linjc16/ctgov huggingface dataset:
Determination of the Prevalence and Prognostic Importance of Unrecognized Non-Q-wave Myocardial Infarction by MRI

Study Overview
=================
Brief Summary
-----------------
The first aim of this study is to determine how often unrecognized myocardial infarction occur in patients using a magnetic resonance imaging (MRI) technique (known as delayed enhancement MRI), as compared to the electrocardiogram. The second aim of this study is to determine the severity of coronary heart disease of the patients with unrecognized myocardial infarction. The final aim is to determine how the presence of unrecognized myocardial infarction detected by the MRI affects lifespan.

Detailed Description
-----------------
Unrecognized myocardial infarction (MI) is known to constitute a substantial portion of lethal coronary heart disease. However, since the diagnosis of unrecognized MI is based on the appearance of incidental Q-waves on 12-lead electrocardiography, the syndrome of unrecognized non-Q-wave MI has not been described. Delayed-enhancement cardiovascular magnetic resonance (DE-CMR) can accurately identify non-Q-wave MI. The aims of this study are three-fold: 1. to determine the prevalence of unrecognized non-Q-wave and Q-wave MI, 2. to define predictors of unrecognized non-Q-wave MI, 3. to determine the prognostic significance of unrecognized non-Q-wave MI.

Official Title
-----------------
Unrecognized Non-Q-wave Myocardial Infarction: Prevalence, Angiographic Correlation, and Prognostic Significance in Patients With Suspected Coronary Disease

Conditions
-----------------
Coronary Arteriosclerosis, Myocardial Infarction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with suspected coronary artery disease referred for invasive coronary angiography Exclusion Criteria: Clinical history of myocardial infarction Percutaneous coronary intervention Coronary artery bypass surgery Known uncured malignancy History of hypertrophic cardiomyopathy, myocarditis, or infiltrative heart disease Contraindication of magnetic resonance imaging

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 |
| --- | --- | --- |
Median Study for Biochemical Serum Markers in First Trimester of Pregnancy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to get initial values (normal medians) for certain biochemical serum markers for pregnancy weeks 10-13. Also initial values for mean arterial blood pressure measurement and certain ultrasound measurement may be established.

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent maternal age 18 - 45 years gestational age 10 -13 (+6 days)verified by ultrasound Exclusion Criteria: mental retardation or other mental disorders that impose doubts regarding the true subject's willingness to participate in the study lack of needed demographic data

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| levels of biochemical serum markers |  | 10-13 wks gestation |
ReSTOR Natural +3.0D Study In Japan

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate safety and effectiveness of ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1 when implanted to replace the natural lens following cataract removal.

Official Title
-----------------
ReSTOR Natural +3.0D (Diopter) Study In Japan

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned bilateral cataract removal by phacoemulsification Potential postoperative best corrected visual acuity of 0.5 or over 1.5 Diopter (D) or less of astigmatism preoperatively, measured by keratometry Exclusion Criteria: Poorly controlled glaucoma Progressive diabetic retinopathy

Ages Eligible for Study
-----------------
Minimum Age: 20 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SN6AD1<br>AcrySof ReSTOR Model SN6AD1 Intraocular Lens | Device: ACRYSOF Multifocal Single-piece Intraocular Lens (IOL) Model SN6AD1<br>* Implantation with the AcrySof ReSTOR Intraocular Lens (IOL) Model SN6AD1 following cataract removal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Intermediate Visual Acuity | Binocular Uncorrected Intermediate Visual Acuity, measured at 1 meter and 50 centimeters measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | 1 year after surgery | 
| Uncorrected Distance Visual Acuity | Binocular Uncorrected Dinstance Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | 1 year after surgery | 
| Uncorrected Near Visual Acuity | Binocular Near Visual Acuity measured in decimal visual acuity. Decimal visual acuity is the normal method to measure visual acuity in Japan. A higher decimal visual acuity value indicates better visual acuity. 0.5 in decimal visual acuity means 20/40 in Snellen fraction. | 1 year after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract
Rotational Stability of the AcrySof® Toric

Study Overview
=================
Brief Summary
-----------------
To assess the rotational stability and the residual refractive cylinder and patient reported outcomes of the AcrySof Toric intraocular lens after unilateral or bilateral implantation.

