linjc16/ctgov huggingface dataset:
Therasphere® for Treatment of Unresectable Primary Liver Cancer and Metastatic Liver Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this protocol is to provide supervised and limited access to Therasphere® treatment for patients with primary liver cancer and chemotherapy refractory liver metastasis who cannot be treated by surgical removal of the affected part of the liver. Patient response to treatment and any side effects of Therasphere® treatment will be examined.

Official Title
-----------------
A Humanitarian Device Exemption Use Protocol of Therasphere® for Treatment of Unresectable Hepatocellular and Metastatic Liver Tumors - HDE #980006

Conditions
-----------------
Carcinoma, Hepatocellular, Neoplasm Metastasis

Intervention / Treatment
-----------------
* Device: yttrium Y 90 microspheres (Therasphere®)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of primary or metastatic intrahepatic carcinoma The cancer must be unresectable with limited established treatment options ECOG Performance Status Score 0-2 Age 19 years or older Able to comprehend and provide written informed consent Exclusion Criteria: Any pre-treatment laboratory findings within 15 days of treatment demonstrating: Absolute granulocyte count ≤ 1,500/ul Platelet count ≤ 75,000/ul Serum creatinine > 2.0 mg/dl Serum bilirubin ≥ 2.0 mg/dl Any of the following contraindications to angiography and selective visceral catheterization: History of severe allergy or intolerance to any contrast media, narcotics, sedatives, or atropine Bleeding, diathesis, not correctable by usual forms of therapy Severe peripheral vascular disease that would preclude catheterization Substantial venous shunt away from the liver Evidence of potential delivery of greater than 11 mCi (20 Gy absorbed dose) of radiation to the lungs on either 1) first Therasphere® administration; or 2) cumulative delivery of radiation to the lungs over multiple treatments Evidence of any detectable Tc-99 MAA flow to the stomach or duodenum, application of established angiographic techniques to stop such flow Significant extrahepatic disease representing an imminent life- threatening situation outcome Severe liver dysfunction or pulmonary insufficiency Active uncontrolled infection Significant underlying medical or psychiatric illness Pregnant women may not participate

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: yttrium Y 90 microspheres (Therasphere®)|This is a local therapy for unresectable liver tumors with limited treatment options. It may be repeated under special circumstances.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in DSAEK

Study Overview
=================
Brief Summary
-----------------
The Tan EndoGlide device results in less endothelial cell trauma during insertion of the donor corneal graft indicated by reduced endothelial cell loss at 1 year follow-up compared to the Busin glide.

Official Title
-----------------
Randomized Prospective Study Comparing Tan EndoGlide With the Busin Glide for Insertion of the Donor Graft in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Conditions
-----------------
Endothelial Cell Loss With Different Insertion Devices

Intervention / Treatment
-----------------
* Device: Use of the Tan EndoGlide to insert donor graft
* Device: Busin Glide for delivery of the donor graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients presenting with corneal decompensation requiring DSAEK with or without cataract surgery for visual rehabilitation. Clinical diagnosis include endothelial cell dysfunction secondary to Fuchs endothelial dystrophy, pseudophakic or aphakic bullous keratopathy, failed penetrating keratoplasty or DSAEK, iridocorneal endothelial syndrome or trauma. Ability to understand the nature of the procedure and give full informed consent. Patients who are able to comply with the standard DSAEK follow-up protocol at the Toronto Western Hospital. Exclusion Criteria: Patients with late stage corneal decompensation with stromal scarring unsuitable for DSAEK and therefore requiring penetrating keratoplasty. Patients with complex anterior segment pathology precluding successful DSAEK procedure. Patients not giving full informed consent to participate in the trial

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 |
| --- | --- |
| Active Comparator: Busin glide delivery of donor graft<br>Use of the Busin glide to insert the donor graft | Device: Busin Glide for delivery of the donor graft<br>* Use of the forceps for delivery of the donor graft into the eye<br>|
| Experimental: Tan EndoGlide for insertion of the donor graft<br>Use of the Tan EndoGlide for insertion of the donor graft | Device: Use of the Tan EndoGlide to insert donor graft<br>* Using the Tan EndoGlide to insert donor graft into the eye<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell counts at 1, 3, 6 and 12 months postoperatively |  | 1 year | 
| Best corrected visual acuity at 1, 3, 6, and 12 months postoperatively |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications of surgery |  | 1 year |
Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients

Study Overview
=================
Brief Summary
-----------------
In this study, brain imaging predictive factors related to motor recovery will be investigated. Lastly, the prediction model will be established.

