linjc16/ctgov huggingface dataset:
Cognitive Function After Treatment of Primary CNS Malignancy

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators propose to evaluate cognitive function and determine the feasibility of neurocognitive assessment using a select CogState test battery in patients with primary intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent. The investigators will use the CogState software to quantify changes in verbal learning, memory, and executive function over the initial months and years following radiation treatment. Cognitive changes and temporal patterns of function will be compared to baseline performance for each patient. Data regarding cognitive function, fatigue, quality of life, and standard patient reported outcomes will be collected to characterize the daily impact of treatment. In addition, observed outcomes will be correlated with dosimetry values, radiation dose volumes, and anatomic dose distribution.

Official Title
-----------------
Observational Study Evaluating Neurocognitive Function in Patients With Primary CNS Malignancy Receiving Radiation Treatment to the Brain

Conditions
-----------------
CNS Malignancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 4 years with primary CNS malignancy Able to use computer for assessment battery Receiving photon- or proton-based radiation for primary intracranial malignancy Demonstrates the capacity to sign informed consent Exclusion Criteria: Patients with WHO Grade IV tumors

Ages Eligible for Study
-----------------
Minimum Age: 4 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 |
| --- | --- | --- |
| characterize the rate and magnitude of change in cognitive performance within 12 months of completion of therapy in patients with intracranial malignancies receiving photon- or proton-based cranial irradiation with curative intent | Using the CogState software | baseline, completion of treatment, 3 months, 6 months, 1 year and 2 years after radiotherapy |
The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery

Study Overview
=================
Brief Summary
-----------------
Evaluating analgesic effect of intraoperative magnesium sulfate infusion in the outpatient surgery case

Official Title
-----------------
The Effect of Intraoperative Magnesium Sulfate Infusion on the Postoperative Recovery After Outpatient Surgery

Conditions
-----------------
Postoperative Pain

Intervention / Treatment
-----------------
* Drug: Magnesium Sulfate
* Drug: Normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged between 18-65 year-old-patient (ASA I-II) who are planned to undergoing day surgery Exclusion Criteria: ASA class ≥ III suspected imbalance of electrolyte myocardial damage or conduction delay myasthenia gravis or other neuromuscular disease impaired renal function already using any type of analgesia denial of participating in the study or not giving the informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Normal saline group<br>after loading normal saline 100cc in 10-20 minutes, continuous infusion of normal saline until the end of surgery | Drug: Normal saline<br>* Placebo<br>|
| Active Comparator: Magnesium group<br>after loading magnesium sulfate dosing 50 mg/kg (100cc) in 10-20 minutes, continuous infusion of magnesium sulfate 15 mg/kg/h until the end of surgery | Drug: Magnesium Sulfate<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| severity of postoperative pain | checking the postoperative pain in score at the recovery room and outpatient surgery center | 1 hour interval |
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese subjects with coronary artery disease.

Official Title
-----------------
A Double-Blind Study of E5555 in Japanese Subjects With Coronary Artery Disease

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

Intervention / Treatment
-----------------
* Drug: E5555 50 mg
* Drug: E5555 100 mg
* Drug: E5555 200 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45 - 80 years old (at time of informed consent). Male or female (females of childbearing potential must use contraception). Confirmed coronary artery disease. All subjects must be receiving aspirin (75 - 325 mg). Exclusion Criteria: Unwilling or unable to provide informed consent. History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder. Recent trauma or major surgery. Evidence of active pathological bleeding or history of bleeding such as gastrointestinal or genitourinary, unless the cause has been definitely corrected. History of intracranial bleeding or history of hemorrhagic retinopathy. New York Heart Association class III or IV congestive heart failure. Pregnant or lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: E5555 50 mg<br>* E5555 50 mg (tablet) taken orally, once a day.<br>|
| Experimental: 2<br> | Drug: E5555 100 mg<br>* E5555 100 mg (tablet) taken orally, once a day.<br>|
| Experimental: 3<br> | Drug: E5555 200 mg<br>* E5555 200 mg (tablet) taken orally, once a day.<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Placebo (tablet) taken orally, once a day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Coronary artery disease
Effectiveness of Varenicline: Testing Individual Differences

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the effectiveness of smoking cessation using Varenicline versus placebo. Effectiveness will be measured by the average number of cigarettes smoked per smoking day for up to 36 weeks.

