linjc16/ctgov huggingface dataset:
Clinical Performance Evaluation of Veye Lung Nodules

Study Overview
=================
Brief Summary
-----------------
Veye Lung Nodules (Aidence B.V., Amsterdam, the Netherlands) is a medical software device that is intended to assist radiologists with pulmonary nodule management on CT chest scans. This clinical trial aims to assess the clinical performance of Veye Lung nodules via a standalone performance evaluation and a reader study.

Official Title
-----------------
Clinical Performance Evaluation of Veye Lung Nodules

Conditions
-----------------
Lung; Node

Intervention / Treatment
-----------------
* Device: Veye Lung nodules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Subjects that underwent a CT chest scan for either lung cancer screening or routine practice Exclusion Criteria: Subjects with >10 pulmonary nodules; Subjects with pulmonary mass(es) = largest axial diameter >30mm; Subjects with interstitial lung disease.

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 |
| --- | --- |
| Intervention<br>Intervention is the use of Veye Lung Nodules during the reading of the CT scans | Device: Veye Lung nodules<br>* Veye Lung Nodules<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection accuracy | Demonstrate that the accuracy for detecting actionable pulmonary nodules by radiologists using the device (AIDED) is superior to that of radiologists not using the device (UNAIDED) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segmentation accuracy | Demonstrate that the accuracy for segmenting actionable pulmonary nodules by the device is non-inferior to expert radiologists | 1 month |
Expression of BCRP in Icteric Patients

Study Overview
=================
Brief Summary
-----------------
The expression of transporters involved in bile acid homeostasis is differentially regulated during obstructive cholestasis. Bile acids are also substrates of the drug efflux transporter breast cancer resistance protein (BCRP) that is highly expressed in the human intestine. Therefore we intend to analyze whether intestinal BCRP expression could be altered during cholestasis.

Detailed Description
-----------------
BCRP is capable of transport bile acids and may indicate that this transporter is involved in bile acid homeostasis. As an efflux pump, it could protect the enterocytes from potential toxic bile acid concentrations. During cholestasis, where the enterohepatic circulation is disrupted, there occurs an adaptive regulation of transporters for bile acids, bilirubin and cholesterol. These changes take place in liver, kidney, as well as in the intestine. Using real-time RT-PCR analysis we determine BCRP mRNA expression levels in duodenal tissue of healthy subjects and cholestatic patients. BCRP protein levels will be determined by immunohistochemistry. Healthy subjects and cholestatic patients are enrolled in the study after giving informed consent. Control subjects with an indication for a gastrointestinal tract endoscopy within a cancer-screening program and patients with obstructive cholestasis with an interventional endoscopic retrograde cholangiopancreatography (ERCP) are included in this study. During endoscopy four biopsy specimens are obtained from the distal part of the duodenum. Biopsies are immediately stored at -70°C until further processing.

Official Title
-----------------
Influence of Cholestasis on Intestinal BCRP Expression

Conditions
-----------------
Icterus

Intervention / Treatment
-----------------
* Behavioral: no intervention, pathophysiological study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical diagnosis of obstructive cholestasis (obstructive jaundice was defined on the basis of chemical parameters (bilirubin, g-glutamyltransferase, and alkaline phosphatase) and on imaging procedures (ultrasound and ERCP) demonstrating a dilated bile duct system) control subjects had an indication for a gastrointestinal tract endoscopy within a cancer-screening program 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: no intervention, pathophysiological study|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
-----------------
cholestasis, BCRP, multidrug resistance, duodenum, bile acids, ABCG2
Protein Ingestion and Resistance Exercise in Elderly

Study Overview
=================
Brief Summary
-----------------
The mail goal of this randomized controlled, dietary intervention study is to investigate whether protein supplementation in combination with resistance exercise can increase muscle mass and strength in elderly. Loss of muscle mass and -strength is frequent in this group. Participants (N = 220, equal distribution between men and women) are randomized to one of three groups receiving different quantities and qualities of protein supplementation after exercise. The results of this study will be used to form recommendations regarding diet and exercise for the prevention of this frequent health problem in elderly.

Official Title
-----------------
Effects of Protein Quantity and Quality in Combination With Resistance Exercise on Muscle Mass and -Strength in Icelandic Elderly.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Dietary Supplement: Whey protein
* Dietary Supplement: Milk protein
* Dietary Supplement: Carbohydrates


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 65 years and older Exclusion Criteria: uncontrolled coronary heart disease pharmacological interventions with drugs known to affect muscle mass major orthopedic disease low cognitive function.

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Whey protein<br>20 g whey protein + 20 g carbohydrates | Dietary Supplement: Whey protein<br>* Dietary supplement after training<br>|
| Experimental: Milk protein<br>20 g milk protein + 20 g carbohydrates | Dietary Supplement: Milk protein<br>* Dietary supplement after training<br>|
| Active Comparator: Carbohydrates<br>40 g carbohydrates | Dietary Supplement: Carbohydrates<br>* Dietary supplement after training<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
-----------------
protein consumption, Elderly, resistance exercise, muscle mass
Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.