Official Title
-----------------
Rotational Stability of the AcrySof® Toric

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: AcrySof® Toric intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Monolateral or bilateral cataracts anticipated intraocular lens (IOL) power of +10 Diopters (D)   +25D 0.75   2.0 D of astigmatism measured preoperatively by Keratometry readings able to sign the informed consent, to comply with scheduled visits and other study procedures Exclusion Criteria: Preoperative ocular pathology previous intraocular or corneal surgery an increased risk for complications which could require vitreoretinal surgery corneal irregularities corneal opacities current contact lens usage uncontrolled diabetes

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Toric<br>Implantation with the AcrySof® Toric intraocular lens | Device: AcrySof® Toric intraocular lens<br>* Implantation of the AcrySof Toric intraocular lens (IOL) into the eye following cataract extraction surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rotational Stability | Average magnitude of intraocular lens (IOL) rotation from day of surgery to 6-months post-surgery, measured in degrees. | 6 Months post-surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Residual Refractive Cylinder | The refractive astigmatism 6 months post-surgery, measured in diopters. | 6 Months post-surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract
Phase 1 Study(Additional) of URC102 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, PK and PD of URC102 in healthy subjects.

Detailed Description
-----------------
Tolerability, safety, and pharmacokinetics (PK) of URC102 will be assessed after 7-day repeated oral dose in healthy adult Korean males. In addition, pharmacodynamic (PD) response of blood and urinary uric acid levels will be assessed.

Official Title
-----------------
A Phase I, Placebo-controlled, Randomized, Double Blind, Dose-escalation Study to Assess the Safety and Pharmacokinetic and Pharmacodynamic Characteristics of Repeated-dose URC102 in Healthy Korean Adult Males

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: URC102


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers Exclusion Criteria: Participated in other clinical study within past 3 months prior to receiving an IP administration

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 49 Years

Sexes Eligible for Study
-----------------
Male

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br> <br> |
| Active Comparator: URC102<br>URC102 | Drug: URC102<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with AE |  | 2 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma URC102 concentration |  | 2 week | 
| Change of plasma uric acid |  | 2 week |
Study of VIR-2482 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This is a phase 1 study in which healthy volunteers will receive VIR-2482 or placebo and will be assessed for safety, pharmacokinetics, and immunogenicity of VIR-2482 in preventing Influenza A illness.

Official Title
-----------------
A Phase 1, Randomized, Placebo-Controlled Study to Evaluate the Safety, Pharmacokinetics, and Immunogenicity of VIR-2482 for the Prevention of Influenza A Illness

Conditions
-----------------
Influenza A

Intervention / Treatment
-----------------
* Drug: VIR-2482
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Male or Female age 18 to < 65 years Body mass index (BMI) of 18.0 kg/m^2 to 32.0kg/m^2 Exclusion Criteria: Any clinically significant chronic or acute medical condition that makes the volunteer unsuitable for participation History of influenza-like illness or confirmed influenza infection within 3 months prior to randomization. Fever-like illness within 5 days of randomization. History or clinical evidence of conditions considered high risk for developing influenza-related complications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: VIR-2482<br>VIR-2482 | Drug: VIR-2482<br>* VIR-2482 given by intramuscular injection<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Sterile normal saline (0.9% NaCl) given by intramuscular injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-emergent adverse events. |  | Up to 12 months post-dose | 
| Number of participants with abnormalities in vital signs. |  | Up to 12 months post-dose | 
| Number of participants with abnormalities in electrocardiogram (ECG). |  | Up to 12 months post-dose | 
| Number of participants with abnormalities in clinically significant laboratory findings. |  | Up to 12 months post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentrations of VIR-2482 in serum |  | Up to 12 months post-dose | 
| Incidence of anti-drug antibody (ADA) to VIR-2482 |  | Up to 12 months post-dose | 
| Titers (if applicable) of anti-drug antibody (ADA) to VIR-2482 |  | Up to 12 months post-dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Influenza A
Cemented vs Non-cemented Semiendoprosthesis in the Treatment of Proximal Femoral Fractures

Study Overview
=================
Brief Summary
-----------------
The hip semiendoprosthesis is an acceptable method to treat the proximal femoral fractures. Traditionally, the cemented version of the semiendoprosthesis has been used for this indication. However, the cementing carries a risk of fat embolism during the pressurization of the cement. The fat embolism can be avoided when using the non-cemented semiendoprosthesis. In this study we want to find out whether there are any differences in the treatment results between the cemented and non-cemented semiendoprostheses when treating the proximal femoral fractures.