Official Title
-----------------
Effectiveness of Varenicline: Testing Individual Differences

Conditions
-----------------
Smoking Addiction

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 yrs to 55 yrs smoker Exclusion Criteria: Medical Contraindications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Varenicline<br>Varenicline | Drug: Varenicline<br>* Days 1-3 - .5mg tablet 1xdaily Days 4-7 - .5mg tablet 2xdaily Days 8-84 - 1mg tablet 2xdaily<br>* Other names: Chantix;|
| Placebo Comparator: Microcrystal Cellulose<br>Microcrystal cellulose placebo | Drug: Placebo<br>* 25mg look alike riboflavin tablets to match active study medication.<br>* Other names: riboflavin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cigarettes Per Smoking Day | The number of cigarettes smoked were assessed only on a smoking day, i.e., when a participant smoked at least 1 cigarette. Data was recorded each day for up to 36 weeks. | up to 36 weeks |
Descriptive Study of Pain, Anxiety and Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to investigate pain, anxiety and depression in chronic pain patients with and without neuropathic pain compared with healthy volunteers

Detailed Description
-----------------
Primary outcome measures: Symptom checklist 92 Secondary outcome measures: Hamilton Depression and Anxiety Rating Scale Major Depression Inventory GAD-10 Anxiety Scale Health Survey SF-36 McGill Pain Questionnaire Sweat test Heart rate variability testing Coping Strategy Questionnare Quantitative sensory testing Pain Catastrophizing Scale Pain rating (VAS) Interview

Official Title
-----------------
Pain, Anxiety and Depression in Chronic Pain Patients With and Without Neuropathic Pain Compared With Healthy Volunteers

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Behavioral: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neuropathic pain patient or patient with fibromyalgia Daily pain in more than 6 months Weekly average pain score 4 or more (VAS) Exclusion Criteria: Treatment with antidepressants, anticonvulsants or any other pain medication except paracetamol Serious or unstable medical disease Prior or present diagnosis of mania, bipolar or psychotic disorder, delirium, suicidal, drug and alcohol dependence, severe agitation Patients who cannot cooperate and do not understand Danish

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Observation|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
-----------------
Neuropathic pain, Chronic pain, Depression, Anxiety
Chylothorax Following Heart Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine at risk populations for certain congenital heart defects or certain operative procedures and to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection.

Detailed Description
-----------------
Chylothorax is not uncommon following congenital heart surgery. It often results in prolonged chest tube drainage and hospital stays. Due to the feeding difficulties, it often results in malnutrition and the need for central hyperalimentation. In addition, it results in a depressed immune system with the possibility of subsequent infection. Chylothorax can be a significant contributor to post-operative morbidity and mortality. The primary aims are to determine at risk populations - certain congenital heart defects or certain operative procedures, to define the associated morbidity secondary to chylothorax - prolonged chest tube drainage, prolonged hospital stay, need for central access and hyperalimentation, subsequent infection and to review our current treatment methods - change formulas, hyperalimentation, somatostatin. The secondary aims are to determine ways to prevent chylothorax, determine the most successful treatment method, and to discover better treatment methods. This study will be conducted through a retrospective chart review.

Official Title
-----------------
Chylothorax in Children Following Congenital Heart Surgery

Conditions
-----------------
Chylothorax

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients in the congenital surgery database patients have developed post-operative chylous effusions 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric health, cardiac, congenital heart surgery, post-operative chylous effusions, heart defects, children
Evaluation of Cataract Surgery Outcome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the visual outcome of the cataract surgery, including best uncorrected and corrected visual acuity, spherical equivalent, wavefront aberration and other measurements.

Official Title
-----------------
Evaluation of Surgical Outcomes of Cataract Surgery

Conditions
-----------------
Cataract, High Myopia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of cataract Must be able to cooperate with the ophthalmic examination Exclusion Criteria: Clinical diagnosis of mental illness Mentally disabled

Ages Eligible for Study
-----------------
Maximum Age: 90 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 |
| --- | --- | --- |
| Change from baseline in visual acuity at one month after cataract surgery |  | Follow-up until one month after surgery | 
| Change from baseline in spherical equivalent at one month after cataract surgery |  | Follow-up until one month after surgery | 
| Change from baseline in visual acuity at six months after cataract surgery |  | Follow-up until six months after surgery | 
| Change from baseline in spherical equivalent at six months after cataract surgery |  | Follow-up until six months after cataract surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in wavefront aberration at one month after cataract surgery |  | Follow-up until one month after surgery | 
| Change from baseline in contrast sensitivity at one month after cataract surgery |  | Follow-up until one month after surgery | 
| Change from baseline in intraocular light scattering at one month after cataract surgery |  | Follow-up until one month after surgery | 
| Change from baseline in wavefront aberration at six months after cataract surgery |  | Follow-up until six months after surgery | 
| Change from baseline in contrast sensitivity at six months after cataract surgery |  | Follow-up until six months after surgery | 
| Change from baseline in intraocular light scattering at six months after cataract surgery |  | Follow-up until six months after surgery |
Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare changes in the body's self-defense (immune response) after two different treatments for small kidney tumors: 1) Cryoablation (freezing) therapy in which the tumor and a margin of normal kidney tissue are frozen and thawed twice with a needle probe and 2) radiofrequency ablation (RFA) in which radiofrequency energy delivered through a needle probe is used to heat tissue and thereby destroy a tumor.

