linjc16/ctgov huggingface dataset:
SQuISH-COVID: A Pilot Study

Study Overview
=================
Brief Summary
-----------------
This is a single-site prospective study to evaluate the diagnostic performance of the investigational SeptiScan System for patients presenting to the Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases.

Official Title
-----------------
SQuISH-COVID: A Pilot Study

Conditions
-----------------
Sepsis, COVID-19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects meeting the following criteria may be eligible for participation in the study: ≥ 18 years old or older The first vital sign (any one of: blood pressure, temperature, pulse or respiratory rate) has been recorded in the medical record A complete blood count has been ordered for which a blood sample has been collected within 4.5 hours since the first vital sign was recorded Signs or suspicion of a respiratory infection, defined as: Subject designated for evaluation in the ED respiratory or pulmonary pod or similar location. OR An order placed for a respiratory viral panel. OR An order placed for a SARS-CoV-2 test. OR A subject self-reported as having tested positive for the SARS-CoV-2 test within the previous 7 days and returning with a related complaint. Exclusion Criteria: Subjects are excluded from study participation if they meet any of the following criteria: a. Blood sample volume is < 300 ul; insufficient quantity for SeptiScan testing.

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 |
| --- | --- | --- |
| To demonstrate the performance of the SeptiScan System as a diagnostic marker of life-threatening organ dysfunction caused by a dysregulated host immune response to infection. | The SeptiScan System is an investigational microfluidic assay that measures the biophysical properties of human leukocytes as an aid, in conjunction with other clinical assessments, to detect life-threatening organ dysfunction caused by a dysregulated host immune response to infection. The SeptiScan System score is presented in three Interpretation Bands of low, intermediate, and high probability of disease. Remnant blood samples will be obtained from subjects in Emergency Department with signs or suspicion of COVID-19 or other infectious respiratory diseases. The blood samples will be analyzed using the SeptiScan System. | Day of enrollment through Day 5 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, COVID
Drug Eluting Balloon in peripherAl inTErvention SFA

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of drug-eluting balloon angioplasty followed by nitinol stent implantation versus nitinol stent implantation in superficial femoral artery and popliteal artery stenosis.

Official Title
-----------------
Drug Eluting Balloon in peripherAl inTErvention: the DEBATE SFA Study

Conditions
-----------------
Peripheral Arterial Disease

Intervention / Treatment
-----------------
* Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation
* Device: nitinol stent implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age>18 years intermittent claudication(Fontane III or IV) angiographic stenosis>50% or occlusion of superficial femoral-popliteal artery>40mm at least one below-knee vessel to the ankle Exclusion Criteria: allergy to Paclitaxel contraindication for combined antiplatelet treatment life expectancy <1 year hypersensitivity or contraindication to one of the study drugs lack of consent

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: standard PTA<br>nitinol stent implantation | Device: nitinol stent implantation<br>* nitinol stent implantation<br>|
| Experimental: DEB<br>paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation | Device: paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation<br>* paclitaxel-eluting balloon angioplasty followed by nitinol stent implantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| angiographic binary restenosis | incidence of binary restenosis | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| major amputation | incidence of major amputation | 24 months | 
| target lesion revascularization | incidence of target lesion revascularization | 24 months | 
| vessel reocclusion | incidence of vessel reocclusion | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peripheral arterial disease, drug-eluting balloon, restenosis
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is not being conducted in the United States. The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to gliclazide in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Official Title
-----------------
Efficacy and Safety of Vildagliptin Compared to Gliclazide in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: Gliclazide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently on drug therapy for type 2 diabetes Body mass index (BMI) in the range 22-45 Blood glucose criteria must be met Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of significant diabetic complications Evidence of serious cardiovascular conditions Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: vildagliptin<br> | Drug: vildagliptin<br> <br> |
| Active Comparator: Gliclazide<br> | Drug: Gliclazide<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 104 weeks |  | 104 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event profile at 104 weeks |  | 104 weeks | 
| Change from baseline in fasting plasma glucose at 104 weeks |  | 104 weeks | 
| Patients with endpoint HbA1c <7% after 104 weeks |  | 104 weeks | 
| Patients with reduction in HbA1c >/= 0.7% after 104 weeks |  | 104 weeks | 
| Patients with reduction in HbA1x >/= 0.5% after 104 weeks |  | 104 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Intraabdominal Hypertension and Occurrence of Microaspiration in Cirrhotics Under Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The study aims to demonstrate the relationship between intra-abdominal hypertension (IAH) and abundant microaspirations in mechanically ventilated cirrhotic.

