linjc16/ctgov huggingface dataset:
Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation: NIV (Non Invasive Ventilation) HFNC (High-flow nasal canula oxygen therapy)

Detailed Description
-----------------
Design: Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device. Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation. Randomized study, inclusion in two groups: NIV or HFNC. Experimental group: NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2. Control group: NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%. Duration of participation of each patient: 28 days

Official Title
-----------------
Comparison of Pre-oxygenation by Non-invasive Ventilation With High-flow Nasal Oxygen Therapy for Intubation of Intensive Care Patients in Cases of Acute Respiratory Failure: A Prospective, Randomized, Controlled Study (FLORALI 2)

Conditions
-----------------
Acute Respiratory Failure, Intratracheal Intubation

Intervention / Treatment
-----------------
* Procedure: High Flow nasal canula oxygen therapy
* Procedure: Noninvasive ventilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion Criteria: acute hypoxemic respiratory failure requiring endotracheal intubation Main exclusion Criteria: coma NIV contraindication

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: NIV<br>NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%. | Procedure: Noninvasive ventilation<br>* Pre-oxygenation with non-invasive ventilation<br>|
| Active Comparator: HFNC<br>High-flow nasal canula oxygen therapy. NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2 | Procedure: High Flow nasal canula oxygen therapy<br>* Pre-oxygenation with high-flow nasal canula oxygen therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe desaturation as defined by a pulse oxymetry below 80% | drop below 80% of pulse oxymetry measurement | through five minutes after preoxygenation period |
Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The goal of the project: to study the dynamics of the humoral and cellular immunity in patients after pneumonia caused by the SARS-CoV-2 virus at different time intervals, in order to predict the duration of immune protection

Detailed Description
-----------------
to form study groups of patients (at least 60 patients in total) who have recovered from pneumonia of varying severity caused by the SARS-CoV-2 virus (at least 30 patients in each of the groups of patients who have had pneumonia in moderate and severe forms); to investigate the parameters of cellular immunity (the content of antigen-specific T-cells to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia; to investigate the indicators of humoral immunity (the content of IgG to the main viral antigens - proteins S, N, M) in patients of different groups included in the trials, in dynamics 3, 6, 9 and 12 months after the COVID-19-associated pneumonia.

Official Title
-----------------
Estimation of Dynamics of Humoral and Cellular Immunity in COVID-19 Patients

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Humoral and cellular immunity


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients recovered from the COVID-19 associated pneumonia (moderate and severe) in 1-3 month interval before inclusion into the trial; Exclusion Criteria: cancer; drug and alcohol addiction; autoimmune diseases.

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 |
| --- | --- |
| COVID-19 moderate<br>moderate COVID-19 associated pneumonia | Diagnostic Test: Humoral and cellular immunity<br>* Humoral (IgG) and cellular (antigen-specific cells) immunity<br>|
| COVID-19 severe<br>severe COVID-19 associated pneumonia | Diagnostic Test: Humoral and cellular immunity<br>* Humoral (IgG) and cellular (antigen-specific cells) immunity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The dynamics of humoral and cellular immunity | The dynamics of both humoral and cellular immunity in response to COVID-19 infection | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COVID-19
Prevail-Us: A Study Of Pitavastatin 4 mg Vs. Pravastatin 40 mg In Patients With Primary Hyperlipidemia Or Mixed Dyslipidemia

Study Overview
=================
Brief Summary
-----------------
Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.

Official Title
-----------------
A RANDOMIZED, DOUBLE-BLIND, ACTIVE CONTROLLED, PARALLEL GROUP STUDY OF PITAVASTATIN 4 MG VS. PRAVASTATIN 40 MG IN PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA

Conditions
-----------------
Primary Dyslipidemia, Mixed Dyslipidemia

Intervention / Treatment
-----------------
* Drug: pitavastatin
* Drug: pravastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female subjects with primary hypercholesterolemia or mixed dyslipidemia who are ≥18 and ≤80 years of age at the time of consent Plasma Low-density lipoprotein cholesterol (LDL-C) ≥130 milligrams per deciliter (mg/dL) and ≤220 mg/dL and triglyceride (TG) levels of ≤400 mg/dL Exclusion Criteria: Homozygous familial hypercholesterolemia Any conditions which may cause secondary dyslipidemia Uncontrolled diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: pitavastatin 4 mg once daily (QD)<br> | Drug: pitavastatin<br>* pitavastatin 4 mg once daily (QD)<br>* Other names: Livalo;|
| Active Comparator: pravastatin 40 mg once daily (QD)<br> | Drug: pravastatin<br>* Pravastatin 40 mg once daily (QD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Percent Change in Low Density Lipoprotein Cholesterol(LDL-C) From Baseline to Week 12 |  | Baseline and 12 weeks |
Microbial Markers for AGI

Study Overview
=================
Brief Summary
-----------------
AGI is very common in ICU and sometimes will trigger the development of gut derived sepsis. Thus, to find out the biomarker in early stage is very important to improve the overall prognosis of critically ill patients. In this project we try to find out the microbial biomarker of AGI through multi-omic technology.

