linjc16/ctgov huggingface dataset:
Plasma Exchange vs Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
To compare effectiveness in reducing triglycerides between daily plasma exchange and glucose+insulin infusion in patients with non-severe acute hypertriglyceridemic pancreatitis with mildly elevated triglycerides

Official Title
-----------------
Comparison of Plasma Exchange and Conservative Management in Non-severe Acute Hypertriglyceridemic Pancreatitis With Mildly Elevated Triglycerides

Conditions
-----------------
Acute Pancreatitis

Intervention / Treatment
-----------------
* Procedure: plasma exchange
* Drug: conservative treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild acute hypertriglyceridemic pancreatitis triglycerides >15 but < 40 mmol/l Exclusion Criteria: pregnancy severe course of pancreatitis

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 |
| --- | --- |
| Experimental: plasma exchange<br>plasma exchange, with 1.5 estimated plasma volume exchanged with albumin solution, using citrate anticoagulation, performed daily until triglycerides <=10 mmol/l | Procedure: plasma exchange<br>* see arm description<br>|
| Active Comparator: conservative treatment<br>infusion of 5% glucose and insulin, to maintain blood glucose at 5-8 mmol/l | Drug: conservative treatment<br>* see arm description<br>* Other names: glucose and insulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in triglycerides | as % of starting value | within first 24 h after admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time until triglycerides drop to <10 mmol/l | expressed in days | by the end of hospital stay, up to 100 days | 
| highest C-reactive protein (CRP) |  | by the end of hospital stay, up to 100 days | 
| % of patients with severe pancreatitis |  | by the end of hospital stay, up to 100 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
plasma exchange, hypertriglyceridemia
HIP: HIV Intervention for Providers

Study Overview
=================
Brief Summary
-----------------
The purpose is to encourage Provider participants to evaluate high risk HIV transmission behaviors and offer prevention messages to their HIV+ patients which will, in turn, reduce rates of unprotected anal and/or vaginal sex with partners of known HIV sero-negativity or unknown HIV serostatus. It is hypothesized that patients of providers participating in the HIP intervention will report higher reduction in sexual risk practices, when compared to the patients of the providers who were randomized into the control condition.

Official Title
-----------------
HIP: HIV Intervention for Providers

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Behavioral: HIP: HIV Intervention for Providers


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provider participants: (1) licensed MD, NP or PA on staff at the participating institution; (2) has a minimum panel of 5 HIV+ patients; (3) sees patients at least one-half day per week in the clinical setting; (4) is willing to participate in all intervention training sessions; and (5) is willing and able to provide full informed consent. HIV+ patient participants:(1) report at least 1 encounter of unprotected anal or vaginal sex with known HIV- or unknown serostatus partner in the preceding six months; (2) patient's Primary Provider is enrolled as a participant in the study; (3) age 18 years or older; and (4) willing and able to provide informed consent. Exclusion Criteria: -

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: HIP: HIV Intervention for Providers|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported, unprotected (without condoms) anal or vaginal sex with HIV-negative and unknown-status persons. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV
Platelet-Rich and Concentrated Platelet-Poor Plasma to Reduce Air Leak Post-Lobectomy: A Randomized Controlled Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the use of platelet-rich plasma (PRP) and concentrated platelet-poor plasma (PPPc) can reduce the duration of post-operative air leak after lobectomy for lung tumours.

Official Title
-----------------
Platelet-Rich and Concentrated Platelet Poor Plasma to Reduce Air Leak Post Lobectomy: A Randomized Controlled Trial

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively
* Procedure: Standard post-lobectomy wound care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring a lobectomy Exclusion Criteria: Pneumonectomy Sleeve lobectomy Determination of unresectability (prior to the initiation of lobectomy) Wedge resection alone

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>Standard post-lobectomy wound care plus use of PRP and PPPc in the thoracic cavity. | Procedure: Standard post-lobectomy wound care plus use of PRP and PPPc prepared by GPS and Plasmax respectively<br>* GPS is used to create the platelet rich plasma (PRP). Plasmax is used to create the concentrated platelet-poor plasma (PPPc). Both PRP and PPPc will be used for wound care in the thoracic cavity post-lobectomy.<br>|
| Active Comparator: 2<br>Standard post-lobectomy wound care in the thoracic cavity | Procedure: Standard post-lobectomy wound care<br>* Standard post-lobectomy wound care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of postoperative air leak |  | Every 4 hours of postop hospital stay, between 4-6 weeks postop | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of air leak, Prolonged air leak (> days), Complications |  | Every 4 hours of postop hospital stay, between 4-6 weeks postop |
The 36-month Extension to Follow up Sub Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate leg health for one additional year in patients with symptomatic proximal deep venous thrombosis who did not already develop Post-Thrombotic Syndrome (PTS) during the 2 years of follow up in the SOX Trial.

