linjc16/ctgov huggingface dataset:
Alicaforsen (ISIS 2302) in Patients With Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
ISIS 2302 is an antisense oligonucleotide drug that reduces the production of a specific protein called intercellular adhesion molecule (ICAM-1), a substance that plays a significant role in the increase of inflammation. People with Crohn's disease have been shown to over-produce ICAM-1 in their gut tissues. Alicaforsen works by blocking ICAM-1 messenger RNA, the instruction molecule that is required for the production of ICAM-1 protein. This trial will examine effects of alicaforsen delivered by 2-hour intravenous infusion over a four-week period, compared to a placebo. Patients may remain on stable background 5-ASA, antibiotic, or immunosuppressive drugs, and prednisone (or equivalent) at </= 30 mg per day.

Official Title
-----------------
ISIS 2302-CS21, Phase 3 Double-Masked, Placebo-Controlled Study of Alicaforsen (ISIS 2302), an Antisense Inhibitor of ICAM-1, for the Treatment of Patients With Active Crohn's Disease

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Alicaforsen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Age >/= 12 years Weight >/= 36 kg CDAI score of 220 - 400 Documentation of Crohn's disease activity by endoscopy, biopsy or imaging in the last 2 years No TNF-α inhibitor treatment for three months prior to first study drug infusion Exclusion Criteria Known severe, fixed, symptomatic stenosis of the small or large intestine with significant dilation Extensive external fistulization (> 3 external fistulae which are expressible with gentle compression); colostomy or ileostomy Active infection, including infectious colitis, or infection with HIV, Hepatitis B or Hepatitis C Malignancy within 3 years or poorly controlled medical illness Requires intravenous heparin therapy or with a history of a bleeding problem

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Screening Epidemiological Program on Compensation Evaluation of Diabetes Mellitus Type 2 (DMT2) Patients on Oral Anti-diabetic (OAD) Monotherapy and Physicians Satisfaction of Their Usage

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is assessment of glycemic control and physicians satisfaction with results of DM2 OAD monotherapy

Official Title
-----------------
Screening Epidemiological Program on Compensation Evaluation of DM Type 2 Patients on OAD Monotherapy and Physicians Satisfaction of Their Usage

Conditions
-----------------
Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients have an established diagnosis of T2D Experience of therapy with one OAD during the from 6 months to 5 years before the registration in the Program Exclusion Criteria: Experience of therapy with two or more OADs and/or insulin therapy and/or incretin mimetics (exenatide) at any time before registration in the Program Absence of changes in HbAc1 level during the last year before registration in the Program

Ages Eligible for Study
-----------------
Minimum Age: 35 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 |
| --- | --- |
| 1<br>Patients have an established diagnosis of T2D, Age 35 years and more, Experience of therapy with one OAD during the from 6 months to 5 years before the registration in the Program | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess levels of compensation of T2D by HbA1c levels in patients on OAD monotherapy |  | 1 visit within 4 month | 
| To assess frequency of target levels of HbA1c ≤ 7% in patients with T2D during OAD monotherapy |  | 1 visit within 4 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess fasting glycemia in patients with T2D on OAD monotherapy |  | 1 visit within 4 month | 
| To assess postprandial levels of glycemia in patients with T2D during OAD monotherapy |  | 1 visit within 4 month | 
| To evaluate the physicians' satisfaction with the results of OAD monotherapy in patients with Typ 2 Diabetes (T2D) |  | 1 visit within 4 month | 
| To compare the results of OAD monotherapy in different groups of patients |  | 1 visit within 4 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 Diabetes
Comparison of Pre-hospital and In-hospital Iv-tPA Stroke Treatment

Study Overview
=================
Brief Summary
-----------------
This is a comparison of clinical outcomes between a pre-hospital and an in-hospital thrombolysis patient registry.

Conditions
-----------------
Ischemic Stroke

Intervention / Treatment
-----------------
* Other: thrombolysis in a pre-hospital setting (STEMO concept)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute ischemic stroke diagnosis with thrombolytic treatment Admission via EMS Known premorbid status of need of assistance NIHSS before treatment available Time of onset (or last well seen) between 4:00am and 10:30pm Exclusion Criteria: Unknown time of onset In-hospital thrombolysis despite decision against treatment because of contraindications in STEMO

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 |
| --- | --- |
| Pre-hospital thrombolysis<br>Patients with acute ischemic stroke who are cared in a specialized STroke Emergency MObile (STEMO) before admission to the Hospital and receive thrombolytic therapy (either in STEMO or in Hospital). | Other: thrombolysis in a pre-hospital setting (STEMO concept)<br> <br> |
| In-hospital thrombolysis<br>Patients with acute ischemic stroke who receive thrombolytic therapy after admission to an University Hospital. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) score | dichotomized mRS 0-1 and 2-6 in patients who lived at home without assistance prior to the index stroke. | three months after event | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modified Rankin Scale (mRS) score | dichotomized mRS 1-3 and 4-6 | three months after event | 
| modified Rankin Scale (mRS) score | mortality (mRS=6) | three months after event | 
| modified Rankin Scale (mRS) score | ordinal analysis across whole mRS range | three months after event | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, thrombolysis, STEMO
REGULarity of Physical ActivitieS (REGUL'APS)

