linjc16/ctgov huggingface dataset:
Pharmacokinetics of Vancomycin in ICU Patients

Study Overview
=================
Brief Summary
-----------------
Vancomycin is frequently under-dosed in ICU patients during the first 24-48 hours of treatment. Glomerular hyperfiltration syndrome, increased drug volume of distribution, vasopressor use, male sex and hypoalbuminemia are identified risk factor for vancomycin underdosing in ICU patients, among others. To date, bedside estimation of vancomycin volume of distribution is challenging, and new methods for optimizing drug administration are required. The Picco device is a moderately invasive hemodynamic monitoring system, providing parameters that may help estimation of vancomycin pharmacokinetics parameter. The aim of this study is to test whether addition of hemodynamic parameters would improve pharmacokinetics modelling of vancomycin concentration in ICU patients.

Official Title
-----------------
Pharmacokinetics of Vancomycin in ICU Patients

Conditions
-----------------
Suspected Infection With Vancomycin Susceptible Bacterial Strains

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient hospitalized in intensive care unit under intravenous vancomycin started during current ICU hospitalization with at least one vancomycin serum concentration available under hemodynamic monitoring with the Picco ® device Exclusion Criteria: vancomycin treatment for less than 24 hours vancomycin concentration in serum unavailable rare comorbidities influencing vancomycin pharmacokinetics myeloma cystic fibrosis burn injury on more than 20 % of the body surface previous inclusion in present study

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 |
| --- | --- | --- |
| Akaike information criterion as a measurement of goodness of fit of pharmacokinetic modeling of vancomycin serum concentration | All available vancomycin measurements during the first week of treatment will be included in the pharmacokinetics model. All vancomycin dosages up to seven days of treatment will be used in a population pharmacokinetic model and an individual pharmacokinetic model | week 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with under-dosage of vancomycin at day 2 of treatment | under-dosage of vancomycin is defined by a vancomycin serum concentration below 15 mg/l on day 2 of treatment. | day 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vancomycin, under dosage, intensive care unit, pharmacokinetics
Controlled Study to Evaluate the Efficacy and Safety of the Treatment With Growth Hormone in Tibia Fractures

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa, Europe and Middle East. This trial investigates the efficacy and safety of three dose levels of Norditropin® (growth hormone) as compared to placebo in the treatment of tibia fractures. The trial will be conducted in two parts: in the first part, the patients will be evaluated with regard to efficacy (fracture healing) and safety at short time intervals until week 24 post-surgery. In the second part, long-term safety and fracture healing up to 12 months post-surgery will be evaluated.

Official Title
-----------------
A Multi-centre, Randomised, Double-blind, Placebocontrolled, Parallel-group Trial Investigating the Efficacy and Safety of Norditropin® SimpleXx® in Tibia Fractures

Conditions
-----------------
Bone Fracture, Tibia Fractures

Intervention / Treatment
-----------------
* Drug: somatropin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary surgical treatment of tibia fracture using intramedullary nailing Closed fractures: Tscherne Type C1, C2 and C3 Open fractures: Gustilo Grade I, II and IIIa Exclusion Criteria: Open growth plate on X-rays Known chronic endocrine or metabolic disease including diabetes and severe obesity defined as body mass index (BMI)1 > 32.0 Severe head injury defined as patients who are stuporous or comatose with pupillary enlargement or asymmetry Critically ill patients defined as patients in need of mechanical ventilation (except during surgical procedures) or circulatory support (defined as use of inotropic drugs)

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from surgery until fracture has healed |  | During a 12 month period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's assessment: fracture healed |  |  | 
| Number of fractures healed |  |  |
Chinese PICU Collaborative Network on Pathogens and Drug Resistance of Severe Infections

Study Overview
=================
Brief Summary
-----------------
To investigate PICUs in major cities in China by establishing a high-quality standardized clinical database of PICU inpatients Incidence, fatality rate, pathogen distribution, anti-infective treatment of community-acquired/nosocomial infections in inpatients.

Detailed Description
-----------------
All patients admitted to the PICU during January 1, 2016 to December 31 2025 were included in the study, and all patients were followed up until death or PICU withdrawal. To establish the standardized Access database collected patients' general information, infection, PICU treatment, catheter, and short-term Prognosis and other clinical data.

Official Title
-----------------
Children's Hospital of Fudan University

Conditions
-----------------
Severe Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PICU patients with severe infection Exclusion Criteria: Non-infected patient

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- | --- |
| Pathogenic spectrum of PICU severe infection | the 10 years of pathogenic spectrum of PICU severe infection | 2016-2025 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PICU, pathogen, severs infection, drug resistance
Lime Powder Regimen in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The study aims to investigate the pharmacokinetic parameters and its antioxidative effects in Thai healthy men.

