linjc16/ctgov huggingface dataset:
Sublingual Fentanyl and Procedural Burn Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury.

Detailed Description
-----------------
The purpose of this study is to examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury.

Official Title
-----------------
A Randomized, Double-blind, Placebo-controlled, Cross-over Trial of Sublingual Fentanyl Spray (Subsys) and Oral Morphine for Procedural Wound Care in Adult Patients With Burn Injury Pain

Conditions
-----------------
Burn Pain

Intervention / Treatment
-----------------
* Drug: Sublingual Fentanyl Spray


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject capable of giving consent Age 18-65 Total burn surface area greater than or equal to 5% Opioid tolerant BMI less than or equal to 35 Exclusion Criteria: Subjects with cognitive or psychiatric impairment that would preclude study participation or compliance with protocol Allergy to fentanyl, morphine, naloxone Pregnancy, intent to become pregnant or lactating Evidence of burn injury to oral mucosa Active illicit drug use or illicit drug abuse history

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual Fentanyl Spray<br>Examine the efficacy and safety of sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement) in patients with burn injury. | Drug: Sublingual Fentanyl Spray<br>* Patients with burn injuries will receive sublingual fentanyl spray (Subsys) for procedural pain (dressing changes/minor debridement).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Relief | Patients suffering from burn injuries will receive sublingual fentanyl spray (Subsys) to address procedural pain (dressing changes/minor debridement). It will be compared with a standard treatment regimen of oral morphine. The hypothesis is that the fentanyl spray will be more effective for the treatment of procedural pain in patients with burn injury. | 60 min | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn pain, Procedural pain, Sublingual fentanyl, Morphine
Alfuzosin XL Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Study Overview
=================
Brief Summary
-----------------
To assess, under daily practice conditions, the safety profile and the efficacy of a new formulation of alfuzosin administered once daily (Xatral XL) in patients with lower urinary tract symptoms (LUTS) suggestive of benign prostatic hyperplasia (BPH).

Official Title
-----------------
ALEX-XL: Alfuzosin XL-Lower Urinary Tract Symptoms Efficacy and Sexuality Study

Conditions
-----------------
Prostatic Diseases

Intervention / Treatment
-----------------
* Drug: Alfuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ambulatory patients suffering from lower urinary tract symptoms suggestive of BPH. Exclusion Criteria: Patients requiring BPH surgery immediately or within the 12 following months: Acute renal obstruction Chronic renal obstruction Chronic renal failure from BPH Bladder stone Recurrent urinary tract infection Other bladder pathology such as cancer of the bladder, bladder bidiverticulum (big size) Hematuria from BPH Patients whose urinary symptoms are satisfactorily controlled on other BPH medication ( alpha-blockers or 5 alpha-reductase) Patients previously not improved by an alpha1-blocker treatment Known hypersensitivity to alfuzosin History of postural hypotension or syncope Combination with other alpha1-blockers Hepatic enzyme (SGOT or/and SGPT ) > 1.5 Upper Normal Limit Unstable angina pectoris Severe concomitant condition threatening life. Patients who had failed treatment with finasteride (Proscar) Patients with neuropathic bladder. Patients with history of previous surgery for BPH Patients with high risk for prostate cancer based on the clinical judgement of the investigator The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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: Alfuzosin|Alfuzosin 10 mg One tablet per day after evening meal|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvements in urinary symptoms and quality of life index |  | During all the study conduct | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sexual function |  | During all the study conduct | 
| Improvement in maximum flow rate (determined by uroflowmetry) |  | During all the study conduct | 
| Collection of spontaneously reported adverse events |  | At each visit |
Use of Saliva for COVID-19 Diagnosis

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to evaluate the presence of SARS-CoV2 RNA in the saliva of patients with suspected or confirmed COVID-19 in order to validate the analysis of this type of sample for the diagnosis of SARS-CoV2 infections.

Official Title
-----------------
Use of Saliva for Diagnosis of SARS-CoV2 Infection

Conditions
-----------------
SARS-CoV2 Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients ≥ 18 years of age hospitalized in the COVID-19 wards of ASST Monza - San Gerardo Hospital with positive, weakly positive or negative nasopharyngeal swabs; initially assessed at the E.R.; symptomatic or asymptomatic with indication to hospitalization. Informed consent freely granted and acquired before the start of the study. Exclusion Criteria: Patients with significant clinical conditions which could interfere with the study in the opinion of the researchers.

