linjc16/ctgov huggingface dataset:
China Valve Registry Study-1

Study Overview
=================
Brief Summary
-----------------
With the aging of Chinese population, degenerative valvular disease is becoming more and more frequent, which has brought a heavy burden to our society. Taking aortic stenosis (AS) as an example, the incidence of AS in population over the age of 65 are about 2%, and in population above the age of 85 can be amounted to 4-8%, in the Western country. Since the invention of transcatheter aortic valve replacement (TAVR),aortic valve disease (AVD),including AS and aortic regurgitation (AR), has attracted more and more attention. To date, there are few data about the prevalence of AVD in China. The characteristics and prognosis of AVD in China are still unknown. Therefore, the investigators design a prospective, observational cohort study to investigate characteristics, treatments and prognosis of AVD in Chinese elderly population. The results of the study will provide a basis for the future national health policy for prevention and treatment of AVD in the elderly.

Official Title
-----------------
Registry Study of Aortic Valve Diseases in Chinese Elderly

Conditions
-----------------
Aortic Valve Disease, Aortic Valve Stenosis, Aortic Valve Insufficiency, Heart Valve Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe AS or AR indicated by echocardiography ; 60 years old or older. Exclusion Criteria: Having both Severe AR and Severe AS; Having underwent surgical or transcatheter treatment for AVD; Non-degenerative AVD.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| AS group<br>Severe AS patients, without severe AR | |
| AR<br>Severe AR patients, without severe AS | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiovascular (CV) death or hospitalization for heart failure (HF) | from date of enrollment until the date of first documented HF or date of death from any cause, whichever came first, up to 36 months | 36 months | 
| Surgical or transcatheter aortic valve replacement | from date of enrollment until the date of surgical or transcatheter aortic valve replacement, whichever came first, up to 36 months | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of all-cause mortality |  | from date of enrollment until the date of death for any-cause, up to 36 months | 
| Number of patients developing major cardiovascular and cerebral events (MACCE) |  | 36 moths |
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are to determine: The safety of duloxetine and any side effects that might be associated with it. Whether duloxetine can help patients with major depression. The safety associated with switching from a medication you may be taking for depression to taking duloxetine. It is possible that information collected during this study will be analyzed by the sponsor in the future to evaluate duloxetine for other possible uses or for other medical or scientific purposes other than those currently proposed.

Official Title
-----------------
Open-Label Treatment With Duloxetine Hydrochloride Once-Daily Dosing for Evaluation of Stabilization Dose in Patients With Major Depression

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: duloxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You must be at least 18 years old. You must have been diagnosed with major depressive disorder. You must be able to visit the doctor's office once a week to once every 2 weeks for a total of 14 weeks Exclusion Criteria: You are a woman and are pregnant or breastfeeding. You have a current or previous major psychiatric disorder other than depression, such as bipolar disorder, schizophrenia, or other psychotic disorder. You have had a primary diagnosis of an anxiety disorder within the past 6 months. You have a history of alcohol or drug dependence or abuse within the past 6 months.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine|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
-----------------
Depressed, blues, sadness, feelings of guilt, hopelessness, lack of energy
Genetic Influences on Statin Blood Concentrations in African Americans

Study Overview
=================
Brief Summary
-----------------
This study intends to determine the effects of genetic polymorphisms on statin response and daily systemic exposure (24-hour area under the time-concentration curve) of statins in African-American patients.

Official Title
-----------------
An Observational Study Investigating Genetic Influences on Statin Plasma Concentrations in Adult African American Patients

Conditions
-----------------
Hyperlipidemia, Hypercholesterolemia, Dyslipidemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African-American patients taking a statin metabolized by CYP3A (e.g., atorvastatin, simvastatin, or lovastatin) Exclusion Criteria: Age less than 18 years

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 |
| --- | --- |
| statin<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 24-hour area under the time-concentration curve of statin concentrations in plasma |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of statin-associated muscle symptoms (SAMS) |  | 10 years |
Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.

Study Overview
=================
Brief Summary
-----------------
The next generation of personalized medical treatment according to the type of personal genetic information are evolving rapidly. The genome analysis needs systematic infra and database based on personal genetic information. Therefore, a big data of genome-clinical information is important. To determine the feasibility of the use of tumor's molecular profiling and targeted therapies in the treatment of advanced cancer and to determine the clinical outcome(Response rate,PFS, duration of response and overall survival )of patients with advanced cancer, the investigators are going to take a tumor tissue of patients and process molecular profiling and receive molecular profile directed treatments.

Official Title
-----------------
Clinical Sequencing Project for Metastatic Cancer Patients for Personalized Cancer Clinic.