Study Overview
=================
Brief Summary
-----------------
Observational Study analyzing the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies.

Detailed Description
-----------------
Background. Prevention of incisional hernias with a prophylactic mesh in emergency surgery is controversial. The present study aimed to analyze the long-term results of prophylactic mesh used for preventing incisional hernia after emergency midline laparotomies. Methods. This study was a retrospective analysis of patients who underwent an emergency midline laparotomy between January 2009 and July 2010 with a follow-up period of longer than 2 years. Long-term outcomes and risk factors for the development of incisional hernias between patients who received a prophylactic reinforcement mesh (Group M) and suture (Group S) were compared.

Official Title
-----------------
Long-term Follow-up of Prophylactic Mesh Reinforcement After Emergency Laparotomy.

Conditions
-----------------
Prevention of Incisional Hernia in Emergency Surgery

Intervention / Treatment
-----------------
* Procedure: Prophylactic mesh use


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing emergency midline laparotomy Exclusion Criteria: Those with need of concomitant hernia repair. Those who received incisions outside the midline. Those with delayed abdominal closure. Those who died in the immediate postoperative period. Those without a minimum 2 years of follow-up.

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 |
| --- | --- |
| Prophylactic mesh<br>Patients who received a prophylactic mesh after emergency surgery due to high risk of incisional hernia. | Procedure: Prophylactic mesh use<br>* After laparotomy sutured clousur the abdominal wall wound is reinforced using a suprafascial synthetic mesh.<br>* Other names: Incisional hernia prevention;|
| Suture<br>Patients who's laparotomies closure was using only suture without any abdominal wall reinforcement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incisional hernia | Detection of clinical or subclinical incisional hernia during postoperative longterm followup | 2 years |
Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Study Overview
=================
Brief Summary
-----------------
The objective of this trial is to evaluate the safety and efficacy of Xyrem® in long term use.

Detailed Description
-----------------
The trial is an open-label safety and efficacy study of subjects with fibromyalgia who completed either study 06-008 or 06-009. Total duration is up to 40 weeks of trial participation.

Official Title
-----------------
A Long-Term, Open-Label, Safety and Efficacy Study of Xyrem® (Sodium Oxybate) in Subjects With Fibromyalgia.

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Drug: Xyrem®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has qualified for and completed either study 06-009 (NCT00423813) or 06-008 (NCT00371137). Subject is able, in the opinion of the investigator, to take Xyrem® for approximately 9-1/2 months. Exclusion Criteria: Subject terminated early from either study 06-009 or 06-008. Subject experienced any serious adverse event related to study drug in either study 06-009 or 06-008. Subject, in the opinion of the investigator, experienced an adverse event in 06-009 or 06-008 that may prevent him/her from safely participating in this study.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Xyrem®<br>* flexible dosing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Subjects Reporting Adverse Events | Number of subjects reporting adverse events. | Treatment Period (38 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FMS, Fibro, Pain, Body Pain, Tenderness, Joint pain, Stiffness, Muscular Pain
Insulin Cardioplegia for Poor Left Ventricular Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this investigation is to develop a means to improve the recovery of cardiac metabolism and ventricular function following coronary artery bypass surgery (CABG) in patients with poor preoperative ventricular function (e.g. ejection fraction <40%).

Detailed Description
-----------------
Hypothesis Insulin added to blood cardioplegia will improve the results of Coronary Artery Bypass Graft by reducing the incidence of low output syndrome (i.e., the requirement for inotropic or balloon pump assistance) in patients with a preoperative ejection fraction <40%.

Official Title
-----------------
Insulin Cardioplegia Trial for Poor Left Ventricular Function

Conditions
-----------------
Left Ventricular Dysfunction

Intervention / Treatment
-----------------
* Drug: Insulin Cardioplegia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has been referred for isolated coronary bypass surgery. LV grade 3 or 4, LVEF <40% by angio, echo, RNA. Exclusion Criteria: Patient is undergoing reoperative surgery (i.e., has had any previous cardiac surgery) Surgeon has planned another procedure in addition to coronary bypass surgery (e.g., valve repair, replacement, ascending aorta repair or replacement, left ventricular aneurysm resection, repair of congenital defect, carotid surgery, repair of abdominal aortic aneurysm). Patient is scheduled for minimally invasive surgery. More recent assessment of LV function with LV grade 1 0r 2, LVEF>40%. 5 or 6 days post MI.

