linjc16/ctgov huggingface dataset:
Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Study Overview
=================
Brief Summary
-----------------
Previous studies have demonstrated that altered microvascular blood flow is an important marker of severe sepsis. Usually, these patients need invasive ventilatory support, frequent use of sedatives and it is unknown if these agents interfere or not on microvascular blood flow. The goal of this study was to compare effects of propofol and midazolam infusions on sublingual microcirculation of septic shock patients.

Official Title
-----------------
Effects of Sedatives on Sublingual Microcirculation of Patients With Septic Shock

Conditions
-----------------
Shock,, Sepsis

Intervention / Treatment
-----------------
* Drug: Sedation drug (Propofol and Midazolam)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Septic shock patients needing mechanical ventilation in pressure or volume-controlled mode. Exclusion Criteria: age less than 18 years, pregnancy, non-sinus rhythm, and contraindication of daily interruption of sedative drug, mainly with the use of neuromuscular blocking drugs, or patients with intracranial hypertension or epileptical status.

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
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Sedation drug (Propofol and Midazolam)|Septic patients, after intubation, were initially sedated with propofol. During the second day of mechanical ventilation, propofol infusion was interrupted. When the patient awoke, the sedative drug was changed to midazolam. Sedation target was a Ramsay Scale score of 4 to 5.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sublingual Microcirculatory Variables | Patients were sedated with propofol during the first 24 hours after intubation and with midazolam afterwards.Systemic hemodynamics and perfusion parameters were assessed at two time points: just before stopping propofol and thirty minutes after the start of midazolam infusion. At both steps, four microcirculatory sequences were acquired using sidestream darkfield imaging to access sublingual microcirculation | Just before stopping propofol and thirty minutes after the start of midazolam infusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microcirculation, Hypnotics and Sedatives,, Propofol,, Midazolam
Nutrition Beverage Tolerance Study

Study Overview
=================
Brief Summary
-----------------
To evaluate the sensations experienced by subjects consuming a nutritional beverage.

Official Title
-----------------
Nutrition Beverage Tolerance Study

Conditions
-----------------
Human Volunteers

Intervention / Treatment
-----------------
* Other: Nutritional Beverage
* Other: Nutritional Beverage
* Other: Nutritional Beverage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject ≥ 45 years of age. If female, subject is either postmenopausal for at least 1 year or surgically sterile Subject reports that he/she has not participated in a research study in the last three months. Exclusion Criteria: Subject has active metabolic or endocrine disease Subject has an autoimmune disorder Subject has a disorder of gastrointestinal tract or any gastrointestinal surgery in past 12 months. Subject has food allergy, celiac disease or intolerance to any of the ingredients in the study products Subject reports history of parasthesia; and/or is currently taking medication/dietary supplements/substances that may cause parasthesia for 4 weeks prior to screening

Ages Eligible for Study
-----------------
Minimum 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nutritional Beverage #2<br>Nutritional Beverage with an amino acid Oral 237 ml | Other: Nutritional Beverage<br>* Nutritional Beverage Oral 237 mL<br>|
| Experimental: Nutritional Beverage #3<br>Nutritional Beverage with an amino acid Oral 237 ml | Other: Nutritional Beverage<br>* Nutritional Beverage Oral 237mL<br>|
| Placebo Comparator: Nutritional Beverage #1<br>Nutritional Beverage Oral 237 ml | Other: Nutritional Beverage<br>* Nutritional Beverage Oral 237mL<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects experiencing neurologic adverse event(s) |  | 2-3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects experiencing any adverse event(s). |  | 2-3 Weeks |
Montelukast in Chronic Asthma

Study Overview
=================
Brief Summary
-----------------
Treatment of patients insufficiently treated with ICS or ICS + LABA.

Official Title
-----------------
Montelukast in Chronic Asthma: Non-interventional Study With Montelukast 10 mg

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients Insufficiently Treated With ICS Or ICS + LABA.

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 |
| --- | --- |
| 1<br>Mild to moderate adult asthmatics (≥18years of age) insufficiently treated with ICS or ICS + LABA. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of asthma control via ACT (Asthma Control Test). |  | 6 months (12 months optional) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mini Asthma Quality of Life Questionnaire (Mini AQLQ). |  | 6 months (12 months optional) |
Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea

Study Overview
=================
Brief Summary
-----------------
This study has been designed to investigate the comparative effects of sitagliptin vs. pioglitazone as add-on treatments in patients with type 2 diabetes who were uncontrolled on the full-dose of metformin and sulfonylurea

Official Title
-----------------
Efficacy, Durability, Safety, and Tolerability of Sitagliptin vs. Pioglitazone as add-on Treatments in Patients With Type 2 Diabetes Uncontrolled on the Full-dose Metformin Plus Sulfonylurea: a 52-week, Randomized, Open-label, Parallel-group, Phase 3 Clinical Trial

