linjc16/ctgov huggingface dataset:
Prospective Assay for SARS-CoV-2 (COVID-19) Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method

Study Overview
=================
Brief Summary
-----------------
Prospective assay for SARS-CoV-2 antibody detection indirectly by immunofluorescence: SARS-CoV2 IIF method

Detailed Description
-----------------
Sample preparation, serum separation by centrifugation 100 µl of serum for standard SARS-CoV2 ELISA is used according to the instructions for use. 100 µl of serum indirect immunofluorescent (IIF) method is used, the samples thus prepared analysis is performed under an automated microscope

Official Title
-----------------
Prospective Assay for SARS-CoV-2 Antibody Detection Indirectly by Immunofluorescence: SARS-CoV2 IIF Method

Conditions
-----------------
Sars-CoV2

Intervention / Treatment
-----------------
* Diagnostic Test: Immunfluorescence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Person over 18 years of age Signing a package leaflet and a informal consent In the case of a positive group, confirmed by SARS-CoV2 qPCR Patient with COVID-19 or recovered individual. In case of negative group by SARS-CoV2 qPCR test 2 negative in COVID-19 suffering individual Exclusion Criteria: Refuses to sign the consent form

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 |
| --- | --- |
| Positive group<br>Subjects are diagnosed with SARS-CoV2 by qPCR assay. | Diagnostic Test: Immunfluorescence<br>* Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.<br>|
| Negative group<br>Subject were 2 times proved negative SARS-CoV2 by qPCR assay. | Diagnostic Test: Immunfluorescence<br>* Serum indirect immunofluorescent (IIF) method is used, analysis is performed under an automated microscope.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the method by SARS-CoV2 ELISA compared | Sensitivity of the method by SARS-CoV2 ELISA compared | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detectability of the antibodies IgA type against SARS-CoV2 virus | Detectability of the antibodies IgA type against SARS-CoV2 virus in the early stages of the disease. | 8 months |
National,Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh-Prolift

Study Overview
=================
Brief Summary
-----------------
180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.

Detailed Description
-----------------
180 women with genital prolapse will be submitted to genital prolapse surgical correction, half of them with human fascia, and the other half with Prolift.Are eligible women aged between 50 and 80 years old.

Official Title
-----------------
A National Multicentric Randomised Study of the Correction of Genital Prolapse With Fascial Repair or Mesh (Prolift)

Conditions
-----------------
Genital Prolapse

Intervention / Treatment
-----------------
* Procedure: fascial repair
* Procedure: mesh repair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Between 50 and 80 yrs Exclusion Criteria: Less than 50 and more than 80 yrs

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: prolapse surgery with fascial repair<br> | Procedure: fascial repair<br>* surgery to treat genital prolapse with fascia repair<br>* Other names: prolift;Procedure: mesh repair<br>* surgery to genital prolapse with mesh<br>* Other names: prolift;|
| Other: prolapse surgery with mesh repair<br> | Procedure: fascial repair<br>* surgery to treat genital prolapse with fascia repair<br>* Other names: prolift;Procedure: mesh repair<br>* surgery to genital prolapse with mesh<br>* Other names: prolift;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correction of genital prolapse |  | 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
genital prolapse, surgery, fascial repair, mesh, prolift
BEVERLY-C: An Observational Study of Avastin (Bevacizumab) in First-Line Treatment in Elderly Patients With Metastatic Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
This observational study will evaluate the efficacy and safety of Avastin (bevacizumab) in combination with fluoropyrimidine-based chemotherapy in elderly patients (>/= 65 years of age) with newly diagnosed metastatic colorectal cancer. Patients will be followed until disease progression, death, withdrawal of consent, discontinuation of physician-patient relationship or study closure, whichever comes first.

Official Title
-----------------
Program for Assessment of Activity and Safety of 1st-line Bevacizumab (Avastin) Therapy in Elderly Patients With Metastatic Colorectal Cancer (BEVERLY-C Study)

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >/= 65 years of age Patients with newly diagnosed metastatic colorectal cancer starting first-line treatment with Avastin in combination with fluoropyrimidine-based chemotherapy according to the approved Hungarian Summary of Product Characteristics Patients suitable for Avastin treatment as assessed by the treating physician Exclusion Criteria: Any contraindications to Avastin treatment according to the Hungarian Summary of Product Characteristics

