linjc16/ctgov huggingface dataset:
Ventilator-Associated Events: Prevalence, Outcome and Preventability

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine the prevalence of ventilator-associated events (VAE). To analyze the patients profile, morbidity and mortality compared to patients who did not develope VAE. The preventability of VAE will be assessed by comparing the percentage of adherence to the bundle of preventive measures among patients who developed and did not develope VAE.

Detailed Description
-----------------
This is a retrospective analysis of prospectively collected data, approved by the Research Ethics Committee of Hospital Sao Domingos. The need for informed consent was waived. Included were all patients admitted to a surgical (13 beds) and medical (32 beds) of a tertiary hospital over a 3-year period (February 2013 to January 2016), aged above 18 years and submitted to mechanical ventilation for at least 4 days. At admission and daily the following data were collected: head of bed elevation, daily interruption of sedation, gastric ulcer prevention, Thromboembolism prophylaxis, aspiration of subglottic secretions, oral care with chlorhexidine gluconate and monitoring of endotracheal tube cuff pressure. Identification of VAE, Ventilator-associated condition (VAC), Infectious condition associated to mechanical ventilation (IVAC) and ventilator-associated pneumonia possible and probable followed definition criteria of the National Healthcare Safety Network / Center for Disease Control and Prevention. The percentage of adherence to the bundle of preventive measures of VAE prevention was registered.

Official Title
-----------------
Ventilator-Associated Events: Prevalence, Outcome and Preventability

Conditions
-----------------
Ventilator-Associated Lung Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients admitted to a medical and a surgical ICUs over a 3-year period aged above 18 years and submitted to mechanical ventilation for at least 4 days. Exclusion Criteria: Patients aged bellow 18 years and those that remained under mechanical ventilation less than 4 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who developed ventilator-associated events |  | 1 year | 
| All cause Mortality |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of mechanical ventilation |  | 1 year | 
| Percentage of adherence to the package of VAE preventive measures |  | 1 year |
A Study of Pharmacokinetics (PK) and Pharmacodynamics (PD) in Relation to Prednisolone in Healthy Males

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, PK, PD, of BMS-791826 and to assess its marker specific PD in relation to Prednisolone in healthy male subjects

Official Title
-----------------
Placebo-Controlled, Double-Blind, Ascending Single and Multiple Oral Dose Study to Evaluate the Safety, Pharmacokinetics and Pharmacodynamics of BMS-791826 and to Assess Its Marker Specific Pharmacodynamics in Relation to Prednisolone in Healthy Males

Conditions
-----------------
Immunoscience

Intervention / Treatment
-----------------
* Drug: Prednisolone
* Drug: BMS-791826
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ECGs), and clinical laboratory determinations Body Mass Index (BMI) of 18 to 30 kilogram / square meter (kg/m2), inclusive Signed informed consent Exclusion Criteria: Sexually active fertile men not using effective birth control (barrier contraception) if their partners are women of childbearing potential (WOCBP) Any significant acute or chronic medical illness History of Gilbert's disease Other protocol inclusion/exclusion criteria may apply

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Module A<br>Single Ascending Dose | Drug: Prednisolone<br>* Specified dose on specified days<br>Drug: BMS-791826<br>* Specified dose on specified days<br>Drug: Placebo<br>* Specified dose on specified days<br>|
| Experimental: Module B<br>Multiple Ascending Dose | Drug: Prednisolone<br>* Specified dose on specified days<br>Drug: BMS-791826<br>* Specified dose on specified days<br>Drug: Placebo<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | safety and tolerability | Up to 34 days | 
| Incidence of serious adverse events (SAEs) | safety and tolerability | Up to 34 days |
Clinical Presentations, Microbiology, Antibiotic Resistance Patterns and Management Outcomes of Culture-proven Infection Among Adolescent and Adult in A Tertiary Hospital in Saudi Arabia

Study Overview
=================
Brief Summary
-----------------
The characteristics of patients as well as microbiologic profile of culture-proven infection will be studies in conjunction with clinical outcome within 28-days

Official Title
-----------------
Clinical Presentations, Microbiology, Antibiotic Resistance Patterns and Management Outcomes of Culture-proven Infection Among Adolescent and Adult in A Tertiary Hospital in Saudi Arabia

Conditions
-----------------
Culture-proven Infection

Intervention / Treatment
-----------------
* Other: Culture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any individual aged ≥13 year old requested for him/her bacterial/fungal culture. Able to provide a written informed consent. Exclusion Criteria: Age <13 years old. Unable/unwilling to provide a written informed consent.

