linjc16/ctgov huggingface dataset:
Clinical Characteristics and Microbiology of Community-Acquired Pneumonia

Study Overview
=================
Brief Summary
-----------------
Community-Acquired Pneumonia has become common. Additionally, the mortality is high. But the epidemiology of pathogen is various in different areas, which is crucial for the key treatment. In addition, the risk factors of patients who died in 3 or 7 days in china is not clear, comparing with patients who died in 14 or 28 days or who survived.

Official Title
-----------------
Clinical Characteristics and Microbiology of Community-Acquired Pneumonia: A Prospective Study

Conditions
-----------------
Community-acquired Pneumonia

Intervention / Treatment
-----------------
* Other: Cohort Study； pathogen； clinical features


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed community acquired pneumonia Age≥18 ys Exclusion Criteria: HIV infection

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 |
| --- | --- |
| Beijing Haidian Hospital<br> | Other: Cohort Study； pathogen； clinical features<br>* Cohort Study； pathogen； clinical features<br>|
| Chinese PLA General Hospital<br> | Other: Cohort Study； pathogen； clinical features<br>* Cohort Study； pathogen； clinical features<br>|
| Beijing Tsinghua Chang gung Hospital<br> | Other: Cohort Study； pathogen； clinical features<br>* Cohort Study； pathogen； clinical features<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the epidemiology of pathogen of community-acquired pneumonia in the three hospitals | screen out the pathogen of community-acquired pneumonia | confirmed as community-acquired pneumonia （2 weeks） | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk factors of patients who died in 3 or 7 days | patients who die in 3 or 7 days | in one week（3 days or 7days） | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pathogen, Mortality, Risk factors, Community-acquired Pneumonia
Uterus Transplantation From a Multi-organ Donor

Study Overview
=================
Brief Summary
-----------------
Uterus transplantation: screening, in vitro fertilization [IVF] treatment to be able to freeze embryos, uterus transplantation, pregnancy and afterwards removal of the uterus.

Official Title
-----------------
Uterus Transplantation From a Multi-organ Donor: A Prospective Trial

Conditions
-----------------
Infertility, Female, Mayer Rokitansky Kuster Hauser Syndrome

Intervention / Treatment
-----------------
* Procedure: uterus transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female with Maier-Rokitansky-Kuster-Hauser syndrome Mucosal neovagina of at least 7 cm In a stable relationship for at least 1 year Child wish Good renal function (and presence of both kidneys) Psychologically stable and compliant At least 8 frozen embryos after IVF/intracytoplasmic sperm injection [ICSI] Living in Belgium and a good health insurance Willing and able to provide informed consent Exclusion Criteria: Major pelvic surgery Major chronic illnesses Other risk factors or malignancies BMI > 30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 38 Years

Sexes Eligible for Study
-----------------
Female

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: Uterus transplantation<br> | Procedure: uterus transplantation<br>* transplantation of a uterus from a deceased donor<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival of the uterus 1 year after transplantation | Survival of the uterus 1 year after transplantation | 1 year after uterus transplantation | 
| Complications after uterus transplantation | Complications after uterus transplantation | As long as the uterus remains in situ (the uterus will be removed within one year after delivery) | 
| Ongoing pregnancy rate | Ongoing pregnancy rate | 4 weeks after embryo transfer | 
| Take home baby rate | Take home baby rate | 9 months after embryo transfer | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Infertility, female, Mayer Rokitansky Kuster Hauser Syndrome, Transplantation; Deceased donor
Serial Changes in Micturition Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study was to identify the serial changes in lower urinary tract symptoms (LUTS), urine flow and bladder voiding efficiency after transobturator tape (TOT) surgery for treatment of female stress urinary incontinence.

Official Title
-----------------
Serial Changes in Lower Urinary Tract Symptoms, Urine Flow and Bladder Voiding Efficiency Following Transobturator Tape Surgery for Treatment of Female Stress Urinary Incontinence

Conditions
-----------------
Stress Urinary Incontinence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women who underwent transobturator tape surgery for treatment of female stress urinary incontinence Exclusion Criteria: any urinary tract infection pregnancy bladder malignancy postoperative follow-up of less than 12 months

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| transobturator tape<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total overactive bladder symptom score (OABSS) after surgery |  | 1-week, and 1-, 3-, 6- and 12-months after surgery |
A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction

Study Overview
=================
Brief Summary
-----------------
This non randomized study is a comparative study between standard conservative breast surgery and oncoplastic surgery as regard margin status and patient satisfaction.

Detailed Description
-----------------
This planned study was conducted on 70 female patients presented to our tertiary referral breast unit at Ain Shams University hospitals with breast cancer amid the period from September 2012 to May 2013 . Every one of them signed an informed consent to partake in this study that was approved in a meeting held by the ethical committee on august 2012 at Ain Shams University. All patients sharing in the study received closed envelope before surgery in a randomized way in which the surgical technique is written either standard conservative surgery or oncoplastic surgery(Double Blind). Our patients were partitioned into 2 equal groups: group A (35patients) who underwent standard conservative surgery, group B (35patients) who underwent oncoplastic surgery.