Study Overview
=================
Brief Summary
-----------------
In French primary schools, children participate in 3 compulsory hours of physical education (PE) each week unless they have a medical contra-indication. But, there is no scientific evidence (randomized trial) that a weekly physical activity splitting up of these 3 hours of PE brings or not the same effects, particularly to prevent overweight or obesity. Regul'aps is a cluster randomized controlled trial which wants to evaluate whether splitting up the 3 hours into 3 or 4 sessions (vs. 1-2 sessions) of PE per week has an effect on speed of a BMI increase and on health-related quality of life (HRQoL) over the school year. Study hypothesis: reduction of speed of increase of BMI and an increase of HRQoL

Official Title
-----------------
Physical Activity, Health-related Quality of Life and Corpulence Among French Schoolchildren

Conditions
-----------------
Overweight, Obesity

Intervention / Treatment
-----------------
* Other: Physical education sessions
* Other: Physical education sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All teachers under the cover of the headmasters in charge of classes from grades 2 to 5 in 2 counties in the Lorraine region of France (Meurthe-et-Moselle and Vosges [District of Golbey]) headmasters or teachers had to agree to modify the organisation of PE sessions Exclusion Criteria: Classes composed only of 2d grade Set schedule of physical educational sessions
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Control group<br> | Other: Physical education sessions<br>* 1 (3 hours) or 2 long PE sessions (1 hour and 30 minutes each)<br>|
| Other: Intervention group<br> | Other: Physical education sessions<br>* 3(60 minutes each) or 4 (45 minutes each) short sessions of physical education (PE) sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body mass index (BMI) and waist circumference | September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later) | September 2006 and June 2007 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life | September 2006 : at the beginning of school year June 2007 : at the end of school year (31 weeks later) | September 2006 and June 2007 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
body mass index, health-related quality of life, physical education, children, cluster randomized controlled trial, prevention, Child, French, Schoolchildren
Different β -Blockers in STEMI and Primary PCI

Study Overview
=================
Brief Summary
-----------------
Carvedilol, target dose: 50 mg daily; Bisoprolol, target dose: 10 mg daily; Metoprolol tartrate, target dose: 150 mg daily; Metroprolol succinate, target dose: 200 mg daily

Detailed Description
-----------------
The investigators will investigate the efficacy and safety of different β -blockers, as well as heart rate variability, in STEMI patients undergoing primary PCI.

Official Title
-----------------
Different β -Blockers in Patients With ST-segment Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Conditions
-----------------
Primary PCI

Intervention / Treatment
-----------------
* Drug: β -Blockers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; Age ≥18 years; Informed consent from patient or next of kin. Exclusion Criteria: Nonischaemic Cardiomyopathy; Cardiac surgery planed in the 6 months; Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); Renal or hepatic failure; Malignancy, HIV, or central nervous system disorder; Cardiopulmonary resuscitation >15 min and compromised level of consciousness; Cardiogenic shock; Current participation in any research study involving investigational drugs or devices; No written consensus; Previous myocardial infarction.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carvedilol<br> | Drug: β -Blockers<br>* Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate<br>|
| Experimental: Bisoprolol<br> | Drug: β -Blockers<br>* Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate<br>|
| Experimental: Metoprolol tartrate<br> | Drug: β -Blockers<br>* Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate<br>|
| Experimental: Metoprolol succinate<br> | Drug: β -Blockers<br>* Target doses of carvedilol, bisoprolol, metoprolol tartrate, or metroprolol succinate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in LVEDV from baseline | The primary outcome of this study will be the change from baseline in left ventricular end diastolic volume (LVEDV) post-PCI. | 1 to 5 years | 
| Major adverse cardiovascular events (MACE) |  | 1 to 5 years |
Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain

Study Overview
=================
Brief Summary
-----------------
Neuropathic pain is due to a lesion or disease affecting the nervous system. Antidepressants (ADs) are recommended as the first line treatment. In a murine model, the investigators evidenced that antidepressants antiallodynic action is mediated through β2-adrenergic receptor stimulation and that β-mimetics display the same effect. These data support the idea that β-mimetics could offer a therapeutic alternative to ADs for neuropathic pain treatment. This study will aim at assessing the effects of terbutaline on neuropathic pain symptoms.

