linjc16/ctgov huggingface dataset:
Medium Term Survivorship of Cementless THA Performed Using the Bone Preservation Tri-Lock Femoral Stem

Study Overview
=================
Brief Summary
-----------------
This prospective, randomized study will study the 2 year survivorship and short term outcomes of a currently-used femoral stem: the Bone Preservation Tri-Lock femoral stem using two surgical approaches. The surgical approaches being studied are direct anterior and anterolateral. Implant survivorship, radiographic positioning, and functional outcomes will be compared. Subjects will be randomized to surgical approach and followed for a period of two years.

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: Total Hip Arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient signed an IRB, study specific informed patient consent Patient is a male or non-pregnant female age 21 years or older at the time of study device implantation Patient has primary diagnosis of non-inflammatory degenerative joint disease. Patient is a candidate for primary cementless total hip replacement Patient is willing and able to comply with postoperative scheduled clinical and radiographic evaluations and rehabilitation. Exclusion Criteria: Patient has a Body Mass Index (BMI) > 40 Kg/m2 Patient has an active or suspected infection at the time of device implantation Patient is immunologically suppressed. Patient requires revision surgery of a previously implanted total hip replacement Patient has a known sensitivity to device materials

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

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Total Hip Arthroplasty performed via direct anterior approach<br> | Procedure: Total Hip Arthroplasty<br> <br> |
| Active Comparator: Total Hip Arthroplasty using anterolateral approach<br> | Procedure: Total Hip Arthroplasty<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survivorship of Bone Preservation Tri-Lock femoral stem | Survivorship will be assessed via radiographic (x-ray) analysis and need for revision surgery (if patient had femoral stem removed for any reason within the first two years after surgery). | 2 years post-op | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TUG (timed up and go) Score |  | 6 weeks post-op |
Long Term Follow-up Hybrid Revascularization

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: The objectives of the year study are two-fold: To determine the 5-7 year patency rate (rate of open bypass grafts) of the LITA graft and stent of patients who have already had robotically-assisted Hybrid CABG surgery using CTA and MPS-MIBI. To determine patient quality of life at 5-7 years after robotically-assisted Hybrid CABG surgery

Detailed Description
-----------------
New techniques such as robotically-assisted Hybrid CABG surgery need proper evaluation to ensure potential benefits gained are not harmful to that which we know to be of significant benefit to the patients, that being the left internal thoracic artery (LITA) graft (one of the main coronary arteries supplying your heart with blood). We are therefore proposing a 5-7 year CT-Angiography (CTA) and Myocardial Perfusion Scintigraphy (MPS-MIBI) to assess the patency rate of the LITA graft and the stented graft in patients that have already undergone robotically assisted Hybrid CABG.

Official Title
-----------------
Long Term Follow-up of Robotic Hybrid Surgical Revascularization With CT Angiography

Conditions
-----------------
Coronary Artery Disease

Intervention / Treatment
-----------------
* Procedure: Robotic Hybrid coronary artery revascularization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Patients that have previously had Hybrid robotic coronary artery revascularization performed approximately 5-7 years ago at the London Health Sciences Centre, University Hospital by Dr. Kiaii. Exclusion Criteria: - Patients not described above

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 |
| --- | --- |
| Hybrid robotic cabg patients<br>Postoperative (5-7 years)Hybrid CABG robotically assisted surgical revascularization patients | Procedure: Robotic Hybrid coronary artery revascularization<br>* Lita to LAD performed by robot, Hybrid stent to other diseased coronary artery<br>* Other names: Robotic Hybrid CABG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Graft patency | To assess the graft patency of the LITA to LAD performed by the robot and the patency of the Stent. | 5-7 years post Hybrid surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, Hybrid, Robotic surgery
Immune Responses to Gluten

Study Overview
=================
Brief Summary
-----------------
This is a study of immune responses after eating gluten powder in people with celiac disease and healthy controls.

Detailed Description
-----------------
This is a multi-site open-label single dose gluten challenge study. Participants will provide a blood sample for measurement of cytokines before and 4 hours after eating gluten powder.

Official Title
-----------------
Changes in Serum IL-2 Levels Following a Single Oral Dose of Gluten

Conditions
-----------------
Celiac Disease, Malabsorption Syndromes, Digestive System Disease, Intestinal Disease, Gastrointestinal Diseases, Gluten Sensitivity, Celiac Disease in Children

Intervention / Treatment
-----------------
* Dietary Supplement: Gluten Powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On a gluten-free diet for ≥ 4 weeks Willing to consume gluten for research For the celiac disease arm, diagnosis confirmed by serology and/or histology Exclusion Criteria: Pregnancy Wheat allergy Type 1 diabetes BMI z-score < -2 History of more than minimal symptoms following gluten exposure on a gluten-free diet Comorbid condition that in the opinion of the investigator would interfere with study participation or would confound study results

