linjc16/ctgov huggingface dataset:
4-D Visualization Using Magnetic Resonance Imaging (MRI) in the Congenital Heart Disease Population

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators wish to use images obtained from standard of care cardiac MRI's performed at Children's Healthcare of Atlanta and transfer the images to a different computer in order to analyze them with a new computer. The investigators are hoping to better their understanding and management of complex congenital heart disease.

Detailed Description
-----------------
All patients enrolled in this study will be receiving standard of care cardiac MRI as prescribed by their physician. These MRI DICOM images will be transferred to a SGI Fuel workstation, where they will be manipulated using the newly developed 4-D Visualization software. No additional scanner time or new imaging sequences are required as presently prescribed sequences and produced data can be analyzed. The workstation is designed to include acceleration hardware for volume rendering, and was developed for advanced cardiac MRI viewing.

Official Title
-----------------
Using 4-D Visualization Software With Magnetic Resonance Images in the Congenital Heart Disease Population

Conditions
-----------------
Congenital Heart Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for a cardiac MRI at Children's Healthcare of Atlanta Informed consent meet MRI eligibility inclusion criteria Exclusion Criteria: Not having a cardiac MRI No informed consent not meeting MRI eligibility exclusion criteria
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 |
| --- | --- | --- |
| To determine if the 4-D visualization software is beneficial in the investigators' understanding and management of complex congenital heart lesions and their associated hemodynamics/anatomy |  | throughout study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the impact and role of 4-D Visualization on surgical planning and outcome |  | entire study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, cardiology, diagnostic imaging using MRI
Plasmakinetic Enucleation of the Prostate and Open Prostatectomy to Treat Large Prostates

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that Plasmakinetic Enucleation of the Prostate (PkEP) might yield functional results comparable to OP but with lower perioperative morbidity, and have equivalent long-term efficacy with OP for large prostates. The first objective was to demonstrate the non-inferiority of PKEP compared to OP concerning Qmax at one year postoperatively. To explore the long-term efficacy, we compared the efficacy, safety, and morbidity of PkEP with those of OP in BPH patients with prostate glands larger than 100 g over a follow-up period of 6 years.

Official Title
-----------------
Comparison of Plasmakinetic Enucleation of the Prostate With Open Prostatectomy for the Treatment of Benign Prostatic Hypertrophy Patients With Large Prostate

Conditions
-----------------
Benign Prostate Hyperplasia

Intervention / Treatment
-----------------
* Procedure: PkEP
* Procedure: OP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: •Qmax < 12 mL/s, IPSS >19 Age between 50 and 70 years Prostate volume larger than 100 mL, as determined by TRUS post-void residual urine volume greater than 50 ml medical therapy failure. Exclusion Criteria: •severe pulmonary disease or heart disease, coagulopathy, neurogenic bladder, bladder calculus, bladder cancer, prostate cancer, urethral stricture and previous prostate or urethral surgery

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PkEP<br> | Procedure: PkEP<br> <br> |
| Active Comparator: OP<br> | Procedure: OP<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qmax at one year postoperatively |  | 1 year postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Qmax at other time points after surgery |  | 1, 3, 6, 24, 36, 48, 60 and 72 months postoperatively | 
| resected adenoma weight |  | right after the operation | 
| operation time |  | during the operation | 
| blood loss |  | perioperatively and on the first postoperative day | 
| postoperative International Prostate Symptom Score |  | 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively | 
| duration of catheterization |  | after the operation | 
| length of postoperative hospital stay |  | after the operation | 
| QOL |  | 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively | 
| PVR |  | 1, 3, 6, 12, 24, 36, 48, 60 and 72 months postoperatively |
Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury

Study Overview
=================
Brief Summary
-----------------
To investigate the renal protective effect of dexmedetomidine in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy

Detailed Description
-----------------
A cytoreductive surgery and hyperthermic intraperitoneal chemotherapy may lead to the renal hypoperfusion, systemic inflammatory response, and oxidative stress. Dexmedetomidine has been known to protect the kidney against inflammation and oxidative stress in diverse clinical settings. It may also enhance a renal perfusion by inhibition of renal sympathoexcitation. We hypothesized administration of dexmedetomidine might protect the kidney in patients undergoing cytoreduction and hyperthermic intraperitoneal chemotherapy.