Official Title
-----------------
Analgesic Effect of Beta 2-mimetics in the Treatment of Neuropathic Pain

Conditions
-----------------
Postthoracotomy Pain, Postthoracoscopy Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: Terbutaline sustained release 5 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults from 18 to 75 years old neuropathic painful condition following a thoracotomy or thoracoscopy for at least 3 months Exclusion criteria: cardiovascular risk unstable diabetes mellitus allergy for terbutaline hypokaliemia without treatment untreated hypothyroidism HIV- or chemotherapy-induced neuropathy cancer being treated by chemo- or radio-therapy concomitant treatment with β-blockers, tricyclic ADs or morphine concomitant pain more severe than neuropathic pain- pregnant women

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: first period with terbutaline and second period with placebo<br>The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods. | Drug: Terbutaline sustained release 5 mg<br>* Terbutaline 10mg oral per day (5 mg twice a day) during 28 days<br>|
| Other: first period with placebo and second period with terbutaline.<br>The studies will be randomized, double-blind, placebo-controlled. It will use a 4 + 4 weeks crossover design for terbutaline vs. placebo (no titration). A washout period (2 weeks) will separate the treatment periods. | Drug: Terbutaline sustained release 5 mg<br>* Terbutaline 10mg oral per day (5 mg twice a day) during 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the average intensity of pain during the last 24 hours reported by the patient on a 11 points Numeric Scale |  | Day one, day 14 and day 28 of each 4 weeks period |
Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Non-cardiac surgery is associated with significant cardiac morbidity and mortality. Volatile anesthetics have a cardioprotective effects which results in preservation of left ventricular function and lower troponin I levels. Lower troponin release has been correlated with better long term event free survival in both cardiac and non cardiac surgery. A recently completed meta-analysis suggests that sevoflurane is a superior volatile agent. The evidence of a cardioprotective effect in non-cardiac surgery is lacking. Base on the current literature, we intend to evaluate the protective potential of sevoflurane versus propofol anesthesia in high risk patients undergoing elective non-cardiac procedures. Hypothesis: The use of Sevoflurane as a general anesthetic reduces postoperative troponin release, the incidence of myocardial infarction and/or long term morbidity in patients at low to moderate risk of postoperative cardiac complications, who are undergoing noncardiac surgery.

Official Title
-----------------
Peri-Operative And Long-Term Cardioprotective Properties Of Sevoflurane In High Risk Patients Undergoing Non-Cardiac Surgery

Conditions
-----------------
Non Cardiac Surgery

Intervention / Treatment
-----------------
* Drug: Sevoflurane or Propofol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing non-cardiac surgery is eligible if s/he: 1.) is ≥45 years old;2.) Has an expected length of stay ≥48 hours; AND3.) Fulfills any 2 of the six criteria for high cardiac risk as defined by the revised Cardiac Risk Index.(see details in protocol)4.) Informed consent Exclusion criteria:A patient will be ineligible for this study if s/he:1) Prior adverse reaction to sevoflurane (MH patient) or propofol.2) Previous coronary artery bypass graft (CABG) surgery with complete revascularization in the preceding five years with no evidence of cardiac ischemia since the procedure; or3) Has concomitant life-threatening disease likely to limit life expectancy to <30 days. -

Ages Eligible for Study
-----------------
Minimum Age: 45 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

| Intervention/Treatment |
| --- |
|Drug: Sevoflurane or Propofol|nan|

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
-----------------
anesthesia, non cardiac surgery, cardiac outcomes
Epigenetics in Lupus Nephritis

Study Overview
=================
Brief Summary
-----------------
This is a translational study for the identification of epigenetic changes detectable in sera of patients suffering from Systemic Lupus erythematosus. The aim of the study is to analyze whether circulating DNA fragments are 1) different in patients with or without Lupus nephritis and 2) present and detectable in the circulation before the development of Lupus nephritis.

Official Title
-----------------
Unmethylated CpG-rich DNA Fragments in TLR-mediated Renal Fibrogenesis of Lupus Nephritis

Conditions
-----------------
Systemic Lupus Erythematosus, Lupus Nephritis

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of systemic lupus erythematosus according to the current classification criteria a subgroup requires the presence of Lupus nephritis (no restriction to specific LN histologic subtypes) Exclusion Criteria: patients not able or unwilling to provide written informed consent

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 |
| --- | --- |
| Lupus nephritis +ve<br>This group consists of patients with Lupus nephritis | Diagnostic Test: Blood sampling<br>* Blood sampling will be performed to allow analyses of epigenetic markers<br>|
| Lupus nephritis -ve<br>This group consist of patients with SLE without Lupus nephritis | Diagnostic Test: Blood sampling<br>* Blood sampling will be performed to allow analyses of epigenetic markers<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylated CpG-rich DNA fragments | it will be analyzed whether circulating CpG-rich DNA fragments are present in patients' blood | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epigenetics, Methylation, Toll-like receptors, Fibrosis