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 101 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a multi-center study of immune responses to gluten in persons with celiac disease and healthy controls. All participants will have baseline blood drawn to assess immune responses at baseline in addition to four hours after a single oral dose of gluten.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Celiac Disease<br>Individuals with a confirmed diagnosis of celiac disease based on serology and/or histology | Dietary Supplement: Gluten Powder<br>* Single oral dose of gluten powder<br>|
| Experimental: Healthy Controls<br>Individuals without a diagnosis of celiac disease | Dietary Supplement: Gluten Powder<br>* Single oral dose of gluten powder<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in serum interleukin-2 (IL-2) level from baseline to 4 hours after a single oral dose of gluten | To determine the change in serum IL-2 level from baseline after a single oral dose of gluten | Baseline, 4 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gluten, cytokine, T cell immune response
Compare the Pharmacokinetics of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the pharmacokinetics of NVP-1205 and coadministration of rosuvastatin and ezetimibe.

Detailed Description
-----------------
rosuvastatin and ezetimibe(anti-dyslipidemia)

Official Title
-----------------
A Clinical Trial to Compare the Pharmacokinetics and Safety of NVP-1205 and Coadministration of Rosuvastatin and Ezetimibe in Healthy Male Volunteers

Conditions
-----------------
Dyslipidemia

Intervention / Treatment
-----------------
* Drug: NVP-1205
* Drug: rosuvastatin and ezetimibe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subjects age between 19 and 55 signed informed consent Exclusion Criteria: subjects have a history of allergy reaction of this drug or other drugs

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Primary Purpose: Screening
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVP-1205<br>administration of NVP-1205(rosuvastatin+ezetimibe) | Drug: NVP-1205<br>* rosuvastatin/ezetimibe fixed dose combination orally, once daily on Period 1 or Period 2<br>* Other names: NVP-1205(rosuvastatin+ezetimibe);|
| Active Comparator: rosuvastatin and ezetimibe<br>coadministration of rosuvastatin and ezetimibe | Drug: rosuvastatin and ezetimibe<br>* coadministration of rosuvastatin and ezetimibe orally, once daily on Period 1 or Period 2<br>* Other names: Crestor and Ezetrol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUClast |  | 0-96hr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCinf |  | 0-96hr |
Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer

Study Overview
=================
Brief Summary
-----------------
Mutation-positive peripheral blood ctDNA became mutation-negative after surgical removal of the cancer tissue. All subjects in the control group were negative for ctDNA mutations。

Official Title
-----------------
Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cancer

Conditions
-----------------
Preoperative and Postoperative ctDNA Comparison in Early Stage Lung Cnacer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients with pulmonary nodules who underwent curative-intent resection were able to enter the study - Exclusion Criteria:Patients who received any invasive examination or treatment prior to resection or had a history of malignancy; patients who do not attend follow up after surgery; blood samples that were contaminated; and biopsies that exhibited advanced lung cancer in pathology。 -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The potential value of ctDNA in the diagnosis of NSCLC | The sensitivity,specificity,positive predictive valueand the negative predictive value of mutations in plasma ctDNA for detecting early-stage lung cancer | Half a year |
Biobehavioral Mechanisms of Blood Pressure Regulation

Study Overview
=================
Brief Summary
-----------------
To investigate the role of biobehavioral factors in the pathogenesis of concentric left ventricular hypertrophy.

Detailed Description
-----------------
BACKGROUND: Hypertension is more prevalent in Black than white men, and is more prevalent in men than women. Furthermore, even controlling for blood pressure, concentric left ventricular hypertrophy, an early structural adaptation of hypertension, is more prevalent in Black than white men, and more prevalent in men than women. Concentric left ventricular hypertrophy is the strongest predictor, other than age, of the cardiovascular morbidity associated with high blood pressure. DESIGN NARRATIVE: In a biracial sample, concentric left ventricular hypertrophy and concentric remodelling were assessed by echocardiographic measures of left ventricular mass and relative wall thickness. Laboratory procedures were used to: (i) assess hemodynamic and neurohumoral responses during exposure to a diverse battery of physical and psychological stressors, and; (ii) evaluate alpha and beta adrenergic receptor responsiveness, baroreceptor reflex gain and minimal forearm vascular resistance. Since blood pressure during a typical workday was an established predictor of left ventricular hypertrophy, it was also assessed. A new biobehavioral model was tested that implicated the hemodynamic pattern of behaviorally-evoked pressor responses in the pathogenesis of concentric left ventricular hypertrophy. One prediction of this model was that a predisposition to exhibit increased vascular resistance during stress (characteristic of black men) would favor the development of concentric hypertrophy. Thus, systemic vascular resistance responses, evaluated in the laboratory, were hypothesized to independently predict left ventricular mass and relative wall thickness, even after controlling for established risk factors, including workday blood pressure. Sympathetic nervous system function was examined to test hypothesized mechanisms responsible for race and gender differences in the hemodynamic patterns of blood pressure regulation. The results of these studies emphasized the importance of race and gender in prescribing pharmacological and/or behavioral treatment for hypertensive heart disease. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 39 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 |
| --- | --- | --- |
Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil in Subjects With Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
This study tested the hypothesis that vardenafil was both clinically effective and well-tolerated compared to placebo in men diagnosed as being unresponsive to sildenafil.