Official Title
-----------------
Effect of Intraoperative Dexmedetomidine on Development of Acute Kidney Injury Following Cytoreduction and Hyperthermic Intraperitoneal Chemotherapy: a Double-blind Randomized Clinical Trial

Conditions
-----------------
Malignant Tumor

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of malignant tumor with peritoneal metastasis Scheduled for elective cytoreduction and hyperthermic intraperitoneal chemotherapy Exclusion Criteria: Preoperative chronic kidney disease stage ≥4 defined by KDOQI ( eGFR < 30 mL/min/1.73m2) Congestive heart failure Atrioventricular block > 1st degree Bradycardia < 45 beat per minute History of myocardial infarction within 3 months Pregnancy

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

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

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

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: Dexmedetomidine<br>1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery | Drug: Dexmedetomidine<br>* Dexmedetomidine group :1ug/kg IV loading over 20 minutes followed by 0.5ug/kg/hr IV infusion after induction of anesthesia until the completion of the surgery<br>|
| Placebo Comparator: Normal Saline<br>IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery | Drug: Normal Saline<br>* Control group :IV loading and infusion of same volume of normal saline after induction of anesthesia until the completion of the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Creatinine clearance from baseline | Assessment of the creatinine clearance which reflects kidney function during postoperative 7 days | Postoperative day 1,2,3,4,5,6,7 |
A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain

Study Overview
=================
Brief Summary
-----------------
To determine the safety and efficacy of SNX-111 in controlling severe, chronic pain in cancer and AIDS patients.

Detailed Description
-----------------
Patients are randomized to receive SNX-111 or placebo (AS PER AMENDMENT 1/22/98: with randomization weighted 2:1 in favor of SNX-111) via external pump and an intrathecal catheter (thin tube inserted into the spinal canal). (AS PER AMENDMENT 1/22/98: the dose is increased every 24 hours, in the absence of onset of analgesia or adverse events. After 2-5 days, patients who respond to their medication continue treatment at home for 5-8 days. Patients who do not respond will be switched to the other regimen (i.e., placebo to SNX-111, or SNX-111 to placebo). After 10 days, responding patients are unblinded and asked to enroll in the long-term, open-label extension protocol. Patients remain on a fixed dose at the therapeutic level found in the previous study. The dose may be increased or decreased at the discretion of the investigator. Patients may continue therapy on a long-term basis until the drug is approved.

Official Title
-----------------
A Multicenter Phase II/III, Placebo-Controlled Study of SNX-111 Administered Intrathecally to Cancer and AIDS Patients With Chronic Pain

Conditions
-----------------
Cancer, HIV Infections, Pain

Intervention / Treatment
-----------------
* Drug: Ziconotide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Rescue analgesia. Patients must have: Chronic pain related to AIDS or cancer. Unsatisfactory response to prior opioid therapy. Life expectancy > 3 months (or 1 month if an infusion pump is in place). Exclusion Criteria Co-existing Condition: Patients with the following symptoms or conditions are excluded: Signs of sepsis or inadequately treated infection. Patients with the following prior conditions are excluded: History of heart disease, heart failure, or asthma.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ziconotide|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
-----------------
Acquired Immunodeficiency Syndrome, AIDS-Related Complex, Pain, Palliative Care, omega-conopeptide MVIIA, Calcium Channel Blockers
Biological Variability in Cartilage Specific Biomarkers in Healthy Volunteers.

Study Overview
=================
Brief Summary
-----------------
The purposes of the study are to assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage.

Detailed Description
-----------------
To assess intra individual biological variability of serum and urinary cartilage specific biomarkers and define the best standardized conditions for blood and urine sampling in the frame of biomarkers dosage. Variation factors assessed are: Fasting condition Sampling time Sampling season Physical activity Duration and temperature of total blood treatment Type of blood collection tube.

Official Title
-----------------
Evaluation of Biological Variability in Cartilage Specific Biomarkers (Coll2-1, Coll2-1NO2, FIB3-1 and FIB 3-2) in Healthy Volunteers.

Conditions
-----------------
Effects of; Serum, Urine Marking

Intervention / Treatment
-----------------
* Other: serum and urine sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged above 18 years. Sign an informed consent after being informed Able to follow the instructions of the study Exclusion Criteria: Serious associated diseases: Severe liver disease Renal failure HIV hepatitis B or C Patient who are the subject of a judicial protection measure or under guardianship

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 15 healthy volunteers<br>Other: serum and urine sample | Other: serum and urine sample<br>* Serum and urine samples will be collected at baseline, weeks2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation of serum and urine sample between baseline, weeks 2, 16, 52 and 68 to assess intra-individual biological variability of cartilage-specific biomarkers Coll2-1/Coll2-1NO2 / FIB3-1 and FIB3-2. | Change from baseline will be assess by biomarkers dosage using ELISA (Enzyme Linked ImmunoAssay) | Baseline and weeks 2, 16, 52 and 68 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Biological markers, Cartilage
High-intensity Exercise Training or Multidisciplinary Treatment in Extremely Obese Adolescents

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to determine the effects of a multidisciplinary approach and intensity-controlled interval training on cardiovascular risk factors in overweight adolescents

Official Title
-----------------
Reducing Cardiovascular Risk Factors In Overweight Adolescents: Multidisciplinary Treatment and Intensity Controlled Interval Training

