linjc16/ctgov huggingface dataset:
Coronary Drug Project Mortality Surveillance

Study Overview
=================
Brief Summary
-----------------
To determine whether there were any long term sequelae of the drugs used in the Coronary Drug Project (estrogens, dextrothyroxine, nicotinic acid, clofibrate).

Detailed Description
-----------------
BACKGROUND: Three of the CDP treatments (two doses of estrogen and dextrothyroxine) were stopped prematurely because of toxicity. At the time the treatments were stopped, it was thought that future assessment of the status of patients on those treatments would be important to evaluate long-term sequellae. Another clinical trial evaluating clofibrate for primary prevention found that more patients on that treatment than on placebo had died. This effect persisted even after the treatment was stopped. Therefore, it was considered necessary to follow the CDP patients on clofibrate. Of the original 834l patients, about 6000 were still alive in March l975. Cause-specific mortality in those patients was assessed through March l980. DESIGN NARRATIVE: The vital status of the subjects known to be alive at the end of the CDP in March l975 was assessed as of March l980. This was accomplished through questioning the local investigators, letters to the subjects, and by use of Social Security Administration and National Death Index records. The study completion date listed in this record was obtained from the Query/View/Report (QVR) System.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Infarction, Myocardial Ischemia

Intervention / Treatment
-----------------
* Drug: estrogen
* Drug: clofibrate
* Drug: dextrothyroxine sodium
* Drug: niacin


Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 64 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: estrogen|nan|
|Drug: clofibrate|nan|
|Drug: dextrothyroxine sodium|nan|
|Drug: niacin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Examination of Valve Insufficiency Before and After MitraClip or TAVI Procedure by 3D Echocardiography Compared to MRI

Study Overview
=================
Brief Summary
-----------------
Aim of the study is the definition of criteria for a standardized assessment of heart function by 3D echocardiographic procedures. Standardized criteria will be defined to assess aortic valve insufficiency after TAVI and success of mitral valve replacement respectively.

Detailed Description
-----------------
Echocardiography: GE Healthcare Vivid E9

Official Title
-----------------
Quantitative Analysis of Catheter-based Interventional Therapies for Treating Valve Insufficiency by Using 3D Echocardiography.

Conditions
-----------------
Development of Standardized Assessment TAVI and MitraClip Procedures by Echocardiography, Aortic Stenosis, Mitral Valve Insufficiency

Intervention / Treatment
-----------------
* Device: Echography GE Healthcare Vivid E9


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with severe symptoms of an aortic stenosis who underwent catheter based implantation of an aortic valve patients who are planned to undergo a reconstruction of the mitral valve with the MitraClip System Patients who are aged above 18 years and legally competent signed informed consent Exclusion Criteria: patients with previous myocard infarction, previous heart surgeries, malignity or valvular abnormities > stage 1 patients with atrial fibrillation pregnant and breast-feeding women patients with disturbed central nerve system patients with pacemaker, implants, ferrous clamps,insulin pump patients with tattoo patients with claustrophobia patiens with asthma

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 |
| --- | --- |
| Experimental: TAVI<br>Echocardiography after TAVI | Device: Echography GE Healthcare Vivid E9<br>* Echography GE Healthcare Vivid E9<br>|
| Experimental: MitraClip<br>Echocardiography after MitraClip procedure | Device: Echography GE Healthcare Vivid E9<br>* Echography GE Healthcare Vivid E9<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative analysis of geometric changes and heart function after heart valve replacement and reconstruction respectively by 3D echocardiographic procedures |  | Analysis will be performed after heart valve replacement or reconstruction procedures and after 6 month |
Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation

Study Overview
=================
Brief Summary
-----------------
Due to the increasing importance of BKV infection on the survival of kidney transplants, a better knowledge, in the pretransplant phase, of the risk factors leading to viral reactivation could allow the follow-up physician to be more vigilant and better prevent this pathology. There are no commercial tests for BKV serology. In the virology laboratory, the investigators have developed the technique for producing Virus-like particles (VLP) that mimics the antigenic structure of the BK virus. The investigators plan to evaluate seroreactivity to the five BK virus serotypes in the recipient of a kidney transplant as a pretransplant and to compare this data with the detection or not of viral reactivation in the recipient during the first post-transplant year.

