linjc16/ctgov huggingface dataset:
Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study

Study Overview
=================
Brief Summary
-----------------
Amikacin is the aminoglycoside of choice for treatment of severe infections in intensive care. An achievement of its objectives in pharmacokinetics and pharmacodynamics is difficult in intensive care patients because of modification of their volume of distribution and renal clearance. Acute renal failure requiring renal replacement therapy is frequent in intensive care. Extrarenal purification modalities (continuous versus intermittent, type of dialysis membrane), which can influence amikacin clearance, are multiple and teams dependent. Guidelines of good practice for Amikacin in intensive care patients do not exist.

Detailed Description
-----------------
The aim of this study is to describe strategies of prescription and monitoring of Amikacin in intensive care patients on renal replacement therapy.

Official Title
-----------------
Prescription Strategies of Amikacin in Intensive Care Patients on Renal Replacement Therapy: an Observational Prospective Multicenter Study

Conditions
-----------------
Amikacin Treatment

Intervention / Treatment
-----------------
* Other: Data record


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria : patients in intensive care patients on extrarenal replacement patients with Amikacin treatment patients accepting to participate in the study exclusion criteria : patients less than 18 years old pregnant women patients with Amikacin treatment in the previous 7 days

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 |
| --- | --- |
| Amikacin treatment group<br>Intensive care patients on renal replacement therapy with Amikacin treatment | Other: Data record<br>* Data record<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of maximum concentration observed | Monitoring of Amikacin treatment using measurement of maximum concentration observed performed or not | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amikacin, intensive care, renal replacement therapy, prescription strategy,, monitoring strategy
A Study of OSI-7904L as Treatment in Patients With Head and Neck Cancer Who Have Failed First-Line Therapy

Study Overview
=================
Brief Summary
-----------------
Multi-center, Phase II study to evaluate the efficacy and safety of OSI-7904Lin head and neck cancer in patients who have failed first-line therapy

Official Title
-----------------
A Phase II Study of Single-Agent OSI-7904L in Patients With Locally Advanced or Metastatic Squamous Cell Carcinoma of the Head and Neck Who Have Failed First-Line Therapy

Conditions
-----------------
Locally Recurrent or Metastatic Cancer of the Head and Neck, Must Have Failed First-Line Therapy

Intervention / Treatment
-----------------
* Drug: OSI 7904L


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically or cytologically confirmed metastatic or locally recurrent SCCHN that is incurable with surgery or radiation therapy ECOG performance status 0-2 No more tha 1 prior chemotharapy regimen for metastatic or locally recurrent disease Adequate bone marrow, Hepatic and renal function. At least one target lesion greater than or equal to 20 mm. Exclusion Criteria: Symptomatic brain metasteses which are not stable, are not adequately controlled, are potenially life threatening or required radiation in the last 28 days Pregnant or lactating women. Concurrent anticancer therapy or other investigational drugs Patients with active or uncontrolled infections or other serious illnesses or medical conditions.

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: OSI 7904L|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Implications of DNA Analysis on ADPKD

Study Overview
=================
Brief Summary
-----------------
Autosomal dominant polycystic kidney disease (ADPKD) is an inherited disease. We plan DNA analysis using the next generation sequencer (NGS) and examine the relationship between mutational types and clinical phenotypes. The accuracy of DNA analysis with NGS is tested by Sanger's method. The kidney and life survival curves will be compared between PKD1, PKD2 and non-ADPKD family members.

Detailed Description
-----------------
80 unrelated patients with ADPKD attending to the Kyorin University Hospital whose clinical data are compiled. DNA analysis is performed at Otsuka Pharmaceutical Laboratory. Clinical data include total kidney volume (TKV), TKV slope, eGFR, eGFR slope and other clinically relevant data.

Official Title
-----------------
Mutational Types and Phenotypes Relationship in Autosomal Dominant Polycystic Kidney Disease

Conditions
-----------------
Autosomal Dominant Polycystic Kidney Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The unrelated patients with ADPKD. Exclusion Criteria: The patients whose clinical data are not compiled.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 relationship between mutational types and phenotypes | Total Kidney Volume (TKV) measured by MRI and its slope. Total Liver Volume (TLV) measured by MRI and its slope. GFR estimated by plasma creatinine and cystatin C (eGFR). Other clinical data, such as QOL scores and ADPKD-related symptoms. | Depends on the observational period at least more than one year. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the efficacy of next generation sequencing method | Compatibility of sequence results between two NGSs. Compatibility of sequence results between NGS and Sanger's method. | One year. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autosomal Dominant Polycystic Kidney Disease, PKD 1 gene, PKD 2 gene, Truncational mutation, Hypomorphic mutation
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction in Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion.

