linjc16/ctgov huggingface dataset:
Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China

Study Overview
=================
Brief Summary
-----------------
Klebsiella pneumoniae is one of the most common pathogens causing nosocomial infection. Recently, the emergency of Carbapenem-Resistant Klebsiella pneumoniae (CRKP) had cause the clinical therapy be very difficult. However, there is not much empirical data as to the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection. Thus, the study was aimed to investigate the epidemiology and risk factors, characteristics, and the rationality of the current therapy for the CRKP infection.

Detailed Description
-----------------
All the patients with culture positive of Klebsiella pneumoniae were screened and reported to the the clinical doctors and confirmed by them. And the clinical characteristics of the patiens, such as baseline data, outcomes etc, were recorded. Finially, to find the prevalence, risk factors, characteristics, and the rationality of the current therapy for the CRKP infection

Official Title
-----------------
Epidemiological Characteristics and Treatment Protocol for Carbapenem-Resistant Klebsiella Pneumoniae in China

Conditions
-----------------
Klebsiella Pneumoniae Infection

Intervention / Treatment
-----------------
* Other: Carbapenem-Resistant Klebsiella pneumoniae


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: new confirmed noscomial infection of CRKP Exclusion Criteria: Age<18, or >85 years old; Mixed infection of CRKP and other microbes

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Carbapenem-Resistant K. pneumoniae<br>Patients with clinical confirmed Carbapenem-Resistant Klebsiella pneumoniae infection. | Other: Carbapenem-Resistant Klebsiella pneumoniae<br>* no intervention, this is an obervational study.<br>|
| Carbapenem-Sensitive K. pneumoniae<br>Any patients with clinical confirmed Carbapenem-Sensitive Klebsiella pneumoniae infection. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRKP infection | Culture postitive results confirmed the infection of CRKP | 7 days |
Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
The present study will examine the treatment effect of sodium thiosulfate on coronary calcification in patients on hemodialysis.

Detailed Description
-----------------
Coronary calcification (CAC) is prevalent among patients with end-stage renal disease (ESRD). High serum phosphate, the intake of calcium containing phosphate binder as well as dialysis vintage have been shown to be associated with the increasing prevalence of CAC. High CAC score examined by electron-beam CT scan or multi-slice CT scan associates with an increased cardiovascular mortality in ESRD. In series of case reports, intravenous sodium thiosulfate (STS) reduced the calcium burden in calcific uremic arteriopathy and soft tissue calcification. This was believed to be due to the calcium chelation effect of STS.

Official Title
-----------------
The Treatment Effect of Intravenous Sodium Thiosulfate on Coronary Calcification in Patients on Hemodialysis

Conditions
-----------------
Coronary Calcification, Vascular Calcification

Intervention / Treatment
-----------------
* Drug: 25% intravenous (IV) sodium thiosulfate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CAC score > 300 Life expectancy > 6 months Dialysis vintage > 6 months Exclusion Criteria: Non-compliance to hemodialysis

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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Drug: 25% intravenous (IV) sodium thiosulfate<br>* 50 ml IV drip twice/week post hemodialysis<br>|
| No Intervention: B<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CAC score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density, calcium removal |  | 6 months, 1 and 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary calcification, vascular calcification, sodium thiosulfate
PPI for Prevention of Post-sphincterotomy Bleeding

Study Overview
=================
Brief Summary
-----------------
Endoscopic biliary sphincterotomy is a common and important procedure for biliary access and therapy during endoscopic retrograde cholangiopancreatography (ERCP). Bleeding is one of the important complications related to sphincterotomy. This study determines the role of proton pump inhibitor (PPI) in preventing post-sphincterotomy bleeding in patients undergoing ERCP and sphincterotomy.

Detailed Description
-----------------
Eligible patients will be randomized to receive either high dose PPI or standard care. PPI will be given before ERCP and continue for one week after the sphincterotomy. Both overt and occult bleeding will be documented up to 10 days after the sphincterotomy. Bleeding rates of the two groups will be compared.