Official Title
-----------------
A Study on Factors Related to Functional Recovery Using Brain Imaging of Stroke Patients

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Behavioral: Data acquisition of functional abilities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults more than 19 years First-ever unilateral stroke Ischemic subacute stroke patients Exclusion Criteria: Major active neurological disease or psychiatric disease Metallic implants in their brain Hemorrhagic stroke Bilateral lesions Recurrent stroke

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Stroke<br>Patients with ischemic or hemorrhagic stroke who were admitted to Samsung Medical Center and transferred to the Department of Physical and Rehabilitation Medicine | Behavioral: Data acquisition of functional abilities<br>* MRI data, motor evoked potentials, and behavior data acquisition<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fugl-Meyer Assessment score at 3 months after stroke onset | Measurement of motor function of upper and lower extremities | 3 months after stroke onset] |
Abdominal Computed Tomography and the Blood Reactive Oxygen Species Level

Study Overview
=================
Brief Summary
-----------------
The clinically widely used X-ray computed tomography examination has a low-grade radiation effect and recently has attracted much attention concerning the possible adverse effects of radiation on human body [ref. 1-5]. The radiation is harmful to human tissues and cells mainly because it can interact with water (which makes up to 80% of cells) to generate reactive oxygen species (ROS), especially the formation of hydroxyl radicals. So far as we can reach, there is no report concerning the relation between X-ray computed tomography examination and the blood ROS level. Therefore, we wish to conduct this study to clarify if the routinely applied abdominal X-ray computed tomography examination may induce a higher level of ROS in the peripheral blood. Study subjects will be patients who are admitted to our hospital because of abdominal diseases that need to receive abdominal X-ray computed tomography examination for diagnosis. In total, sixty cases will be enrolled for the study. The formal consent will be delivered and explained to the patients and families several hours before the performance of abdominal X-ray computed tomography. The formal consent will be retrieved and then the peripheral blood will be sampled just before the performance of computed tomography.ROS level in the sampled peripheral blood, before and after the performance of abdominal X-ray computed tomography, will be measured, compared, and analyzed. Totally 120 blood samples, including 60 samples just before and 60 samples 2 hours after the performance of computed tomography, will be collected from 60 study subjects within 5 months (August 10   December 30, 2008). Reactive oxygen species（ROS）levels will be measured by a chemiluminescence (CL) analysing system (CLD-110, Tohoku Electronic Industrial, Sendai, Japan).

Official Title
-----------------
Effect of Abdominal X-ray Computed Tomography Examination on the Blood Reactive Oxygen Species Level

Conditions
-----------------
Radiation Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with abdominal illness that needs a computed tomography examination Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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>Sixty patients with abdominal illness and scheduled abdominal X-ray computed tomography examination will be included. | |

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
-----------------
radiation injury, computed tomography, reactive oxygen species, free radicals
Effects of Postoperative Residual Paralysis on Hospital Costs

Study Overview
=================
Brief Summary
-----------------
This is a secondary analysis of a previously performed prospective, observer-blinded, observational study at Massachusetts General Hospital. The primary aim of this study is to evaluate the effects of residual paralysis at admission to the post-anesthesia care unit (PACU) on total costs of hospital care. Secondary analyses will be conducted to evaluate the effects of postoperative residual paralysis on potential cost-influencing factors, i.e. incidence of minor and major postoperative respiratory complications, hospital length of stay (LOS), unplanned intensive care unit (ICU) admission rate, as well as length of stay in the PACU.

Official Title
-----------------
Effects of Postoperative Residual Paralysis on Costs of Hospital Care, Length of Hospitalization and Intensive Care Unit Admission Rate

Conditions
-----------------
Residual Paralysis, Post-Anesthesia

Intervention / Treatment
-----------------
* Procedure: Quantitative measurement of neuromuscular transmission


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each subject has been given non-depolarizing neuromuscular blocking agents as part of general anesthesia. Each subject must be at least 18 years of age Train-of-four monitoring in the post-anesthesia care unit Exclusion Criteria: The subject is scheduled to be transferred to an intensive care unit after surgery. Children and pregnant women

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 |
| --- | --- |
| Postoperative Residual Paralysis<br>Patients with train-of-four ratio less than 0.9 measured in the postanesthesia care unit | Procedure: Quantitative measurement of neuromuscular transmission<br>* Quantitative measurement of neuromuscular transmission with train-of-four watches.<br>|
| No Postoperative Residual Paralysis<br>Patients with train-of-four ratio greater than 0.9 measured in the postanesthesia care unit | Procedure: Quantitative measurement of neuromuscular transmission<br>* Quantitative measurement of neuromuscular transmission with train-of-four watches.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital costs |  | Patients will be followed from date of admission to date of hospital discharge, an expected 2 days to 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Length of Stay |  | within 100 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cost Analysis, Postoperative Complications, Length of Stay, Intensive Care Units
University of Minnesota Transplant Registry

Study Overview
=================
Brief Summary
-----------------
Under Transplant Information Services (TIS), the University of Minnesota Transplant Registry (UMTR) will serve as the repository for core research data.

Detailed Description
-----------------
UMTR is a system of ongoing registration of cases seen in the transplant program at the University of Minnesota. The registry will: (1) provide core outcomes data and background information necessary to conduct outcomes management research in solid organ transplantation and advanced lung disease, and (2) support cutting edge research through existing program specific databases in liver, intestine, pancreas, islet, kidney, heart and lung transplantation.