Ages Eligible for Study
-----------------
Minimum Age: 65 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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median progression-free survival |  | approximately 3.5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate (complete response + partial response) |  | approximately 3.5 years | 
| Clinical benefit rate (complete response + partial response + stable disease) |  | approximately 3.5 years | 
| Metastasectomy rate |  | approximately 3.5 years | 
| Mean duration of Avastin treatment |  | approximately 3.5 years | 
| Safety: Incidence of adverse events |  | approximately 3.5 years | 
| Median progression-free survival in subgroup receiving Avastin plus fluorouracil monotherapy |  | approximately 3.5 years | 
| Median progression-free survival according to age group (65-74 years; >/= 75 years) |  | approximately 3.5 years |
A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients

Study Overview
=================
Brief Summary
-----------------
This study evaluates the safety profile and effectiveness of adalimumab in Korean intestinal Behcet's disease (BD) patients in routine clinical practice.

Official Title
-----------------
A Prospective, Mono-Country and Multi-center Study to Observe Safety and Effectiveness of Adalimumab in KoREan Intestinal Behcet's Disease(BD) Patients

Conditions
-----------------
Intestinal Behcet's Disease (BD)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be an adult >= 19 years Subjects who are eligible to be treated with adalimumab for intestinal Behcet's disease in accordance with the approved label in Korea Subjects provide written authorization form for use/disclose of personal health data prior to participating in this study Exclusion Criteria: Subjects who are contraindicated to any anti-TNF agent Female subjects who are pregnant or breast feeding Subjects who are participating in other interventional clinical trials

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 99 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 |
| --- | --- |
| Subjects receiving adalimumab<br>The subjects who are prescribed adalimumab for intestinal Behcet's disease (BD) in accordance with the approved Korean label. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events | All adverse events including serious and unexpected events will be assessed. | From Day 1 to 70 days following 56 weeks from first dose of adalimumab or the last administration of adalimumab if the participant stopped receiving adalimumab before 56 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse drug reactions | All adverse reactions including serious and unexpected reactions will be assessed. | From Day 1 to 70 days following 56 weeks from first dose of adalimumab or the last administration of adalimumab if the participant stopped receiving adalimumab before 56 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intestinal Behcet's disease (BD), Adalimumab, Safety, Effectiveness, AMORE study
Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should non-selectively stop the RPE leakage.

Detailed Description
-----------------
To evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation in twelve eyey per group versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells. BCVA in EDTRS score, OCT, and leakage in FLA, static perimetry of both groups will be correlated to a control group without treatment over 10 months.

Official Title
-----------------
Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy

Conditions
-----------------
Central Serous Chorioretinopathy

Intervention / Treatment
-----------------
* Device: subthreshold micropulselaser
* Drug: bevacizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: CSC of >4 months duration Exclusion Criteria: History of macular or chorioretinal inflammation Lens / corneal opacities

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs | Device: subthreshold micropulselaser<br>* on demand if leakage is persistent or recurs after initial treatment<br>Drug: bevacizumab<br>* 1.5 mg initial intravitreal injection<br>|
| Active Comparator: 2<br>initial selective subthreshold micropulselasercoagulation and on demand if leakage is persistent or recurs | Device: subthreshold micropulselaser<br>* on demand if leakage is persistent or recurs after initial treatment<br>|
| No Intervention: 3<br>control | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BCVA in EDTRS values |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCT, leakage in FA, defects in satic perimetry |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CSC, micropulselaserphotocoagulation, bevacizumab
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response

Study Overview
=================
Brief Summary
-----------------
This is a randomized, double-blinded, placebo-controlled, crossover study to evaluate the pressor effects of pseudoephedrine when administered with TR-701 FA in healthy adult volunteers.

Detailed Description
-----------------
Eligible subjects will be randomized to 1 of 2 possible treatment sequences (N=9 per sequence) on Study Day 1. Subjects will receive oral 200 mg TR 701 FA or Placebo for TR 701 FA once daily for 5 days during each treatment period, with a 2 day washout between periods (72 hours between doses). On Study Day 5 of each treatment period, subjects will also receive oral 60 mg PSE.

