linjc16/ctgov huggingface dataset:
Procalcitonin in Diagnosis of Bacterial Infections in Young Infants

Study Overview
=================
Brief Summary
-----------------
A diagnostic accuracy study investigating the accuracy of procalcitonin in diagnosing invasive bacterial infections in your infants.

Detailed Description
-----------------
The primary aim of this study was to report on the diagnostic accuracy of procalcitonin in the diagnosis of bacterial infections in young infants. This included invasive bacterial infections; defined as the isolation of a bacterial pathogen in blood or cerebrospinal fluid culture. We conducted a prospective observational diagnostic accuracy study. Young infants less than 90 days of age presenting to the Royal Belfast Hospital for Sick Children with signs of possible bacterial infection were eligible for inclusion. Eligible infants underwent procalcitonin testing using 0.5ml of whole blood with a BRAHMS assay on the Samsung LABGEO IB10® analyser.

Official Title
-----------------
Point-of-care-testing for Procalcitonin in Diagnosis of Bacterial Infections in Young Infants: a Diagnostic Accuracy Study

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected bacterial infection Exclusion Criteria: None

Ages Eligible for Study
-----------------
Maximum Age: 90 Days

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 |
| --- | --- | --- |
| Invasive bacterial infection | Isolation of a bacterial pathogen in blood or cerebrospinal fluid culture | 2 days |
Assessment of the Influence of Cleft Repair on Microcirculation of the Palate

Study Overview
=================
Brief Summary
-----------------
Investigators aim to evaluate the influence of cleft surgery on the tissue microcirculation of the palate with a non-invasive measurement.

Official Title
-----------------
Intraoperative Assessment of the Influence of Cleft Repair on Microcirculation of the Palate

Conditions
-----------------
Cleft Palate, Cleft Lip and Palate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with orofacial clefts, who undergo routine cleft repair Exclusion Criteria: missing datasets no signed consent for research.

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 13 Months

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in tissue perfusion (regional tissue oxygen saturation (StO2%)) before and after surgery non-invasively measured | The difference and impact of our routine surgical technique on the tissue perfusion of the palate is measured non-invasively with a probe (regional StO2%). Localized measurement of the microvascular hemoglobin oxygen saturation. | One measurement before surgery, one measurement immediately after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Status of wound healing | status of wound healing, fistula formation | at 3 month and 6 month after surgery |
CarboMedics Top Hat vs St. Jude Medical Regent Valve Comparing Sizing and Hemodynamics

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the sizing and implant techniques between the CarboMedics Top Hat supra-annular valve and the St. Jude Medical Regent valve.

Official Title
-----------------
A Randomized Study to Compare Sizing, Implant Techniques, & Hemodynamic Performance Between the CarboMedics Supra-annular Top Hat Valve and the St. Jude Medical Regent Valve in the Aortic Position.

Conditions
-----------------
Aortic Valve Disease

Intervention / Treatment
-----------------
* Device: Top Hat
* Device: Regent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are indicated for implant with a mechanical valve prosthesis in the aortic position according to the current practice for valve selection at the center. Exclusion Criteria: Patients < 18 years of age Emergency surgery Pre-existing valve prosthesis Aortic root replacement Active endocarditis

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

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>CarboMedics Supra-annular Top Hat Valve | Device: Top Hat<br>* Implant of CarboMedics Top Hat mechanical valve.<br>|
| Active Comparator: 2<br>St. Jude Medical Regent Valve | Device: Regent<br>* Implant of the St. Jude Medical Regent mechanical valve<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective Orifice Area (EOA) | Effective Orifice Area of the prosthetic valve measured via echocardiography to determine physiological area of blood flow through the valve. | 6 month evaluation | 
| Aortic Mean Gradient | Mean gradient measured across the aortic prosthetic valve via echocardiography to determine mean pressure of blood flow across the valve. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
aortic valve, heart valve, valve replacement, Valve disease
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

Study Overview
=================
Brief Summary
-----------------
The total incidence of abdominal pain after colonoscopy is almost 50%. Butorphanol is a mixed opioid receptor agonist-antagonist, which has strong sedative and analgesic effects. This clinical study aims to explore the effectiveness and safety of butorphanol combined with propofol for colonoscopy to reduce postoperative visceral pain, and provide a basis for improving the quality of surgery and comfortable medical treatment for patients.