Detailed Description
-----------------
The post-thrombotic syndrome (PTS) is a frequent, burdensome and costly condition that occurs in about one third of patients after an episode of deep vein thrombosis (DVT). Affected patients have chronic leg pain and swelling, and sometimes develop skin ulcers. At present, there is little to offer for the treatment of this condition. Prevention of PTS is the key to reducing its burden on patients and society. Elastic compression stockings (ECS) for two years following DVT could be helpful in preventing or delaying onset of PTS at three years, however data supporting this is limited.

Official Title
-----------------
The Extension to Follow up Study of the Compression Stockings to Prevent the Post-Thrombotic Syndrome (SOX Trial)

Conditions
-----------------
Postphlebitic Syndrome, Post-Thrombotic Syndrome, Deep Vein Thrombosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Consecutive patients with a first, symptomatic, objectively confirmed proximal DVT diagnosed within the last 14 days (with or without concurrent distal DVT or pulmonary embolism) Who have no contraindications to standard treatment with heparin and/or warfarin, and Who provide informed consent to participate Exclusion Criteria: Contraindication to compression stockings Limited lifespan (estimated < 6 months) Geographic inaccessibility preventing return for follow-up visits Inability to apply stockings daily and unavailability of a caregiver to apply stockings daily Treatment of acute DVT with thrombolytic agents

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 |
| --- | --- |
| 36-mth follow up visit<br>The cohort will consist of original subjects of the SOX Trial who consent to participate in the extension to follow up sub study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of PTS and PTS severity |  | 3 year follow up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elastic Stockings, Stockings, Compression, Randomized Controlled Trials, Quality of Life
Pilot Evaluation of Youth Chef Academy

Study Overview
=================
Brief Summary
-----------------
This project examined the effectiveness of Youth Chef Academy (YCA), a classroom-based experiential culinary and nutrition literacy curriculum for middle-school students. The primary study hypothesis was that students assigned to YCA would demonstrate greater improvement in F/V and whole grain consumption compared to students in the control group. Eight classrooms in eight public K-8 schools participated in the project. Classrooms were assigned to intervention or control condition in a non-randomized manner. YCA was delivered by project staff to all of the students in the four intervention classrooms. Students completed a survey to assess primary and secondary outcomes at baseline, six-week curriculum completion, and at twelve-week curriculum completion (YCA extended twelve-week curriculum cohort).

Official Title
-----------------
Pilot Evaluation of Youth Chef Academy: A Plant-based Cooking Program for Urban Middle School Students

Conditions
-----------------
Dietary Modification, Child

Intervention / Treatment
-----------------
* Behavioral: Youth Chef Academy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Student in intervention or control classroom Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 14 Years

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Youth Chef Academy<br>Receives intervention | Behavioral: Youth Chef Academy<br>* Nutrition and culinary curriculum delivered in the classroom<br>|
| No Intervention: Control<br>Usual classroom curriculum | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fruit and vegetable consumption | Change in fruit and vegetable consumption calculated from self-reported times per day consuming fruits and vegetables using the 7-item tool from the Youth Risk Behavioral Surveillance System | Baseline, 6 weeks, 12 weeks | 
| Change in whole grain consumption | Change in whole grain consumption calculated from self-reported times per day consuming whole grains using a revised version of the 8-item tool from the Power of 3 project | Baseline, 6 weeks, 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
School health
Early Application of Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesized that early applied pulsed electromagnetic field treatment on delayed union might lead to increased rate of fracture union and shortened period of treatment.

Official Title
-----------------
Phase 4 Study of Early Applied Pulsed Electromagnetic Field in the Treatment of Postoperative Delayed Union of Long-bone Fractures

Conditions
-----------------
Fracture, Delayed Union of Fracture

Intervention / Treatment
-----------------
* Device: pulsed electromagnetic field
* Device: sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The failure of healing after at least 16 weeks and not more than 9 months following surgical reduction and fixation of the fracture. Exclusion Criteria: Implant loosening or failure, infection, established nonunion, fracture gap greater than 5 mm, presence of implant within the fracture gap, metabolic disorders or received medication affecting fracture healing

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: PEMF<br>arm that receive PEMF treatment | Device: pulsed electromagnetic field<br>* PEMF treatment<br>|
| Sham Comparator: Sham<br>arm that receive sham treatment | Device: sham<br>* sham treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of patient achieving fracture union |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain |  | 12 months |
A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of the trial is to investigate the absolute bioavailability of insulin degludec (IDeg) in healthy subjects.

