linjc16/ctgov huggingface dataset:
IRIS-Onyx Cohort in the IRIS-DES Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the relative effectiveness and safety of Onyx stent compared to other (drug eluting stents) DES.

Official Title
-----------------
Evaluation of Effectiveness and Safety of Resolute Onyx™ in Routine Clinical Practice; A Multicenter, Prospective Observational Study

Conditions
-----------------
Coronary Artery Disease, Arterial Occlusive Diseases, Cardiovascular Diseases, Percutaneous Transluminal Angioplasty

Intervention / Treatment
-----------------
* Device: Onyx Drug Eluting Stent group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 and more Intervention with Onyx Drug Eluting Stent Agreed with written informed consent form Exclusion Criteria: Intervention with Onyx drug eluting coronary stent and other drug eluting stent at the same time Life expectancy of 1year and under Cardiac shock

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Onyx Drug Eluting Stent<br> | Device: Onyx Drug Eluting Stent group<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stent thrombosis | As per Academic Research Consortium (ARC) standard, definite or probable stent thrombosis | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All death |  | 5 year | 
| Cardiac death |  | 5 year | 
| Myocardial infarction |  | 5 year | 
| Composite event of death or myocardial infarction |  | 5 year | 
| Composite event of cardiac death or myocardial infarction |  | 5 year | 
| Composite event rate | death, myocardial infarction, target vessel revascularization | 5 year | 
| Target Vessel revascularization |  | 5 year | 
| Target Lesion revascularization |  | 5 year | 
| Stent thrombosis |  | 5 year | 
| Stroke |  | 5 year | 
| Procedural success | defined as less than 30% residual stenosis at the completion of procedure without death or Q wave myocardial infarction or urgent revascularization participants will be followed for the duration of hospital stay, an expected average of 3days. | 3 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Onyx, drug eluting stent, Routine Clinical Practice, Angioplasty, Transluminal, Percutaneous Coronary, Coronary Artery Disease
Simulation-assisted Teaching in Learning Gastroscopy

Study Overview
=================
Brief Summary
-----------------
This project is a single-blinded randomized controlled trial investigating the effect of simulation-based teaching in learning gastroscopy for medical doctors.

Official Title
-----------------
Simulation-assisted Teaching in Learning Gastroscopy

Conditions
-----------------
Endoscopy, Education, Gastroscopy, Esophagogastroduodenoscopy, Simulation

Intervention / Treatment
-----------------
* Other: Simulation-based learning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Medical doctors in medical gastroenterology or surgery Exclusion Criteria: prior experience with gastroscopy
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Simulation-based learning + clinical training<br> | Other: Simulation-based learning<br>* Pre-clinical simulation-based learning at Simbionix GI-mentor II virtual reality simulator and OGI CLA 4 phantom.<br>|
| No Intervention: Clinical training<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of procedures before declared unassisted | Number of gastroscopies before the supervisor declare the participant ready to do unassisted upper GI endoscopies | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction | Survey using Gastrointestinal Endoscopy Satisfaction Questionnaire a validated questionnaire using a scale from 1-5 (5 is the best). | 1 year | 
| Complication rate |  | 1 year | 
| Mucosa visualization percent of the upper gastrointestinal tract | Assessed by endoscopy experts at video documented endoscopies | 1 year | 
| Duration of intubation | Duration of time that the patient is intubated with the endoscope | 1 year | 
| Time | Total time for the procedure | 1 year |
Comparison Between Colorectal Stents and Primary Surgery in Obstructive Colonic Cancer. A Randomized, Controlled Study

Study Overview
=================
Brief Summary
-----------------
To evaluate wether colorectal stenting carry a significant clinical advantage

Detailed Description
-----------------
Randomized controlled comparison between stents and primary surgery in obstructive left colonic obstructive carcinoma outside palliative situations.

Official Title
-----------------
Etude Prospective Multicentrique randomisée Comparant Deux stratégies thérapeutiques Pour Les Cancers Coliques en Occlusion : stratégie Chirurgicale Exclusive Versus stratégie thérapeutique Avec Stent Colique Initial

Conditions
-----------------
Colorectal Obstruction, Left Colonic Adenocarcinoma

Intervention / Treatment
-----------------
* Procedure: stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obstructive stenosis due to left colorectal cancer Exclusion Criteria: previous colorectal cancer other colorectal location