Ages Eligible for Study
-----------------
Minimum Age: 13 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 |
| --- | --- |
| Culture-proven infected patients<br> | Other: Culture<br>* Culture<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All-cause and disease specific mortality | 28 days |
Etanercept Treatment in the Early Course of Polymyalgia Rheumatica

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of the tumor necrosis factor alpha (TNF) antagonist, etanercept, on the early clinical course of polymyalgia rheumatica (PMR). PMR is a common inflammatory disease with an unknown etiology that is characterized by aching, tender, and stiff proximal muscle. Some evidence suggests that TNF plays a central role in the pathophysiology of PMR. The preferred treatment with glucocorticoids (GCs) is adequate for most patients, but a subset of patients have a more prolonged, relapsing disease course. These patients require treatment with GCs for 1 to 2 years. GC related adverse events are frequent during treatment.

Official Title
-----------------
The Effect of Etanercept on the Early Clinical Course of Polymyalgia Rheumatica (Pilot Study)

Conditions
-----------------
Polymyalgia Rheumatica

Intervention / Treatment
-----------------
* Drug: Etanercept (Enbrel)
* Drug: Sodium chloride (placebo)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with active polymyalgia rheumatica (patients only). Signed informed consent and written authorization. Exclusion Criteria: Other inflammatory conditions than polymyalgia rheumatica, including symptoms of giant cell arteritis, e.g. head aches, jaw claudication and visual disturbances. Current malignancy or history of malignancy. Neuromuscular conditions. Infections with systemic impact. Uncontrolled diabetes mellitus. Uncontrolled hypertension. Current tuberculosis or history of tuberculosis. Severe heart failure (NYHA class 3 and 4). Current use of glucocorticoids, biological drugs, and immunosuppressive drugs. Exclusion Criteria (controls): Polymyalgia rheumatica.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Etanercept (Enbrel)|TNF-alpha antagonist, subcutaneous injection, 25 mg twice/week, 14 days.|
|Drug: Sodium chloride (placebo)|NaCl, isotonic saline, subcutaneous injection, 1 ml twice/week, 14 days.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Polymyalgia rheumatica activity score (PMR-AS) |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of various cytokines, chemokines, and adipokines |  | 14 days | 
| Quantitative use of analgesics |  | 14 days | 
| Insulin sensitivity (HOMA) |  | 14 days |
Safety and Efficacy of AS-3201 in the Treatment of Diabetic Sensorimotor Polyneuropathy

Study Overview
=================
Brief Summary
-----------------
This is a safety and efficacy trial of ranirestat(AS-3201) which is an aldose reductase inhibitor in patients with diabetic sensorimotor polyneuropathy.

Conditions
-----------------
Diabetic Neuropathy

Intervention / Treatment
-----------------
* Drug: ranirestat, (AS-3201)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with the following may enter: Clinical signs and symptoms (footpain, numbness, tingling, weakness, etc.) of symmetrical distal Diabetic Sensorimotor Polyneuropathy with diagnosis by Nerve Conduction Tests and/or Quantitative Sensory Test. 18 to 70 years old of either sex and any race Type I or Type II, insulin-dependent or non insulin-dependent diabetes for at least six months prior to study entry Healthy in general No hospitalizations for diabetic control or episodes of ketoacidosis for three months prior to screening Female patients of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: Known non-diabetic causes of neuropathic symptoms Diabetic patients with no neuropathy or severe neuropathy Used any Aldose Reductase Inhibitors within one year of screening Clinically significant illness including unstable cardiac, pulmonary, hematologic, hepatic, renal, or neoplastic disease A history of systemic carcinoma within five years of screening A history of epilepsy or serious head injury A history or evidence of drug or alcohol abuse Test positive at screening for hepatitis B surface antigen or hepatitis C antibody or have a history of a positive result, or patients with evidence of significant hepatic insufficiency A history of known or suspected diagnosis of AIDS, or have tested seropositive for HIV antibody or antigen previously

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: ranirestat, (AS-3201)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic sensorimotor polyneuropathy, Diabetic Neuropathy
Study of Postoperative Nutritional Support in Cardiac Surgery.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether postoperative nutritional support improves postoperative outcomes in cardiac patients with malnutrition .

Official Title
-----------------
Prospective Randomized Study of Postoperative Nutritional Support in Cardiac Surgery.