Conditions
-----------------
Uncontrolled Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Sitagliptin 100mg
* Drug: Pioglitazone 30 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of type 2 diabetes according to the American Diabetes Association Baseline level of 7% ≤ A1C < 11% despite a minimum 6 months period of active treatment with metformin 2000 mg/day plus gliclazide 240 mg/day (uncontrolled type 2 diabetes) Exclusion Criteria: Acute or chronic diseases of heart, lung, kidney, Active or past infectious conditions Malignancy

Ages Eligible for Study
-----------------
Minimum Age: 25 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 |
| --- | --- |
| Active Comparator: Sitagliptin<br> | Drug: Sitagliptin 100mg<br>* Sitagliptin arm took sitagliptin 100 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks<br>|
| Active Comparator: Pioglitazone<br> | Drug: Pioglitazone 30 mg<br>* Pioglitazone arm took pioglitazone 30 mg daily in combination with metformin 500 mg QID and gliclazide 80 mg TDS for 52 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in mean glycated hemoglobin (A1C) levels by sitagliptin vs. pioglitazone |  | 52 weeks |
Symbicort Onset of Action 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the early onset of effect of Symbicort compared to Advair Diskus and Ventolin in adults with asthma

Official Title
-----------------
A Randomized, Multicenter, Placebo and Active-Controlled, Single-Dose, 4-Period, Crossover Study to Evaluate the Bronchodilating Effect of SYMBICORT pMDI Versus Advair Diskus and Ventolin HFA.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: budesonide/formoterol (Symbicort)
* Drug: fluticasone/salmeterol (Advair Diskus)
* Drug: albuterol (Ventolin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of asthma and baseline lung function test results as determined by protocol Required and received asthma maintenance therapy within previous 4 weeks at doses determined by protocol Exclusion Criteria: Severe asthma or asthma markedly affected by seasonal factors Has required treatment with any non-inhaled corticosteroids within previous 4 weeks, has sensitivity to drugs specified in the protocol or requires treatment with beta-blockers

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: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>budesonide/formoterol | Drug: budesonide/formoterol (Symbicort)<br> <br> * Other names: Symbicort;|
| Active Comparator: 2<br>fluticasone/salmeterol | Drug: fluticasone/salmeterol (Advair Diskus)<br> <br> * Other names: Advair Diskus;|
| Active Comparator: 3<br>albuterol | Drug: albuterol (Ventolin)<br> <br> * Other names: Ventolin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FEV1 3 minutes post dose |  | 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 12 hour serial FEV1 |  | 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) | 
| Patients perception of effect |  | 4 assessments across 4 visits whilst on treatment (visits may be between 3 and 14 days apart) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
asthma, bronchodilatation, Symbicort, budesonide/formoterol, Advair Diskus, Ventolin
Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium

Study Overview
=================
Brief Summary
-----------------
The study will use the VereMTB tool for rapid diagnosis of TB or non-tuberculous mycobacterium (NTM) pulmonary infections in hospitalised patients, with positive results in acid-fast bacilli smears, which are emerging in many regions of the world.

Detailed Description
-----------------
Delay in diagnosis and treatment of tuberculosis was common in hospitalised patients all around the world, and was associated with poorer outcomes, including respiratory failure and mortality. Rapid and accurate tools for diagnosis of TB is of great importance in initial treatment and for better treatment outcomes. Other than TB, non-tuberculous mycobacterium (NTM) pulmonary infections are emerging in many regions of the world. These bacterium are more common to be found in respiratory specimens than MTB. With similar clinical presentation of NTM pulmonary infections and pulmonary TB, misdiagnosis of NTM pulmonary infections to pulmonary TB would lead to unnecessary intake of anti-TB medications and delay of the initiation of corresponding treatment. This test aims to detect MTB as well differentiate the NTM species involved in pulmonary infections simultaneously using VereMTB.

Official Title
-----------------
Performance of a Multiplex PCR -Microarray-based Assay in the Detection of Mycobacterium Tuberculosis and Non-tuberculous Mycobacterium Species in Smear-positive Pulmonary Clinical Specimens

Conditions
-----------------
Tuberculosis, Non-Tuberculous Mycobacterial Pneumonia

Intervention / Treatment
-----------------
* Diagnostic Test: VereMTB


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or older One or more symptoms compatible with mycobacterial pulmonary infections, including fever, cough, sputum production,hemoptysis dyspnea, chest pain and weight loss One or more sputum samples with positive AFB smear Exclusion Criteria: Receiving anti-mycobacterial treatment for more than one week Refusal to consent

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 |
| --- |
|Diagnostic Test: VereMTB|At least 2 mL of patient's expectorated or induced sputum would be collected for VereMTB assay and their clinical data would be retrieved for analysis use.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diagnostic test correlation | Sensitivity, specificity, positive predictive value, and negative predictive value, will be calculated to determine accuracy of VereMTB, in diagnosing MTB and NTM | 6 months from the date of first recruitment |
Pectin Supplemented Enteral Feedings in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
The current study will enroll critically ill patients who are going to require enteral nutrition support and randomize them to standard formula enteral nutrition or pectin-supplemented enteral nutrition in 7 days. The occurrence of enteral nutrition-related complications will be recorded and compared between groups. The study is trying to assess whether the use of pectin will improve the enteral nutrition-related complications in critically ill patients.