Study Overview
=================
Brief Summary
-----------------
All consecutive patients admitted in ILBS from MAY 2015 to DECEMBER 2016. Decompensated cirrhosis patients will be randomized into Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres with iv albumin at a dose 8 gms/l of ascitic fluid Group 1: MVP (Moderate Volume Paracentesis) of less than 5 litres without albumin .

Official Title
-----------------
To Study The Incidence And Outcome Of Paracentesis Induced Circulatory Dysfunction In Decompensated Cirrhotics Undergoing Less Than 5 Litres Of Ascitic Fluid Tap With Or Without Albumin Infusion

Conditions
-----------------
Decompensated Cirrhosis

Intervention / Treatment
-----------------
* Drug: Albumin
* Drug: ascitic fluid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Cirrhotics decompensated with ascites admitted in the hospital. Grade II/III ascites Need for paracentesis. Exclusion Criteria: Age <12 or > 75 years Hepatocellular carcinoma Non cirrhotic ascites such as malignancy or tubercular peritonitis Serum Cr >1.5mg% Refractory septic shock Grade III/IV hepatic encephalopathy Abdominal wall cellulitis Active variceal bleed Respiratory, cardiac and renal failure Refusal to participate in the study

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Albumin<br>MVP (Moderate Volume Paracentesis) of less than 5 liters with iv albumin at a dose 8 gms/l of ascitic fluid. | Drug: Albumin<br>* MVP of less than 5 liters with iv albumin at a dose 8 gms/L of ascitic fluid.<br>Drug: ascitic fluid<br> <br> |
| Active Comparator: No Albumin<br>MVP(Moderate Volume Paracentesis) of less than 5 liters without albumin. | Drug: ascitic fluid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PICD (Paracentesis Induced Circulatory Dysfunction). |  | 1 Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 28 days | 
| Total number of patients develop Hepatorenal Syndrome. |  | 1 Year | 
| Total number of patients develop hyponatremia. |  | 1 Year | 
| Changes in plasma Renin activity. |  | 1 Year | 
| Changes in aldosterone with volume of ascitic fluid tap. |  | 1 year |
National Egyptian Network Pediatric Stroke and Hemiplegia Registry

Study Overview
=================
Brief Summary
-----------------
Our aim is to establish multi-center national Egyptian database of information about cerebrovascular stroke and hemiplegia in infants and children from 0 to 18 years of age.

Detailed Description
-----------------
Aims: An open-ended multi-center, national Egyptian study to collect and analyze data for children with cerebrovascular stroke and hemiplegia . Participants: Eligible infants and children with stroke and hemiplegia. DESIGN: This study is a prospective cohort study. Primary outcome measure: Initial acute stroke clinical and radiological presentation, recurrent stroke, mortality, and neurologic deficits in the acute stage, participants will be followed for the duration of hospital stay, an expected average of 6 weeks

Official Title
-----------------
National Egyptian Network Pediatric Stroke and Hemiplegia Registry

Conditions
-----------------
Stroke With Hemiparesis, Perinatal Stroke, Focal Neurologic Deficits

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Focal neurological deficit of acute onset lasting greater than 20 minutes. And CT or MRI showing infarct in location consistent with neurological signs and symptoms Hemiplegia Exclusion Criteria: Cerebral haemorrhage not associated with ischemic infarct. Hypoxic ischemic event with diffuse or bilateral infarction alone.

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum 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 |
| --- | --- |
| Pediatric Stroke and Hemiplegia<br>Any infant or child with acute stroke or hemiplegia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival or neurologic deficit after acute cerebrovascular stroke. | Children with acute stroke will be followed till either death or discharge from hospital, all clinical, radiological and therapeutic data will be collected. | participants will be followed for the duration of hospital stay, an expected average of 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long term neurological deficit | Post-stroke pediatric gross and fine motor function will be assessed. | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, Congenital stroke, neonatal, hemiplegia
Efficacy and Safety of Cipros 10 Association on the Isolated Hypertriglyceridemia and Dyslipidemia Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of Cipros 10 association in the treatment of Dyslipidemia Treatment

Official Title
-----------------
Phase III, National, Multicenter, Randomized, Double Blind Clinical Trial, to Evaluate the Efficacy and Safety of Cipros 10 Association on Dyslipidemia Treatment