Official Title
-----------------
Investigation on the Microbial Biomarkers of AGI in the Early Stage

Conditions
-----------------
Acute Gastrointestinal Injury

Intervention / Treatment
-----------------
* Other: none intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All those critically ill patients with anticipated ICU stay for more than 2 days Exclusion Criteria:Patients will be excluded if they have any of the following situations: patients who have not signed the informed consent; Unable to tolerate intra-abdominal pressure monitoring; pregnant woman; Patients after bladder surgery; Systemic diseases and recent use of related drugs; He had a history of infectious diseases, such as tuberculosis or PPD positive. History of hypertension and poor blood pressure control (SBP / DBP > = 140mmHg); Patients with severe mental illness; Long term use of traditional Chinese medicine, probiotics, gastric mucosal protective agents, proton pump inhibitors, chemotherapy or immunosuppressive drugs, etc. were not included if the drug was not stopped within one month before admission. -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| training group<br>the observational group to find out the potential biomarker | Other: none intervention<br>* none intervention.<br>|
| validation group<br>the validation group to validate the parameters used for early diagnosis | Other: none intervention<br>* none intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The AUC value of the combined markers | The combined diagnostic accuracy of AGI through omic parameters | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
microbiome, metabolome, biomarker
The Effect of Positive End Expiratory Pressure (PEEP) During Laparoscopic Cholecystectomy

Study Overview
=================
Brief Summary
-----------------
During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain. positive end expiratory pressure (PEEP)could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional brain oxygen saturation (rSO2)

Detailed Description
-----------------
During the laparoscopic cholecystectomy, Pneumoperitoneum could affect to the regional oxygen saturation of brain due to increased intracranial pressure, central venous pressure and make worse to respiratory parameters. Positive end expiratory pressure could improve the respiratory parameters include oxygenation. So applying PEEP could improve the regional oxygen saturation of brain during the pneumoperitoneum during the laparoscopic cholecystectomy.

Official Title
-----------------
The Effect of PEEP on Regional Cerebral Oxygen Saturation During Laparoscopic Cholecystectomy

Conditions
-----------------
Brain Ischemia

Intervention / Treatment
-----------------
* Other: PEEP
* Other: ZEEP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II, 20-65 year, patient who undergoing laparoscopic cholecystectomy Exclusion Criteria: cerebrovascular disease, coronary artery disease, morbid obesity (BMI > 30) propofol allergy, addictive

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zero positive end expiratory pressure<br>Number: 30, apply no PEEP during the pneumoperitoneum during the laparoscopic cholecystectomy PEEP was not applied whole investigation period | Other: PEEP<br>* applying PEEP 0 cmH2O during pneumoperitoneum continuously<br>* Other names: PEEP 0;|
| Active Comparator: positive end expiratory pressure<br>applying PEEP 10 cmH2O during pneumoperitoneum continuously | Other: ZEEP<br>* applying PEEP 10 cmH2O during pneumoperitoneum continuously<br>* Other names: PEEP 10;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in regional brain oxygen saturation | FiO2 0.6, Tidal vlume 8 ml/IBW (kg), PEEP 10 cm H2O or not, respiratory rate as end-tidal carbone dioxide concentration (ETCO2). During the peumoperitoneum record rSO2 every 10 minutes with respiratory parameters (Peak pressure, mean pressure, PEEP) and vital signs | from baseline record rSO2 every 10 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
laparoscopic cholecystectomy, PEEP, rSO2
Safety of Pregabalin in the Treatment of Pain Due to Diabetic Peripheral Neuropathy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to 1) provide continued pregabalin treatment for 6 additional months to patients who have taken part in the placebo controlled study A0081060; and 2) find out if pregabalin is safe at a dose of 600 mg/day (taken twice a day)

Official Title
-----------------
An Open Label Extension Safety Trial of Pregabalin (CI-1008) in Subjects With Diabetic Peripheral Neuropathy

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

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with Type 1 or 2 diabetes Patients must have pain in their lower legs or feet due to painful diabetic neuropathy that has lasted for at least 3 months Exclusion Criteria: Patients must not be in poor or unstable health.

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  |
Hepatic Impairment Study

Study Overview
=================
Brief Summary
-----------------
This study is to find out how the subject's body processes and reacts to the study drug, and to find out how long it remains in the subjects system after one dose. Subjects with varying degrees of liver function are being asked to participate in this study. Study results from subjects with normal liver function will be compared with study results from subjects with impaired liver function.