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 |
| --- | --- |
| Experimental: A<br>primary surgery group | Procedure: stent<br>* stent placement for colorectal cancer obstruction<br>* Other names: self-expending metallic stents;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of stoma in each group |  | within the first 6 month(plus or minus 1 month) after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality in each group |  | within the first 6 month (plus or minus 1 month) after surgery | 
| complications |  | within the first 6 month (plus or minus 1 month) after surgery | 
| number of procedures |  | within the first 6 month (plus or minus 1 month) after surgery | 
| length of stay |  | within the first 6 month (plus or minus 1 month) after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal stents, colonic obstruction, colonic adenocarcinoma, colorectal surgery
Efficacy of Valsartan/Hydrochlorothiazide Versus Amlodipine and Hydrochlorothiazide in Patients Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy of valsartan/hydrochlorothiazide versus amlodipine and hydrochlorothiazide in patients with Stage 2 hypertension using 24-hr ambulatory blood pressure monitoring (ABPM)

Official Title
-----------------
A 10-week Multicenter,Forced-titration Study Using 24-hr ABPM to Evaluate the Efficacy of Valsartan/Hydrochlorothiazide (HCTZ) Treatment Regimen vs Conventional Treatment Regimen With Amlodipine and Hydrochlorothiazide (HCTZ) in Patients With Stage 2 Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Valsartan/HCTZ
* Drug: amlodipine
* Drug: HCTZ


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 18 years of age or older Diagnosed of having hypertension, defined as a mean seated systolic BP ≥160 mmHg (Stage 2 hypertension) Exclusion Criteria: Symptomatic or severe hypertension Patients treated with more than 2 antihypertensive medications Clinically known or suspected history of secondary hypertension Myocardial infarction, stroke, transient ischemic attack, cardiovascular revascularization/angioplasty in last 6 months Diagnosis of heart failure (NYHA Class II-IV) Chronic renal or severe hepatic disease

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Valsartan/HCTZ|nan|
|Drug: amlodipine|nan|
|Drug: HCTZ|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Change from baseline in mean 24-hr ambulatory systolic blood pressure (BP) after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in mean 24-hr ambulatory diastolic BP and pulse pressure after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ |  |  | 
| Change from baseline in mean seated systolic and diastolic BP after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ |  |  | 
| Compare the proportion of patients achieving blood pressure goal and tolerability after 10 weeks of treatment of valsartan/HCTZ versus amlodipine and HCTZ |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, valsartan/HCTZ, amlodipine and HCTZ
Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This study was designed to review clincal outcomes of Diffuse Large B Cell Lymphoma (DLBCL) treated with R-CHOP chemotherapy in the era of pegylated-filgrastim. The investigators will prospectively collect clinical data and treatment outcome of patients with DLBCL who use prophylactic pegylated-filgrastim.

Detailed Description
-----------------
Newly diagnosed DLBCL patients treated with R-CHOP chemotherapy Prphylactic peg-filgrastim on the day after chemotherapy

Official Title
-----------------
Multicenter Prospective Registry Study of Diffuse Large B Cell Lymphoma

Conditions
-----------------
Diffuse Large B Cell Lymphoma, Neutropenia, Febrile

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 19 or older newly diagnosed with DLBCL R-CHOP chemotherapy offer informed consent Exclusion Criteria: other subtype of NHL concomitant other cancer previous chemotherapy or radiotherapy

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| CISL 14-03<br>Patients who were newly diagnosed with Diffuse Large B cell Lymphoma (DLBCL). Aged 19 or more Treated with R-CHOP therapy | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of febrile neutropenia |  | within 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of chemotherapy-related adverse events other than febrile neutropenia |  | 4 weeks after completion of chemotherapy | 
| Overall survival |  | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diffuse large b cell lymphoma, peg-filgrastim, febrile neutropenia
Expanded Access Program for Idebenone in Participants With Duchenne Muscular Dystrophy (DMD)

Study Overview
=================
Brief Summary
-----------------
The primary objective of this Expanded Access Program is to provide idebenone as a treatment for eligible participants with Duchenne Muscular Dystrophy before it is commercially available in the United States (U.S.) for the indication of DMD.

Official Title
-----------------
Expanded Access Protocol (EAP) of Idebenone in Patients With Duchenne Muscular Dystrophy

