linjc16/ctgov huggingface dataset:
Long-term Hemodialysis Catheter Removal and Delayed Replacement, Versus Exchange Over a Guidewire to Treat Catheter Related Blood Stream Infection

Study Overview
=================
Brief Summary
-----------------
Prospective, randomized Study of tunneled cuffed hemodialysis catheter removal and delayed replacement, versus exchange over a guidewire to treat catheter related blood stream infection

Detailed Description
-----------------
The aim of this study was to compare the clinical outcomes of catheter-related (CRBSI) managed with two different strategies: Guidewire exchange of the infected catheter with a new one over a guidewire versus catheter removal with delayed replacement.

Official Title
-----------------
Prospective, Randomized Study of Long-term Hemodialysis Catheter Removal, Versus Guidewire Exchange to Treat Catheter Related Blood Stream Infection

Conditions
-----------------
Catheter Related Blood Stream Infection

Intervention / Treatment
-----------------
* Device: catheter replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients end stage renal disease on hemodialysis from tunneled cuffed dialysis catheters with suspected catheter-related bloodstream infection with no identifiable infection source except the catheter were included. Exclusion Criteria: metastatic infection,

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 90 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 |
| --- | --- |
| Active Comparator: group A<br>exchange of the infected catheter with a new one over a guidewire | Device: catheter replacement<br>* catheter removal and delayed replacement, versus exchange over a guidewire<br>|
| Active Comparator: group B<br>removal of the infected catheter followed by delayed placement of a new catheter 3 to 10 days later | Device: catheter replacement<br>* catheter removal and delayed replacement, versus exchange over a guidewire<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| infection free survival |  | 45 days |
Pharmacokinetics of Levofloxacin and Capreomycin in Multidrug-Resistant Tuberculosis Patients

Study Overview
=================
Brief Summary
-----------------
This is an open label observational pharmacokinetic drug study to evaluate Levofloxacine and Capreomycin in patients with Multidrug-Resistant Tuberculosis (MDR-TB).

Detailed Description
-----------------
Patients receive MDR-TB treatment with o.a. Levofloxacin and Capreomycin. At least one week after start of treatment, the PK samples samples will be obtained via an intravenous catheter at 0, 1, 2, 3, 4, 7, and 12 hours after intake.

Official Title
-----------------
Pharmacokinetics of Levofloxacin and Capreomycin in MDR-TB Patients

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Other: Pharmacokinetics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18yrs culture positive diagnosis of MDR-TB Exclusion Criteria: DM2 Pregnancy allergy to IV canula material insertion of IV canula not possibele

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 |
| --- | --- |
| PK of Levofloxacin-Capreomycin<br>Pharmacokinetics (PK) in M/XDR-TB patients receiving at least Levofloxacin and Capreomycin as part of their WHO treatment for M/XDR-TB | Other: Pharmacokinetics<br>* multiple blood samples are obtained by means of an indwelling intravenous catheter for calculating PK parameters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUC/MIC ratio of Levofloxacin | The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the area under the serum concentration-time curve (AUC) over 24 hours (AUC0-24h ), [AUC0-24h /MIC], after administration of Levofloxacin. | after day 8 of treatment | 
| Cmax/MIC ratio of Capreomycin | The primary outcome parameter is the ratio of the in vitro minimum inhibitory concentration (MIC) to the maximum serum concentration, [Cmax/MIC], after administration of Capreomycin. | after day 8 of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volume of Distribution | Based on the measured drug concentration during the dosing interval and patient characteristics (height, bodyweight and age) the volume of distribution will be calculated | after day 8 of treatment | 
| Clearance | Based on the drug concetrations during the dosing interval and patient characteristics (height, bodyweight, age) the drug clearance will be calculated | after day 8 of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDR-TB, Capreomycin, pharmacokinetics, pharmacodynamics, Levofloxacin
Long Term Treatment With L-DOPS

Study Overview
=================
Brief Summary
-----------------
This study is designed to supply L-DOPS (droxidopa) on a long term basis to patients with a genetic form of profound orthostatic hypotension, most commonly DBH deficiency. It also allows us to collect medical history information on this small population of patients that would allow us to determine if there are any complications from this type of treatment.