Official Title
-----------------
Evaluation of Renal Pretransplant Serology for BK Virus on the Risk of Post-transplant Viral Reactivation

Conditions
-----------------
BK Virus Nephropathy, Risk Factor, Kidney Transplantation

Intervention / Treatment
-----------------
* Other: serum withdrawal


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult kidney transplanted patients Renal transplant patients with regular virological follow-up (blood and urine for BKV) during the first year after transplantation. Exclusion Criteria: Renal transplant patients with no follow-up for one year after transplantation (transplant failure, return to dialysis, death, follow-up outside the transplant centre)

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

| Intervention/Treatment |
| --- |
|Other: serum withdrawal|Serum of the transplant patient. In the transplanted patient, the search for the BK virus is traditionally carried out during visits in the first year after transplantation.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient | Serum antibody titre limit measurement of the five BK virus serotypes in pre-transplant patient. Optical density of serum antibody titer will be obtained by Elisa. | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BK Virus Nephropathy, risk factor, kidney transplantation, viral serology
sST2 and Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluation of the prognosis value of sST2 dosed before cardiac surgery on prognosis of long terme prognosis after cardiac surgery. The patients where initialy recruted for another cohort named micro-SIRS and inflammation but the gaved their consent to analyse the blood samples for other studies

Official Title
-----------------
Prognostic Value of sST2 in Cardiac Surgery on Long Term Morbimortality

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 80 cardiac surgery includind coronary arterial bypass of valvular surgery Exclusion Criteria: other surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Mortality rate | 1 year mortality rate | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of rehospitalisation | Number of rehospitalisation | 1 day | 
| Number of cardiac events | Number of cardiac events | 1 day | 
| Number of cardiac stroke | Number of cardiac stroke | 1 day |
Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients

Study Overview
=================
Brief Summary
-----------------
Hemodialysis patients frequently develop catheter-related blood stream bacteremia (CRBSI). Procalcitonin is a marker of sepsis in bacterial infection. this study for detection of its role as a surrogacy marker in CRBSI.

Detailed Description
-----------------
Catheter-related blood stream bacteremia is common among hemodialysis patients. Clinically, fever and/or rigors with laboratory indicator of inflammation as leucocytosis and elevated c-reactive protein level are considered as markers for CRBSI before blood culture results became available. Procalcitonin is a valid indicator of sepsis. In this study, Procalcitonin level will be measured in any patient with suspected CRBSI and correlation will be tested for proved CRBSI by blood cultures.

Official Title
-----------------
Procalcitonin Level as a Surrogate for Catheter-related Blood Stream Bacteremia Among Hemodialysis Patients

Conditions
-----------------
Hemodialysis Catheter Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hemodialysis patients with a dialysis catheter signs suggestive of CRBSI: fever/chills or leucocytosis with no other site of infection. Informed consent signed to be enrolled in the study Exclusion Criteria: Patient with identified cause of fever other than CRBSI

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 |
| --- | --- | --- |
| Procalcitonin Level | Level of serum procalcitonin | 2 minutes after start of fever/chills or other symptoms suggesting CRBSI |
Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients

Study Overview
=================
Brief Summary
-----------------
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases.

Detailed Description
-----------------
Egypt has the highest prevalence of hepatitis C virus (HCV) in the world. In 2015, the prevalence of HCV RNA was found to be 7.0%.(1) The prevalence of HCV was studied in Rheumatoid arthritis in few studies(2,3), but to our knowledge, no previous work studied it in other rheumatologic diseases. This study aims at detecting the prevalence of subclinical HCV infection in different rheumatologic disease groups in Egypt. Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection. Patients' serum samples were screened for the presence of anti-HCV antibodies. Patients with positive serology were further evaluated for the presence of HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)

Official Title
-----------------
Prevalence of Hepatitis c Virus Infection Among Rheumatological Patients

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Diagnostic Test: HCV RT-PCR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with different rheumatologic diseases from seven- geographically different- rheumatology departments were prospectively studied. None of the patients was known to have previous HCV infection Exclusion Criteria: pregnancy and end organ failure

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: HCV RT-PCR|HCV ribonucleic acid by reverse transcriptase polymerase chain reaction (RT-PCR)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RT-PCR | positive | 3 months |
Biomarkers in Predicting Response to Chemotherapy in Samples From Young Patients With Osteosarcoma

Study Overview
=================
Brief Summary
-----------------
This research study is studying biomarkers in predicting response to chemotherapy in samples from young patients with osteosarcoma. Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

Detailed Description
-----------------
Study Subtype: Ancillary/Correlative Observational Study Model: Cohort Time Perspective: Retrospective Biospecimen Retention: Samples With DNA Biospecimen Description: Tissue Study Population Description: Children's Oncology Group Sampling Method: Non-Probability Sample PRIMARY OBJECTIVES: I. Determine whether methylation status predicts response to neoadjuvant chemotherapy in samples from children and young adults with osteosarcoma. OUTLINE: Patients are stratified according to response to neoadjuvant chemotherapy (good vs poor). DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping.