Official Title
-----------------
Medicinal Effect of Lime Powder Regimen in HK-2 Cell Exposed to Lithogenic Crystals and Its Citraturic and Antioxidative Responses in Healthy Volunteers

Conditions
-----------------
Kidney Stone, Oxidative Stress

Intervention / Treatment
-----------------
* Dietary Supplement: Lime powder regime


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Thai healthy male or female aged 18-45 years old BMI 18-25 kg/m2 Normal medical history, physical examination and vital signs Normal screening laboratories no history of drug allergies Willingness to take part in the study and provide informed consent Exclusion Criteria: History of GI, liver, kidney, allergic disease or any other disease that may interfere with the bioavailability of lime powder regimen History of alcohol or drug abuse Heavy smoking Receive any medication within 14 days prior to the study day

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Lime powder regime|1 sachet of lime powder regimen with 200 ml of water|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The pharmacokinetic parameters of plasma and urine citrate | The pharmacokinetic parameters of plasma and urine citrate incluiding Cmax, Tmax, Half life, AUC, and elimination rate constant | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pharmacokinetic, lime powder regimen, kidney stone, Oxidative stress
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the analgesic effect of perioperative nefopam on acute pain in patient undergoing orthognathic surgery.

Official Title
-----------------
Effect of Nefopam on Acute Postoperative Pain in Patients Undergoing Orthognathic Surgery

Conditions
-----------------
Pain, Orthognathic Surgery

Intervention / Treatment
-----------------
* Drug: nefopam
* Drug: normal saline (control)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 20-60 years undergoing elective orthognathic surgery Exclusion Criteria: pregnancy psychiatric disease hepatobiliary or renal disease monoamine oxidase inhibitor-taking patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: nefopam|nefopam infusion for postoperative 24 hours|
|Drug: normal saline (control)|normal saline infusion for postoperative 24 hours|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score on the visual analogue scale |  | after orthognathic surgery (up to postoperative 24 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain, orthognathic
Observational Study of Incidence of Breakthrough Cancer Pain and How it is Treated

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe how often advanced cancer patients experience breakthrough pain (BTcP), and to describe how this pain is treated, and how effective these treatments are.

Official Title
-----------------
Multicenter Observational Study of the Incidence and Treatment Modalities of Breakthrough Cancer Pain in Patients With Chronic Cancer Pain

Conditions
-----------------
Advanced Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of neoplasm in advanced stage Chronic pain controlled for at least one week with opioids 60 mg / day morphine equivalent 1-6 episodes of BTcP within any of 3 days previous to registration into study Signed Informed Consent Exclusion Criteria: · More than 6 episodes of BTcP within any of 3 days previous to registration into study
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced cancer patients with pain<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of patients who experience BTcP |  | one year | 
| treatments used to treat BTcP |  | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | evaluate the relationship between pain intensity, patient characteristics, and clinician choice of pain medication | 4 weeks | 
| time to pain relief of BTcP |  | 4 weeks | 
| initial dose of therapy (in morphine equivalents) for BTcP | to verify a correlation between initial dose for BTcP and daily dose of baseline pain therapy | 4 weeks | 
| effective dose for BTcP | to verify a correlation between effective dose for BTcP and daily dose of baseline pain therapy (dose reported in morphine equivalents) | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breakthrough cancer pain, pain, neuropathic pain, intractable pain, cancer
The Very Old Intensive Care Patient: A Multinational Prospective Observation Study

Study Overview
=================
Brief Summary
-----------------
The primary aim is to document the incidence and short-term outcome of the elderly ICU patient (≥ 80 years) using a multicentre, multi national approach The secondary aim is to investigate the properties of a simple frailty index in this cohort, and in particular if this is an instrument that can be used in resource and outcome prediction in this group To create hypothesis for further studies, in particular on various outcome prediction

Detailed Description
-----------------
The investigators have chosen to use a prospective registration of routinely collected data in this ICU population. The study is mainly European based, but will also allow for ICUs outside Europe to participate. 20 consecutive ICU admission in patients ≥ 80 years of age will be collected OR all patients ≥ 80 years in a three months' period (whatever comes first). Data are collected electronically through an e-CRF and with baseline documentation of the ICU. The database is located in Denmark, at the Department of Epidemiology, University of Aarhus (http://vip1study.com/) . Each ICU will only have access through the database of their own patients, and patient ID is not registered (Names, birth-date or social security numbers) so it is in that sense anonymous. Even with de-identified data, most countries must seek necessary consent from the authorities to collect such data, and hence there will be a period between ICU recruitment (starting April 2016) and patient recruitment (October 1. 2016) to allow for this to be done prior to study start. The goal is to recruit at least 100 ICUs which will give data from approximately 2000 elderly patients.