Conditions
-----------------
Heart Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: Ensure, Abbott Nutrition
* Other: standard hospital diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Absolute lymphocyte count < 1500 Albumin <35 g/L Body mass index<21 kg/m2 B class of nutritional status according to Subjective Global Assessment Exclusion Criteria: Hepatitis B, C Total circulatory arrest Absence of informed consent signed Chronic liver diseases Gastric resection in patient's history Physical limitations of normal feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: postoperative nutritional supplements<br>postoperative nutritional supplements in addition to standard hospital diet | Dietary Supplement: Ensure, Abbott Nutrition<br>* Enteral feeding Ensure, Abbott Nutrition 400 ml per day for seven postoperative days<br>|
| Placebo Comparator: standard hospital diet<br>patients receiving standard hospital diet | Other: standard hospital diet<br>* standard hospital diet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Cardiac arrhythmia, infectious complications. | 1 month | 
| Total lymphocyte count |  | before operation, 7, 14, 21 postoperative days | 
| Serum albumin |  | Before operation, 7, 14, 21 postoperaitve days | 
| Serum prealbumin |  | Before operation, 7, 14, 21 postoperaitve days | 
| Retinol-binding protein |  | Before operation, 7, 14, 21 postoperaitve days |
Single Versus Repeat Betamethasone in Twin Pregnancies

Study Overview
=================
Brief Summary
-----------------
Thus far no robust data exist as to the effect of repeted course of antenatal corticosteroids in twin pregnancies. The investigators hypothesized that repeat course of betamethasone would further reduce neonatal morbidity in twins born before 34 weeks' gestation when compared with single dose.

Detailed Description
-----------------
Observational data suggest benefits in multiple gestations exposed to antenatal corticosteroids, although these studies have not consistently reported a statistical benefit or the benefits achieved in singletons. Nevertheless, based on the improved outcomes reported in singleton gestations, one course of antenatal corticosteroids is administered to all patients who are between 24 weeks and 34 weeks of gestation and at risk of delivery within 7 days, irrespective of the fetal number. Moreover, a repeat course of antenatal corticosteroids should also be considered in women who are less than 34 weeks of gestation who have an imminent risk of preterm delivery within the next 7 days, and whose prior course of antenatal corticosteroids was administered more than 14 days previously, again, irrespective of the fetal number. The objective of the current study is to evaluate fetal outcomes in twin pregnancies following repeat betamethasone administration during pregnancy.

Official Title
-----------------
Repeat Versus Single Course of Betamethasone in Twin Pregnancies

Conditions
-----------------
Twin; Complicating Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study group - women who received 2 courses of betamethasone between 24 - 34 weeks' gestation. Control comparison group - women who received 1 course of betamethasone between 24 - 34 weeks' gestation. Exclusion Criteria: singletone pregnancies higher order multiple pregnancies (triplets and above) known major congenital anomaly
Sexes Eligible for Study
-----------------
Female

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Single course of Betamethasone<br>Women with twin pregnancy who received 1 course of betamethasone between 24 - 34 weeks' gestation. | |
| Repeat course of Betamethasone<br>Women with twin pregnancy who received 2 courses (Repeat course) of betamethasone between 24 - 34 weeks' gestation. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation | The incidence of respiratory morbidity after single versus repeat course of betamethasone for threatened preterm labor between 24-34 weeks' gestation | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Betamethasone, Twin pregnancy, Repeat course, Single course
Predictive Value of Infarction Volume on Hemorrhagic Transformation in Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban

Study Overview
=================
Brief Summary
-----------------
This study was aimed at patients with newly diagnosed stroke / TIA associated with nonvalvular atrial fibrillation. We will observe the effect of early using rivaroxaban anticoagulation on hemorrhagic transformation, and explore the predictive value of multi-mode MRI infarct volume / MMP-9 on hemorrhagic transformation after anticoagulation therapy.

Official Title
-----------------
To Explore the Predictive Value of Infarction Volume on Hemorrhagic Transformation in Newly Diagnosed Ischemic Stroke/TIA With Non-valve Atrial Fibrillation(NVAF) Patients Using Rivaroxaban

Conditions
-----------------
Cerebrovascular Stroke, Intracranial Hemorrhages, Anticoagulant, Matrix Metalloproteinases

Intervention / Treatment
-----------------
* Drug: Rivaroxaban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, age≥18; Were newly diagnosed asischemic stroke/TIA concomitant NVAF; Prescribedand accept Rivaroxaban; Sign thewritten informed consent. Exclusion Criteria: Renal impairment (CrCl<15 ml/min) or severe hepatic impairment. Significant hemorrhagic transformation (parenchymal hematoma type I or type II by the ECASS definition). Stroke or TIA caused by large artery atherosclerosis Planned major surgery or invasive intervention Active internal bleeding Malignancy or other serious medical conditions with a life expectancy <6 months Allergery to Rivaroxaban Pregnancy or breast-feeding

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: Rivaroxaban|new oral anticoagulant molecules which is the selective factor Xa inhibitor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Susceptibility weighted imaging(SWI) detection of newly developed hemorrhagic transformation after 14 days of rivaroxaban treatment |  | 14 days after enrolling |