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is at least 19 years of age. Subject has a histologically or cytologically confirmed diagnosis of Colorectal cancer. Prior treatment with anti-PDL1 antibody or immune check point inhibitor or ramucirumab therapy in the First-line or maintenance setting is allowed They must have refractory or progressive disease for which there is no further curative therapy available. Be willing to provide fresh tissue for biomarker analysis, and, based on the adequacy of the tissue sample quality for assessment of biomarker status. Must have a life expectancy of 3 months or more Written and voluntary informed consent understood, signed and dated. Exclusion Criteria: 1. Patients who do not have enough tissue for acquisition

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 |
| --- | --- |
| Biomarker group<br>Advanced cancer undergoing genomic profiling | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response rate |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival |  | 1 year | 
| Duration of response |  | 1 year | 
| overall survival |  | 1 year |
Pain Relief After Forefoot Surgery

Study Overview
=================
Brief Summary
-----------------
The aim to test whether continues local anaesthetic infusion via tibial catheter or wound catheter will improve pain relief following forefoot surgery In this sequential prospective randomised, controlled clinical trial,75 Patients undergoing forefoot surgery will be randomized into three groups (tibial, wound, control). All groups will receive ankle block ± general anesthetic (standard technique). The tibial group will have a tibial catheter inserted through which local anaesthetic will be infused. The wound group will have a catheter inserted directly into the wound immediately after surgery. The control group will have a sham catheter (covered by a bandage across foot) attached to a pump which will not infuse. Patient maximum pain scores (primary outcome measure), nausea/ vomiting, analgesia use, satisfaction and sleep disturbance will be recorded postoperatively. All groups will be then followed by telephone calls 48 hours. Patients will be instructed to come to the clinic on the 4th postoperative day where the catheter will be removed.

Official Title
-----------------
Pain Relief After Forefoot Surgery: Tibial Perineural Catheter vs. Wound Catheter Infusion

Conditions
-----------------
Orthopedic Surgery

Intervention / Treatment
-----------------
* Device: Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 years or older (ASA I & II) Able to give written consent Patients having elective forefoot surgery with a planned ankle block. Expected postoperative pain to be at least moderate in severity the day following surgery Exclusion Criteria: Refusal Inability to communicate History of alcohol or opioid abuse (also chronic opioid user) Mental or medical conditions which may affect quantifying pain scores (VAS)

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tibial<br> | Device: Catheter<br>* Catheter inserted into either perineural tibial nerve or wound<br>|
| Experimental: Wound<br> | Device: Catheter<br>* Catheter inserted into either perineural tibial nerve or wound<br>|
| No Intervention: Sham<br> | Device: Catheter<br>* Catheter inserted into either perineural tibial nerve or wound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-operative pain |  | 2,8,12,24,48 hr | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative analgesia, opioid, catheter, tibial nerve block
Study of LJP 394 (Abetimus Sodium) in Lupus Patients

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the safety and pharmacodynamic effect of LJP 394 at doses of 100 mg, 300 mg and 900 mg on anti-dsDNA antibody levels in patients with SLE.

Detailed Description
-----------------
STUDY NOW INCORPORATED INTO PHASE 3 STUDY NCT00089804.

Official Title
-----------------
A Randomized, Double-Blind Study to Evaluate the Safety, Pharmacokinetic and Pharmacodynamic Effects of Abetimus Sodium in Patients With Systemic Lupus Erythematosus (SLE)

Conditions
-----------------
Systemic Lupus Erythematosus

Intervention / Treatment
-----------------
* Drug: abetimus sodium (LJP 394)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females between 12 and 70 years old. Diagnosis of Systemic Lupus Erythematosus (SLE) Females must be non-pregnant and non-lactating. Females must agree to use adequate birth control methods during the course of the study. Ability to have weekly intravenous (IV) administration of study drug. Exclusion Criteria: Prior exposure to abetimus sodium within 6 months prior to screening. Patients not on stable medications for 30 days prior to screening. Patients with acute or chronic infections.

Ages Eligible for Study
-----------------
Minimum Age: 12 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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: abetimus sodium (LJP 394)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The assessment of the safety and pharmacodynamic effect of abetimus sodium at |  |  | 
| doses of 100mg, 300mg, and 900mg in reducing the anti-dsDNA antibody levels in |  |  | 
| patients with SLE will be based on laboratory data from the central laboratory |  |  | 
| and confirmed by supporting data. The pharmacodynamic effic will be assessed |  |  | 
| using historical placebo effect as a control. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, Lupus, Nephritis, SLE, Systemic Lupus Erythematosus, Nephritis, Lupus
Levosimendan and Myocardial Protection

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether pharmacological pre-treatment with levosimendan reduces intensive care unit (ICU) length of stay in patients undergoing elective myocardial revascularization under cardiopulmonary bypass.

