linjc16/ctgov huggingface dataset:
A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia

Study Overview
=================
Brief Summary
-----------------
The investigators know little about how patients feel following radiosurgery treatment of trigeminal neuralgia. Patient satisfaction may ultimately be one of the most important outcome measures for an individual patient; however, this has not been adequately assessed or followed. Multiple questions remain unanswered, including whether there is a correlation between patient satisfaction, the level of their current pain score, and the presence and degree of facial numbness, a possible side effect after radiosurgery. Therefore, the goal of this study is to gather this information from the patients who received radiosurgery for trigeminal neuralgia at Stanford and evaluate post-treatment patient satisfaction, the degree of facial numbness, and current pain score. This data will help the investigators understand outcomes that are important for patient satisfaction following treatment of a chronic pain syndrome.

Official Title
-----------------
A Study of Patient Reported Outcomes After Stereotactic Radiosurgical Rhizotomy for Trigeminal Neuralgia

Conditions
-----------------
Trigeminal Neuralgia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of the patients since 2000 who have undergone stereotactic radiosurgical rhizotomy at Stanford for treatment of trigeminal neuralgia. Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Patient satisfaction following CyberKnife radiosurgery | To assess patient reported outcomes following stereotactic radiosurgical rhizotomy for trigeminal neuralgia. | 1 year |
Comparison of Two Interdental Cleaners

Study Overview
=================
Brief Summary
-----------------
Comparison of Two interdental cleaning devices on plaque removal, gingivitis and bleeding.

Detailed Description
-----------------
This study measured plaque accumulation, bleeding on probing and gingivitis using the Rustogi Modification of the Navy Plaque Index, BOP and Modified Gingival Index at baseline, 2-weeks and 4-weeks.

Conditions
-----------------
Gingivitis

Intervention / Treatment
-----------------
* Device: water flosser
* Device: air floss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult Non smoker Available for 4-weeks Able to provide written informed consent. Minimum of 20 natural teeth. Minimum requirement for plaque, gingivitis and bleeding. Exclusion Criteria: Medical condition No antibiotics within 6 months of study start Not on any medication (impact oral health).

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Intervention A<br>water flosser | Device: water flosser<br>* Powered<br>|
| Active Comparator: Intervention B<br>air floss | Device: air floss<br>* Powered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bleeding upon probing | Bleeding upon probing | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gingivitis | Modified Gingival \index | 4 weeks | 
| Plaque | Rustogi Modification of the Navy Plaque Index | 4 weeks |
Impulsivity, Neural Deficits and Cocaine Addiction

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess neurocognitive and associated neural regions/circuitry disruptions relevant to impulsive relapse in cocaine-addicted subjects, and the relationship of the cognitive and neural mechanisms of impulsivity/decision-making to relapse style.

Detailed Description
-----------------
This study is designed to explore putative differences in impulsive behaviors and decision making in cocaine-addicted and healthy control subjects using functional magnetic resonance imaging (fMRI), single photon emission tomography (SPECT), and neurocognitive tasks. We predict that cocaine-addicted subjects will demonstrate neurocognitive and neural alterations in measures of impulsivity and decision-making when compared to healthy controls. That is, cocaine-addicted subjects will show both decreased activation and decreased resting measures of regional cerebral blood flow (rCBF) of the brain structures associated with impulsivity and decision-making. Furthermore, neurocognitive and neural deficits associated with impulsivity and decision-making will be associated with each other and with measures indicative of an impulsive relapse and altered decision making.

Official Title
-----------------
Impulsivity, Neural Deficits, and Relapse in Cocaine Addiction

Conditions
-----------------
Cocaine Dependence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cocaine-dependence (patient population) or no cocaine-dependence (control population). Exclusion Criteria: Other medical or psychiatric disorders that may effect neural functioning. Medications that may effect neural functioning.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 55 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 |
| --- | --- |
| 1<br>Patients with Cocaine Addiction | |
| 2<br>Healthy Control Volunteers | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determine if the brain regions involved in inhibition and decision-making are altered in cocaine-addicted subjects compared to healthy controls. |  | 2 weeks | 
| In cocaine-addicted subjects, determine if neural deficits during disinhibition or decision-making are related to relapse following treatment. |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the predictive validity of self-report measures of impulsive relapse. |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
impulsivity, cocaine dependence, relapse, neuroimaging, functional magnetic resonance imaging (fMRI), single photon emission computed tomography (SPECT)
Novel Prediction Score for Postoperative Acute Renal Failure (ARF) Following Liver Resection

Study Overview
=================
Brief Summary
-----------------
ARF is a frequent event after hepatic resection and therefore clinically highly relevant. There is limited evidence on the incidence of postoperative ARF and its clinical relevance in patients undergoing liver resection. This study will evaluate the incidence of acute renal failure (ARF) after liver resection and its impact on postoperative mortality.