Ages Eligible for Study
-----------------
Minimum Age: 0 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

| Intervention/Treatment |
| --- |
|Drug: Insulin Cardioplegia|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Low Output Syndrome |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Troponin I Release |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myocardial Protection, Myocardial Metabolism, Ventricular Function, Cardiovascular Disease, Cardioplegic Additives
A Mobile and Web-Based Clinical Decision Support and Monitoring System for Diabetes Mellitus Patients in Primary Care

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to develop a user-friendly, comprehensive, fully integrated web and mobile-based Clinical Decision Support and Monitoring System (CDSMS) for DM diseases screening, diagnosis, treatment and monitoring for the use of physicians and patients in primary care and to determine the effectiveness of the system. For validating the CDSMS for diabetes patients, randomized controlled trial will be conducted.A parallel single blind randomized controlled trial will be implemented. 10 physicians and their 439 patients are involved in the study. According to the results of screening which is done using developed CDSMS, DM diagnosed patients will be recruited for trial from the primary care centers by the physicians. The recruited patients will register to the CDSMS with their accounts given by their physicians. Eligible participants will be assigned to intervention and control groups with simple randomization. The significance level will be accepted as p<0,05. In the intervention group, the system recommendations on diagnosis, treatment and monitoring will be carried out as the final decision given by the physician. In the control group, physicians will treat DM patients as the general routine. Patients in both groups will be monitored for 6 months. Patient data on 0th and 6th month will be compared. Clinical and laboratory outcomes will be face-to-face assessed, others will be online self-assessed.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Other: Clinical decision support and monitoring system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Being over age 40 Volunteer Computer and Internet literacy DM diagnosed or having at least one of diagnostic criteria. These criteria; HbA1c ≥ 6.5 FPG ≥ 126 mg / dl 2-hour postprandial glucose ≥ 200 mg / dl Any time postprandial glucose ≥ 200 mg / dl Diabetes symptoms Exclusion Criteria: Having a communication problem Type 1 diabetes MODY type DM Level of psychiatric disorders in psychosis Dementia ones

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical decision support and monitoring system<br> | Other: Clinical decision support and monitoring system<br> <br> |
| No Intervention: Control Group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fasting blood glucose |  | Change from baseline fasting blood glucose at 6 months |
Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Selection criteria for safe hepatectomy for HCC are not well established. The aim of this study was the validation of the selection criteria for safe hepatectomy for hepatocellular carcinoma.

Detailed Description
-----------------
All consecutive patients submitted to hepatectomy for HCC based on the same preoperative selection criteria from our prospectively-maintained liver unit database. Such criteria included the value of bilirubin (BIL), the value of cholinesterases (CHE), the presence of ascites, the presence of esophageal varices, and the rate of residual liver volume.

Official Title
-----------------
Selection Criteria for Safe Hepatectomy for Hepatocellular Carcinoma: Validation on 336 Consecutive Hepatectomies.

Conditions
-----------------
Cirrhosis, Hepatectomy, Hepatecellular Carcinoma

Intervention / Treatment
-----------------
* Procedure: Hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: any patient with HCC submitted to hepatic resection at our Unit in the established frame time Exclusion Criteria: any patient with missing data or lost at follow-up

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Hepatectomy for HCC<br>Patients submitted to surgery for HCC | Procedure: Hepatectomy<br> <br> * Other names: Hepatic resection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of surgery for HCC | The primary endpoint was the validation of our selection criteria for safe hepatectomy for HCC in regards to postoperative complications. The role of total bilirubin and cholinesterases was analzyed together with other clinical parameters. | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Score systems HCC | The secondary endpoint was the testing of the most common score systems for HCC, which are the CPT score, the MELD score, and the APRI score. | 90 days |
Study Evaluating BENEFIX in Previously Treated Patients With Hemophilia B

Study Overview
=================
Brief Summary
-----------------
To assess efficacy and safety of BeneFix® for prophylaxis in Short-term therapy and on demand therapy for all bleeding episodes of subjects with hemophilia B.

Detailed Description
-----------------
Phase IV, open-label, non comparative, multicenter, previously treated patients (PTP) clinical trial. Patients with severe or moderate hemophilia B with baseline levels of plasma factor IX < 5% activity will participate in this study for both treatment regimens: on demand therapy for acute bleeding episodes and therapy for prophylaxis of bleeding episodes ( Short-term therapy)*. * Short-Term Therapy: Prophylactic therapy given before surgery, including dental procedures, prior to a event that would likely result in bleeding ( sports, exercise, or heavy work), as well as to prevent further bleeds into a target joint). This short-term therapy for intermittent secondary therapy.

Official Title
-----------------
Evaluation of Efficacy and Safety of Benefix®- Coagulation Factor ix, Recombinant, in Previously Treated Patients With Hemophilia b.

Conditions
-----------------
Hemophilia B

Intervention / Treatment
-----------------
* Drug: Recombinant Factor IX Coagulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with moderate to severe hemophilia B ( < 5% circulating factor IX activity) having acute hemorrhage or requiring short-term therapy for intermittent secondary prophylaxis regimens. HIV seropositive ( asymptomatic) or seronegative subjects. No history or detectable inhibitors.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Patients will receive Benefix IV according to blood amount | Drug: Recombinant Factor IX Coagulation<br>* Benefix IV each 12 hours for 2 a 5 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary variable will be the clinical response of BeneFix* in avoiding stopping or avoiding bleeding. |  | 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary variables will be hemostasis and blood loss during and after surgery. |  | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BENEFIX, Hemophilia B