Conditions
-----------------
Obesity, Cardiovascular Diseases

Intervention / Treatment
-----------------
* Behavioral: intensity controlled interval training (AIT)
* Behavioral: Multidisciplinary approach (MTG)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >+ 2SD (age adjusted) Fitted for group treatment at least one parent attending the treatment Exclusion Criteria: Not able to join treatment not able to walk

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 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: Aerobic interval training<br>intensity-controlled interval training | Behavioral: intensity controlled interval training (AIT)<br>* 4 x 4 min intervals at 90% of maximal heart rate, each interval separated by 3 min at 70%, twice a week for 3 months<br>|
| Experimental: MTG<br>multidisciplinary approach | Behavioral: Multidisciplinary approach (MTG)<br>* exercise, dietary and psychological advice, twice a month for 12 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Flow mediated Diameter Maximal oxygen uptake BMI |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adolescent, Overweight, Exercise, multidisciplinary approach, Oxygen uptake, Flow mediated dilatation, Cardiovascular Risk Factors
Tiotropium Induced Bronchodilation in Lung CT Scored Emphysema

Study Overview
=================
Brief Summary
-----------------
To evaluate if tiotropium (Spiriva)induced bronchodilation of inspiratory capacity in patients with moderate to severe copd subjected to metronome paced hyperventilation induced dynamic hyperinflation is dependent upon the extent of underlying emphysema as determined by high resolution-thin section CT lung.

Detailed Description
-----------------
We will analyze post hoc, data that was previously published: Gelb AF et al.Chest 2006;131:690-695. We have shown that tiotropium increases resting inspiratory capacity thereby providing lung volume protection against metronome paced hyperventilation induced dynamic hyperinflation. End point will be to correlate increase in tiotropium induced FEV 1(L) and inspiratory capacity with extent of underlying emphysema as scored by lung CT ( Gelb AF et al:Chest 1996; 109: 353-359)in 29 patients with COPD. We will also correlate the decrease in inspiratory capacity following metronome paced hyperventilation induced dynamic hyperinflation with extent of lung CT scored emphysema.

Official Title
-----------------
Effectiveness of Tiotropium to Maintain Inspiratory Capacity Against Metronome Paced Hyperventilation Induced Dynamic Hyperinflation in COPD Patients With Lung CT Scored Emphysema

Conditions
-----------------
COPD, Emphysema

Intervention / Treatment
-----------------
* Drug: tiotropium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria moderate to severe copd Exclusion Criteria unable to tolerate tiotropium unable to perform metronome paced hyperventilation induced dynamic hyperinflation

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 85 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 with moderate to severe copd with varying extent of emphysema | Drug: tiotropium<br>* 18ug capsule daily for 30 days<br>* Other names: Spiriva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate tiotropium induced increase in inspiratory capacity (IC)and FEV 1 with extent of emphysema as scored by lung CT. |  | After 30 days and 1.5hr of tiotropium | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlate decrease in IC and FEV 1 following dynamic hyperinflation with underlying emphysema. |  | After 30 days and 1.5hr of tiotropium | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
copd, emphysema, tiotropium, lung function, dynamic hyperinflation
Emerging Adults Who Use Alcohol and Marijuana

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to if a brief motivational intervention, compared to health education sessions, reduces alcohol and marijuana use and is related to fewer sexually transmitted infections (STI)in emerging adults who are engaging in alcohol and marijuana use.

Official Title
-----------------
Reducing STIs in Emerging Adults Who Use Alcohol and Marijuana

Conditions
-----------------
Alcohol Use, Marijuana Use, Sexually Transmitted Infections

Intervention / Treatment
-----------------
* Behavioral: motivational intervention
* Behavioral: health education


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 18 and 25 Binge drink (5 or more drinks in a 2-hour period for men, 4 or more for women) at least monthly Use marijuana at least weekly Have been heterosexually active in the past six months Are not married Have not been living with a sexual or romantic partner for more than 6 months Be English speaking Reside within 20 miles of Providence, RI and plans to stay in the geographic area for the next 15 months Provide contact information for at least two verifiable locator persons Exclusion Criteria: Have DSM-IV diagnosis of drug abuse or dependence (other than nicotine, marijuana) Have DSM-IV diagnosis of alcohol dependence

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: motivational intervention<br>7-session individual motivationally-based intervention | Behavioral: motivational intervention<br>* 7-session individual motivationally-based intervention<br>|
| Placebo Comparator: health education<br>7-session individual session focusing on health education | Behavioral: health education<br>* 7 individual sessions focusing on health education<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alcohol use |  | 15 months | 
| marijuana use |  | 15 months | 
| sexually transmitted infection |  | 15 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alcohol use, marijuana use, STI