linjc16/ctgov huggingface dataset:
PRospective Prostate biOmarker Study

Study Overview
=================
Brief Summary
-----------------
• Correlation of a glycoprotein panel with prostate biopsy outcome and PCa aggressiveness

Detailed Description
-----------------
The main objective of this study is to correlate a glycoprotein panel with prostate biopsy outcome, i.e. distinguishing PCa from benign prostatic conditions as well as high-grade cancer. The quantities of the two protein analytes cathepsin D (CTSD) and thrombospondin 1 (THBS1) are measured in human serum samples. In combination with percent free PSA (%fPSA), the results are correlated with prostate biopsy outcome. The potential future benefit of using this glycoprotein panel is to validate positive tPSA tests in men with negative digital rectal examination (DRE) and enlarged prostates to reduce the need for undergoing a biopsy, thereby reducing unnecessary biopsies and potentially predicting high-grade disease.

Official Title
-----------------
PRospective Prostate biOmarker Study (PROPOSe)

Conditions
-----------------
Indication for Prostate Biopsy Due to Suspected Prostate Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: Blood sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male patient between 45 and 80 years old. tPSA between 2 and 10 ng/ml Prostate volume >=35 ml Non-suspicious DRE for prostate cancer Scheduled for prostate biopsy Patient must give written informed consent Exclusion Criteria: Patient not undergoing biopsy of the prostate Prior prostate biopsy within the last 12 months Transurethral resection of the prostate (TURP) in the last 5 years Patients with known acute or chronic prostatitis/cystitis or other known prostate abnormalities Patient taking 5-alpha-reductase inhibitor Any other prior treatment of the prostate (cryoablation, hifu, ire, radiation therapy, alcohol instillation, etc.)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients<br>All | Diagnostic Test: Blood sample collection<br>* During a routine blood draw an additional tube of blood will be taken for the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of PCA | Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa | 6 months | 
| Aggressiveness of PCA | Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa | 6 months | 
| Diagnosis of PCA | Correlation of the glycoprotein panel algorithm with histological diagnosis of PCa | 12 months | 
| Aggressiveness of PCA | Correlation of the glycoprotein panel algorithm with diagnosis of significant (Gleason Score ≥7) PCa | 12 months |
Placental Inflammation in Prenatal Care

Study Overview
=================
Brief Summary
-----------------
Objective of study is to explore expression of stress-related genes and inflammation in placentas and umbilical cord blood for women participating in group prenatal care compared with women receiving individual prenatal care.

Detailed Description
-----------------
This study aims to evaluate levels of inflammatory markers and genetic indicators of stress an inflammation in the placentas and umbilical cord blood in pregnancies that undergo group prenatal care as compared to traditional prenatal care. The investigators know that women receiving group prenatal care have fewer spontaneous preterm deliveries. What is not known is the mechanism behind this difference. By collecting umbilical cord blood samples and placentas of 40 women at the time of delivery, the investigators hope to study expression of stress-related genes and levels of inflammatory markers at the maternal-fetal interface.

Official Title
-----------------
Placental Inflammation in Prenatal Care

Conditions
-----------------
Preterm Birth

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years Singleton pregnancy Exclusion Criteria: Presence of known fetal congenital anomalies (lethal anomaly or anomalies that may lead to early delivery or increased risk of neonatal death). Presence of known chromosomal abnormalities Progesterone treatment during the current pregnancy after 14 weeks Chronic corticosteroid (i.e. Prednisone or other steroids) treatment during the current pregnancy (not including inhalers or topical)

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GPNC<br>CenteringPregnancy group prenatal care | |
| IPNC<br>Individual prenatal care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory markers (CRP, IL-6) of cord blood | Circulating concentrations of C-reactive protein and interleukin-6 will be quantified in serum harvested from umblical blood | drawn from the umbilical cord within 15 minutes of delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genome wide expression profiling of cord blood | Mononuclear cells will be isolated from umbilical blood using density gradient centrifugation. RNA will be extracted using Qiagen RNeasy Mini Kits, and quality/quantity checks performed using an Agilent NanoDrop BioAnalyzer. | drawn from the umbilical cord within 15 minutes of delivery |
KoMAC Videolaryngoscope for Double-lumen Intubation

Study Overview
=================
Brief Summary
-----------------
KoMAC videolaryngoscope is a portable intubating device with an angulated single-use blade of adjustable size and a liquid crystal display monitor mounted on top of the handle, which is similar in shape to the McGrath videolaryngoscope. The purpose of this study was to evaluate the efficacy of the KoMAC videolaryngoscope for double-lumen intubation regarding intubation time, laryngeal view and ease of intubation, compared to Macintosh laryngoscope.