Official Title
-----------------
A Comparative Study Between Oncoplastic Breast Surgery and Standard Conservative Surgery:Margin Status and Patient Satisfaction Among Egyptian Females

Conditions
-----------------
Breastcancer

Intervention / Treatment
-----------------
* Procedure: Standard conservative breast surgery
* Procedure: Oncoplastic breast surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Patients with stage 1,2 breast cancer. Exclusion Criteria: Patients >60 years. Patients with previous breast surgery. patients candidate for mastectomy or palliative excision. Patients with collagen disease.

Ages Eligible for Study
-----------------
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- |
| Active Comparator: Standard conservative group<br>Group A (35 patients) have standard curative conservative breast surgery without integration of plastic techniques . . | Procedure: Standard conservative breast surgery<br> <br> |
| Active Comparator: Oncoplastic group<br>Group B(35 patients) have curative oncoplastic surgery in which plastic techniques integrated with oncological procedures | Procedure: Oncoplastic breast surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Margins in all specimens measured in millimeters 2. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oncoplastic surgery, Standard conservative surgery, Patient satisfaction, Margin Status
Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years

Study Overview
=================
Brief Summary
-----------------
The mechanism of bone loss in anorexia nervosa is complex. Marrow adipose tissue seems to play a role in the regulation of bone metabolism. Adipocytes secrete cytokines and adipokines that either stimulate or inhibit adjacent osteoblasts. This study consist to explore the relationship in anorexia nervosa patients with change in bone mineral density and adipokines like leptin, adiponectin and Préf-1 Bone mineral densities will be measure in 180 anorexia nervosa patients at inclusion and every two years during 6 years.It is assessed blood and urinary calcium and phosphate levels, bone remodelling markers and adipokines (leptin, adiponectin and Préf-1)

Official Title
-----------------
Bone Mass Changes in Anorexia Nervosa Patient Followed During 4 Years and Relationship Between Bone Loss and Adipokines.

Conditions
-----------------
Anorexia Nervosa, Osteoporosis

Intervention / Treatment
-----------------
* Device: DEXA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: anorexia patient defined by DSM IV diagnostic criteria Exclusion Criteria: patient with other psychiatric disease patient with other a metabolic bone disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anorexia patient<br>Dual Energy X-ray Absorptiometry (DEXA) | Device: DEXA<br>* The Dual Energy X-ray Absorptiometry (DEXA) is a third generation multi-captor DEXA device that allow short duration measurements. It measures Bone Mineral Density (BMD) at the spine and the femoral neck<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density by Dual Energy X-ray Absorptiometry (DEXA) | measured the evolution of the bone mineral density in 180 anorexia nervosa patients and the relationship with this change and adipokine | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of osteoporotic fractures |  | at 2,4 and 6 years | 
| Adiponectin plasma concentration by ELISA | measurement of circulating biological factors predicative of changes in BMD | at 2,4 and 6 years | 
| Interleukin-7 plasma concentration by ELISA | measurement of circulating biological factors predicative of changes in BMD | at 2,4 and 6 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adiponectin, Bone remodelling markers
Data Collection During CT for Axial Flow VADs

Study Overview
=================
Brief Summary
-----------------
At present, there is not accurate way to determine specific flow rates for axial flow ventricular assist devices (VADS). If a right heart cath is needed for these patients for clinical purposes, they will also undergo a cardiac CT scan while the pulmonary artery catheter is in place. It is possible to visualize the flow rates of axial flow VAD's and determine a more accurate rate per specific patient. Data Analyzed with following results: Article in Press for Cardiopulmonary Support and Physiology, results state Pairwise comparison of calculated output from left ventricular assist devices is feasible using first pass dynamic computed tomography test bolus technique versus thermodilution output measurements yielded good agreement (P=.03). The output calculated using dynamic CT underestimated the thermodilution output measurement by 0.54+ 0.37 L/min (95% confidence interval 0.66-0.94).

Detailed Description
-----------------
Description as listed in Summary. The hemodynamic data collected along with pump parameters may help determine more accurate flow rates specific to each patient.

Official Title
-----------------
Pilot Study of Data Collection During Computerized Tomography (CT) to Determine Accurate Flow Rates for Axial Flow Ventricular Assist Device (VAD) Patients

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Procedure: Cardiac CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Signed Informed 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CCT exam<br> | Procedure: Cardiac CT<br>* 64 slice spiral computerized tomography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| data collection to help determine better clinical evaluation |  | ongoing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Axial Flow Ventricular Assist Device, Cardiac CT, Stage IV heart failure
Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization

Study Overview
=================
Brief Summary
-----------------
This study evaluate topical anaesthesia application for 30 minutes before tranradial catheterization during cardiac catheterization can reduce pain and decrease radial artery spasm

Detailed Description
-----------------
The incidence of Radial artery spasm (RAS) has varied from 5-30% RAS refers to friction between the artery and wires or guide catheters accompanied by a subjective feeling of pain. EMLA anesthetic ointment (AO-Astra Zeneca) is an emulsion of lidocaine 2.5% and prilocaine 2.5% in a ratio of 1:1 by weight Previous study showed that EMLA cream can increase the success rate of femoral cannulation in children.