Conditions
-----------------
Duchenne Muscular Dystrophy

Intervention / Treatment
-----------------
* Drug: Idebenone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented diagnosis of DMD (severe dystrophinopathy) and clinical features consistent of typical DMD at diagnosis (i.e., documented delayed motor skills and muscle weakness by age 5 years) and who in the opinion of the Treating physician would benefit from treatment with idebenone. DMD should be confirmed by mutation analysis in the dystrophin gene or by substantially reduced levels of dystrophin protein (i.e., absent or <5% of normal) on Western blot or immunostaining. Minimum 8 years old at Prescreening. PEF or FVC ≤80% and >25% of predicted value based on most recent assessment noted in the patient's medical record and subsequently confirmed at the Enrollment Visit. Able to understand program requirements and swallow program medication. Signed and dated Informed Consent Form (to be obtained at the Enrollment Visit from patient or parent/legal guardian (if applicable) prior to performing any program-specific procedures and dispensing idebenone to the patient). Exclusion Criteria: Eligible for and able to participate in an ongoing clinical trial of idebenone. Is at high-risk of a fatal outcome from lung infection and/or advanced cardiomyopathy in the opinion of the Treating physician. Known moderate or severe impairment of hepatic function or severe impairment of renal function. Prior or ongoing medical condition or laboratory abnormality which in the Treating physician's opinion may put the patient at significant risk or may interfere significantly with the patient's participation in the program. Abuse of drugs or alcohol, which in Treating physician's opinion would interfere with the compliance to treatment. Known individual hypersensitivity to idebenone or to any of the ingredients/excipients of the program medication.

Ages Eligible for Study
-----------------
Minimum Age: 8 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Idebenone|900 mg idebenone/day (2 tablets to be taken 3 times a day with meals)|

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
-----------------
idebenone, DMD, Duchenne
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers

Study Overview
=================
Brief Summary
-----------------
To determine the sensitivity of HPV OncotectTM to diagnose oropharyngeal cancers induced by oncogenic HPV

Official Title
-----------------
Evaluation of HPV OncoTect ™ for the Etiological Diagnosis of HPV-induced Oropharyngeal Cancers

Conditions
-----------------
Oropharyngeal Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: HPV OncoTect™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Untreated oropharynx epidermoid carcinoma Patient ≥ 18 years old Patient affiliated to a social security scheme or beneficiary of such a scheme Information to the patient or his legal representative and signature of informed consent Exclusion Criteria: Non-oropharyngeal epidermoid carcinoma Oropharyngeal epidermoid carcinoma previously treated

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients with oropharyngeal cancer<br>Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test. Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results. | Diagnostic Test: HPV OncoTect™<br>* Salivary specimens will be collected from 40 patients with oropharyngeal cancer The saliva samples will be sent to incell dx, which will analyze them blindly (without knowledge of the clinicopathological information) with the HPV OncoTect ™ test. Clinical and pathological information will be collected and maintained by the principal investigator At the end of the study, the results obtained with the HPV OncoTect ™ test will be confronted with the clinical and pathological results.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity is defined as the probability that the oncotectTM HPV test is positive if the cancer is HPV-induced. |  | up to 12 months |
Acetyl-L-Carnitine Supplementation During HCV Therapy With Peg IFN-α2b Plus Ribavirin: Effect on Work Performance.

Study Overview
=================
Brief Summary
-----------------
To assess the effects of Acetyl-L-Carnitine, probiotics and antioxidant nutritional substances administration on work productivity, daily activity, and fatigue in subjects with chronic hepatitis C treated with Pegylated-Interferon-α2b and Ribavirin.

Official Title
-----------------
Effect of Supplementation of Antioxidant Substances and Probiotics in HCV Correlated Liver Disease Treated With Interferon and Ribavirin. Studies on Biochemical and Virological Response and on Quality of Life.

Conditions
-----------------
Quality of Life, Daily Activity, Fatigue

Intervention / Treatment
-----------------
* Drug: Acetyl-L-carnitine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible patients are workers who are 18 years of age or older, infected by HCV with a quantifiable serum HCV RNA level (as determined by polimerase chain reaction, COBAS AmpliPrep/COBAS TaqMan - ROCHE). HCV infected populations must have elevated serum alanine transaminase levels and findings on liver biopsy consistent with chronic infection. Cirrhotic patients have to have a Child-Pugh score less than 7 to be eligible. Exclusion Criteria: Ineligible patients are those who had other liver diseases, as well as those who are affected by cancer, severe jaundice, pulmonary and renal chronic diseases, prostatic diseases, autoimmune diseases and diabetes mellitus. Excessive use of alcohol (>20 g/die) or hepato-toxic drugs. Other causes of exclusion include decompensated cirrhosis, pregnancy, and contraindications for Peg-IFN-a or RBV therapy such as cardiopathy, hemoglobinopathies, hemocromatosis, major depression or other severe psychiatric pathological conditions.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Acetyl-L-carnitine<br>Acetyl-L-carnitine 2 gr tablets | Drug: Acetyl-L-carnitine<br> <br> |
| Placebo Comparator: placebo<br> | Drug: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Work performances |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acetyl-L-carnitine, Interferons, Ribavirin, Hepatitis C, Fatigue