linjc16/ctgov huggingface dataset:
Flexible Catheter for Insulin in Diabetes

Study Overview
=================
Brief Summary
-----------------
Use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle.

Detailed Description
-----------------
Assess whether the use of a flexible subcutaneous catheter improves comfort in patients with DKA compared to the usual treatment with a metal needle. Compare the metabolic evolution of patients with DKA using a flexible subcutaneous catheter for insulin administration vs. a metal needle.

Official Title
-----------------
Use of a Flexible Catheter for the Administration of Subcutaneous Insulin in Diabetic Ketoacidosis

Conditions
-----------------
Diabetic Ketoacidosis

Intervention / Treatment
-----------------
* Device: FLEXIBLE CATHETER
* Device: hourly rigid needle puncture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 5 to 18 years, admitted with diagnoses of DKA. DKA is defined when patients meets all the following biochemical baseline criteria (before initial hydration): Glucose> 200 mg / dl pH < 7.3 Bicarbonate < 15mmol/l. Exclusion Criteria: Patients referred from another institution with a different treatment, and those who requires intensive care on admission.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum 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: flexible catheter<br>The flexible Subcutaneous catheter for insulin administration | Device: FLEXIBLE CATHETER<br> <br> |
| Active Comparator: hourly rigid needle puncture<br>Hourly rigid needle puncture for Subcutaneous insulin administration | Device: hourly rigid needle puncture<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comfort measured by a visual analogue scale for pain | Comfort measured by a visual analogue scale for pain (10cm = 0 meaning no pain and 10 meaning maximum pain) shown hourly after insulin administration until metabolic stability is achieved. | between 10 to 14 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Associated complications | complications associated with the insulin administration device (local infection, extravasation) | 24 hours | 
| Metabolic stability according to lab determinations | Time to reach the metabolic stability defined by: glycemia ≤250 mg/dl, pH ≥ 7.3, bicarbonate ≥ 15 mmol/L); | between 10 to 14 hours |
Perfusion Index in Anesthesia

Study Overview
=================
Brief Summary
-----------------
In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)

Official Title
-----------------
Peripheral Perfusion Index as Marker for Systemic Hemodynamics During Anesthesia

Conditions
-----------------
Monitoring, Physiological

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients for elective and sub-acute surgical repair of para-oesophagal hernia. Willingness to participate Exclusion Criteria: Patient refusal
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 |
| --- | --- | --- |
| Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV) |  | Intra-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP) |  | Intra-operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Perfusion Index, Hemodynamics, Anesthesia, Stroke Volume
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media (CSOM) Without Posterior Meatal Flap

Study Overview
=================
Brief Summary
-----------------
Composite Cartilage Perichondrium Graft for tympanoplasty in chronic suppurative otitis media (CSOM) Air Bone Gap (AB Gap) Closure will be taken as successful outcome Endoscopic technique without posterior meatal flap elevation

Detailed Description
-----------------
300 eligible cases of dry CSOM will under go Composite Cartilage Perichondrium Graft tympanoplasty. Air Bone Gap Closure will be taken as successful outcome. The procedure will employ endoscopic technique without posterior meatal flap elevation.

Official Title
-----------------
Composite Cartilage Perichondrium Graft for Air Bone Gap Closure in Chronic Suppurative Otitis Media Without Posterior Meatal Flap

Conditions
-----------------
Tympanic Membrane Perforation

Intervention / Treatment
-----------------
* Other: Endoscopic ear surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both genders between 21 to 55 years Dry chronic suppurative otitis media Air bone gap between 15 to 25 Deci bel Exclusion Criteria: Discharging ear Pediatric population Ossicular Necrosis Previous ear surgery

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 300 cases of dry perforation CSOM
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: AB Gap Closure<br>Air Bone gap closure following surgery will be considered as successful outcome | Other: Endoscopic ear surgery<br>* Endoscopic approach without posterior meatal flap elevation will be employed in the ear with dry chronic suppurative otitis media. Tympanoplasty utilizing composite cartilage-fascia graft will be performed. After three months of time period successful outcome will be taken as closure of air bone gap on pure tone audiometry.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful air bone gap closure on pure tone audiometry | Three months of endoscopic tympanoplasty using composite cartilage-fascia graft, pure tone audiometry will be carried out measuring both air and bone conduction. Successful outcome will be closure of the air bone gap as compared with pre surgery air bone gap. | Three months |
CP4ACS - Delphi Study to Determine Appropriateness of STEMI Quality Indicators in Belgium

Study Overview
=================
Brief Summary
-----------------
RAND/UCLA modified Delphi study on quality indicators for STEMI to determine the appropriateness of quality indicators retrieved from literature and guideline review. We aim to engage 20 cardiologists and 20 nurses with relevant experience in the care for STEMI patients.