Conditions
-----------------
Hypertriglyceridemia, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: Cipros 10 association
* Drug: Crestor 10 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants of both sexes, aged 18 years or more; Participants with the diagnosis of Dyslipidemia presentinf low or intermediate cardiovascular risk, according to the Brazilian Guidelines on Dyslipidemia and Prevention of Atherosclerosis; Signed consent. Exclusion Criteria: Diagnosis of familial hypercholesterolemia and other genetic diseases; Using medications that may interfere with the metabolism or serum levels of triglycerides; Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants; Presence of concomitant cardiovascular disease, renal failure and hepatic Failure; Decompensated diabetes; Current smoking; History hypersensitivity to the active ingredients used in the study; Pregnancy or risk of pregnancy and lactating patients; History of alcohol abuse or illicit drug use; Participation in clinical trial in the year prior to this 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CIPROS 10<br>The study is double-Masked, the patient wil take 2 tablets, as follow: 1 tablet Cipros 10 association; and 1 tablet crestor placebo Oral, once a day. | Drug: Cipros 10 association<br>* oral, once a day.<br>* Other names: EMS association;|
| Active Comparator: Crestor<br>The study is double-Masked, the patient wil take 2 tablets, as follow: 1 tablet Crestor 10mg; and 1 tablet Cipros association placebo Oral, once a day. | Drug: Crestor 10 mg<br>* oral, once a day.<br>* Other names: Rosuvastatin 10 mg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of serum triglyceride levels measured between the first visit and last visit. |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and severity of adverse events recorded during the study. |  | 13 weeks |
Cohort of STEMI Patients

Study Overview
=================
Brief Summary
-----------------
Ischemic heart disease is the leading cause of mortality in industrialized countries. ST elevated acute myocardial infarction is one of its most frequent and deadly manifestation. In the last 20 years, STEMI mortality has been reduced by 50% with the advent of timely reperfusion (primary percutaneous intervention) and significant progression in pharmacologic intervention. However, death and heart failure incidence after STEMI remain elevated: up to 20% at one year. Also, therapeutic management following international guidelines is standardized toward a one-size fits all therapeutic management. In order to continue improving myocardial infarction outcomes, there is a need to better understand and individualize therapeutic targets such myocardial reperfusion injury, post reperfusion inflammation, adverse left ventricular (LV) remodeling …. This knowledge will allow us to propose new therapeutic strategies and in the long run strive towards personalized medicine. The aim objective of this cohort of STEMI patients is to identify new biological markers of injury and prognosis.

Official Title
-----------------
CoHort of STEMI Patients

Conditions
-----------------
Myocardial Infarction

Intervention / Treatment
-----------------
* Other: STEMI PATIENT Cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18 years Diagnosis of STEMI defined by ST segment elevation ≥ 0.2 mV in 2 contiguous leads on a 12-lead ECG. Primary PCI within 12 hours of symptoms onset. Exclusion Criteria: Diagnosis of STEMI not confirmed by angiography Refusal to participate in the study or to sign the consent Inability to give information to the subject about the study Lack of medical social coverage Deprivation of civil rights

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 |
| --- | --- |
| STEMI PATIENT Cohort<br>STEMI PATIENT Cohort | Other: STEMI PATIENT Cohort<br>* PCI<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Troponin | Dosage of Troponin at hospital admission and 4 hours after Percutaneous coronary intervention (PCI) | Day 0 | 
| Change in Creatine Kinase | Dosage of Creatine Kinase at hospital admission and 4 hours after PCI | Day 0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New York Heart Association (NYHA) Class |  | at admission (Day 0) | 
| Left ventricular ejection fraction (LVEF) | LVEF measured by echocardiography | 24 hours after PCI (Day 1) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial infarction, biomarkers, STEMI
The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the concurrent validity information of the 24-, 30-, and 36-month Indonesian ASQ-3 with the Bayley Scales of Infant and Toddler Development 3rd Edition (BSID-III) in Indonesian children. Children living in Tanah Tinggi subdistrict, Central Jakarta, were recruited conveniently from November to December 2019. Children within the 24-, 30-, or 36-month age group were assessed for Indonesian ASQ-3 concurrently with BSID-III as the reference standard according to their age groups. Screening test accuracy was measured in sensitivity, specificity, and predictive values for both overall dan specific domains.

Official Title
-----------------
The Indonesian Version of Ages and Stages Questionnaire III Accuracy Compared to Bayley Scales of Infant Development III

Conditions
-----------------
Child Development, Child Development Disorder, Development Delay, Developmental Delay, Global Developmental Delay, Motor Delay, Speech Delay

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents with children aged 23 - 38 months Parents who finished at least elementary school Exclusion Criteria: Parents with communication difficulties Parents who could not speak Indonesian language

Ages Eligible for Study
-----------------
Minimum Age: 23 Months
Maximum Age: 38 Months

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Child development | Measured once with Indonesian Ages and Stages-3 questionnaire (cross sectional study) with scores ranging between 0 to 60 per domain. Higher score means better development. | Day 1 | 
| Child development | Measured once with Bayley Scales Infant Development-III with scores ranging between 40 to 160 per domain. Higher score means better development. | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASQ-3, BSID-III, child development, Indonesia, screening test, validity