linjc16/ctgov huggingface dataset:
LUNAR IIIb Study Comparing Rosuvastatin and Atorvastatin in Subjects With Acute Coronary Syndromes

Study Overview
=================
Brief Summary
-----------------
Comparison of rosuvastatin and atorvastatin in subjects with acute coronary syndromes

Official Title
-----------------
A 12-week Randomized, Open-label 3-arm, Parallel Group, Multicenter Phase IIIb Study Comparing Efficacy and Safety of Rosuvastatin 20mg and 40mg With That of Atorvastatin 80 mg in Subjects With Acute Coronary Syndromes

Conditions
-----------------
Acute Coronary Syndromes

Intervention / Treatment
-----------------
* Drug: rosuvastatin calcium
* Drug: atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-ST segment elevation ACS and ST segment elevation ACS who receive optimal reperfusion therapy Exclusion Criteria: Previous Q-wave infarct within the last 4 weeks CK elevation not caused by myocardial injury uncontrolled hypertension at time of randomization

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: rosuvastatin calcium|nan|
|Drug: atorvastatin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of LDL-C following 12 weeks of treatment |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change from baseline in LDL-C following 2 & 6 weeks of treatment; % change from baseline in TC, HDL-C, triglycerides, non-HDL-C, apolipoprotein A-1, apolipoprotein B, LDL-C/HDL-C, TC/HDL-C, non-HDL-C/HDL-C, ApoB/Apo A-1 @ weeks 6 & 12 |  |  |
Multicenter Single-port Colectomy RCT

Study Overview
=================
Brief Summary
-----------------
This clinical trial is going to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment, in terms of safety, efficacy, and cost. The investigators hypothesize that the single-port laparoscopic colectomy is not inferior to multiport laparoscopic colectomy.

Detailed Description
-----------------
This clinical trial is a multicenter prospective randomized trial to compare the single-port and multi-port laparoscopic colectomy for colon cancer treatment.

Official Title
-----------------
A Multicenter Prospective Randomized Clinical Trail on the Efficacy of the Single Port Laparoscopic Surgery Compared With Multiport Laparoscopic Surgery

Conditions
-----------------
Colon Neoplasms

Intervention / Treatment
-----------------
* Procedure: Single-port
* Procedure: Multi-port


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colon adenocarcinoma curative resection age : 20   85 Exclusion Criteria: distal transverse colon cancer splenic flexure colon cancer descending colon cancer emergency operation obstruction perforation ASA 3 or 4 pregnant woman tumor associated with FAP, HNPCC, or IBD distant metastasis adjacent organ invasion synchronous colorectal cancer other malignancy within last five years

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Single-port|Single-port laparoscopic colon resection|
|Procedure: Multi-port|Multi-port laparoscopic colon resection|

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
-----------------
Single-port, Laparoscopy, colectomy, Single port, colon cancer, minimally invasive surgery
Peer-Supported Diabetes Self-Management Support

Study Overview
=================
Brief Summary
-----------------
The objective is to evaluate the efficacy of a web-trained workforce of Hispanic and African American diabetes peer mentors delivering Diabetes Self-Management Support (DSMS) to patients with poorly-controlled diabetes.

Official Title
-----------------
Web-based Training of Peers to Deliver Diabetes Self-Management Support

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Behavioral: Peer-Supported DSMS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes HbA1c>9% African American or Hispanic ethnicity

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetes Self-Management Support (DSMS)<br>Patient receives 6-months of DSMS while receiving support from a trained peer mentor (Peer-supported DSMS). | Behavioral: Peer-Supported DSMS<br>* Phone, SMS/text, and smartphone-based intervention.<br>|
| No Intervention: Usual Care<br>Patient continues to receive usual care. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average reduction in HbA1c from baseline |  | 6-months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
peer mentor, peer supporter, peer coach, peer-to-peer mentoring
Heart Rate Variability During Weaning From Mechanical Ventilation

Study Overview
=================
Brief Summary
-----------------
The discontinuation of mechanical ventilation (MV) and the recovery of spontaneous breathing can lead to important cardiovascular alterations due to changes in the intrathoracic pressure. The autonomic modulation assessed through heart rate variability (HRV) during weaning from MV and its impact on cardiorespiratory variables has not been well elucidated yet. To evaluate the effect of T-tube (TT) and pressure support ventilation (PSV) during weaning from MV on cardiorespiratory variables and heart rate variability.

Detailed Description
-----------------
Thirty patients who had received MV for ≥ 48 hours and who met the criteria for weaning were assessed. Two different weaning methods were used and randomization was performed to choose one of the following sequences (baseline, PSV, rest, TT; or baseline, TT, rest, PSV). HRV was assessed by heart rate spectral analysis during MV, PSV, and TT. Each intervention lasted 30 minutes and there was a 30-minute rest period between the interventions. At the end of each period of time, the following cardiorespiratory variables were analyzed: respiratory rate (f), minute ventilation (VE), tidal volume (VT), rapid shallow breathing index (f/VT), peripheral oxygen saturation (SpO2), heart rate (HR) and blood pressure. In the HRV, the total spectral power (TP), the low frequency (LF) and the high frequency (HF) components, and the ratio between the low/high frequency (LF/HF) components were calculated.