Official Title
-----------------
Quality of Care for STEMI - Patients. a Research to Determine Appropriateness of STEMI Quality Indicators in Belgium, a RAND/UCLA Modified Delphi Study

Conditions
-----------------
STEMI, Quality Indicators

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cardiologist or cardio nurse with relevant experience in the care for STEMI patients Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| cardiologists<br> | |
| study coordinators<br> | |
| registred nurses<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| validated quality indicators for STEMI care in belgium (both on patient and on hospital level) | 33 experts in cardioloy, cardio nursing and quality rated quality indicators for STEMI care in belgian hospitals on a 9 point Likert Scale. All indicators with a median score between 7 and 9 were discussed in an expert panel. The expert panel selected validated quality inidicators for STEMI care. | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Quality improvement, STEMI, Belgium
Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes

Study Overview
=================
Brief Summary
-----------------
Currently, no clear consensus exists regarding the effect of epidural anesthesia upon breast-feeding. In theory, epidurals may increase breast-feeding failure via inadequate maternal milk production, deficiencies in neonatal neurobehavior, or both, but most studies have failed to separate these potential mechanisms. The present study examines whether epidural duration correlates with 1) likelihood of breast-feeding at hospital discharge and 2) neonatal neurobehavioral deficits in feeding, as measured by the L&A components of the standardized, validated LATCH scoring system.

Official Title
-----------------
Intrapartum Epidural Fentanyl/Bupivacaine Analgesia, Infant Feeding Behavior, & Breast-Feeding Outcomes

Conditions
-----------------
Anesthesia, Epidural, Breast Feeding

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vaginal delivery Delivery of a single live neonate Exclusion Criteria: NICU admission following delivery Pitocin augmentation

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epidural Recipients<br> | |
| Non-Epidural Recipients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast-Feeding at Hospital Discharge | This outcome variable is binary. If a woman is breast-feeding with bottle supplementation at the time of hospital discharge, then she is recorded as Yes. | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| L&A Components of LATCH Score | The L component of the score measures neonatal ability to latch at the breast and the A component measures the presence of audible swallows, which are variables that reflect neonatal neurobehavioral capacity with respect to feeding. | Baseline |
An Evaluation of the Fixed Combination Brimonidine Tartrate 0.2%/ Timolol Maleate 0.5% to Latanoprost 0.005% in Glaucoma or Ocular Hypertension Subjects

Study Overview
=================
Brief Summary
-----------------
A three-month evaluation comparing the safety and efficacy of a fixed combination of 0.2% brimonidine tartrate/0.5% timolol maleate with that of latanoprost 0.005%, a prostaglandin analogue in glaucoma or ocular hypertension subjects

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution
* Drug: latanoprost 0.005%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be at least 18 years of age; Give written informed consent; Be in good general health as determined by your doctor; Have a diagnosis of unilateral or bilateral glaucoma or ocular hypertension; If you are a female of child bearing potential, you must be willing to practice effective contraception for the duration of the study (i.e., abstinence, spermicide, condoms, or birth control pills); Understand the study instructions, and be able to follow the study instructions; and Be likely to complete the entire study period (12 weeks), including all regularly scheduled study visits. Exclusion Criteria: Have any active ocular disease other than glaucoma or ocular hypertension that would interfere with study interpretation; Any systemic disease or clinical evidence of any condition which would make the subject, in the opinion of the investigator, unsuitable for the study or could potentially confound the study results; and Concurrent participation or prior participation in any investigational drug or device study within the last 30 days prior to the Screening Visit

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Fixed combination of brimonidine tartrate 0.2%/timolol maleate 0.5% ophthalmic solution | Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution<br>* 1 drop of study medication taken approximately 12 hours apart, dosed 2 times a day<br>* Other names: Combigan™;|
| Active Comparator: 2<br>Latanoprost 0.005% ophthalmic solution | Drug: latanoprost 0.005%<br>* 1 drop of study medication taken once daily<br>* Other names: Xalatan™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure (IOP) at Week 12 | Mean IOP at week 12. IOP is a measurement of the fluid pressure inside the eye. | Week 12 |
An Experimental Medicine Study to Evaluate Serum Biomarkers of Lipid Metabolism

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to validate novel assays for serum biomarkers of lipid metabolism (PCSK9 and LDL receptor) and to obtain information about how these biomarkers differ in subjects with normal or high cholesterol levels

Official Title
-----------------
An Experimental Medicine Study to Quantify PCSK9 Serum Concentrations and LDL Receptor Expression in Peripheral Blood Cells in Normal and Hypercholesterolemic Subjects

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypercholesterolemia Statin monotherapy Exclusion Criteria: Significant acute or chronic illness Secondary causes of hypercholesterolemia

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

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

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

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: Blood draw (Group 1)<br>Normocholesterolemic Subjects Normal Healthy Volunteers | Procedure: Blood draw<br>* 1 day<br>|
| Other: Blood draw (Group 2)<br>Hypercholesterolemic Subjects | Procedure: Blood draw<br>* 1 day<br>|
| Other: Blood draw (Group 3)<br>Hypercholesterolemic Subjects with Statin Treatment | Procedure: Blood draw<br>* 1 day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum PCSK9 concentration |  | Initial assessment will occur when Group 1 has 50 subjects enrolled and Groups 2 and 3 have 30 subjects enrolled | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum LDL cholesterol concentration |  | Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects | 
| Serum HDL cholesterol concentration |  | Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects | 
| Serum TG concentration |  | Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects | 
| Serum Apo B concentration |  | Initial assessment will occur when Groups 2 and 3 have enrolled 30 subjects |
Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High-flow Nasal Cannula Oxygen.