Official Title
-----------------
Long Term Treatment With L-DOPS

Conditions
-----------------
Dopamine Beta Hydroxylase (DBH) Deficiency

Intervention / Treatment
-----------------
* Drug: droxidopa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old or older with orthostatic hypotension established diagnosis of DBH deficiency and fractionated plasma catecholamine levels that show high dopamine levels and very low norepinephrine and epinephrine levels. Blood pressure increase in response to oral treatment with L-DOPS during previous studies. Exclusion Criteria: subjects with orthostatic hypotension that do not have a genetic form of the disorder and catecholamine pattern is not consistent with that above.

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

| Intervention/Treatment |
| --- |
|Drug: droxidopa|Droxidopa (L-DOPS) comes in capsule form, 100 mg or 200 mg strength and is usually administered 2 - 3 times per day. It would be taken indefinitely to improve symptoms of orthostatic hypotension|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Application of the ELFI-TECH Monitor for Perioperative Hemodynamic Measurements

Study Overview
=================
Brief Summary
-----------------
The elfitor device is a small non invasive device that uses dynamic light scattering to measure skin bloodflow, blood velocity, coagulation and hemodynamic parameters. In this study, the investigators will investigate whether the elfitor device is able to detect changes in bloodpressure, cardiac output during general anesthesia. Furthermore, the investigators will investigate changes in cutanuous blood flow in different parts of the body during peripheral nerve or neuraxial block.Being able to monitor these entities, under- and overdosing of general and local anesthetics may be prevented, resulting in favorable hemodynamics and better intra and postoperative pain relieve.

Official Title
-----------------
The Application of the ELFI-TECH Monitor for Measurement of Blood Pressure, Cardiac Output and Extend of Regional and Neuraxial Anesthesia: The Elfitor Study

Conditions
-----------------
Colon Carcinima

Intervention / Treatment
-----------------
* Device: Elfi tech monitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any elective surgery under general or neuraxial anesthesia Exclusion Criteria: non elective procedures

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 |
| --- | --- |
| General anesthesia<br>Patients that will recieve general anesthesia for elective surgery | Device: Elfi tech monitor<br> <br> * Other names: Elfitor;|
| Regional or neuraxial anesthesia<br>Patients that will revieve regional or neuraxial anesthesia for elective surgery | Device: Elfi tech monitor<br> <br> * Other names: Elfitor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | bloodpressure will be compared using conventional techniques and elfitor | up to 1 day | 
| Neuraxial block | neuraxial block will be compared using conventional techniques and elfitor | up to 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output | during induction of anesthesia the effect of anesthetics or neuraxial blok on cardiac output will be recorded | up to 1 day |
Retrospective Study on the Use of CEFALY® Device During Migraine Attacks

Study Overview
=================
Brief Summary
-----------------
This is an Internet survey to collect data on the use of the Cefaly device to treat migraine attacks in regular Cefaly users.

Detailed Description
-----------------
About 1000 CEFALY users, having the device since more than one year and having reordered electrodes in the last year, will be invited to participate to an Internet survey. This survey contains at most 8 questions, and data will be collected completely anonymously. Questions concern the use or not of the CEFALY during migraine attacks, the number of treated attacks and the number and type of acute anti-migraine drugs that were avoided thanks to the use of the CEFALY.

Official Title
-----------------
Retrospective Study on the Use of CEFALY® Device During Migraine Attacks