Official Title
-----------------
A Randomized, Double-blind, Parallel-group, Placebo-controlled Study Evaluating the Efficacy and Safety of Vardenafil Administered for 12 Weeks in a Flexible-dose Regimen Compared to Placebo in Male Erectile Dysfunction Subjects

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Levitra (Vardenafil, BAY38-9456)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men >/= 18 years of age, with 6 months or longer diagnosis of ED as defined by NIH Consensus statement, History of unresponsiveness to sildenafil Stable sexual relationship for > 6 month Exclusion Criteria: Primary hypoactive sexual desire History of myocardial infarction, stroke or life-threatening arrhythmia within prior 6 month Nitrate therapy

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- |
| Placebo Comparator: Arm 2<br> | Drug: Placebo<br>* Matching placebo<br>|
| Active Comparator: Arm 1<br> | Drug: Levitra (Vardenafil, BAY38-9456)<br>* Vardenafil 5mg or 10mg or 20mg taken orally on demand 1 hour prior to sexual intercourse<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Function domain of the International Index of Erectile Function |  | 12 weeks | 
| Sexual Encounter Profile Question 2 |  | 12 weeks | 
| Sexual Encounter Profile Question 3 |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Erectile Function domain scores > 26 |  | 12 weeks | 
| Sexual Encounter Profile 2 |  | 12 weeks | 
| Global Assessment Question |  | 12 weeks | 
| Reliability of insertion |  | 12 weeks | 
| Reliability of maintenance |  | 12 weeks | 
| Other subject diary based variables |  | 12 weeks | 
| Safety and tolerability |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Erectile Dysfunction, Vardenafil
Postconditioning in the Treatment of Acute ST-segment Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Standard treatment of patients with acute ST-segment elevation myocardial infarction consist of acute re-opening of the occluded coronary artery (primary PCI). Despite successful treatment of the epicardial vessel reperfusion is sometimes inadequate leading to large final infarct sizes. This phenomenon is known as the reperfusion injury. Several animal studies have indicated that graded re-opening of the artery may limit tissue damage. Generally this is referred to as mechanical postconditioning. The study investigates the effect on final infarct size evaluated by magnetic resonance scan of postconditioning of ST-segment elevation myocardial infarctions. Mechanical postconditioning is performed by means of several balloon inflations in the injured vessel following its acute re-opening.

Detailed Description
-----------------
Please see above

Official Title
-----------------
Postconditioning Used to Limit Final Infarct Size in Patients With Acute ST-segment Elevation Myocardial Infarction

Conditions
-----------------
ST-segment Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Standard primary PCI
* Procedure: Mechanical postconditioning


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients more than 18 years STEMI < 12 hours TIMI 0-1 in infarct related artery Exclusion Criteria: Multivessel disease (stenoses in non-infarct related arteries >70%) Cardiogenic shock Left main occlusions Lesions that cannot be treated with stents Previous CABG Pregnancy Severe renal insufficiency Previous extensive Q-wave infarction LBBB

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 |
| --- | --- |
| Experimental: Mek postcon<br>Re-opening of the infarcted coronary artery by several balloon inflations separated by reperfusion of the vessel. | Procedure: Mechanical postconditioning<br>* Mechanical postconditioning with 4 cycles 30/30 sek balloon inflations<br>|
| Active Comparator: Standard treatment<br>Standard treatment (primary PCI) | Procedure: Standard primary PCI<br>* Acute re-opening of the occluded coronary artery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Final infarct size evaluated by MR |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MACE (death, re-infarction, TLR) |  | 1, 15 month | 
| Stent thrombosis |  | 15 month |
Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section.

Study Overview
=================
Brief Summary
-----------------
To determine the risk of surgical site infection after surgical skin incision, comparing electrocautery vs. scalpel.

Official Title
-----------------
Electrocautery Versus Scalpel for Surgical Skin Incisions in Cesarean Section. A Randomized Controlled Trial.

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Device: Scalpel
* Device: Electrocautery
* Procedure: Skin incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective Cesarean section, regardless of gestational age. Exclusion Criteria: Skin infection in the cesarean section area. Emergency cesarean section. Presence of a maternal pathology that increases the risk of infection (immunocompromised state).
Sexes Eligible for Study
-----------------
Female

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: Scalpel<br>Skin incision performed with a scalpel during cesarean section. | Device: Scalpel<br>* Skin incision performed with a scalpel during cesarean section.<br>Procedure: Skin incision<br> <br> |
| Experimental: Electrocautery<br>Skin incision performed with an electrocautery during cesarean section. | Device: Electrocautery<br>* Skin incision performed with an electrocautery during cesarean section.<br>Procedure: Skin incision<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Surgical Site Infection | Presence of signs of surgical site infection after cesarean section. | 8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post operative pain | Post operative pain using a visual scale after surgery. | 8 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scalpel, Surgical Wound Infection, Electrocautery