Official Title
-----------------
University of Minnesota Transplant Registry

Conditions
-----------------
Transplant Recipient, Transplant Donation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Received a transplanted organ at the University of Minnesota Living donor who donates an organ at the University of Minnesota Exclusion Criteria: Did not receive a transplant at the University of Minnesota Did not donate an organ at the University of Minnesota
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Transplant Recipients and Living Donors<br>All transplant recipients receiving transplants at the University of Minnesota (kidney, pancreas, liver, heart, lung, islet, intestine). All ages. All living donors donating an organ at the University of Minnesota (kidney, pancreas, liver, lung) (by law, living donors are required to be at least 18 years old) | |

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
-----------------
Recipient, Donor, Organ Transplant, Registry, University of Minnesota
Maintenance of Efficacy.

Study Overview
=================
Brief Summary
-----------------
The hypothesis of Study A6061054 is to demonstrate superiority of efficacy of esreboxetine at 3 and 6 months compared to placebo.

Official Title
-----------------
A 6-month, Double-blind, Placebo-controlled, Multi-center, Parallel Group, Maintenance Of Effect Study Of Esreboxetine (Pnu-165442g) Administered Once Daily (qd) In Patients With Fibromyalgia

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

Intervention / Treatment
-----------------
* Drug: Esreboxetine
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must meet the American College of Rheumatology (ACR) criteria for fibromyalgia Pain score greater than or equal to 4 on an 11-point NRS FIQ-Total score greater than or equal to 45 points Exclusion Criteria: Other severe pain that may confound assessment or self evaluation of the pain associated with fibromyalgia Any autoimmune rheumatic disorder, non-focal rheumatic disease (other than fibromyalgia), clinically significant active infection, or untreated endocrine disorder Uncontrolled hypertension Pending Worker's Compensation; Current or recent diagnosis or episode of major depressive disorder, dysthymia and/or uncontrolled depression; Subjects to be at risk of suicide;

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Esreboxetine<br> | Drug: Esreboxetine<br>* Film coated tablets (2, 6, 8, 10 mg esreboxetine), once daily for 6 months<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Film coated tablets (0 mg esreboxetine), once daily for 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline to 3 and 6 months in the mean daily pain rating score measured by the 11 point pain intensity Numerical Rating Scale (NRS). |  | 6 months | 
| Change from baseline to 3 and 6 months in the FIQ-Total score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (including other measures of daily pain and responder analyses); |  | 6 months | 
| Function (including sub-scales of the FIQ, responder analyses of FIQ and SF-36); |  | 6 months | 
| Global efficacy measures PGIC); |  | 6 months | 
| Sleep (MOS); |  | 6 months | 
| Work productivity; |  | 6 months | 
| Depression (HADS) |  | 6 months | 
| Safety (vital signs, ECG, laboratory, suicidal ideation) |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
double-blind placebo-controlled maintenance of efficacy
Social Support and Myocardial Ischemia

Study Overview
=================
Brief Summary
-----------------
To examine the role of social support in attenuating ischemic responses to psychological stress, both in the laboratory and during daily life.

Detailed Description
-----------------
BACKGROUND: A large quantity of epidemiological data has accumulated attesting to a link between social support and the progression of cardiovascular disease in cardiac patients. One way that social support might exerts its health effects is by attenuating physiological responses to psychological stress, since these responses have been related to cardiovascular disease. Much myocardial ischemia occurring during daily life appears to be related to periods of psychological stress, and laboratory mental stress tasks have been found to induce ischemia. Thus, the incidence, severity, and duration of myocardial ischemia might be modified by changes in the social environment. DESIGN NARRATIVE: There are two components to the study. In the first component, the investigators are testing the hypothesis that the presence of a supportive spouse attenuates ischemic responses to psychological stress in the laboratory. Using a counterbalanced crossover, repeated measures design, patients are asked to complete a public speaking task in the laboratory in two conditions: with a spouse present; and alone. Hemodynamic, radionuclide angiographic, and catecholamine responses to the task are assessed in both conditions. In the second component, the investigators are examining whether married patients show reduced duration of ischemia compared to unmarried patients. In addition, they plan to examine whether presence of a supportive other (spouse, or friend in the case of unmarried patients) reduces the incidence and duration of ischemia in patients during daily life activities. Patients are asked to keep a detailed diary for a two week period to ascertain patterns of daily activities. Using these diaries and in consultation with patients, the investigators are selecting a two day period during which patients have a busy and varied schedule. Patients are then asked to follow the same pattern of activities for a 48 hour period on two consecutive weeks when heart rate, and the incidence and duration of ischemia are measured. During one week their spouse, in the case of married patients, or friend, in the case of unmarried patients, is present; during the other week patients are to repeat the activities alone.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Myocardial Ischemia, Coronary Disease

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

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |