linjc16/ctgov huggingface dataset:
Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19 Compared to the Placebo

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy and safety after administration of DWJ1248 in patients with mild to moderate COVID-19 compared to the placebo.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Multi-center, Phase II/III Study to Evaluate the Efficacy and Safety of DWJ1248 in Patients With Mild to Moderate COVID-19

Conditions
-----------------
Mild to Moderate COVID-19

Intervention / Treatment
-----------------
* Other: Part 1
* Other: Part 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over the age of 19 as of the signed date in written consent Subjects with mild or moderate COVID-19 according to RT-PCR test (Total score of NEWS is 0-6 or if one item is 3 points) Subjects who have symptoms within 7 days or 72 hours after diagnosis Exclusion Criteria: Subjects who cannot orally administer the investigational products Subjects who need administration of immunosuppressants Subjects who are allergic or sensitive to investigational products or its ingredients Subjects who have a history of drug and/or alcohol abuse within 52 weeks before screening Subjects who have been identified with uncontrolled concomitant diseases or conditions, including significant mental illness and social conditions, that may affect compliance with clinical trial procedures according to the determination of the investigators

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: DWJ1248<br>Camostat mesylate | Other: Part 1<br>* - DWJ1248 600mg PO (100mg 2 tab, TID)<br>Other: Part 2<br>* - DWJ1248 600mg PO (200mg 1 tab, TID)<br>|
| Placebo Comparator: Placebo<br>Placebo | Other: Part 1<br>* - DWJ1248 600mg PO (100mg 2 tab, TID)<br>Other: Part 2<br>* - DWJ1248 600mg PO (200mg 1 tab, TID)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Part 1) Time to SARS-CoV-2 eradication | Time to reach undetectable SARS-CoV-2 RNA level | Up to 28 days | 
| (Part 2) Time to clinical improvement of subjective symptoms | Clinical improvement of subjective symptoms (days) | Up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| (Part 1) Rate of SARS-CoV-2 eradication | Percent of patients with undetectable SARS-CoV-2 RNA level | Days 4, 7, 10, and 14 | 
| (Part 1/2) Time to clinical improvement of subjective symptoms |  | Up to 28 days | 
| (Part 2) Change from baseline of subjective symptom scores |  | Days 4, 7, 10, 14, 21 and 28 |
Percutaneous Coronary Intervention Registry FRIBOURG

Study Overview
=================
Brief Summary
-----------------
The registry aims to follow clinically all consecutive patients treated by percutaneous coronary interventions at hospital & university Fribourg.

Official Title
-----------------
Percutaneous Coronary Intervention Registry FRIBOURG

Conditions
-----------------
Coronary Artery Disease, Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Device: Percutaneous coronary intervention, stents


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive patients treated by percutaneous coronary intervention at our institution Able to give informed consent and willing to participate Exclusion Criteria: Unwillingness to participate Enable to provide inform consent

Ages Eligible for Study
-----------------
Minimum Age: 17 Years
Maximum Age: 120 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Percutaneous coronary intervention, stents|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-oriented composite endpoints (POCE) | Academic Research Consortium definition | 2 years | 
| Major Bleeding | Bleeding Academic Research Consortium definition | 2 years | 
| Patient-oriented composite endpoints (POCE) | Academic Research Consortium definition | 5 years | 
| Major Bleeding | Bleeding Academic Research Consortium definition | 5 years | 
| Patient-oriented composite endpoints (POCE) | Academic Research Consortium definition | 10 years | 
| Major Bleeding | Bleeding Academic Research Consortium definition | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause death | Academic Research Consortium definition | 2 years | 
| any revascularization | Academic Research Consortium definition | 2 years | 
| any myocardial infarction | Academic Research Consortium definition | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCI
A Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare biomarker levels in Multiple Sclerosis (MS) patients before and after beginning Natalizumab.

Official Title
-----------------
A Longitudinal Study of MSDx Complex 1 as a Marker for Therapy Response in Multiple Sclerosis

Conditions
-----------------
Relapsing Remitting Multiple Sclerosis

Intervention / Treatment
-----------------
* Other: MSDX Complex-1 Biomarker test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of clinically definite relapsing remitting MS (RRMS) Age 45 years and older Willing and able to provide written informed consent Patient has high disease activity. Patient is about to begin Natalizumab (Tysabri) therapy. Exclusion Criteria: Any clinically significant disease other than MS that is likely to interfere with the evaluation of CDMS Known infectious or hematological disease. Unwilling or unable to comply with the requirements of this protocol Subject can not have a gadolinium enhanced MRI