Detailed Description
-----------------
ARF is a frequent event after hepatic resection and therefore clinically highly relevant. There is limited evidence on the incidence of postoperative ARF and its clinical relevance in patients undergoing liver resection. This study will evaluate the incidence of acute renal failure (ARF) after liver resection and its impact on postoperative mortality.

Official Title
-----------------
Novel Prediction Score for Postoperative Acute Renal Failure (ARF) Following Liver Resection

Conditions
-----------------
Acute Renal Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age >/= 18 years Benign and malign liver diseases Exclusion Criteria: Trauma cases

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 |
| --- | --- |
| 1<br>Postoperative no renal dysfunction | |
| 2<br>Postoperative renal dysfunction | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictor score |  |  | 
| Incidence of ARF Length of hospital stay |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
evaluation, incidence, liver surgery, resection, impact, postoperative, mortality
Diet and the Aging Brain

Study Overview
=================
Brief Summary
-----------------
We investigate whether a change in diet could provide positive effects on general brain functions in healthy elderly people.

Detailed Description
-----------------
The age-related degradation of cognitive functions even to the point of neurodegenerative disorders such as alzheimer's disease are a growing public-health concern with potentially devastating effects. Refering to animal data and empirical studies, a healthy diet rich in unsaturated fatty acids and low in calories should improve cognitive functions such as learning and memory. To test this hypothesis, we study general brain functions in healthy elderly subjects (50-80 years old) during a short term diet.

Official Title
-----------------
Phase IV Interventional Study: Effect of Diet on Brain Function in Elderly Healthy People

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

Intervention / Treatment
-----------------
* Behavioral: diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects 50-80 years old moderate to heavy weight must be able to change diet at home Exclusion Criteria: diabetes younger than 50 years BMI < 23 already participating in other studys MMSE > 26 eating disorders

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implicit visual-motor learning of a finger sequence of the hand. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implicit learning of an artificial language |  |  | 
| several plasma levels related to cognitive functions |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diet, elderly, age-related diseases, prevention, cognitive decline, Clinical study
Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study

Study Overview
=================
Brief Summary
-----------------
To collect and analyze specimens that will correlate with clinical outcomes such as acute and late toxicities, quality of life, local control, and survival of patients treated with photon/proton therapy.

Official Title
-----------------
Mayo Clinic Radiotherapy Patient Outcomes Registry and Biobanking Study

Conditions
-----------------
Solid Tumors, Hematologic Malignancies

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Treated with photon/proton at Mayo Clinic Rochester in Radiation Oncology Radiation therapy for curative intent Exclusion Criteria: None
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 |
| --- | --- | --- |
| analyze acute and late toxicities using CTCAE 4.03 |  | Patients will be followed for the duration of their life, an expected average of 20 years | 
| analyze quality of life using LASA-3 and FACT-E |  | Patients will be followed for the duration of their life, an expected average of 20 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| analyze local control through tumor assessments |  | Patients will be followed for the duration of their life, an expected average of 20 years | 
| analyze survival by contacting patient and EMR (electronic medical record) review |  | Patients will be followed for the duration of their life, an expected average of 20 years |
Needle Radiofrequency Treatment for Submental Fat

Study Overview
=================
Brief Summary
-----------------
The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.

Official Title
-----------------
Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat

Conditions
-----------------
Obese

Intervention / Treatment
-----------------
* Procedure: microinsulated needle radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with excess submental fat on a grade of 1 4, as assessed by the Physician-Assisted Submental Fat Rating Scale Exclusion Criteria: mental impairment, infectious disease history of keloid development pregnancy, pacemaker use of anticoagulants undergoing a facelift procedure within the prior 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: prospective, single-blinded, pre-post comparative study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Post-treatment<br>After a single treatment using a microinsulated needle RF device | Procedure: microinsulated needle radiofrequency<br>* A single treatment using a microinsulated needle radiofrequency device<br>|
| No Intervention: Pre-treatment (Baseline)<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe) | submental fat rating by an independent investigator | 1 month after the treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| submental fat volume (cc) | fat volume quantified with a three-dimensional camera | 1 month after the treatment | 
| patient satisfaction score from 0 (not satisfied) to 10 (most satisfied) | patient's satisfaction score for reduction of submental fat | 1 month after the treatment | 
| any adverse effects at any time during or after treatment | adverse events | assessed through study completion, an average of 2 months |
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques

Study Overview
=================
Brief Summary
-----------------
This study aims to explore whether the increased supply of dietary plant sterols and plant stanols have any influence on serum levels of phytosterols and on consistency of carotid atheromatous plaques.