Official Title
-----------------
Prevention of Delayed Post-sphincterotomy Bleeding by High Dose Proton Pump Inhibitor

Conditions
-----------------
Bleeding, ERCP

Intervention / Treatment
-----------------
* Drug: Esomeprazole
* Other: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients undergoing ERCP who will require sphincterotomy Exclusion Criteria: Previous sphincterotomy/papillotomy Previous Polya gastrectomy Patients on maintenance PPI Pregnant and lactating women Age <18 years Previous liver transplant unable to consent for 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Esomeprazole<br>esomeprazole 40mg bd for 10 days | Drug: Esomeprazole<br> <br> * Other names: Nexium;|
| Sham Comparator: Standard care<br>No other study drug or placebo will be given | Other: Standard care<br>* No PPI or other study medication given<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients with bleeding after sphincterotomy |  | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of patients who require transfusion, endoscopic hemostasis and other intervention to control bleeding |  | 10 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ERCP, sphincterotomy, proton pump inhibitor
Safety and Efficacy of ActiGraft Treatment in Wound Care in Medical Centers

Study Overview
=================
Brief Summary
-----------------
Multicenter observational study to explore the efficacy of ActiGraft in the treatment of exuding cutaneous wounds in real-life usage.

Official Title
-----------------
An Observational Clinical Registry to Collect Safety and Efficacy Data on Wound Care in Medical Centers

Conditions
-----------------
Cutaneous Wounds

Intervention / Treatment
-----------------
* Device: ActiGraft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is ≥18 years of age Subject has an exuding cutaneous wound Subject agrees to the use of his health data, including photos of his wound in analysis and publications Subject/LAR must be able to read and understand English and/or Spanish Exclusion Criteria: Subject/LAR is unable to read and understand English or Spanish.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ActiGraft<br>Whole blood clot (WBC) gel | Device: ActiGraft<br>* Whole blood clot (WBC) gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage area reduction (PAR) at 4 weeks | Change from baseline at 4 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT). | 4 weeks | 
| Nature, frequency, and severity of adverse events in the intent to treat population | Nature, frequency, and severity (by CTCAE5) of adverse events | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage area reduction at 8 and 12 weeks | Change from baseline at 8 and 12 weeks of wounds treated with ACTIGRAFT compared to other treatments (no ACTIGRAFT). | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
DFU, PU, Surgical, Vascular, Trauma
Evaluation of the Rotational Stability

Study Overview
=================
Brief Summary
-----------------
To evaluate rotational stability of the investigational device implanted after cataract surgery.

Detailed Description
-----------------
The primary endpoint is angle of intraocular lens rotation between the day of surgery and postoperative 6 months.

Official Title
-----------------
Rotational Stability of the Blue Light-absorbing Hydrophobic Acrylic Posterior Chamber Single Piece Intraocular Lens

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Device: intraocular lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, 18 years or older Subject who diagnosed unilateral or bilateral age-related cataract. Potential postoperative BCVA of 0.2 log MAR (0.63) or better. Calculated IOL power in within the range of investigational IOL. Subject is able to understand, agree and sign the informed consent statement. Subject is able and willing to comply with the postoperative follow-up examination schedule. Exclusion Criteria: Uncontrolled systemic or ocular disease. Extremely shallow anterior chamber. Previous intraocular and corneal surgery. Traumatic cataract. Pregnancy or lactation. Concurrent participation in another drug and device clinical investigation.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: one group<br>one group receiving NIDEK intraocular lens | Device: intraocular lens<br>* Implant NIDEK intraocular lens after cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The intraocular lens rotation | The angle of the intraocular rotation. | postoperative 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual acuity | Distance BCVA | postoperative 6 months | 
| Adverse event | severity and causal relationship | postoperative 6 months |
Tight Glycemic Control and Insulin Administration During Parenteral Nutrition

Study Overview
=================
Brief Summary
-----------------
In this study the investigators want to comare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.

Detailed Description
-----------------
In this study the investigators want to compare safety and efficacy of two different metods to administrate insulin during parenteral nutrition.

Official Title
-----------------
Tight Glycemic Control and Insulin Administration During Parenteral Nutrition, in Critical Ill Patients

Conditions
-----------------
Critical Ill Patient Undergone Parenteral Nutrition

Intervention / Treatment
-----------------
* Dietary Supplement: Insulin separated
* Dietary Supplement: Insulin added to parenteral nutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critical ill patients undergone parenteral nutrition Exclusion Criteria: Acute cerebral injury, pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin separated<br>Seprated infusion of insulin | Dietary Supplement: Insulin separated<br>* separate continuos infusion of insulin<br>|
| Active Comparator: Insulin added to parenteral nutrition<br>Insulin added to parenteral nutrition | Dietary Supplement: Insulin added to parenteral nutrition<br>* Insulin added to parenteral nutrition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of glucose level control out of range (80-110 mg/dl) |  | ICU stay (a week on average) |
Observational Study to Evaluate Risks of Side Effects, Drug Abuse and Dependence in Patients Who Received Xyrem ® on Prescription

Study Overview
=================
Brief Summary
-----------------
Patients will be followed up for max 18 months. Information on the Adverse Events and potential misuse or abuse of Xyrem ® will be collected.