Official Title
-----------------
A Phase 1 Crossover Study of Blood Pressure and Heart Rate Response to Pseudoephedrine Concurrent With Placebo or TR 701 FA

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: TR-701 FA with PSE
* Other: TR-701 FA Placebo with PSE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects between 18 and 45 years of age, inclusive Healthy males and females with no clinically significant abnormalities identified by a detailed medical history Body mass index ≥ 19.0 kg/m2 and ≤ 31.0 kg/m2 Exclusion Criteria: Systolic blood pressure > 130 mmHg or < 90 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1 Diastolic blood pressure > 90 mmHg or < 60 mmHg measured after 10 minutes supine at the Screening Visit and Study Day 1 Heart rate > 90 bpm or < 50 bpm measured after 10 minutes supine at the Screening Visit and Study Day Known allergy or hypersensitivity to PSE

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TR-701 FA with PSE<br>TR-701 FA 200 mg oral with PSE | Drug: TR-701 FA with PSE<br>* TR-701 FA Oral 200 mg oral with PSE<br>* Other names: Tedizolid Phosphate;|
| Placebo Comparator: TR-701 FA Placebo with PSE<br>TR-701 FA Placebo 200 mg oral with PSE | Other: TR-701 FA Placebo with PSE<br>* TR-701 FA Placebo Oral 200 mg with PSE<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure | To compare systolic blood pressure post administration of pseudoepherine concurrent with TR-701 FA and Placebo | 13 days |
Studies of White Blood Cells Derived From HHT Patients

Study Overview
=================
Brief Summary
-----------------
Hereditary Haemorrhagic Telangiectasia (HHT, also known as Osler-Weber-Rendu Syndrome) is an inherited vascular disease that leads to the development of dilated and fragile blood vessels. The study goal is to culture white blood cells that express the proteins mutated in HHT and examine in the laboratory to explain aspects of the HHT disease phenotype.

Detailed Description
-----------------
HHT is a vascular condition but many of the genes that are mutated to cause HHT (endoglin, ALK-1 and SMAD4) are also expressed in white blood cells. In this study, investigators will take blood samples from people with HHT, culture the white blood cells and study their properties in media prompting different types of differentiation, or infection of cell lines with Epstein Barr virus to provide cell lines which can be repeatedly studied. RNA and proteins will be extracted from these cells for study of white cell responses and association with expression levels of endoglin, ALK-1 and SMAD4. The investigators hypothesize that these cells which express half-normal endoglin, ALK-1 or SMAD4 will show differences when compared to normal white blood cells. It is also anticipated that that these findings may help to explain aspects of the HHT disease phenotype.

Official Title
-----------------
Studies of White Blood Cells Derived From HHT Patients

Conditions
-----------------
Telangiectasia, Hereditary Hemorrhagic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with HHT, HHT patients family members Exclusion Criteria: Unable to provide informed consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with HHT<br>People with molecularly confirmed HHT. No intervention, blood sample only | |
| Controls<br>People without HHT No intervention, blood sample only | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proteins and cellular markers related to coagulation | Not specified at outset. Blood samples will be collected over the recruitment period, usually on a single day. Analyses of biomarkers relate to the SAME DAY, within 24hs, though will be evaluated over subsequent months, on average completing in 1-5 years. | on average completing each biomarker study in 1-5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Telangiectasia
Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures

Study Overview
=================
Brief Summary
-----------------
A randomized, controlled trial to determine whether the use of ultrasound guidance for vascular access during coronary angiography or percutaneous coronary intervention (PCI) will reduce the rates of major vascular complications.

Detailed Description
-----------------
Patients who will undergo a coronary angiography or PCI using femoral access will be allocated to either: 1) femoral access using fluoroscopic and ultrasound guidance, or 2) femoral access using fluoroscopic guidance alone.

Official Title
-----------------
Routine Ultrasound Guidance for Vascular Access for Cardiac Procedures: a Randomized Trial

Conditions
-----------------
Myocardial Infarction, Coronary Artery Disease, Myocardial Ischemia

Intervention / Treatment
-----------------
* Procedure: Fluoroscopic + Ultrasound Guidance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient referred for coronary angiography or percutaneous coronary intervention (PCI) in whom femoral access is planned. Planned femoral access Exclusion Criteria: Age ≤ 18 years STEMI Absence of palpable femoral pulse

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fluoroscopic + Ultrasound Guidance<br> | Procedure: Fluoroscopic + Ultrasound Guidance<br>* Fluoroscopic Guidance Alone<br>|
| No Intervention: Fluoroscopic Guidance Alone<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of major vascular complications | Femoral artery pseudoaneurysm, AV fistula, retroperitoneal bleed, large hematoma (>5 cm), ischemic limb requiring intervention or surgery, or major bleed based on BARC II, III, or V criteria | up to 30 days post-procedure |