Conditions
-----------------
Migraine

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects using Cefaly device regularly for more than a year identify by reordering of electrodes during the last year. History of likely episodic or chronic migraine with or without aura diagnosed by a physician Exclusion Criteria: N/A
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 |
| --- | --- | --- |
| Monthly number of acute drug intake avoided when using Cefaly to treat a migraine attack | On average, mean number of anti-migraine acute drug intake avoided per month per patient in regular Cefaly users, based on self reported average monthly number of attacks and percentage of attacks treated successfully with the Cefaly | Maximum 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Cefaly users that report using also the device to treat migraine attacks | Percentage of regular Cefaly users using the device to treat attacks | Maximum 1 year | 
| Proportion of migraine attacks treated with the Cefaly device | Percentage of migraine attacks treated with the Cefaly device by the Cefaly users | Maximum 1 year | 
| Proportion of migraine attacks for which the use of the Cefaly device generate a reduction of drug intake | Percentage of migraine attacks treated with the Cefaly device and for which the acute anti-migraine drug intake is reduced thanks to the Cefaly | Maximum 1 year |
Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing Cardiac Surgery With the Use of Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Cardiopulmonary bypass surgery is associated with extensive blood loss in upto 20% of patients. Tranexamic acid (TXA) is a routinely administered antifibrinolytic agent that reduces blood loss and blood transfusion requirement. However, standard dosing of TXA in patients suffering from renal dysfunction and undergoing cardiopulmonary bypass surgery may lead to higher blood concentration of TXA when compared to the patients with normal renal function. Solid phase microextraction (SPME) is a fast and simple method to measure TXA levels. This prospective study on cadiac surgical patients undergoing cardiopulmonary bypass aims to study the pharmacokinetics of TXA in patients with renal dysfunction. Two patient groups will be studied who will receive either TXA 50mg/kg bolus or BART regimen (30 mg/kg, 16 mg/kg/h + 2 mg/kg pump prime) depending on the type of cardiac surgical procedure and bleeding risk. Hypothesis: Standard dosing of TXA used in cardiac surgery result in higher blood concentration of TXA in patients with renal dysfunction when compared to patients with normal renal function.

Official Title
-----------------
Pharmacokinetics of Tranexamic Acid in Patients With Varying Renal Function Undergoing Cardiac Surgery With the Use of Cardiopulmonary Bypass

Conditions
-----------------
Cardiac Disease, Renal Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cardiac surgical patients above 18 years of age with renal dysfunction (stage 1, 2 ,3, 4 and 5 of the Kidney Disease Outcome Quality - Initiative classification of chronic kidney disease) Exclusion Criteria: All patients under 18 years of age or unable to give consent Documented drug allergy to tranexamic acid Deep hypothermic circulatory arrest Pre-existing coagulopathy Pregnancy Advanced liver disease Renal transplant recipients Concomitant treatment with contraceptives, tretinonin

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 |
| --- | --- | --- |
| Tranexamic acid blood concentration | Sampling schedule for blood TXA concentration Baseline (before administration of TXA) 5 minutes after TXA 10 minutes after TXA Post-sternotomy Before commencing CPB Every 30 mins on Cardiopulmonary bypass (CPB) Off CPB Prior to sternotomy closure Post-operative blood sampling schedule On admission to Intensive Care Unit (ICU) 1, 2, 4, 8, 12, 24, 48 and 72 hours post-op | Baseline, intraoperatively, postoperatively up to 72 hourss | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, renal dysfunction, pharmacokinetics, tranexamic acid
Staphylococcus Aureus Bacteraemia in Adults

Study Overview
=================
Brief Summary
-----------------
The purpose of this evaluation is to record the management and outcome of adults with S.aureus bacteraemia (SAB) across multiple European, Asian and North American sites and to identify key quality indicators associated with improved outcome.

Detailed Description
-----------------
Staphylococcus aureus (S. aureus) is one of the most common causes of bloodstream infections. Associated mortality has been reported to vary widely (4%-40%) although no obvious explanation for such variation has been identified. Despite the existence of clinical guidelines, there is considerable variation in the management of S.aureus bacteraemia (SAB) between centres. Part of the variation in clinical management is due to the limited evidence base defining optimal therapy. Fewer than 1500 patients have been recruited to randomised controlled trials in the past 40 years; practice is therefore based largely on experience and observational studies. The purpose of this evaluation is to record the management and outcome of adults with SAB across multiple European, Asian and North American sites. We aim to establish a broader knowledge base, identify key quality indicators associated with improved outcomes, and to provide comparator data to ensure that patients enrolled in randomized controlled trials are representative of bacteraemic S. aureus patients as a whole. All participating centres are experienced in the management of S. aureus bacteraemia and in conducting evaluations of current management practice and outcomes from S. aureus bacteraemia. Data is checked for plausibility by a centralized data quality control group.