Detailed Description
-----------------
Intra-abdominal pressure monitoring will be performed using intra-vesical pressure every 8 hour in the first 2 days of mechanical ventilation. Micro aspiration is defined by pepsin or amylase positivity in trachea suction. Two groups will be compared : one with IAH , one without IAH.

Official Title
-----------------
Impact of Intraabdominal Hypertension on Microaspiration Incidence in Cirrhotic Patients

Conditions
-----------------
Cirrhosis, Liver, Critical Illness

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients Cirrhosis intubation and mechanical ventilation Exclusion Criteria: pregnancy oliguric patients impossibility to measure intravesical pressure

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- |
| intraabdominal hypertension group<br>patients with intraabdominal hypertension defined as intravesical pressure more than 12 mmHg | |
| control group<br>patients with no intraabdominal hypertension | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| abundant microaspiration | presence of pepsin or alpha amylase at significant level in at least 30% of tracheal aspirates | 48 hours after inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | number of death | from ICU admission until day 28 | 
| Incidence of ventilator associated pneumonia (VAP) | percentage of patients with VAP | from intubation until day 28 or extubation | 
| duration of mechanical ventilation | number of days with mechanical ventilation | from intubation until day 28 or extubation | 
| incidence of patients requiring renal replacement therapy | percentage of patients with renal replacement treatment | from ICU admission until Day 28 or ICu discharge, whichever came first | 
| incidence of cirrhosis related complications | percentage of patients with cirrhosis related complications | from ICU admission until Day 28 or ICU discharge, whichever came first |
Results of Different Location of Ahmed Glaucoma Valve Implantation in Refractory Glaucoma, Superior Versus Inferior

Study Overview
=================
Brief Summary
-----------------
Purpose:To compare the efficacy and safety of Ahmed Glaucoma Valve (AGV) implantation in the superior versus inferior quadrants. Methods: In a non-randomized clinical trial and over a period of two years, consecutive patients with refractory glaucoma underwent AGV implantation in the superior or inferior quadrants. Main outcome measures included best corrected visual acuity (BCVA), intraocular pressure (IOP), number of glaucoma medications, complications and success rate (defined as at least 30% IOP reduction below preoperative values and 5<IOP<22 mmHg with or without glaucoma medications). Other criteria for failure included implant removal, additional glaucoma surgery, phthisis bulbi or loss of light perception.

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: AGV implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with refractory glaucoma who need AGV implantation Exclusion Criteria: Eyes with less than 3 months follow-up Severe conjunctival adhesions and scarring for the site of surgery Presence of thin sclera and staphyloma for the site of surgery The presence or anticipated need for silicone oil for superior implantation Active neovascular glaucoma for inferior implantation
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients with refractory glaucoma who were candidate for AGV implantation allocated in superior site | Procedure: AGV implantation<br> <br> |
| Experimental: 2<br>patients with refractory glaucoma who were candidate for AGV implantation allocated in inferior site | Procedure: AGV implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis

Study Overview
=================
Brief Summary
-----------------
To determine the effect of three different percutaneous revascularization strategies (Balloon Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication

Detailed Description
-----------------
Endovascular revascularization of the superficial femoral artery (SFA) has become one of the most commonly performed endovascular procedures.The ability to offer the patient an alternative to surgical revascularization, limited by significant morbidity and mortality, with a same-day outpatient percutaneous procedure underlies the popularity of the endovascular approach. Although surgical bypass of the SFA remains the gold standard for revascularization, it is associated with significant morbidity and mortality.Comparative data between cryoplasty, angioplasty or stenting of the SFA will ultimately be required to provide more robust evidence of the efficacy of each mode of therapy.This registry is designed to determine the efficacy of three different percutaneous revascularization strategies (Cryoplasty vs. Stent Placement vs. Atherectomy) in the treatment of lifestyle limiting lower extremity claudication.