Official Title
-----------------
The Effect of T-Tube and Pressure Support on Cardiorespiratory Variables and Heart Rate Variability During Weaning From Mechanical Ventilation

Conditions
-----------------
Critical Care, Weaning

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with respiratory failure receiving MV for more than 48 hours for weaning from MV according to the parameters previously defined were selected to participate in this study Exclusion Criteria: arterial hypotension (systolic blood pressure < 100mmHg), severe brain disease, barotraumas, presence of thoracic drain or tracheostomy, using vasoactive and sedative drugs

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| heart rate variability analysis |  | minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiorespiratory variables |  | minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
autonomic modulation, heart rate, pressure support ventilation, T-tube, Mechanical ventilation
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes

Study Overview
=================
Brief Summary
-----------------
This study is being carried out to find out how patients suffering from the acute manic phase of bipolar disease are currently managed with Quetiapine Immediate Release (IR) or Quetiapine Extended Release (XR) in the hospital setting in real life practice, including length of stay.

Official Title
-----------------
European Study to Describe Hospital Stay in Patients Admitted for Acute Bipolar Manic Episodes Treated With Immediate Release Quetiapine or Extended Release Quetiapine

Conditions
-----------------
Acute Bipolar Manic Episode

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with Bipolar Disorder (ICD-10). Admitted for acute bipolar manic episode from 1st October 2009 to 1st October 2010 Patients treated with quetiapine IR or quetiapine XR during the hospitalization period. Exclusion Criteria: Patients in which BD is not the main reason for hospitalization Patients admitted for acute bipolar mania episodes but finally diagnosed with mixed or bipolar disorder not otherwise specified (NOS) episodes Patients receiving both quetiapine IR and XR during the same hospitalization period.

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 |
| --- | --- |
| 1<br>patients admitted as for an acute bipolar manic episode and treated with quetiapine IR | |
| 2<br>patients admitted as for an acute bipolar manic episode and treated with quetiapine XR | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of resources |  |  | 
| Treatments used |  |  | 
| Demographics |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients admitted as for an acute bipolar manic episode, Description of management patterns and hospital stay in patients admitted for acute bipolar manic episode and treated with either quetiapine IR or quetiapine XR
Invasive Fungal Infections Surveillance Initiative

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to optimize the management of patients treated for invasive fungal infections by establishing a real-time, continuous clinical data base that will capture and monitor trends in the epidemiology, diagnosis, treatment and outcomes of invasive fungal infections; reflect routine clinical management of patients with invasive fungal infections in order to evaluate treatment and provide a rationale for future treatment paradigms; and allow physicians to assess adherence to institutional clinical practice guidelines, validate current standardized definitions for patients with invasive fungal infections and promote change where appropriate.

Detailed Description
-----------------
Gender, height, weight, ethnicity, antifungal treatment, fungal colonization, laboratory results, past medical history, invasive fungal infection diagnosis, medications, outcomes

Official Title
-----------------
Invasive Fungal Infections Surveillance Initiative

Conditions
-----------------
Fungal Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with a diagnosis of proven or probable invasive fungal infection . This includes patients with proven or probable invasive mold infections as well as patients with proven candidemia. Exclusion Criteria: All patients with a diagnosis of possible invasive fungal infection . This includes patients with possible mold infections as well as patients with possible candidemia.

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 |
| --- | --- |
| patients with funal infections<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| outcome after invasive fungal infection | outcome after invasive fungal infection | 60 days post infection | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
invasive fungal infection
Bosentan and Pulmonary Endothelial Function

Study Overview
=================
Brief Summary
-----------------
6 months therapy of Bosentan, an endothelin antagonist, will lead to improvement in pulmonary microvascular endothelial function.

Official Title
-----------------
Pulmonary Artery Remodelling With Bosentan

Conditions
-----------------
Pulmonary Arterial Hypertension

Intervention / Treatment
-----------------
* Drug: Bosentan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pulmonary arterial hypertension; idiopathic and connective tissue disease associated Confirmed or invasive haemodynamic: Mean pulmonary arterial pressure greater than or equal to 25 millimeters of mercury Pulmonary capillary wedge pressure less than 15 millimeters of mercury No prior pulmonary hypertension specific therapy Ability to provide informed consent Exclusion Criteria: Contra-indications to medications used to test endothelial function; acetylcholine, sodium nitroprusside, NG-Monomethyl-L-Arginine, L-arginine Advanced renal disease Previous allergic reaction to contrast agents