Official Title
-----------------
A Prospective, Randomized Study Comparing Cemented and Non-cemented Semiendoprostheses in the Treatment of Proximal Femoral Fractures in the Elderly Patients

Conditions
-----------------
Hip Fracture, Proximal Femoral Fracture

Intervention / Treatment
-----------------
* Device: Cemented semiendoprosthesis
* Device: non-cemented


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A proximal femoral fracture Exclusion Criteria: Rheumatoid arthritis Pathologic fracture Severe dementia (preventing the informed consent)
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 - cemented<br>Patients are treated with a cemented semiendoprosthesis | Device: Cemented semiendoprosthesis<br>* Application of a cemented semiendoprosthesis (Basis, Smith & Nephew)<br>|
| Active Comparator: 2 - non-cemented<br>Patients are treated with a non-cemented semiendoprosthesis | Device: non-cemented<br>* Patients are treated with a non-cemented semiendoprosthesis (Biomet Taperloc, Biomet Inc.)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary mortality |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prosthetic complications |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hip, Hip endoprosthesis, Hip fracture, Femoral fracture, Bone cement, Non-cemented
Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL

Study Overview
=================
Brief Summary
-----------------
Assessment of the mutational profile of the residual clone and the distribution of lymphocyte subpopulations at 3 years of treatment with ibrutinib This project has an epidemiological part: to establish the percentage of patients, in a real-life situation, still undergoing treatment 3 years after its initiation, as well as a biological part: to determine the evolution of the clone and the prevalence of BTK mutations and PLCg2 in the absence of clinical or biological criteria for scalability.

Detailed Description
-----------------
Observationnal and biological study

Official Title
-----------------
Tolerance and Resistance to Ibrutinib in Patients With Chronic Lymphocytic Leukemia (CLL): Analysis of Real-life Data: Snapshot at 3 Years From the End of Ibrutinib ATU. A National Study of the FILO-LLC Group

Conditions
-----------------
B Cell Chronic Lymphocytic Leukemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients included in the ATU (epidemiology) under treatment at 3 years of ibrutinib more than 18 years old Exclusion Criteria: no ibrutinib treatment

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ibrutinib resistance | In the long term, this study will help to draft new recommendations from FILO-LLC concerning the detection of resistance and the management of patients. | under treatment at 3 years of ibrutinib |
Intraperitoneal Hyperthermic Chemotherapy in Epithelial Ovarian Carcinoma

Study Overview
=================
Brief Summary
-----------------
Phase II to study results and morbidity of intra peritoneal hyper-thermic chemotherapy as consolidation therapy in patients with FIGO stage IIIC epithelial ovarian carcinoma treated by surgery and a total of 6 cycles of platinum based chemotherapy. A second look operation is performed after treatment; during this second look secondary cytoreductive surgery is accepted without bowel resection.If none or milimetric peritoneal disease is obseved an intraperitoneal chemotherapy is achieve

Official Title
-----------------
Phase II Study of Intra-Peritoneal Hyper-Thermic Chemotherapy as Consolidation Therapy for Advanced Epithelial Ovarian Carcinoma

Conditions
-----------------
Epithelial Ovarian Carcinoma, Figo Stage IIIC

Intervention / Treatment
-----------------
* Procedure: hyper thermic chemo + surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: epithelial ovarian carcinoma previous surgery + 6 cycles platinum based chemotherapy - Exclusion Criteria: Patients ASA 3 patients with no residual tumor at first operation negative microscopic second look

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- |
|Procedure: hyper thermic chemo + surgery|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
-----------------
previous treatment surgery + 6 cycles of platinum based chemotherapy
Identification of Genetic Factors Determining Disease Course in the New Type of Coronavirus Infection, COVID-19

Study Overview
=================
Brief Summary
-----------------
The study aims to identify environmental factors and genetic (gene mutation and gene expression) changes, which influencing the course of the disease the new type of coronavirus infection COVID-19 in patients nationwide in a multicenter study. At first in the study will be performed 200 patients, selected for a homogeneous groups on the basis of the patient's anamnestic data, genetic testing. Following the interim analysis, based on the results, another 800 people are planned to involve.

Official Title
-----------------
Identification of Genetic Factors Determining Disease Course and Preparation of Pharmacogenetic Applications in the New Type of Coronavirus Infection, COVID-19

Conditions
-----------------
COVID-19, Sars-CoV2

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirmed covid 19 infection Exclusion Criteria: informed refusal

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 |
| --- | --- | --- |
| Identification of genetic factors determining the course of the disease in case of COVID-19 | Exploring genotype-phenotype connections based on anamnestic data of patients and joint bioinformatics analysis of its genetic variants | 2020. December |