Official Title
-----------------
Observational - Methylation Status as Predictor of Response to Neoadjuvant Chemotherapy in Osteosarcoma

Conditions
-----------------
Localized Osteosarcoma, Metastatic Osteosarcoma, Osteoblastic Osteosarcoma, Recurrent Osteosarcoma

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with high-grade osteoblastic osteosarcoma Biopsy samples from patients who had good or poor response to neoadjuvant chemotherapy available All specimens should be from post-menarchal females or age-matched males with appendicular tumors Patients' clinical data including chemotherapy received, event-free survival, and overall survival available See Disease Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 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 |
| --- | --- |
| Correlative studies<br>DNA and RNA extracted from biopsy samples are analyzed for methylation changes and transcription changes by ligation-mediated PCR and mass-array genotyping. | Other: laboratory biomarker analysis<br>* Correlative studies<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Methylated status as predictor of response to neoadjuvant chemotherapy | Performed on a locus-by-locus basis using Poisson regression (for count data) and/or two-group t-tests, with correction (Satterwaithe's) for unequal within-group variances. | Baseline |
the Effect of Trans-nasal Fixation of Endotracheal Tubes for Prone Ventilation

Study Overview
=================
Brief Summary
-----------------
The aim of this randomized controlled trial is to evaluate the clinical effects of trans-nasal ETT fixation for prone ventilation.

Official Title
-----------------
Trans-nasal ETT Fixation

Conditions
-----------------
Prone Craniotomy, Endotracheal Intubation Fixation

Intervention / Treatment
-----------------
* Device: SFC


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria age 18-60 years old, ASA grade Ⅰ-Ⅱ, 18<BMI<24. Exclusion criteria the intubation time was less than 5 hours, oral and facial skin damage, allergic to adhensive tapes, nasotracheal intubation, patients were edentulous.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Group A<br>The tracheal tube was routinely fixed with a teeth pad and adhesive tape (3M). | |
| Experimental: Group B<br>The tracheal tube was fixed by the trans-nasal Silicone Foley Catheter (SFC) and adhesive tape. | Device: SFC<br>* The lubricated SFC passed nasally into the oropharynx under the visual guidance of visual laryngoscope to ensure that the cuff had passed through the posterior choanae and reached the oropharynx. The guide wire is removed and the balloon inflated with 5 ml normal saline. The catheter is then pulled slightly until the balloon is fixed and concealed by the soft palate . The ETT is anchored to the SFC with a cable tie .<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the distance of tube movement | It is the difference between the preoperative depth of the supine tracheal tube and the postoperative depth of the prone tracheal tube. | The participants will be followed from intubation to extubation, an expected average of 6 hours. |
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of rabeprazole (pariet) versus placebo in treating reflux laryngitis in Chinese patients. Patients who attend the voice clinic of Department of ENT, Queen Mary hospital with suspected reflux laryngitis will be recruited. A questionnaire will be administered by the research assistant of the Department of Medicine and ENT, Queen Mary hospital. A 12-week course of PPI versus placebo trial will be commenced and patients' symptoms and signs will be documented at 6-week and 12-week time. The study will finish after a 12-week course of rabeprazole.

Official Title
-----------------
Prospective Double-blinded Randomized Controlled Trial of 12-weeks High Dose Rabeprazole (Pariet) in the Treatment of Reflux Laryngitis in Chinese Patients

Conditions
-----------------
Gastroesophageal Reflux, Laryngitis

Intervention / Treatment
-----------------
* Drug: Rabeprazole 20mg twice daily


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory patients with age between 18-80 years old Patients with newly presented laryngitis. Exclusion Criteria: They were under 18 or over 80 years of age Has significant concomitant medical disease Pregnancy or lactating women Chronic cough attributable to known chronic pulmonary or tracheobronchial disease Previous glottal surgery, radiotherapy or malignancy Acid suppressive therapy within 4 wk prior to recruitment Pharyngo-laryngeal infection in the previous 3 months Tracheal intubation in previous 12 months Immunosuppression and use of inhaled corticosteroid

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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: Rabeprazole 20mg twice daily|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms assessment, quality of life. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compliance |  | 4 weeks | 
| Adverse effects |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Reflux laryngitis