Official Title
-----------------
Effect of Topical Anesthesia on Patient's Pain Discomfort and Radial Artery Spasm in Transradial Catheterization

Conditions
-----------------
Radial Artery Spasm

Intervention / Treatment
-----------------
* Drug: Topical Anesthetic
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients age >18 years. Patients who was schedule to performed coronary angiogram Exclusion Criteria: Previous ipsilateral transradial approach Raynaud's syndrome ESRD History of sensitivity to local anesthetics Non-palpable redial pulse Abnormal Barbeau's test Local site infection Patient's refusal

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Interventional<br>EMLA group layer of 2.5 gr EMLA cream (standard adult dose) was applied to both wrists | Drug: Topical Anesthetic<br>* EMLA Cream 2.5 gr applied to both wrists<br>|
| Placebo Comparator: Placebo<br>Placebo cream was applied to both wrists | Drug: Placebo<br>* Placebo Cream 2.5gr applied to both wrist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial pain assessed during artery puncture | Record pain by visual analog score sub-scale 0(no pain)-10(max pain) | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radial pain assessed 30 min after sheath removal | Record pain by visual analog score | 4 hr post procedure | 
| Number of puncture attempts | Number of puncture attempts | imediate post procedure | 
| Occurrence of radial artery spasm | NuNumber of radial artery spasm | during and post procedure up to 1 years |
Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy

Study Overview
=================
Brief Summary
-----------------
Post-marketing surveillance of Telostop TAB (Telmisartan/Rosuvastatin)

Detailed Description
-----------------
Telostop TAB is fixed-dose combination of telmisartan and rosuvastatin, which was approved in 2015 in the Republic of Korea for the treatment of patients with hypertention and dyslipidemia. A post-marketing surveillance was conducted following the approval to obtain data on the safety and efficacy of Telostop TAB in real-world practice.

Official Title
-----------------
Post Marketing Surveillance of Telostop TAB (Telmisartan/Rosuvastatin) for Evaluating the Safety and Efficacy

Conditions
-----------------
Dyslipidemias, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient who is first prescribed and administered Telostop plus Tab. Exclusion Criteria: The patients who are overreacting to this drug or its components The patients to the Do not administer to the next patient section of the approved instructions for use

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |
| Incidence of adverse event after this drug administration in general medical practice | Any adverse events occurred after this drug dosing will be recorded. Description of adverse event(s) including type of adverse event(s), onset/end date, severity, action taken, causal relationship to the drug and investigator's view on the adverse event(s) will be captured, whether it is related to the drug or not and until follow up visit more than 1 time during the surveillance period. Lab abnormalities and changes in vital signs are considered to be adverse events only if they result in discontinuation from the study, necessitate therapeutic medical intervention, and/or if the investigator considers them to be adverse events. | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline to week 24 in the LDL cholesterol | LDL cholesterol is measured before administration of the drug and within 24 weeks after administration. | 24 weeks | 
| The change from baseline to week 24 in the blood pressure | Blood pressure is measured before administration of the drug and within 24 weeks after administration. | 24 weeks |
Study to Evaluate Safety & Effectiveness of Spinal Sealant

Study Overview
=================
Brief Summary
-----------------
To evaluate a spinal sealant as an adjunct to sutured dural repair compared to standard of care techniques.

Detailed Description
-----------------
Neurosurgical procedures in the spine often involve incision of the dura mater to access the spinal cord. If the dural incision is not properly repaired and watertight closure is not achieved cerebrospinal fluid (CSF) can escape presenting a risk for significant morbidity. The most frequent complication of CSF leak is recurring headache complicated with symptoms of nausea and vomiting. Furthermore fluid collection under skin prevents proper wound healing and may lead to wound breakdown and infection of the incision or both. Persistent CSF leak has also been associated with the development of cerebellar hemorrhage and subdural hematoma. Primary repair and watertight closure are paramount to minimizing risk and sequelae associated with CSF leak.

Official Title
-----------------
A Prospective, Multi-Center, Randomized Controlled Study to Compare the Spinal Sealant System as an Adjunct to Sutured Dural Repair With Standard of Care Methods During Spinal Surgery

Conditions
-----------------
Cerebrospinal Fluid Leakage, Subdural

Intervention / Treatment
-----------------
* Device: Spinal Sealant
* Other: Standard of Care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects scheduled for a spinal procedure that requires a dural incision

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spinal Sealant System<br>Spinal Sealant System | Device: Spinal Sealant<br>* Spinal Sealant System<br>|
| Active Comparator: Standard of Care<br>Standard of care methods as an adjunct to sutured dural repair | Other: Standard of Care<br>* Standard of Care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent(%) Success in Obtaining a Watertight Closure Following Assigned Treatment (Spinal Sealant or Control) | Percent(%) success in obtaining a watertight closure following assigned treatment (Spinal Sealant or Control) where success is defined as: A watertight closure of the dural repair intraoperatively after study treatment, confirmed by Valsalva maneuver at 20-25 cm H2O for 5-10 seconds. | Intra-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prevention of CSF leak