemophilia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- |
|Device: Biojector|All patients received biojector to use with BID enfuvirtide doses|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide. | To compare quality of life, satisfaction, and adverse events in patients using a Biojector® versus using a standard needle system for administration of enfuvirtide. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Injection site reactions, enfuvirtide administration