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Tysabri Group<br>Patients with a diagnosis of relapsing remitting multiple sclerosis (RRMS) who is about to begin Natalizumab (Tysabri) therapy for a relapse in clinical symptoms (either diagnosed clinically or via gadolinium MRI). | Other: MSDX Complex-1 Biomarker test<br>* MSDX Complex-1 Biomarker test<br>* Other names: Biomarker Test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in MSDX Complex-1 between baseline and 6-month visit | This outcome measure will evaluate a difference in the level of MSDX Complex-1 form the baseline visit to the 6-month visit. MSDX Complex-1 is a biomarker for MS disease activity and its change should correspond with a change in the disease activity in MS. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gadolinium MRI and MSDX Complex-1 level | This outcome will evaluate whether a change seen in a Gadolinium MRI (a diagnostic test for MS) matches with a change in the MSDX Complex-1 level in a patient with MS. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS, RRMS, RR Multiple Sclerosis
Perceived Health After Hospitalization for COVID-19

Study Overview
=================
Brief Summary
-----------------
There are currently no precise data available on the impact of COVID-19 on the daily life of patients after hospitalization. For the moment, studies have only demonstrated a strong impact of the diagnosis on the domains of quality of life explored by the MOS-SF36 questionnaire and the PHQ-9 depression score. Concerning the impact of COVID-19 disease after conventional hospitalization, field reports indicate extremely intense fatigue and a major physical impact lasting several weeks

Official Title
-----------------
Perceived Health After Hospitalization for COVID-19

Conditions
-----------------
COVID-19, Post-hospitalization, Disease Impact

Intervention / Treatment
-----------------
* Other: Questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patient Patient with a diagnosis of COVID-19 confirmed by PCR and/or CT scan Patient hospitalized in a short stay unit (excluding intensive care and rehabilitation) for a COVID-19 infection Patient providing oral consent to participate in the study Patient able to understand and answer the questionnaires used Patient able to answer the questions on an electronic device and to receive requests by email and/or SMS Patient who has electronic equipment at home and an Internet subscription allowing him/her to answer the questionnaires online Exclusion Criteria: Patient under guardianship, curatorship or a measure of judicial safeguard

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 |
| --- | --- |
| COVID-19 Patient<br>Patient discharged from a conventional short-stay hospitalization unit. | Other: Questionnaires<br>* SF-12, GHQ-12 and HAQ<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to PASS and CID in patients discharged from conventional hospitalization for COVID-19 disease |  | Through study completion, an average of 6 months | 
| The value of perceived health scores in patients who achieved PASS and MCII |  | Through study completion, an average of 6 months |
Finger Hardness Measure in Scleroderma

Study Overview
=================
Brief Summary
-----------------
Thirty subjects with systemic sclerosis and 30 age and sex matched controls without any known condition that should cause increased skin hardness in the fingers with undergo examination by manual palpation and durometer measured hardness of their digital tuft skin by 2 observers on 2 separate occasions. There will be 1 hour between individual observer's scorings. Observers will be blinded from the observer's scores and from their previous scores. Results will be tabulated and compared for manual scores versus durometer measurements, intra-observer scores by both methods and inter-observer scores by both methods.

Detailed Description
-----------------
It is pretty straightforward. We will measure and record the hardness of the digital tufts on ten digits by palpation and the hardness in the same area by using a durometer. We will repeat this one hour later. Scores will be compared as a measure of how consistent and precise they are.

Official Title
-----------------
Durometer Skin Assessment in Scleroderma: a Study to Validate This New Tool in the Digital Tufts

Conditions
-----------------
Scleroderma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scleroderm Rheumatologic condition not effecting the skin tightness

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fingertip hardness in patients with scleroderma and controls: comparing manual assessment(scale0 - 3) with durometer assessment(scale 0- 100). | Two investigators will compare data from 30 patients with scleroderma and 30 control patients without fingertip inflammation or tightness twice using durometer readings to those done by manual palpation. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scleroderma, skin, tightness, durometer
Paroxysmal Nocturnal Hemoglobinuria Human Anti-Human Antibodies Study

Study Overview
=================
Brief Summary
-----------------
How does long term treatment with Soliris affect HAHA in PNH patients?

Detailed Description
-----------------
To determine the long term effect of Soliris (eculizumab) treatment on the presence of human anti-human antibodies (HAHA) in Paroxysmal Nocturnal Hemoglobinuria (PNH) patients.

Official Title
-----------------
A Post Marketing, Multi-Center, Trial to Measure Human Anti-Human Antibodies (HAHA) to Soliris (Eculizumab) in Patients With Paroxysmal Nocturnal Hemoglobinuria

Conditions
-----------------
PNH, Paroxysmal Nocturnal Hemoglobinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PNH patients who previously participated in study E05-001; Patients who have an eculizumab naive serum sample for comparison; Patients who currently used commerical Soliris; Patients who are willing and able to gie written informed consent. Exclusion Criteria: There are no exclusion criteria for this study.
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 |
| --- | --- | --- |
| To summarize the proportion of patients with neutralizing HAHA antibodies. |  | Six (6) months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To summarize the proportion of patients with non-neutralizing HAHA antibodies. |  | Six (6) months | 
| To summarize the proportion of patients with increased hemolysis in setting of neutralizing HAHA antibodies. |  | Six (6) months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Paroxysmal Nocturnal Hemoglobinuria, PNH, Human Anti-Human Antibody, HAHA, Soliris, eculizumab
Matrix Metalloproteinases and Diabetic Nephropathy