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 |
| --- | --- | --- |
| Presence of SARS-CoV2 RNA in the saliva of patient with suspected or confirmed COVID-19. | Positive - Negative | Up to 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Salivary test
Milrinone Pharmacokinetics and Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
Acute kidney injury (AKI) occurs in 40% of children following heart surgery. Serum creatinine (Scr) is a late biomarker of AKI, rising 24-48 hours after surgery. Thus, for medicines excreted in the urine, AKI could potentially lead to toxic levels in the blood. Urinary biomarkers have the ability to detect AKI earlier. Whether early detection of AKI through urinary biomarkers can predict altered drug levels is unknown. Milrinone is used to improve heart function after surgery, but accumulates in AKI resulting in low blood pressure. Dose adjustments are not currently possible because of the late rise in SCr, and are based on clinical parameters that may lead to clinically relevant over or under-dosing. Thus, this study will address an important knowledge gap being the first to use elevations of AKI biomarker concentrations to anticipate increased milrinone levels.

Official Title
-----------------
USE OF ACUTE KIDNEY INJURY BIOMARKERS TO PREDICT IMPAIRED MILRINONE PHARMACOKINETICS IN CHILDREN FOLLOWING CARDIAC SURGERY

Conditions
-----------------
Congenital Heart Disease, Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undergoing cardiothoracic surgery with cardiopulmonary bypass weight greater than 2500 grams (5 pounds 8 ounces) at the time of surgery gestational age > 36 weeks age less < to 1 year infants with complex congenital heart disease use of milrinone in the intra-operative and post-operative period. Exclusion Criteria: Pre-existing kidney disease (structural and functional abnormalities) as determined by the Principal Investigator use of aminoglycosides within 48 hours of planned surgery cardiac arrest prior to cardiac surgery extracorporeal membrane oxygenation prior to cardiac surgery urinary tract infection prior to surgery repair of an isolated atrial or ventricular septal defect

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 1 Year

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Acute kidney injury<br>AKI defined by an elevation in urinary AKI biomarkers | |
| No acute kidney injury<br>No AKI defined by normal urinary AKI biomarkers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarker elevation and milrinone clearance | The primary outcome variables for Aim 1 are an elevation in urinary AKI biomarkers to predict a 25% reduction in milrinone clearance. | By 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Creatinine elevation and milrinone clearance | The secondary outcome variables for Aim 2 include a 50-75% increase in SCr to predict a 25% reduction in milrinone clearance | by 72 hours |
An Open Label, Phase II Trial of Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin (Visudyne®) for the Treatment of Cutaneous Metastases of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this Phase II study is to evaluate the efficacy and safety of Continuous Low- Irradiance Photodynamic Therapy (CLIPT) when used with Verteporfin in the treatment of cutaneous metastases of breast cancer for which no curative or significantly palliative therapy exists, including chest wall therapy.

Conditions
-----------------
Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: Verteporfin
* Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed Stage IIIb or IV breast cancer with cutaneous metastases. Exclusion Criteria: Participants receiving any medications or substances that are known to cause photosensitivity (e.g. tetracyclines, sulfonamides, phenothiazines, sulfonylurea hypoglycemic agents, thiazide diuretics, griseofulvin, fluoroquinolones, St. Johns' wort, amiodarone) are ineligible. Participants who have received prior systemic therapy (chemotherapy or targeted therapy) within 7 days of Study Day 1 or those who have not recovered from clinically significant adverse events due to agents administered more than 7 days earlier. (continuation of the same regimen of HER-2 antibody targeted therapy agents, hormonal therapy and treatment with bisphosphonates or denosumab are permitted) Participants who are receiving any other investigational agents during the proposed treatment cycle.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Open Label<br>Continuous Low-Irradiance Photodynamic Therapy (CLIPT) Using Verteporfin | Drug: Verteporfin<br> <br> Device: Continuous Low-Irradiance Photodynamic Therapy (CLIPT)<br> <br> * Other names: CLIPT Illumination System;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective Response Rate | To evaluate the objective response rate (ORR=CR+PR) at Day 23 (3 weeks) after the initial treatment. The objective response rate is defined as the rate of complete response (CR) plus the rate of partial response (PR). | Day 23 |
Zirconia Based Fixed Dental Prostheses

Study Overview
=================
Brief Summary
-----------------
The objective of this prospective clinical study is to investigate the differences in the complication rates between tooth- and implant- supported zirconia based fixed dental prostheses (FDPs) with at least 4 units. The null-hypothesis is that there is no difference in the complication rates between implant- supported and tooth- supported zirconia FDPs.