Official Title
-----------------
Effect of Butorphanol on Colonoscopy for Patients With Postoperative Visceral Pain

Conditions
-----------------
Colonoscopy

Intervention / Treatment
-----------------
* Drug: Butorphanol Injection
* Drug: Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA status I-11 patients performing colonoscopy sign the informed consent Exclusion Criteria: BMI>30, pregnant diabetes depression patients dependent on opioids hypertension poorly controlled serious complications of important organs obvious abdominal pain before colonoscopy

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Butorphanol group<br> | Drug: Butorphanol Injection<br>* Inject 10 μg/kg of butorphanol, then propofol is injected until the patient's eyelash reflex disappears before performing colonoscopy<br>|
| Placebo Comparator: control group<br> | Drug: Saline<br>* Inject saline and propofol until the patient's eyelash reflex disappears before performing colonoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visceral pain | VAS score of visceral pain | 10 minutes after recovery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visceral pain at 20 and 30 minutes after recovery | VAS score of visceral pain | 20 and 30 minutes after recovery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Butorphanol, Visceral pain, Propofol, Gastroscopy, Colonoscopy
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This is an 80-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to rosiglitazone in lowering overall blood glucose levels in people with type 2 diabetes who have not previously been treated with drug therapy to lower their blood sugar. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Official Title
-----------------
Extension to a Study on the Efficacy and Safety of Vildagliptin Compared to Rosiglitazone in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2327 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from study CLAF237A2327 Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety during 104 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 104 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between 24 weeks and 104 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 104 weeks |  |  | 
| Change in fasting plasma glucose between 24 weeks and 104 weeks |  |  | 
| Change from baseline in HOMA B at 104 weeks |  |  | 
| Change in HOMA B between 24 weeks and 104 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
Quantitative MR Biomarkers for Sarcoma Treatment

Study Overview
=================
Brief Summary
-----------------
To determine if MRI imaging can be used to accurately determine if a sarcoma is responding to the type of chemotherapy being used.

Detailed Description
-----------------
The purpose of this study is to determine if MRI imaging can be used to accurately determine if a sarcoma is responding to the type of chemotherapy being used or if it is ineffective early on in the treatment; instead of finding this out 2-3 months later. If it is determined that MRI can accurately diagnose tumor response, medications can be switched early on potentially improv8ing the patients'chances of recovery.

Official Title
-----------------
Quantitative MR Biomarkers for Sarcoma Treatment

Conditions
-----------------
Soft Tissue Tumors

Intervention / Treatment
-----------------
* Procedure: MRI Scan of soft tissue tumor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Biopsy proven primary bone or soft tissue tumor No previous treatment for this malignancy Will be given chemotherapy before having surgery or radiation on the tumor. Are able to undergo a MRI examination If your tumor measures at least 1/2 inch in length. Exclusion Criteria: Younger than 3 yrs. of age or need general anesthesia(sedation that puts you to sleep) to have a MRI performed. History of Renal Failure Are not able to have a MRI performed for any reason such as you have a pacemaker or other implanted device that may malfunction or move because of the magnetic field inside the MRI room and scanner. Have any history of an allergic reaction to gadolinium based contrast agents (a medication injected in a vein that helps create clearer MRI images. -

Ages Eligible for Study
-----------------
Minimum Age: 3 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRI Scan<br>MRI scan of soft tissue tumor | Procedure: MRI Scan of soft tissue tumor<br>* MRI scan will be completed at baseline (prior to start of subject's clinically ordered chemotherapy treatments.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if MRI imaging can accurately determine if a sarcoma (tumor)is responding to the type of chemotherapy being used. | To image and evaluate the size of the soft tissue tumor prior to chemotherapy treatment. | Baseline prior to chemo | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Scan | To evaluate the size of the soft tissue tumor after start of chemotherapy to determine if the chemo is having any notable effect on tumor prior to surgery. | 3 weeks post start of chemo and end of chemo |
Evaluation of an Intervention Program for the Prevention of Anemia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine whether improvement in the accessibility to iron supplement will decrease anemia rates in infants.