Official Title
-----------------
A Prospective International Study of Staphylococcus Aureus Bacteraemia in Adults by the International Staphylococcus Aureus Collaboration

Conditions
-----------------
Staphylococcus Aureus Bacteremia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: S. aureus (methicillin sensitive or resistant) isolated from one or more blood cultures Exclusion Criteria: Recurrent episodes of S. aureus bloodstream infection Polymicrobial infection

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 |
| --- | --- | --- |
| Mortality |  | 90 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | 90 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bacteremia, Staphylococcus aureus, bloodstream infection
EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic ( EPISODEPSCOVID )

Study Overview
=================
Brief Summary
-----------------
Prehospital providers encounter patients with suspected stroke frequently. Stroke and COVID-19 are related potentially putting these healthcare workers at risk of COVID-19 infection. In addition, prehospital providers need tools to help triage large vessel stroke patients to comprehensive stroke centers.

Detailed Description
-----------------
This observational prospective study will document COVID-19 status on patients seen in the prehospital environment for suspected stroke. This will provide an estimate of how frequently stroke occurs in stroke and also the exposure risk to providers in this setting. Additionally, patients will have a headset placed to record their headpulse during the encounter. These measurements will be used to further develop an analytic model used to predict the presence of large vessel occlusion (LVO) stroke. This may help create a device that can be used in the prehospital environment to aid in the trade decision of destination hospital.

Official Title
-----------------
EPISODE-PS-COVID: hEad Pulse for Ischemic StrOke DEtection Prehospital Study During the COVID-19 Pandemic

Conditions
-----------------
Stroke, Acute, COVID-19

Intervention / Treatment
-----------------
* Device: MindRhythm Harmony


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: suspected stroke in the prehospital setting patient at risk for COVID-19 Exclusion Criteria: scalp laceration Patient refusal Prisoner, other vulnerable population Prehospital provider feels that the recording may interfere with care

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 |
| --- | --- |
| Device: MindRhythm Harmony<br>Passive recording of the head pulse | Device: MindRhythm Harmony<br>* Passive recording of the head pulse<br>* Other names: Cranial Accelerometry;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of COVID-19 infection in suspected stroke population |  | Through Study Completion, an average of 6 months | 
| Quality head pulse recordings | Proportion of head pulse studies deemed of high quality for further analysis | Through Study Completion, an average 6 months |
Barriers and Facilitators in Access to OT/PT in Pediatric Cancer Survivors

Study Overview
=================
Brief Summary
-----------------
This study aims to identify the modifiable facilitators and barriers to occupational and physical therapy care for children during and after cancer treatment that may be contributing to disparities in health outcomes. The investigators will identify these facilitators and barriers by surveying and interviewing healthcare administrators at MD Anderson Cancer center. The investigators will also survey and interview physicians, advanced practice providers, and occupational and physical therapists to obtain their feedback on these issues.

Official Title
-----------------
Exploring Barriers and Facilitators to Mitigate Disparities in Access to OT/PT in Pediatric Cancer Survivors

Conditions
-----------------
Pediatric Cancer

Intervention / Treatment
-----------------
* Other: Patient population


Participation Criteria
=================
Eligibility Criteria
-----------------
Aim 1 Inclusion Criteria: Employed as an administrator at MD Anderson Cancer Center and the sister institutions and working in the areas of pediatrics, survivorship, cancer control, health policy, and rehabilitation services. Aim 2 Inclusion Criteria: Employed as a referring provider (e.g., oncologist, surgeon, advanced care practitioner), or an OT/PT therapist at MD Anderson Cancer Center and the sister institutions. Exclusion Criteria: Inability 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 |
| --- | --- |
| Healthcare administrators<br>Healthcare administrators at MD Anderson Cancer Center and the sister institutions | Other: Patient population<br>* Questionnaire, standard of care<br>|
| Physicians/referring providers<br>Physicians/referring providers and the occupational therapy (OT) and physical therapy (PT) therapists at MD Anderson Cancer Center and the sister institutions | Other: Patient population<br>* Questionnaire, standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify modifiable barriers to occupational and physical therapy care for children during cancer treatment that may be contributing to disparities in health outcomes. |  | Through study completion, an average of 1 year |