Official Title
-----------------
A Trial Investigating the Absolute Bioavailability of Insulin Degludec in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: insulin degludec
* Drug: insulin degludec


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history, physical examination, analysis of laboratory safety variables, vital signs and ECG (electrocardiogram), as judged by the investigator Body mass index 18.0-27.0 kg/m^2 (both inclusive) Exclusion Criteria: Subject who has donated any blood or plasma in the past month or more than 500 mL within 3 months prior to screening Smoker (defined as a subject who is smoking more than 5 cigarettes or the equivalent per day) Not able or willing to refrain from smoking and use of nicotine gum or transdermal nicotine patches during the inpatient period

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: s.c.<br> | Drug: insulin degludec<br>* A single dose of 0.4 U/kg body weight will be administered subcutaneously (s.c., under the skin).<br>|
| Experimental: i.v.<br> | Drug: insulin degludec<br>* A single dose of 0.04 U/kg body weight will be administered intravenously (i.v., into the vein).<br>* Other names: IDeg;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin degludec concentration-of s.c. administration |  | From 0 to infinity after single dose | 
| Area under the serum insulin degludec concentration-of i.v. administration |  | From 0 to infinity after single dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Terminal half-life for insulin degludec |  | From 0 to 30 hours after single dose | 
| Volume of distribution of insulin degludec, estimated during the terminal phase |  | From 0 to 30 hours after single dose |
Long-term Cardiovascular Risk in Cured Cushing's Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether subjects who have been affected by Cushing's disease in the past maintain some different characteristics compared with subjects who have never been diagnosed with the disease.

Official Title
-----------------
Role of Adipokines in Long-term Cardiovascular Risk in Cured Cushing's Patients

Conditions
-----------------
Cushing's Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who have been cured of Cushing's disease at least 5 years ago. Exclusion Criteria: patients who have been cured of Cushing's disease more than 15 years ago.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 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 |
| --- | --- |
| cured Cushing's disease<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| adipokine measurements |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cushing's disease
Study on the Effect of Prostacyclin Compared to Placebo in Traumatic Brain Injury

Study Overview
=================
Brief Summary
-----------------
This study is a prospective consecutive double-blinded randomized study on the effect of PGI2, prostacyclin (epoprostenol, Flolan®) versus placebo (saline)in patients with severe traumatic brain injury. All patients with severe traumatic brain injury were eligible for inclusion. Inclusion criteria: verified traumatic brain injury, Glasgow Coma Score (GCS) at intubation and sedation of ≤ 8, age 15-70 years, a first-recorded cerebral perfusion pressure (CPP) of > 10 mm Hg, and arrival within 24 hours after trauma. Tne primary aim was to evaluate whether treatment with epoprostenol would reduce a lactate/pyruvate ratio,as measured by cerebral microdialysis after 24 hours of treatment. A secondary aim was to evaluate the effect of epoprostenol on systemic inflammatory markers, measured by different cytokines.

Official Title
-----------------
Prostacyclin Treatment in Severe Traumatic Brain Injury: a Microdialysis and Outcome Study

Conditions
-----------------
Traumatic Brain Injury

Intervention / Treatment
-----------------
* Drug: epoprostenol versus normal saline
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: traumatic brain injury, Glasgow coma scale ≤ 8 Exclusion Criteria: pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epoprostenol, Flolan®<br>Measurement on the effect of epoprostenol on lactate/pyruvate ratio measured by cerebral microdialysis | Drug: epoprostenol versus normal saline<br>* 0.5 ng/kilogram/minute during 4 days<br>* Other names: Normal saline;|
| Placebo Comparator: normal saline<br>Effect of saline on the lactate/pyruvate ratio measured by cerebral microdialysis | Drug: epoprostenol versus normal saline<br>* 0.5 ng/kilogram/minute during 4 days<br>* Other names: Normal saline;Drug: normal saline<br>* 0.5-1.5 ml/hour during 4 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate/pyruvate ratio 24 hours after start of epoprostenol versus placebo |  | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Levels of systemic inflammatory markers |  | 4 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
traumatic brain injury