Detailed Description
-----------------
Iron deficiency anemia is the most common type of anemia in infants, children and women of reproductive age. The most frequent cause of iron deficiency in infants at 6 months of life is poor nutrition during a period of rapid growth and a diet lacking in iron rich foods. Children who suffered from anemia in infancy demonstrated slower cognitive development, were low achievers in school and had a high rate of behavioral disturbances. The Ministry of Health implements a primary prevention program for anemia. If by making iron supplements more accessible would increase parental compliance in acquisition of the iron supplement and subsequently reduce the rate of iron deficiency anemia, the result would be the immediate application of the finding. It is possible to implement a program whereby the supplement will be directly available at the family health centers for purchase by the parent.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Behavioral: Iron supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infant who visit Family Health Centers

Ages Eligible for Study
-----------------
Minimum Age: 4 Months

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Prevention
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Iron supplement|nan|

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
-----------------
Anemia, Iron, Supplement
Implementation of a qSOFA Score in the Emergency Department

Study Overview
=================
Brief Summary
-----------------
The Quick-SOFA score (qSOFA), identifies septic patients with a mortality risk higher than 10%. In our study all adult patients coming to the emergency for suspected infection are screened according to the qSOFA score on arrival. If qSOFA ≥ 2, the patient should be referred to emergency vital room, if the score <2, the patient will be in the box. The objectives are : 1) to evaluate the mortality at 28 days with the orientation, 2) to compare support time of medical contact and initiation of antibiotics according to the orientation in the emergency department.

Official Title
-----------------
Impact of the Implementation of a qSOFA Score on the Care of Adult Patients Referred to the Emergency Department for Suspected Infection

Conditions
-----------------
Sepsis

Intervention / Treatment
-----------------
* Procedure: emergency vital room
* Procedure: box


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: body temperature below 36 °C or above 38 °C require hospitalization Exclusion Criteria: hospital transfer, patients with pre hospital care language barrier, refusal to participate

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: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: patients with qSOFA ≥ 2<br>adult patients with a qSOFA score ≥ 2 at the screening in the emergency department, will be referred to the emergency vital room | Procedure: emergency vital room<br>* At the arrival of the patient, the qSOFA will be carried out to guide the orientation. Patient with score ≥ 2 will be supported in emergency vital room<br>|
| Other: patients with qSOFA <2<br>adult patients with a qSOFA score < 2 at the screening in the emergency department, will be referred to the box | Procedure: box<br>* patient with score < 2 will be supported in box<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality rate | compare mortality rate with orientation in emergency | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| support time to medical contact | compare support time with orientation of patients according to the orientation of the patient in the emergency department | 1 day | 
| support time to initiation of antibiotics | compare support time with initiation antibiotics of patients according to the orientation of the patient in the emergency department | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
screening, qSOFA, sepsis, Emergency care unit
Supplemental Oxygen in Colorectal Surgery: A Quality Improvement Project

Study Overview
=================
Brief Summary
-----------------
Our primary objective is to develop a clinical pathway for care of patients having colorectal surgery at the Clinic. In particular, the investigators would like to determine what intraoperative concentration of oxygen is optimal in our patients.

Detailed Description
-----------------
The investigators therefore propose to test the primary hypothesis that supplemental oxygen (80% versus 30%) reduces the risk of a composite of surgical sites infection and potentially oxygen-related wound complications. Secondarily, the investigators will assess the incremental cost benefit of 80% versus 30% oxygen. As a safety measure, enough oxygen will always be given to maintain oxygen saturation (as determined by pulse oximetry) ≥95%.

Official Title
-----------------
Supplemental Oxygen and Surgical-site Infections: An Alternating Intervention Controlled Trial.

Conditions
-----------------
30% Oxygen Concentration During Colorectal Surgery, 80% Oxygen Concentration During Colorectal Surgery

Intervention / Treatment
-----------------
* Drug: 30% oxygen
* Drug: 80% oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult colorectal surgical patients

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
Interventional Model Description: The designated operating-room suite alternated between using either 30% oxygen as tolerated or 80% oxygen for periods of 2 weeks. For example, the first period used 30% oxygen, the second 80% oxygen, and so on. The oxygen concentration during the initial period was randomly designated by the study statistician. But, thereafter, oxygen delivery was not randomized on a per-patient or even per-period basis.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 30% oxygen<br>Inspired oxygen will be maintained at 30%. | Drug: 30% oxygen<br>* Inspired oxygen will be maintained at 30%.<br>|
| Experimental: 80% oxygen<br>Inspired oxygen will be maintained at 80%. | Drug: 80% oxygen<br>* Inspired oxygen will be maintained at 30%.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With One or More Composite Complications | A composite of complications: surgical sites infection (organ space / deep) Anastomotic leak Intra-abdominal abscess Sepsis Wound dehiscence Death | Postoperative 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Superficial SSI (Surgical Site Infection) | superficial SSI (Surgical Site Infection) | Postoperative 30 days |