Official Title
-----------------
Levosimendan Pre-Treatment in Patients Undergoing Coronary Artery Bypass Graft Surgery: a Double-Blind, Single Center, Prospective, Randomized, Placebo-Controlled Trial

Conditions
-----------------
Myocardial Protection

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥18 years intention to perform first-time multi-vessel CABG Exclusion Criteria: unstable angina valvular disease diabetes mellitus treated with sulphonylurea drugs renal failure severe hepatic disease severe chronic obstructive pulmonary disease a history of prior CABG surgery recent myocardial infarction (MI) within the previous month

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L<br> | Drug: levosimendan<br>* 24 μg/kg administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB<br>|
| Experimental: P<br> | Drug: Placebo<br>* an identical-appearing placebo prepared and labelled by the pharmacy was administered as a slow i.v. 50 ml bolus through the central venous port of a pulmonary artery catheter over the 10 minutes before initiation of CPB<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of ICU stay |  | two weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 3 weeks | 
| Tracheal intubation time |  | one week | 
| Inotropic support over the first 7 days |  | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Levosimendan, pre-conditioning, cardiac surgery, myocardial function, contractility, heart, ischaemia
Qualitative Evaluation of Tear Fluid and Blood for Auto Antibodies Produced in Response to COVID-19

Study Overview
=================
Brief Summary
-----------------
This study objective is to collect tear and blood samples from individuals with positive SARS-COV2 diagnosis and test those samples for the presence of various SARS-COV2 viral antigens and autoantibodies.

Official Title
-----------------
Qualitative Evaluation of Tear Fluid and Blood for IgM and IgG Produced in Response to SARS-CoV2, the Virus Responsible for COVID-19.

Conditions
-----------------
SARS-CoV 2 Infection, Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: SARS-CoV2 Autoantibody detection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Has been tested for SARS-CoV2 and awaiting results Sample collection for SARS-CoV2 testing Tested positive for SARS-CoV2 virus (confirmed by RT-PCR) prior to enrollment Exclusion Criteria: Under 18 years of age Concurrent eye infection or trauma unrelated to presence of SARS-CoV2 virus. Advanced COVID-19 state what would preclude safe and feasible sample collection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 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 |
| --- | --- |
| SARS-CoV2 Positive<br>Tear Samples: Tear samples will be collected from 100 patients who have tested positive for the SARS-CoV2 virus. A total of 100 Blood samples will be drawn using standard phlebotomy techniques for venipuncture from patients who have tested positive for the SARS-CoV2 virus. | Diagnostic Test: SARS-CoV2 Autoantibody detection<br>* Through the data collected from this study we hope to support the development of an ELISA assay for the detection of IgM and IgG autoantibodies produced in response to the presence of SARS-CoV2<br>|
| Control<br>Control tear and serum samples will be selected from Namida Lab's own biorepository. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qualitative assessment of IgM and/or IgG by indirect ELISA assay. | Determination of the presence or absence of IgM and/or IgG autoantibodies in response to SARS-CoV2 infection. In the case of presence, concentration may be determined as well. | through study completion, up to 8 months |
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information about the immediate effects and recovery time for treatment with EVOLENCE/EVOLENCE BREEZE for soft tissue augmentation. The time it takes for patients to feel comfortable with the results, and return to their normal daily routine is also of important interest

Detailed Description
-----------------
The primary objective of this Investigator Initiated Study is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler. In addition, the immediate effects such as swelling, bleeding, bruising will be assessed.

Official Title
-----------------
EVOLENCE® Assessment of Recovery Time and Impact of Dermal Filler Selection: The E-ART™ Study

Conditions
-----------------
Aging

Intervention / Treatment
-----------------
* Device: collagen (EVOLENCE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Female > 18 years of age Need for soft tissue augmentation as evidenced by any of the following: Bilateral-aging defects > 1 on the Modified Fitzpatrick Wrinkle Scale Decrease in soft tissue volume in other areas of the face Exclusion Criteria: History of positive hypersensitivity to porcine collagen-based products History of multiple food, drug, and substance allergies Autoimmune or collagen vascular disease Facial tissue augmentation within 6 months (HA) or 12 months Evolence/Evolence Breeze Botulinum-toxin A within 6 weeks Ablative laser treatments within 12 months Permanent facial implants Investigational product use within 30 days Pregnant and/or nursing woman or woman who plan to become pregnant during the study.

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?
-----------------

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: aging<br> | Device: collagen (EVOLENCE)<br>* injectable collagen<br>* Other names: EVOLENCE and EVOLENCE BREEZE;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Is to document recovery time/return to daily activities following facial soft-tissue augmentation with an EVOLENCE dermal filler |  | 7 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the immediate effects such as swelling, bleeding, bruising will be assessed |  | 7 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wrinkles, dermal filler, collagen, soft tissue augmentation, aesthetic