linjc16/ctgov huggingface dataset:
Fecal ESBL Resurgence During Antibiotic Treatment

Study Overview
=================
Brief Summary
-----------------
Norwegian hospitals are struggling to control spread of extended-spectrum beta-lactamase producing Enterobacteriaceae (ESBL-E) in health care settings. Strict screening and isolation criteria are enforced in hospital, and patients previously infected by ESBL-E are regarded as possible ESBL-E carriers indefinitely. This observational multi-centre cross-sectional study aims to estimate the duration of fecal ESBL-E carriage and to assess the risk of ESBL-E resurgence during hospital stay for patients previously infected by ESBL-E. Through better knowledge of these risk factors, infection control procedures may be better tailored to rhe individual patient.

Official Title
-----------------
Fecal ESBL Resurgence During Antibiotic Treatment

Conditions
-----------------
Antibiotic Drug Resistance

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with previous infection or colonization with ESBL-E admitted to one of the participating wards. - Exclusion Criteria: Not able to give informed 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal carriage of ESBL-E |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fecal ESBL-E carriage developed during admission |  | Baseline (admission) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ESBL, Enterobacteriaceae, multidrug-resistance
Heartrate Variability and Intraoperative Brain Conditions in Supratentorial Tumors

Study Overview
=================
Brief Summary
-----------------
This study aims to determine the relationship between heart rate variability and intraoperative brain relaxation conditions in patients with brain tumors.

Detailed Description
-----------------
Patients undergoing brain surgery for treatment of brain tumors will be studied to determine the relationship between heart rate variability and intraoperative brain relaxation conditions.

Official Title
-----------------
The Usefulness of the Combination of Preoperative Assessment of Optic Nerve Sheath Diameter and Heart Rate Variability to Predict Intraoperative Brain Condition in Patients With Supratentorial Tumors

Conditions
-----------------
Supratentorial Brain Tumors

Intervention / Treatment
-----------------
* Device: ANSiscope


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient aged 18 to 75 years ASA(American Society of Anesthesiologists ) I - III Patients undergoing surgery for supratentorial tumors Glasgow coma scale > 10 Exclusion Criteria: Patient aged below 18 and above 75 years. Pregnancy ASA(American Society of Anesthesiologists) IV-V Previous cranial surgery Morbid obesity ( BMI>40) Ocular injury/ Glaucoma Head injury Patient on beta blockers, ACE(angiotensin-converting-enzyme) inhibitors, Clonidine Diabetes mellitus for more than 5 years

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ANSiscope|Heart rate variability will be assessed using ansiscope before surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain relaxation | Tight Brain-the brain surface is jutting out or expanding beyond the craniotomy margins, brain pulsations are not clearly defined. Brain surface at level of craniotomy margins, Brain pulsations faintly observed Brain surface just below the surface of craniotomy margin. Brain pulsations well seen. Brain surface well below the surface of craniotomy margin, well retracted in to the cranial cavity with good brain pulsations.Brain relaxation score will me measured only once. There is no follow up | 2hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemodynamic Measurement-Heartrate | The change in hemodynamic variable heart rate in beats per minute will be measured through the study period | 2hours | 
| Hemodynamic Measurement-Bloodpressure | The change in hemodynamic variable blood pressure in mmHg will be measured through the study period | 2hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart rate variability,, supratentorial brain tumors, optic nerve sheath diameter
A Clinical Practice Snapshot on Pediatric Kidney Transplantation

Study Overview
=================
Brief Summary
-----------------
The aim is to create an overview of the similarities and differences in daily practice among the different centers performing pediatric kidney transplantation in Europe. For this purpose, a Clinical Practice Snapshot will be used to provide insight in the current approaches.

Detailed Description
-----------------
In order to create an overview of the current care for pediatric kidney transplant (PKT) recipients a clinical practice snapshot was developed. All participating centers were asked to answer 6 clinical questions on their last 30 transplanted patients. Patient characteristics, donor charactertistics, use of stents, immunosuppressive medication and renal function are compared between centers.

Official Title
-----------------
A Clinical Practice Snapshot on Pediatric Kidney Transplantation Healthcare in Europe

Conditions
-----------------
Kidney Transplant Failure

Intervention / Treatment
-----------------
* Other: Kidney Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Kidney received <18 years at least one month of follow-up transplantation and follow-up in dedicated PKT center Exclusion Criteria: combined transplantation

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Kidney Transplantation|Kidney transplantation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft survival | Functioning graft | at end of follow-up at least one month | 
| Donor type | Living or deceased donor | At transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunosuppressants prescribed at discharge | Immunosuppressive medication at discharge after transplant | 2 weeks | 
| Number of infections | Viral infections after transplantations | end of follow-up, at least one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney transplantation
A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis

Study Overview
=================
Brief Summary
-----------------
To determine the MTD and dose-limiting toxicities of a regimen of therapeutic ganciclovir, antiretroviral therapy, and recombinant interleukin-2 (aldesleukin; Proleukin) as an immune adjuvant in HIV-seropositive patients. To investigate the effect of increasing doses of Proleukin on the time to progression of CMV retinitis in patients being treated with therapeutic ganciclovir and antiretroviral therapy. To evaluate the incidence and level of anti-IL-2 antibody formation to subcutaneously administered Proleukin in this patient population.