Official Title
-----------------
The Effect of Pectin Supplement on Enteral Nutrition-related Complications in Critically Ill Patients

Conditions
-----------------
Enteral Nutrition, Dietary Fiber

Intervention / Treatment
-----------------
* Dietary Supplement: pectin-supplemented enteral nutrition feeding
* Other: enteral nutrition feeding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18-80 years old, with informed consent to participate; Critically ill patients who require enteral nutrition support Exclusion Criteria: Patients with lung infection at admission Condition which contraindicates enteral feeding (i.e. intestinal obstruction) Lack of enteral access Any condition that would contraindicate use of the enteral nutrition Require enteral nutrition support for less than 1week or more than 4 weeks from enrollment

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pectin<br>sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days | Dietary Supplement: pectin-supplemented enteral nutrition feeding<br>* sequential supplementation with combination of 90ml pectin and 500ml enteral nutrition formula for 7 days<br>|
| Placebo Comparator: Control<br>standard formula enteral nutrition feeding without pectin for 7 days | Other: enteral nutrition feeding<br>* standard formula enteral nutrition feeding without pectin for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication of enteral feeding | Record daily diarrhea ,complications, aspiration pneumonia,poor gastric emptying | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| feeding time of enteral nutrition | Record daily feeding time of enteral nutrition | 7 days | 
| total energy intake | Record daily energy intake | 7 days |
Adjuvant Radiation in Aortic Valvuloplasty - ARAVA

Study Overview
=================
Brief Summary
-----------------
This study will examine the effect of external beam radiation therapy in the prevention of restenosis following successful balloon aortic valvuloplasty in severe, symptomatic aortic stenosis.

Conditions
-----------------
Aortic Valve Stenosis

Intervention / Treatment
-----------------
* Procedure: Balloon Aortic Valvuloplasty
* Procedure: External Beam Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe Aortic Stenosis NYHA Class 2-4 CHF Symptoms Age > 75 EuroSCORE > 7 Prohibitively High Risk for Aortic Valve Replacement Surgery as Designated by a Cardiac Surgeon

Ages Eligible for Study
-----------------
Minimum 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Balloon Aortic Valvuloplasty|nan|
|Procedure: External Beam Radiation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
'OLAP' (OLAparib Regulatory Post-marketing Surveillance)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess safety and effectiveness of Lynparza tablet (olaparib, hereinafter the study drug) in a real world setting in patients who are prescribed with the study drug according to the approved indications in South Korea

Detailed Description
-----------------
Primary Objective: To assess the safety of the study drug for patients prescribed with the study drug under the approved indications in South Korea Secondary Objective: To assess effectiveness of the study drug for patients prescribed with the study drug under the approved indication in South Korea Exploratory Objective: To assess effectiveness of the study drug for ovarian cancer patients diagnosed as Homologous Recombination Deficiency (HRD) positive via locally available validated HRD test and prescribed with the study drug under the approved indication in South Korea

Official Title
-----------------
Lynparza Tablet (Olaparib) Regulatory Post-Marketing Surveillance

Conditions
-----------------
Ovarian Cancer, Breast Cancer, Prostate Cancer, Pancreatic Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for the study drug treatment according to the approved label in South Korea Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: History of hypersensitivity to excipients of the study drug or to drugs with a similar chemical structure or class to the study drug Prior exposure to any Polyadenosine 5'diphosphoribose polymerase (PARP) inhibitors, including the study drug Pregnant and/or breast feeding Current participation in any interventional trial Other off-label indications according to the approved label

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 150 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 |
| --- | --- | --- |
| Safety (adverse events (AEs), serious AEs (SAEs), adverse drug reactions(ADRs), serious ADRs (SADRs), unexpected AEs/ADRs) |  | For about 1 year since the first dose of the study drug | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6-month real-world Progression free survival (rwPFS) | In this PMS, the secondary/pre-specified endpoint is not just PFS, but real-world PFS (rwPFS). That means the sponsor cannot claim investigator/patients to visit hospital for study assessment purposes. We, study sponsor, can only assess and record patient's disease progression status when patients visit hospital for their original follow-up. That's why we need further +50% duration for assessing rwPFS. | For about 1 year since the first dose of the study drug |