Study Overview
=================
Brief Summary
-----------------
Matrix metalloproteinases (MMPs) are a family of protein-degrading enzymes that are involved in the breakdown and remodeling of many tissues and organs. Abnormal activity of these enzymes has been implicated in many disease processes including rheumatoid arthritis, dental disease and metastatic cancer. Recent studies also suggest that elevations in blood sugar may abnormally effect MMP enzyme activity. Decreased activity of some of these MMP enzymes may be a partial cause of the abnormal enlargement of the kidney (renal hypertrophy) seen at the start of diabetic kidney disease (nephropathy). Preliminary clinical data from our laboratory confirm that children with newly diagnosed type 1 diabetes mellitus (DM) have lower blood levels of some of these enzymes at the time of very high blood sugar readings. However, these enzyme levels become normal again as blood sugar levels improve with insulin treatment. In the present study, we propose to investigate the hypothesis that MMPs are involved in the cause of diabetic kidney disease by measuring concentrations of specific MMPs and some related proteins in the blood and urine of patients with type 1 DM who are between the ages of 14-40 years. We will enroll some patients who are recently diagnosed with diabetes, some who have had diabetes for several years, but without signs of kidney disease, and some with long-term diabetes and various degrees of kidney disease. Continuous Subcutaneous Glucose Monitoring, conducted for 3-4 days, will also be provided as a part of this study, to determine how different levels of blood sugar control might relate to different levels of MMP enzyme activity in the blood. We anticipate that this study will help to establish a link between abnormal MMP activity and the cause of nephropathy in type 1 DM, allowing scientists to design better therapies for the prevention and treatment of diabetes-related kidney problems.

Official Title
-----------------
Matrix Metalloproteinases and Diabetic Nephropathy

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetic Nephropathy

Participation Criteria
=================
Eligibility Criteria
-----------------
Type 1 Diabetes with or without kidney disease and past puberty.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 Years

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 |
| --- | --- | --- |
Study of VSN16R for the Treatment of Spasticity in Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
Phase II a Proof of concept study in Multiple Sclerosis (MS) patients with spasticity.

Detailed Description
-----------------
Single dose escalation followed by multiple fixed dose administrations to assess short term safety and to determine whether spasticity improves.

Official Title
-----------------
A Phase II Proof of Concept (PoC), Double-Blind, Randomised, Placebo-controlled Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of VSN16R for the Treatment of Spasticity in Subjects With Multiple Sclerosis

Conditions
-----------------
Spasticity in People With Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: VSN16R
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a confirmed diagnosis of MS Have an Expanded Disability Status Scale (EDSS) ≤ than 6.5 at screening. Spasticity due to MS of at least 3 months duration with minimum mean score of >/=2 mASH Exclusion Criteria: Acute MS relapse requiring treatment with steroids within 30 days of screening. Initiation or discontinuation of MS disease modifying treatment (DMT) within 30 days of screening. Receiving medications that would potentially interfere with the actions of the study medication or outcome variables Significant renal and hepatic abnormalities Previous history of other significant medical disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Active<br>VSN16R (Canbex name for molecule) oral capsules, 50mg-400mg daily or twice daily, total exposure 26 days | Drug: VSN16R<br>* Small molecule<br>* Other names: Not yet available;|
| Placebo Comparator: Placebo<br>Placebo capsules, 50mg-400mg daily or twice daily, total exposure 26 days | Other: Placebo<br>* dummy tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numerical Rating Scale |  | 26 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale |  | 26 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MS, Spasticity, VSN16R
Norwegian Study on District Treatment of ST-Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
In the district areas of Norway patients with acute myocardial infarction with ST-elevation, are treated with thrombolysis. An increasing part of them receives thrombolysis before arrival to the local hospital.Usually these patients have been sent to an invasive center if thrombolysis fails or the patient gets ischemic symptoms during the stay. This study will compare this strategy against immediate transportation to an invasive center after the patient has received thrombolysis.

Official Title
-----------------
Benefits and Costs in Two Different Strategies for Treating Acute Myocardial Infarction With ST-Elevation.

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Duration of painless than 6 hours. ST-segment elevation of at least 0.1 mV in two or more extremity leads or at least 0.2 mV in two or more precordial leads. The patient is getting thrombolysis. Time to reach an invasive center is more than 1 hour. Age 18-75 years. Exclusion Criteria: Known serious renal failure (creatinin > 250 mmol/l) Pregnancy Cardiogenic chock Life threatening arrythmias Other serious diseases with life expectancy less than 1 year. Inability to perform an informed consent

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: PCI|Immediate transport to invasive center after thrombolysis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death , myocardial infarction ,stroke or ischemia during 12 months. |  | 12 months | 
| Costs during 12 months. |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Size of infarction. |  | 3 months | 
| Complications |  | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute myocardial infarction, Fibrinolysis, Health effects /Quality of life