Detailed Description
-----------------
Patients will receive subcutaneous Proleukin in combination with ganciclovir and antiretroviral therapy, and the MTD will be determined.

Official Title
-----------------
A Phase I Study of the Safety of Proleukin (Aldesleukin) in Combination With Ganciclovir and Antiretroviral Therapy in HIV Seropositive Patients With Cytomegalovirus (CMV) Retinitis

Conditions
-----------------
Cytomegalovirus Retinitis, HIV Infections

Intervention / Treatment
-----------------
* Drug: Aldesleukin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Patients must have: Documented HIV seropositivity. Prior Medication: Required: FDA-approved antiretroviral therapy for at least 2 months prior to study entry. Allowed: Prior G-CSF.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aldesleukin|nan|

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
-----------------
Antiviral Agents, Retinitis, Interleukin-2, Ganciclovir, Drug Therapy, Combination, Acquired Immunodeficiency Syndrome
Post-Implant Performance of the EC-3 IOL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain data on the performance of the EC-3 lens at an interval of two years (and beyond) from subjects who were implanted. The primary aim of the study will be to evaluate the presence, if any, of PCO, lens glistening, and other anomalies in the subjects.

Detailed Description
-----------------
Anomalies include, but are not limited to: Posterior Capsule Opacification (PCO) (pathological condition) - delayed clouding of the lens capsule after cataract surgery. Glistenings - fluid-filled micro-vacuoles that form within the intraocular lens (IOL) optic when the IOL is in an aqueous environment. They may appear to be on the lens surface. Artifacts - glares, halos, starbursts and/or shadows caused by IOLs. Fibrosis - the formation of fibrous connective tissue, as in a scar. Glare - undesirable sensation produced by brightness that is much greater than that to which the eyes are adapted. Causes annoyance, discomfort, or loss in visual performance. Halos (symptom) - the appearance of hazy ring(s) around light.

Official Title
-----------------
Post-Implant Performance of the EC-3 IOL ADDENDUM TO THE PROTOCOL: Clinical Evaluation of the EC-3 Hydrophobic Acrylic Posterior Chamber Aphakic Intraocular Lens

Conditions
-----------------
Cataract

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in the EC-3 clinical trial Subjects who were implanted with EC-3 IOL Exclusion Criteria: Removal of the EC-3 IOL at any time
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 evaluate the presence, if any, of PCO (Posterior Capsule Opacification) in the EC-3 lens. | Routine eye exam by the investigator. | 2-3 years post-implantation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract replacement surgery, implantation, EC-3 IOL
A Phase I Study to Evaluate the Pharmacokinetics of Multiple Doses of Varenicline in Healthy Adolescent Smokers

Study Overview
=================
Brief Summary
-----------------
This study will investigate the multiple dose pharmacokinetics, safety, and tolerability of two dose strengths of varenicline in adolescents aged 12 to 16 years who regularly smoke at least three cigarettes per day.

Official Title
-----------------
Phase 1 Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Multiple-Dose Pharmacokinetics, Safety and Tolerability of Varenicline in Healthy Adolescent Smokers

Conditions
-----------------
Smoking Cessation

Intervention / Treatment
-----------------
* Drug: varenicline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and female adolescents (12 - 16 years inclusive) with a total body weight greater than 30 kg who currently smoke an average of at least 3 cigarettes per day. Exclusion Criteria: Male and female subjects with a positive urine drug screen and female subjects with a positive pregnancy test.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 16 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: varenicline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: Population mean estimate for apparent plasma clearance (CL/F), central volume of distribution (V2/F) and steady-state volume of distribution (Vss/F). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters: Individual predicted estimates of Cmax, Tmax, and AUCτ on Day 14 (steady-state) using the final PK model and individual post-hoc estimates of the PK parameters. |  |  |
Predictors of Intracranial Hemorrhage in ARDS Patients on ECMO

Study Overview
=================
Brief Summary
-----------------
Intracranial hemorrhage is is a rare, but critical incident in patients with acute lung failure undergoing ECMO therapy. Predictors of intracranial hemorrhage are yet to be defined to identify patients at (high) risk. This retrospective analysis investigates the predictive value and validity of parameters and specific risk factors of critically ill ARDS patients treated with ECMO.