Study Overview
=================
Brief Summary
-----------------
Preoxygenation is routinely performed before endotracheal intubation. In the intensive care unit, preoxygenation is often accomplished using a nose-mouth mask. It seems probable that high flow nasal cannula oxygen, which is used in the treatment of patients with hypoxemic respiratory failure, is equally effective in preventing the development of hypoxemia during intubation. In this prospective randomized study preoxygenation using high flow nasal cannula oxygen is compared with preoxygenation via nose-mouth mask in patients with hypoxemic respiratory failure.

Official Title
-----------------
Prospective Randomised Study on Preoxygenation in the Intensive Care Unit Using a Nose-mouth Mask Versus High Flow Nasal Cannula Oxygen.

Conditions
-----------------
Respiratory Failure

Intervention / Treatment
-----------------
* Device: Nose-mouth mask
* Device: High flow nasal cannula oxygen
* Procedure: Intubation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated in an intensive care unit indication for intubation presence of hypoxemic (SaO2/fraction of inspired oxygen(FiO2): 300 or less) respiratory failure informed consent Exclusion Criteria: blocked nasopharynx contraindications for nose-mouth mask or high flow nasal cannula oxygen expected difficult airway

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 |
| --- | --- |
| Active Comparator: Nose-mouth mask<br>Performance of intubation after preoxygenation using a nose-mouth mask. | Device: Nose-mouth mask<br>* Preoxygenation using a nose-mouth mask.<br>Procedure: Intubation<br>* Intubation<br>|
| Experimental: High flow nasal cannula oxygen<br>Performance of intubation after preoxygenation using high flow nasal cannula oxygen. | Device: High flow nasal cannula oxygen<br>* Preoxygenation using high flow nasal cannula oxygen.<br>Procedure: Intubation<br>* Intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean decrease in the saturation of oxygen (SpO2) during intubation. | Mean decrease in the saturation of oxygen measured by pulse oximetry (SpO2 [%]) during intubation. | during intubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood gases after intubation. | Changes in arterial blood gases collected from arterial line (PaO2/FiO2 [mmHg] and PaCO2 [mmHg]) after intubation. | 30 minutes after intubation |
Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the long-term outcomes after curatively intended resection of duodenal adenocarcinoma.

Official Title
-----------------
Long-term Outcomes After Resection of Primary Duodenal Adenocarcinoma

Conditions
-----------------
Duodenal Cancer

Intervention / Treatment
-----------------
* Procedure: Pancreaduodenectomy and possible adjuvant therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients subjected to resection of primary duodenal adenocarcinoma Exclusion Criteria: None.

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 |
| --- | --- |
| Patients undergoing resection of primary duodenal cancer<br>Tumors comprised histologically confirmed adenocarcinomas in the duodenum excluding adenocarcinoma of the ampulla of Vater and adenocarcinomas with gastric and pancreato-biliary morphology and immunohistochemistry. | Procedure: Pancreaduodenectomy and possible adjuvant therapy<br>* Adjuvant therapy was generally offered to patients with T4 or lymph node positive disease. As no national Danish guidelines exist, patients were treated based on the oncologists' preference.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3-year survival | Cumulative survival after three years | Three years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duodenal cancer recurrence | Recurrence found by computed tomography scan | 5 years |
Phase II Trial of Neoadjuvant[FEC100]/Cisplatin-Docetaxel ± Trastuzumab in Women With Over Expressed or Amplified Her2/Neu With Locally Advanced Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Phase II trial of Neoadjuvant [FEC100]/Cisplatin-Docetaxel ± Trastuzumab in women with over expressed or amplified Her2/Neu with Locally advanced Breast Cancer

Official Title
-----------------
Phase II Trial of Neoadjuvant[FEC100]/Cisplatin-Docetaxel ± Trastuzumab in Women With Over Expressed or Amplified Her2/Neu With Locally Advanced Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Radiation: Cisplatin-Docetaxel ± Trastuzumab
* Other: Cisplatin-Docetaxel ± Trastuzumab
* Drug: Cisplatin-Docetaxel ± Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with locally advanced breast cancer
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

| Intervention/Treatment |
| --- |
|Radiation: Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT|
|Other: Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT|
|Drug: Cisplatin-Docetaxel ± Trastuzumab|Chemo & RT|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | overall |