Official Title
-----------------
Clinical Outcomes of Three Different Percutaneous Revascularization Strategies for the Treatment of Lifestyle Limiting Claudication: A Retrospective Analysis

Conditions
-----------------
Peripheral Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Superficial Femoral Artery disease as assessed by angiography

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PAD, Peripheral Artery Disease, PVD, Peripheral Vascular Disease, Leg Blockage, Angioplasty, Stent, Claudication
Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation

Study Overview
=================
Brief Summary
-----------------
The stomach of the newborn baby is often emptied soon after birth to prevent breathing problems (respiratory distress). Babies born with meconium-stained amniotic fluid and those with increased secretions associated with birth by C-section are thought to be at particular risk of breathing problems during the first minutes of life. Emptying the stomach by sucking out all its contents (gastric suctioning) is alleged to lessen the risk of aspiration and improve respiratory distress. This study will evaluate the usefulness of gastric suctioning during neonatal resuscitation.

Official Title
-----------------
Efficacy and Safety of Gastric Suctioning During Neonatal Resuscitation- A Randomized Clinical Trial

Conditions
-----------------
Respiratory Distress

Intervention / Treatment
-----------------
* Procedure: Gastric suctioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Term infant with meconium stained amniotic fluid or born by C-section Exclusion Criteria: Prematurity Congenital Abnormality

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br> | |
| Experimental: 2<br> | Procedure: Gastric suctioning<br>* The stomach will be suctioned shortly following birth with an orogastric tube<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiratory Distress |  | Birth | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apgar scores |  | Birth | 
| Successful feeding/weight gain |  | Birth | 
| Hospital length of stay |  | Birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Meconium Aspiration, Respiratory Distress, Meconium Stained Amniotic Fluid
Poorly Differentiated Adenocarcinoma With Signet Ring Cells of the Gallbladder Producing a High Level of Alpha-fetoprotein: a Case Report

Study Overview
=================
Brief Summary
-----------------
Alpha-fetoprotein (AFP) can become elevated in hepatocellular carcinoma (HCC), yolk sac tumors and other malignant tumors of various organs. Herein, the investigator present a case of AFP-producing gallbladder carcinoma with signet ring cells successfully treated with laparoscopic whole-layer cholecystectomy.

Official Title
-----------------
Poorly Differentiated Adenocarcinoma With Signet Ring Cells of the Gallbladder Producing a High Level of Alpha-fetoprotein: a Case Report

Conditions
-----------------
Gallbladder Cancer

Intervention / Treatment
-----------------
* Procedure: laparoscopic whole-layer cholecystectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
The study eligibility criteria for patient were as follows: AFP-producing gallbladder carcinoma (cT2aN0M0, cStage IIa, UICC 8th) or gallbladder metastasis from HCC.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: laparoscopic whole-layer cholecystectomy|laparoscopic whole-layer cholecystectomy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the efficacy of measuring value of AFP for patients with gallbladder cancer. |  | 1 year |
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

Study Overview
=================
Brief Summary
-----------------
Effectiveness and reliability of TachoSil in cholecystectomy (elective and acute) Evaluation of TachoSil in laparoscopic cholecystectomy Risk profile of patient under anticoagulant therapy undergoing acute cholecystectomy Pharmaco-economic evaluation Recording of AE's/SAE's Considering the total number of cholecystectomies in Germany (170.000 cases/y), out of them about 75% laparoscopic and 10.000 conversions totally it seems urgent to record data about usage of TachoSil in such procedures. For the time being TachoSil is applied in about 2% of the gall bladder procedures. Aim is to evaluate a possible patient and procedure profile where TachoSil is most beneficial.

Official Title
-----------------
Non-interventional Trial About Treatment of Haemorrhages in Cholecystectomy With TachoSil (TC-027-DE)

Conditions
-----------------
Hemorrhage

Intervention / Treatment
-----------------
* Drug: Fibrinogen (human) + thrombin (human) (TachoSil)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing elective or acute cholecystectomy The only restrictions of use will be those resulting from the contraindications (see section 4.3 of the Summary of Product Characteristics)

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 |
| --- | --- |
| A<br> | Drug: Fibrinogen (human) + thrombin (human) (TachoSil)<br>* haemorrhages in cholecystectomy<br>|

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
-----------------
Patients undergoing elective or acute cholecystectomy