Official Title
-----------------
Open Label, Phase 1 to Evaluate the Effect of Hepatic Impairment on the Pharmacokinetic of Sorafenib ( BAY43-9006)

Conditions
-----------------
Liver Disease

Intervention / Treatment
-----------------
* Drug: Sorafenib (Nexavar, BAY43-9006)
* Drug: Sorafenib (Nexavar, BAY43-9006)
* Drug: Sorafenib (Nexavar, BAY43-9006)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects, Child Pugh A and Child Pugh B Liver Disease Patients.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 75 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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Mildly Hepatic Impaired Subjects<br>|
| Experimental: Arm 2<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Moderately Hepatic Impaired Subjects<br>|
| Experimental: Arm 3<br> | Drug: Sorafenib (Nexavar, BAY43-9006)<br>* Healthy Subjects<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK measurements |  | Day 1-6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Exam |  | Screening, Day 6 | 
| Labotatory Safety, Chemistry panel, PTT, hematology Urine Analysis |  | Screening Day 1, Day 6 | 
| ECG |  | Screening Day 1, Day 6 | 
| Vital Signs |  | Screening Day 1, Day 6 | 
| Follow up phone call |  | Day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Liver disease
Quality of Life and Adverse Effects in Epilepsy Patients (EPIKA)

Study Overview
=================
Brief Summary
-----------------
Observational, multicentre, epidemiological study to determine the HRQOL of patients with epilepsy according to treatment sub-group and to validate the Spanish version of the Adverse Events Profile, produced by G. Baker et al. Three treatment groups will be examined: patients receiving only a new anti-epilepsy drug (AED), patients receiving a classic AED; patients receiving combination therapy.

Official Title
-----------------
Quality of Life and Adverse Effects in Epilepsy Patients According to Treatment Group (EPIKA)

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Epileptic adult patients treated at a stable dose with one or more AEDs for ≥ 3 months Exclusion Criteria: Symptomatic epilepsy due to malignant brain tumour or progressive brain disease. Confirmed diagnosis of a concomitant chronic disease

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
Observational, cross-sectional, health-related quality of life, adverse effects, Baker´s AEP scale validation, epilepsy
Reliability of Chinese Version of Verbal Learning Test and Selective Reminding Test

Study Overview
=================
Brief Summary
-----------------
Mild cognitive impairment (MCI) is distinguished from healthy aging by cognitive difficulties that are greater than expected for one's age and education. Amnestic mild cognitive impairment (aMCI) is a major sub-type of MCI with noticeable impairments in memory. Approximately 12% of aMCI will progress to AD per year. There are two test to evaluate the effects on memory, but both without Chinese version. This study is to know the test-retest reliability of the Chinese version of the Verbal learning test and Selective reminding test among people with mild cognitive impairment.

Official Title
-----------------
Test-retest Reliability of the Chinese Version of the Verbal Learning Test and Selective Reminding Test Among People With Mild Cognitive Impairment

Conditions
-----------------
Mild Cognitive Impairment, Test-retest Reliability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥50 years Complained of memory impairment Chinese Version Verbal Learning Test 10-minute delays ≤ 6 words MMSE score≥24 and CDR score=0.5 Activities of daily living are intact DSM-IV criteria for the diagnosis of dementia is not met Exclusion Criteria: Any significant neurologic disease other than suspected incipient Alzheimer's disease Psychotic features, contraindication of exercise... which could lead to difficulty complying with the protocol

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 100 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 |
| --- | --- | --- |
| Chinese Version of Verbal Learning Test |  | Change from baseline at two week | 
| Chinese Version of Selective Reminding Test |  | Change from baseline at two week |
Hematological Disorders in Covid 19 Patients

Study Overview
=================
Brief Summary
-----------------
aim of the research is to detect hematological abnormalities in covid 19 patients and its correlation with the severity and outcome of the disease.

Detailed Description
-----------------
Covid 19 is an infectious disease caused by a newly discovered coronavirus.most people infected with the covid 19 virus will have mild to moderate respiratory illness and recover without specific treatment.older people and those with underlying medical problems like cardiac diseases,diabetes,any chronic respiratory disease and cancer are more likely to have serious illness.the covid 19 virus spreads primarily through droplets of saliva or discharge from the nose oral cavity when an infected person coughs or sneezes.people with covid19 have had a wide range of symptoms reported _ranging from mild to severe symptoms.symptoms may appear 2_14 days after exposure to the infection .any one can have mild to severe symptoms.people with these symptoms may have covid 19: fever or shivering,cough,shortness of breath,fatigue,body or muscle aches,headache,new loss of smell or taste ,sore thraot,congestion or running nose , nausea or vomiting,diarrhoea. The most common hematological clinical findings include lymphocytopenia,neutrophilia,eosinophilia,mild thrombocytopenia,and less frequently thrombocytosis,the presence of reactive lymphocytes has been reported only occasionally the leucocyte count may be normal,reduced or increased.according to a meta analysis leucocytosis,lymphopenia and thrombocytopenia are associated with greater severity and fatality in covid 19 cases

Official Title
-----------------
Hematological Disorders in Covid 19 Patients

Conditions
-----------------
Hematological Abnormalities in covid19

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all covid 19 patients diagnosed by pcr or CT chest - Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematological disorders in covid 19 patients | to detect hematological abnormalities in covid 19 patients and its correlation to outcome and severity of the disease | Baseline |