Official Title
-----------------
Differences in Immunologic Response to Cryoablation Versus Radiofrequency Ablation in the Treatment of Renal Cell Carcinoma

Conditions
-----------------
Immune Response to 3 Approaches

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: You are eligible to participate in this study if you are an adult (older than 18 years) Diagnosed with renal cell cancer 1-3 centimeters in size on the CT scan. Exclusion Criteria: You are not eligible to participate in this study if you are immune compromised (chemotherapy,corticosteroid use, HIV [as documented in your medical record], etc.) Have an autoimmune disorders (Rheumatoid arthritis, Crohn's disease, etc) Have a tumor larger than 4 cm Are pregnant.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adults 18-99<br>Adults who are undergoing cryoablation | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immune Response to Cryoablation, RFA and Laparoscopic Partial Nephrectomy | The number of leukocytes found in the tissues cryoablation, radiofrequency ablation, or laparoscopic partial nephrectomy (control) | 4 years |
Open Label Safety and Efficacy Study of Levetiracetam in Korean Patients With Epilepsy

Study Overview
=================
Brief Summary
-----------------
A Korean open-label, community-based trial assessing the efficacy and safety of levetiracetam as adjunctive therapy in partial epilepsy. Similarity with a similar study conducted in Caucasian epileptic subjects will be assessed.

Official Title
-----------------
A Korean Open-label, Multi-center, Community-based Trial Assessing the Efficacy and Safety of Levetiracetam as Adjunctive Therapy in Adult Subjects With Uncontrolled Partial Epilepsy for Bridging Purpose With a Similar Study on Caucasian Epileptic Subjects

Conditions
-----------------
Epilepsy, Partial

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with epilepsy experiencing partial seizures, whether or not secondarily generalized. Subjects must present between 3 and 42 partial seizures over the three months prior to protocol Visit 1. Use of one (1), but no more than two (2) concomitant marketed AEDs at the time of trial entry. Exclusion Criteria: Subjects on felbamate with less than 18 months exposure. Subjects on vigabatrin, whose visual field has not been assessed as per recommendation of the manufacturer, i.e. every 6 months. Presence of known pseudoseizures within the last year. Presence of progressive cerebral disease, any other progressively degenerative neurological disease, or any cerebral tumors. Uncountable seizures (clusters) or history of convulsive status epilepticus within the last five years.

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate efficacy of levetiracetam in community based practice (seizure frequency per week over 16 weeks). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess safety of levetiracetam |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Partial Onset Seizures, Keppra, Levetiracetam
This Study is to Assess the Efficacy and Safety of ZD6474 in Subjects With Non-small Cell Lung Cancer.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of ZD6474 in patients with NSCLC after Failure of Prior Platinum-based Chemotherapy.

Official Title
-----------------
A Randomized, Double-blind, Multicenter, Phase II Study to Assess the Safety, Tolerability, and Efficacy of ZD6474 in Combination With Docetaxel (TAXOTERE™) in Subjects With Locally Advanced or Metastatic Non-small Cell Lung Cancer (NSCLC) After Failure of Prior Platinum-based Chemotherapy.

Conditions
-----------------
Non-Small Cell Lung Cancer (NSCLC, Locally Advanced or Metastatic, Second-line

Intervention / Treatment
-----------------
* Drug: ZD6474
* Drug: Placebo
* Drug: Docetaxel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic confirmation of NSCLC (locally advanced or metastatic, IB-IV) Failure of first-line platinum-based chemotherapy Exclusion Criteria: Mixed small cell or non-small-cell histology Bronchoalveolar carcinoma Prior chemotherapy or herbal preparations must be discontinued more than 4 weeks before the start of study therapy (6 weeks for nitrosoureas, mitomycin and suramin) Prior treatment with docetaxel

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

| Intervention/Treatment |
| --- |
|Drug: ZD6474|nan|
|Drug: Placebo|nan|
|Drug: Docetaxel|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome Progression free survival |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence and type of adverse events (Aes), clinically significant laboratory abnormalities, and ECG changes; |  |  | 
| Objective response rate and duration of response |  |  | 
| QoL and lung cancer subscale (LCS) from the FACT-L questionnaire |  |  | 
| WHO performance status |  |  | 
| Time to death |  |  |