Official Title
-----------------
Post Marketing Non-interventional Surveillance Pharmacoepidemiology Study (PMSS) to Evaluate Long-term Safety, Tolerability and Compliance in Administration of Xyrem® (Sodium Oxybate) Oral Solution in Patients Who Receive Treatment With This Medication in Regular Clinical Practice.

Conditions
-----------------
Narcolepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received Xyrem ® on prescription Exclusion Criteria: No limitations
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 |
| --- | --- | --- |
| Evaluation of risk for development adverse events, withdrawal syndrome and potential for dependence, abuse, overdose and misuse of Xyrem®. Obtaining information about adherence to Xyrem® prescribing information regarding indication and dosage. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Narcolepsy, Cataplexy, Oxybate, Xyrem, Misuse, Safety
P53 in Differentiated Thyroid Cancer

Study Overview
=================
Brief Summary
-----------------
In clinical practise patients with negative radioiodine scan with positive tyhroglobulin is considered as radioiodine resistant or in another words in the process of dedifferentiation. The aim of the present study was to search a simple blood test that could lead to early identification of patients with dedifferentiation. In this respect, we investigate whether the serum level of anti-p53 antibody has the diagnostic value in the follow-up of patients with high levels of thyroglobulin (tg) and negative I-131 scan.

Detailed Description
-----------------
In the present study enrolled were 171 patients with mean age of 47.7±13.5 yrs (range; 16-80yrs) and 28 healthy subjects with an age range of 18-52 yrs (mean: 36.0±9.8 yrs). 134 (78.4%) patients were female and 37 (21.6%) patients were male.

Official Title
-----------------
P53 Antibody; Is it an Indicator of Dedifferentiated Thyroid Cancer?

Conditions
-----------------
Thyroid Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed with DTC Treated with total and/or near-total thyroidectomy Referred for I-131 ablation therapy or low dose I-131 whole body scan (WBS) Between December 2010 and January 2013. Exclusion Criteria: Dose 131-I given in another hospital Radioiodine treatment more than one year after thyroidectomy.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum 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 |
| --- | --- |
| thyroid cancer, healty<br>Thyroid cancer group: patients with differentiated or dedifferentiated thyroid cancer Healty: control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| There was not any risk for patients. |  | with in the first 8-10 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tumor Suppressor Protein p53,, Iodine Radioisotopes
Change in Plaque Characteristics With Atorvastatin

Study Overview
=================
Brief Summary
-----------------
To examine effects of intensive lipid lowering therapy with atorvastatin on stabilization of coronary plaque by using optical coherence tomography (OCT) in patients with acute coronary syndrome.

Detailed Description
-----------------
Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI and have at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS are enrolled. Fibrous cap thickness of a target coronary plaque is evaluated by optical coherence tomography.

Official Title
-----------------
Effect of Atorvastatin Therapy on Fibrous Cap Thickness in Coronary Atherosclerotic Plaque as Assessed by Optical Coherence Tomography

Conditions
-----------------
Acute Coronary Syndrome, Atherosclerosis, Dyslipidemia

Intervention / Treatment
-----------------
* Drug: high-dose atorvastatin
* Drug: low-dose atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with acute coronary syndrome (myocardial infarction or unstable angina) who will undergo PCI. plasma LDL cholesterol levels : >=100mg/dL and ≤160mg/dL at least one atherosclerotic lesion of >25% stenosis other than culprit lesions of current ACS Exclusion Criteria: Patients who will undergo coronary bypass surgery. Patients with major complications during treatment of culprit coronary lesions. Patients with an atherosclerotic lesion with >50% stenosis at a left main trunk.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Atorvastatin 20mg | Drug: high-dose atorvastatin<br>* 20mg/day<br>* Other names: Lipitor20;|
| Active Comparator: 2<br>atorvastatin 5mg | Drug: low-dose atorvastatin<br>* 5mg/day<br>* Other names: Lipitor5;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibrous cap thickness by OCT |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| macrophage number |  | 12 months |