Official Title
-----------------
Predictors of Intracranial Hemorrhage in Critically Ill Patients With Acute Lung Failure (ARDS) on Extracorporeal Membrane Oxygenation (ECMO)

Conditions
-----------------
ARDS, Human, Extracorporeal Membrane Oxygenation Complication

Intervention / Treatment
-----------------
* Other: complication versus no complication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ARDS following Berlin definition (mild, moderate, severe) ECMO therapy (veno-venous cannulation) Exclusion Criteria: ECMO, other than VV ICH at initiation of ECMO no cerebral CT scan at any time

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 |
| --- | --- |
| intracranial hemorrhage (ICH)<br>ARDS patients treated with ECMO developing ICH | Other: complication versus no complication<br>* development of ICH<br>|
| no intracranial hemorrhage<br>ARDS patients treated with ECMO not developing ICH | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality | mortality after ICH/no ICH in ARDS patients with ECMO | up to 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay | days on ICU | up to 28 days | 
| ventilator/ECMO-free days | Ventilator/ECMO-free days | up to 28 days |
NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up

Study Overview
=================
Brief Summary
-----------------
This observational study aims to chart patients which get their prostacyclin treatment via the subcutaneous LenusPro pump. How the surgical procedure is performed and the clinical follow-up of these patients. And by this also charting complications that might occur in relation to treatment. Participating centres are located in Denmark, Norway and Sweden.

Official Title
-----------------
NIMS- New Implantable Pump in Pulmonary Arterial Hypertension, a Safety Follow up

Conditions
-----------------
Pulmonary Hypertension Group 1 and 4 According to Nice Classification

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient should have been diagnosed with Pulmonary Arterial Hypertension The patient has received or will receive treatment with the implanted pump LenusPro Exclusion Criteria: The patient is participating in another study which means treatment of the patient no longer follows the normal clinical practice
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with LenusPro pump<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number and severity of events reported for the Lenus Pro in a clinical environment. |  | Up to 3,5 years | 
| Changes in baseline variables during follow-up on quality of life. | Patient reported outcome measures, mainly CAMPHOR and SF-36 | Up to 3,5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Description of baseline and follow-up of hemodynamic and functional capacity. | Mainly right hearth catheterization, echo and 6MWD data. | Up to 3,5 years |
The Role of Laryngopharyngeal Reflux in IPF

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to show that the Supraglottic Index (SGI) is an easily-collected index that accurately identifies the presence and severity of laryngopharyngeal reflux (LPF) in idiopathic pulmonary fibrosis (IPF).

Detailed Description
-----------------
The study team hypothesizes the SGI will correlate more strongly with measures of IPF severity (at baseline and over time) than gastroesophageal reflux (GER) data derived from the esophageal detector channels of a pH/impedance probe.

Official Title
-----------------
The Role of Laryngopharyngeal Reflux in IPF

Conditions
-----------------
IPF, Reflux

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of IPF Age 40-95 Able to read, speak, and understand English If subjects are currently taking medication for reflux or GERD, they much be on a stable does for at least 4 weeks prior to consent. Exclusion Criteria: Patients who do not meet all inclusion criteria Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 95 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 |
| --- | --- | --- |
| The supraglottic index (SGI) quantifies laryngopharyngeal reflux (LPF) and is associated with severity of pulmonary fibrosis. | Correlation between the supraglottic index and forced vital capacity. The supraglottic index is an index derived by assigning scores for edema and erythema of five supraglottic structures (epiglottis, false cords, arytenoids, posterior commissure, piriform recess) as viewed through a fiber-optic scope. Scores range from 0-22, with higher scores indicating more severe LPR. | 6 months |
Treatment of Hepatocellular Carcinoma: Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is a consequence of liver cirrhosis. In early tumour stages, tumour resection or liver transplantation are therapeutic options; later tumour stages may be treated with locally ablative treatments such as percutaneous ethanol instillation (PEI), transarterial chemoembolization (TACE) or radio-frequency thermoablation. This randomized study investigates the effect of PEI on survival of patients with HCC. All patients will receive hormonal treatment (long-acting somatostatin intramuscularly [i.m.]) and will be randomized for treatment with PEI or no additional treatment.

Detailed Description
-----------------
This is a randomized two-arm parallel group study. Study group: PEI + long-acting somatostatin Control group: long-acting somatostatin alone Aims of the study: Does treatment with PEI+ long-acting somatostatin prolong survival as compared to treatment with long-acting somatostatin alone? Can time to tumour progression be extended in patients treated with PEI + long-acting somatostatin as compared to treatment with long-acting somatostatin alone?

Official Title
-----------------
Treatment of Hepatocellular Carcinoma: A Randomized Controlled Study With Long-Acting Somatostatin Plus Percutaneous Ethanol Instillation (PEI) Versus Long-Acting Somatostatin Alone

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Procedure: percutaneous ethanol instillation (PEI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically-proven hepatocellular carcinoma Treatable with percutaneous ethanol instillation Inoperable tumour Age 18-85 years Exclusion Criteria: Liver cirrhosis Child C Tumour diameter > 8 cm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: percutaneous ethanol instillation (PEI)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival time |  |  | 
| time to tumour progression |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| quality of life |  |  | 
| causes of death |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Carcinoma, Hepatocellular,, percutaneous ethanol instillation, long-acting somatostatin