Official Title
-----------------
The Very Old Intensive Care Patient: A Multinational Prospective Observation Study

Conditions
-----------------
Critical Illness, Old Age; Debility, Survival

Intervention / Treatment
-----------------
* Other: Observation prospective


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All admissions in the group Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- |
| Admission of elderly ICU patients (≥80)<br>All consecutibve admission in 3 month period or 20 pateints | Other: Observation prospective<br>* No intervention<br>* Other names: Observation and registration of data;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival | ICU and 30 days | 30 days | 
| Frailty | Clinical Frailty Scale | Pre admission |
Masitinib in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
A 12-week with possible extension, phase II study to compare efficacy and safety of masitinib at 3 and 6 mg/kg/day in combination with methotrexate, in treatment of patients with active rheumatoid arthritis refractory to standard treatments.

Official Title
-----------------
A 12-week With Possible Extension, Prospective, Multicenter, Randomized, Open Label, Uncontrolled, 2-parallel Group, Phase II Study to Compare Efficacy and Safety of AB1010 at 3 and 6 mg/kg/Day in Combination With Methotrexate, in Treatment of Patients With Active Rheumatoid Arthritis With Inadequate Response to 1. Methotrexate or to 2. Any DMARD Including Anti TNF Alpha if Patients Previously Failed Methotrexate or to 3. Methotrexate in Combination With Any DMARD Including Anti TNF Alpha

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

Intervention / Treatment
-----------------
* Drug: masitinib
* Drug: masitinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Disease duration of at least 6 months Meet American College of Rheumatology (ACR) criteria for RA. ACR functional class I-III Have active RA Failed (defined as active RA with stable dose during 3 months) i. methotrexate or ii. any DMARD including anti TNF alpha if patients previously failed methotrexate or iii. methotrexate in combination with any DMARD including anti TNF alpha Exclusion Criteria: Patient had a major surgery within 2 weeks prior to study entry. Life expectancy < 6 months.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: masitinib 3 mg<br>masitinib 3 mg/kg/day | Drug: masitinib<br>* 3 mg/kg/day oral route<br>* Other names: AB1010;|
| Experimental: masitinib 6 mg<br>masitinib 6 mg/kg/day | Drug: masitinib<br>* masitinib 6 mg/kg/day oral route<br>* Other names: AB1010;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American College of Rheumatology Score 50 |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DAS28 |  | week 4, 8 and 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DMARD, rheumatoid arthritis, methotrexate, c-kit inhibitor
Estimating Volume Using LiDCO

Study Overview
=================
Brief Summary
-----------------
We hypothesize that the stroke volume variation measured using the commercially available LiDCO monitor provides a reasonable estimate of volume when compared to standard measures. This study will collate data that is already being collected by the bedside nurses.

Detailed Description
-----------------
Objective: To compare measurement of stroke volume variance with intake/output measurements, weight, BUN/Creatnine values, and central venous pressure. Design: Non-experimental, non-randomized observational comparative study. Setting: The sixteen bed Neurocritical Care Unit at Duke University Hospital. Patients: 45 adult (over 18 years) subjects with intracranial pathology who require volume resuscitation. Only patients with current LiDCO monitoring will be considered eligible for inclusion in the study. Interventions: This is an observational study. Subjects will receive standard-of-care treatment without additional intervention. Data Analysis: All data will be collected by the principal investigator / study coordinator. Personal patient information will be removed (deidentified) from the permanent data collection records to protect patient confidentiality. Data collected will be entered into a Microsoft Excel electronic spreadsheet and will be saved on a USB Disk drive to be stored in a locked cabinet in the investigator's office. Statistical analysis using SAS v9.1, (Cary, NC) will be conducted with a level of significance set at .05 (alpha) using standardized comparative analysis techniques.

Official Title
-----------------
Estimating Volume Using LiDCO Versus Other Measures of Volume

Conditions
-----------------
Brain Injury, Ischemic Stroke, Hemorrhagic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted to the neurocritical care unit have an arterial line in place already connected to LiDCO monitor Physician order for monitoring intake and output Exclusion Criteria: pregnant females

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 |
| --- | --- |
| Primary<br>All subjects are included in this group, non-randomized observational study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stroke volume variation |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, Brain injury, nursing, Critical care