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bosentan<br>62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months | Drug: Bosentan<br>* 62.5 mg Bosentan twice a day for 1 month 125 mg Bosentan twice a day for 5 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acetylcholine Vascular Reactivity Response | Percent pulmonary flow change from baseline after acetylcholine | Baseline and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intravascular Ultrasound - Pulmonary Artery Wall Thickness | Change in intima-media thickness | baseline and 6 months |
Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Recruitment of 28 subjects that will be randomized to consume fruit or nuts as snacks between regular meals for two months. Laboratory tests for cardiovascular risk factors, metabolic rate, liver steatosis and physical activity are investigated ahead of start of the study and at the end of the trial period och two months. Participants will be allowed to buy fruits or nuts on their own but to keep track (diaries) of the amount consumed. They will be reimbursed for the costs of the snacks.

Official Title
-----------------
Prospective Randomized Trial of Fruits or Nuts Eaten Between Regular Meals in Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Dietary Supplement: Fruits
* Dietary Supplement: Nuts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: significant diseases that can affect outcomes, mental disorders that can affect participation.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 76 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: fruit<br>Participants are given +7kCal/kg body weight of fruit to be eaten as snack in between regular meals | Dietary Supplement: Fruits<br>* Randomization to extra fruit or nuts as snacks<br>|
| Active Comparator: nuts<br>Participants are given +7kCal/kg body weight of nuts to be eaten as snack in between regular meals | Dietary Supplement: Nuts<br> <br> * Other names: Randomization to extra fruit or nuts as snacks;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of fat in the liver by magnetic resonance imaging | exact measurement of fat in the liver by liver spectroscopy | two months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular risk factors | Collection of markers for cardiovascular risk including glucose, insulin, lipoproteins etc. Analyses will be performed from blood samples. | two months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fruit, nuts, liver fat, insulin, glucose, Focus of the study is to compare the often given advice to eat fruit, containing large amount of glucose and fructose, with nuts that are more rich in fat.
Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome

Study Overview
=================
Brief Summary
-----------------
In mechanically ventilated patients the PaO2/FiO2 ratio might not be the best reflection of the severity of ARDS. It does not incorporate variables and settings used during mechanical ventilatory support such as the positive end expiratory pressure (PEEP), inspiratory time to expiratory time ratio (Ti:Te), and the peak alveolar pressure (Palv). The aim is to identify a new oxygenation index for stratification of severity of ARDS

Official Title
-----------------
Comparison of the PaO2/FiO2 Ratio to Other Oxygenation Indexes for the Classification of Severity of Acute Respiratory Distress Syndrome

Conditions
-----------------
Acute Respiratory Distress Syndrome

Intervention / Treatment
-----------------
* Diagnostic Test: Obtaining arterial blood gases


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving mechanical ventilation in the Intensive Care Unit. Patients in whom the managing medical team requested an arterial blood gas (ABG) analysis. Exclusion Criteria: Patients in whom arterial blood gas could not be obtained or not ordered.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| P/F less than 100<br>Patients receiving mechanical ventilation with paO2/FiO2 less than 100 | Diagnostic Test: Obtaining arterial blood gases<br>* Obtaining arterial blood sample<br>* Other names: No other intervention;|
| P/F between 100 and 200<br>Patients receiving mechanical ventilation with paO2/FiO2 between 100 and 200 | Diagnostic Test: Obtaining arterial blood gases<br>* Obtaining arterial blood sample<br>* Other names: No other intervention;|
| P/F between 200-300<br>Patients receiving mechanical ventilation with paO2/FiO2 between 200 and 300 | Diagnostic Test: Obtaining arterial blood gases<br>* Obtaining arterial blood sample<br>* Other names: No other intervention;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New oxygenation index | Oxygenation index that incorporates ventilator parameters | Immediate |
Liver Regeneration After Liver Resection

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to characterize Kupffer cell activity and activation of the innate immune response in the early phase of liver regeneration after right hepatectomy. The investigators hypothesise that liver regeneration after right hepatectomy in humans is associated with Kupffer cell activation and initiation of the innate immune response and that impaired liver regeneration, liver failure and sepsis following liver resection are associated with Kupffer cell dysfunction and an impaired innate immune response. The objectives for this study are to characterise Kupffer cell activity and the innate immune response in human liver before and after right hepatectomy.

Official Title
-----------------
An Observational Study of Liver Regeneration After Right Hepatectomy: Understanding the Molecular Primers of Liver Regeneration

Conditions
-----------------
Liver Diseases, Hepatectomy

Intervention / Treatment
-----------------
* Procedure: Liver biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients requiring right hepatectomy for colorectal liver metastases Exclusion Criteria: Age >75, neoadjuvant chemotherapy, recurrent disease

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Right hepatectomy<br>Intervals from inflow division. | Procedure: Liver biopsy<br>* 0, 30, 60, 90 min post inflow-division<br>|

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
-----------------
Liver regeneration, Innate immune response