Detailed Description
-----------------
This is a double-blind randomized study. The study population will consist of 30 consecutive patients who will undergo an elective carotid endarterectomy due to a tight asymptomatic stenosis. The patients will be randomized into two groups consuming either plant sterol (2g/day) or plant stanol (2g/day) spreads for two to six weeks, until the operation. Serum lipids, lipoproteins and sterols will be analyzed at the randomization, before the operation and one month after the operation. The carotid arteries will be examined for their composition of sterols. This study gives new information concerning the relationship between dietary consumption of plant sterols and stanols and the sterol composition of the carotid plaques.

Official Title
-----------------
The Influence of Dietary Plant Sterols and Plant Stanols on Cholesterol and Plant Sterol Levels in Atheromatous Plaques

Conditions
-----------------
Atherosclerosis

Intervention / Treatment
-----------------
* Dietary Supplement: Plant Stanol
* Dietary Supplement: Plant Sterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asymptomatic tight carotid plaques Age 40-80 Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| Active Comparator: 1<br>A group of subjects consuming daily 2 grams of plant stanols 4-6 weeks before the operation | Dietary Supplement: Plant Stanol<br>* Plant stanols in margarines daily 2 grams<br>|
| Active Comparator: 2<br>A group of patients consuming daily 2 grams of plant sterols 4-6 weeks before the operation | Dietary Supplement: Plant Sterol<br>* Plant sterols in margarines daily 2 grams<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sterols in serum and carotid plaques at the operation |  | at operation and one month after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, Plant sterols, Atherosclerotic carotid plaques
AZD1152 in Patients With Advanced Solid Malignancies-Study 3

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this protocol is to investigate the safety and tolerability of AZD1152 when given as a continuous 7-day infusion every week and every 2 weeks in patients with advanced solid malignancies.

Official Title
-----------------
A Phase I, Open-Label, Multi-Centre Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD1152 Given as a Continuous 7-Day Intravenous Infusion in Patients With Advanced Solid Malignancies

Conditions
-----------------
Solid Tumours

Intervention / Treatment
-----------------
* Drug: AZD1152


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histological or cytological confirmation of a solid, malignant tumour Exclusion Criteria: Participation in an investigational drug study within 21 days prior to entry or who have not recovered from the effects of an investigational study drug Treatment with radiotherapy/chemotherapy with 4 weeks of first dose Recent major surgery within 4 weeks prior to entry to the study

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: AZD1152|7-day continuous intravenous infusion|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | Assessed at each visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | Assessed at predetermined timepoints after dose administration | 
| Effect on biomarkers |  | Assessed after treatment | 
| Anti-tumor activity |  | Assessed at the end of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
advanced solid tumours
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, multi-center, non-randomized, open label observational study. The objective of this study is to compare the accuracy of the EyeBOX to a clinical diagnosis of abnormal ICP as determined by an external ventriculostomy drain (EVD) or ventriculostomy catheter.

Official Title
-----------------
Non-invasive Diagnostic for Assessing Elevated Intracranial Pressure

Conditions
-----------------
Intracranial Pressure Increase

Intervention / Treatment
-----------------
* Diagnostic Test: EyeBOX for ICP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provide written informed consent. Require placement of an ICP monitor or ventriculostomy catheter for clinical purposes. Be between the ages of 4 and 70 years old. Have baseline vision correctable to within 20/500 bilaterally. Have no prior history of ocular dysmotility. Be awake with spontaneous eye opening at the time when eye tracking is performed. Exclusion Criteria: Have a prior history of strabismus, diplopia, or palsy of CN-III, IV or VI. Be blind (no light perception), have missing eyes, be unable to open their eyes. Have a prior history of ocular motility dysfunction. Have had extensive prior eye surgery. Have any physical or mental injury or baseline disability rendering task completion difficult. Be intoxicated or have blood alcohol level greater than 0.2. Be a prisoner or in the company of a police officer or law enforcement officer pending arrest.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 70 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| single<br>subjects with abnormal intracranial pressure | Diagnostic Test: EyeBOX for ICP<br>* non-invasive ICP Score algorithm using eye-tracking data from the EyeBOX(TM) device, which tracks the movement of the pupils over time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity and Specificity | EyeBOX assessment of abnormal ICP relative to invasive intracranial pressure monitor | from time of enrollment through the period that ICP monitoring is required for clinical purposes up to 104 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
noninvasive diagnosis