Official Title
-----------------
Comparison of the KoMAC Videolaryngoscope With the Macintosh Laryngoscope for Double-lumen Intubation

Conditions
-----------------
Intubation

Intervention / Treatment
-----------------
* Device: KoMAC videolaryngoscope
* Device: Macintosh Laryngoscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for thoracic surgery requiring one lung ventilation Exclusion Criteria: predicted difficult airway rapid sequence intubation cervical injury

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: KoMAC group<br>Orotracheal intubation with KoMAC videolaryngoscope | Device: KoMAC videolaryngoscope<br>* Double lumen endotracheal intubation was performed with the KoMAC videolaryngoscope<br>|
| Active Comparator: Macintosh group<br>Orotracheal intubation with Macintosh laryngoscope | Device: Macintosh Laryngoscope<br>* Double lumen endotracheal intubation was performed with the Macintosh Laryngoscope<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intubation time | Time interval between laryngoscope passing the teeth to the confirming of end tidal CO2 | from 2 min after rocuronium injection to completion of intubation (time interval is about 120 seconds) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
double lumen intubation, videolaryngoscope
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy After Abdomino-perineal Resection

Study Overview
=================
Brief Summary
-----------------
This retrospective study asses if a prophylactic, funnel-shaped, intraperitoneal mesh prevents parastomal hernia in patients undergoing abdominoperineal rectum resection with permanent end colostomy.

Official Title
-----------------
Prophylactic Funnel Mesh to Prevent Parastomal Hernia in Permanent End Colostomy: A Retrospective Cohort Study

Conditions
-----------------
Hernia, Colostomy Stoma

Intervention / Treatment
-----------------
* Device: funnel-shaped, intraperitoneal mesh placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elecitve abdominoperineal resection Exclusion Criteria: rejection of a retrospective data Analysis age under 18 years meshes other than the funnel-shaped mesh

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 |
| --- | --- |
| mesh group<br>patients undergoing abdominoperineal resection with end colostomy and implantation of a prophylactic, funnel-shaped, intraperitoneal mesh | Device: funnel-shaped, intraperitoneal mesh placement<br>* Implantation of a prophylactic, 3D funnel-shaped, intraperitoneal, non-absorbable and synthetic mesh (Dyna Mesh IPST 2x15x15 cm™ and 3x16x16 cm™, FEG Textiltechnik, Aachen, Germany,)<br>|
| no-mesh group<br>patients undergoing abdominoperineal resection with end colostomy without implantation of a prophylactic, funnel-shaped, intraperitoneal mesh | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of parastomal hernia | clinical or radiological diagnosed parastomal hernia | initial operation until an avarage of 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reoperations due to parastomal hernia | Reoperation due to problems caused by parastomal hernia | initial operation until an avarage of 3 years | 
| Mesh-associated complications | any complications due to the mesh | initial operation until an avarage of 3 years |
D Tc 99m Dimercaptosuccinic Acid SPECT Versus Planar

Study Overview
=================
Brief Summary
-----------------
Knowing what will DMSA spect add to the DMSA planar in detection in renal cortical defects

Official Title
-----------------
Added Value of Tc99m Dimercaptosuccinic Acid SPECT Versus Planar Imaging in Detection of Renal Cortical Defects

Conditions
-----------------
Dimercaptosuccinic Acid SPECT and Planar

Intervention / Treatment
-----------------
* Device: Gamma camera imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient with history of peylo nephritis. Exclusion Criteria: pregnant women
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Gamma camera imaging|Use gamma camera in detection of renal cortical defects|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between DMSA spect and planar imaging | Analysis of DMSA spect and planar imaging to clarify early renal cortical defects | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clarify added value of DMSA spect over planar | Know if DMSA spect is necessary? | Baseline |
A Pharmacokinetic Study of an Experimental Paracetamol Formulation

Study Overview
=================
Brief Summary
-----------------
This PK study is designed to show bioequivalence between the study treatments.

Official Title
-----------------
A Pivotal Pharmacokinetic Study Investigating the Extent of Absorptions of Paracetamol and Caffeine for Two Different Paracetomol Formulations Containing Caffeine

Conditions
-----------------
Headache, Tension-Type

Intervention / Treatment
-----------------
* Drug: Experimental paracetamol
* Drug: Paracetamol marketed formulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteer Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental paracetamol formulation<br>experimental formulation | Drug: Experimental paracetamol<br>* experimental paracetamol with caffeine<br>|
| Active Comparator: paracetamol marketed formulation<br>Paracetamol marketed formulation | Drug: Paracetamol marketed formulation<br>* marketed formulation containing caffeine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables (AUC 0-10hrs, AUC 0-inf, and Cmax) to determine bioequivalence |  | 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK variables to compare speed of absorption (AUC 0-30min, AUC 0-60min, Tmax) |  | 10 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
paracetamol, Bioequivalence, Pharmacokinetics, Healthy volunteers, caffeine
Left Ventricular Lead Position in Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
Left ventricular (LV) lead position has crucial impact on cardiac resynchronization therapy (CRT) success. This study will compare fluoroscopy and myocardial deformation imaging for optimal definition of LV lead position.