Detailed Description
-----------------
The study aims to provide evidence regarding the clinical behaviour of long-span tooth- and implant-supported FDPs.

Official Title
-----------------
Prospective Evaluation of Zirconia Based Tooth- and Implant- Supported Fixed Dental Prostheses

Conditions
-----------------
Zirconia Based Fixed Dental Prostheses

Intervention / Treatment
-----------------
* Device: Teeth abutment
* Device: Implant abutments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years Missing of at least two adjacent teeth in the maxilla or mandibular Sufficient oral hygiene Exclusion Criteria: Addiction to alcohol or drugs Severe craniomandibular disorders Severe systematic diseases Patients unable or unwilling to sign the informed consent form Untreated periodontitis

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tooth-supported<br>Long-span tooth-supported zirconia based fixed dental prostheses | Device: Teeth abutment<br> <br> * Other names: Zenotec system;|
| Active Comparator: Implant-supported<br>Long-span implant-supported zirconia based fixed dental prostheses | Device: Implant abutments<br> <br> * Other names: Wital (Implant system);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Fixed Dental Prostheses (FDPs) With Failure | Failure was recorded if there was a need to remove the Fixed Dental Prosthesis over the observation period. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Fixed Dental Prostheses (FDPs) With Chip/s | Measurement of the amount of fractures of the veneering material 6,12,18,24,30 and 36 months after placement of the restorations. The percentage of chips for the implant- and tooth- supported restorations will be reported. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prospective study, chipping, survival rate, fracture resistance, zirconia
A Study to Assess the Effect of Tocilizumab + Methotrexate on Signs and Symptoms in Patients With Moderate to Severe Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This 3 arm study will compare the safety and efficacy, with regard to reduction of signs and symptoms, of tocilizumab versus placebo, both in combination with methotrexate (MTX). in patients with moderate to severe active rheumatoid arthritis (RA) who currently have an inadequate response to MTX. Patients wil be randomized to receive tocilizumab 4mg/kg iv, tocilizumab 8mg/mg iv, or placebo iv, every 4 weeks; all patients will also receive methotrexate 10-25mg weekly. The anticipated time on study treatment is 3-12 months, and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Versus Placebo, in Combination With Methotrexate, in Patients With Moderate to Severe Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: tocilizumab [RoActemra/Actemra]
* Drug: tocilizumab [RoActemra/Actemra]
* Drug: Placebo
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients at least 18 years of age with moderate to severe active RA for at least 6 months; inadequate response to a stable dose of MTX; patients of reproductive potential must be using reliable methods of contraception. Exclusion Criteria: major surgery (including joint surgery) within 8 weeks before entering study, or planned surgery within 6 months after entering study; prior treatment failure with an anti-tumor necrosis factor agent; women who are pregnant or breast-feeding.

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 |
| --- | --- |
| Experimental: 1<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* 4mg/kg iv / month<br>Drug: Methotrexate<br>* 10-25mg/week<br>|
| Experimental: 2<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* 8mg/kg iv / month<br>Drug: Methotrexate<br>* 10-25mg/week<br>|
| Placebo Comparator: 3<br> | Drug: Placebo<br>* iv / month<br>Drug: Methotrexate<br>* 10-25mg/week<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 20 response |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients ACR 50/70 responses; change from baseline in ACR core set components. |  | Week 24 | 
| AEs, laboratory parameters, vital signs |  | Throughout study |
Cerebrovascular Autoregulation During Sepsis

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.

Official Title
-----------------
Dynamic Cerebrovascular Autoregulation During Sepsis and Sepsis-associated Delirium

Conditions
-----------------
Sepsis, Delirium

Intervention / Treatment
-----------------
* Other: no interventions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical symptoms of sepsis, severe sepsis and septic shock possibility for measurement of transcranial doppler ultrasound age over 18 years Exclusion Criteria: preexisting cerebrovascular disease preexisting immunological disease traumatic brain injury intracranial infectious disease pregnancy

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 |
| --- | --- |
| Sepsis<br>All patients with sepsis defined by actually sepsis guidelines | Other: no interventions<br>* No interventions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disturbed cerebrovascular autoregulation correlates with sepsis associated delir | The Index of autoregulation (Mx) was measured and correlated with the clinical incidence of a sepsis associated delir | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation |  | 1 year | 
| Correlation between inflammatory parameters and sepsis-associated delirium |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain, blood flow, Measurement techniques, flow velocity waveform analysis, Monitoring, intensive care, Sepsis, transcranial doppler ultrasound (TCD), Cerebrovascular autoregulation, sepsis-associated delir