Detailed Description
-----------------
In a 16 segment model circumferential strain will be used to determine the segment with latest peak systolic circumferential strain prior to CRT, considered as the optimal LV lead target. LV lead will be defined by (1) fluoroscopy, (2) the maximal temporal difference of peak circumferential strain before-to-on CRT and (3) the earliest peak systolic circumferential strain during LV pacing. For all 3 modalities optimal LV lead position is defined as concordance or immediate neighbouring of the segment with defined LV lead position to the determined optimal target segment. At follow-up echocardiography will be performed to determine improvement in LV function and remodeling.

Official Title
-----------------
Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy by Myocardial Deformation Imaging

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Implantation of a cardiac resynchronization therapy device
* Procedure: Echocardiography (myocardial deformation imaging)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: See above Males and females Ages 18 to 80 years Exclusion Criteria: Patients who already have had a pacemaker device Patients with poor echocardiographic window Patients who are not able to understand the study and to give informed written consent

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A1<br>heart failure patients undergoing CRT implantation | Procedure: Implantation of a cardiac resynchronization therapy device<br> <br> Procedure: Echocardiography (myocardial deformation imaging)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in LV function and LV remodelling |  | 6 to 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac resynchronization therapy, echocardiography, heart failure, left ventricular function, pacing, myocardial deformation imaging, Optimal Definition of Left Ventricular Lead Position in Cardiac Resynchronization Therapy
Clinical Characteristics of Patients Referred to a Substance Abuse Liaison Department in an Academic Hospital, France

Study Overview
=================
Brief Summary
-----------------
The Coalition on Psychiatric Emergencies (CPE) stressed in 2016 that emergency providers were increasingly recognizing the important role of the Emergency Department (ED) in reducing adverse outcomes associated with untreated with substance abuse liaison department (SUDs). Additional research is required to close identified knowledge gaps and improve care of ED patients with SUD. Of the more than 4.5 million ED visits in 2009 in US for drug-related causes,34-32% involved alcohol use alone or in combination with other drugs. Few studies investigated the clinical characteristics of patients referred to an addiction liaison department in a general hospital. The present study will be retrospective in a sample of 700 patients consecutively admitted for addictive behaviors in the emergency department and in the Medicine or Surgery departments of the Amiens University Hospital Center, France.

Official Title
-----------------
Clinical Characteristics of Patients Referred to a Substance Abuse Liaison Department in an Academic Hospital, France

Conditions
-----------------
Substance Abuse, Emergencies, Personality Disorders, Substance Use Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient addressed to University Hospital Emergency Department and consecutively referred to a substance abuse liaison department in the Amiens Academic Hospital, France between 2017 and 2020. Patients must be able to speak French Exclusion Criteria: Neurological disorders patients who are not able to speak French

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| sociodemographic characteristics of patients referred to an addiction liaison department in a Academic general hospital |  | one month | 
| clinical characteristics of patients referred to an addiction liaison department in a Academic general hospital |  | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Substance abuse liaison-department, Emergencies, Academic Hospital, Personality Disorders, Substance Use Disorders
Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
This study is a prospective observation study for lower respiratory tract infections in medical intensive care unit. Microbiologic and clinical characteristics and outcomes of patients with severe pneumonia in medical intensive care unit will be monitored and analyzed.

Detailed Description
-----------------
All patients admitting medical ICU will be monitored for pneumonia. Both community-acquired (including health-care associated pneumonia) and hospital-acquired pneumonia will be included. Collecting data will include patient demographic characteristics, clinical features, microbiological characteristics including molecular work, and outcome.

Official Title
-----------------
Detection and Characterization of Lower Respiratory Infections in Critically Ill Patients

Conditions
-----------------
Severe Pneumonia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitting medical ICU with pneumonia Medical ICU admitted patients who is developed new pneumonia Exclusion Criteria: Patients already treated more than 48 hours for pneumonia in transferring hospital and no causative organism is isolated

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
| Identification of etiology of pneumonia |  | 7 day from the time of pneumonia diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pneumonia-related death |  | 1 month | 

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