linjc16/ctgov huggingface dataset:
NGX-4010 for the Treatment of Postherpetic Neuralgia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is determine if an investigational drug, NGX-4010 (high-concentration capsaicin dermal patches) is effective in treating pain associated with post-herpetic neuralgia (PHN).

Detailed Description
-----------------
Participants will be randomly assigned to receive initial treatment according to one of three doses (application durations), and will receive either NGX-4010 patch (high-concentration capsaicin) or matching control (low-concentration capsaicin). Participants who complete the study evaluations for 12 weeks will have the option of receiving up to 3 additional open-label re-treatments over 1 year.

Official Title
-----------------
A Randomized, Double-Blind, Controlled Dose Finding Study of NGX-4010 for the Treatment of Postherpetic Neuralgia

Conditions
-----------------
Herpes Zoster, Neuralgia, Pain, Peripheral Nervous System Diseases, Shingles

Intervention / Treatment
-----------------
* Drug: Capsaicin Dermal Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Eligibility Criteria: Must be diagnosed with PHN and be at least 6 months after crusting of the skin vesicles, with moderate to severe pain. Must not have significant pain due to causes other than PHN (for example, arthritis). Painful areas should not be located on the face, above the hairline of the scalp, and/or in proximity to mucous membranes. Must have intact and unbroken skin at the treatment area. Must be prepared to remain on the same pain medications at the same doses as before the study for the entire duration of the study (1-year). Must not have any implanted medical device (spinal cord stimulator, intrathecal pump or peripheral nerve stimulator) for the treatment of pain. Must not use topical pain medications for PHN. Must be able to comply with study requirements such as completing a daily pain diary, attending study visits and refraining from extensive travel during study participation. No significant medical problems of the heart, kidneys, liver or lungs, or cancer. No history or current problem with substance abuse.

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Capsaicin Dermal Patch|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
-----------------
Diary, Dermal assessment, Pain measurement, Shingles, Neuropathy, Analgesics/*therapeutic use, Capsaicin/*administration & dosage/adverse effects, Herpes Zoster/*complications/drug therapy, Neuralgia/*drug therapy/etiology, Pain, Peripheral Nervous System Diseases/*complications
Accuracy Evaluation for SIS Software-based Visualization of Anatomical Brain Structures

Study Overview
=================
Brief Summary
-----------------
SIS has developed a software technology, based on machine learning and image processing, designed to enhance standard clinical images for the visualization of anatomical structures.

Detailed Description
-----------------
A cohort of 30 subjects will be scanned on a clinical MRI scanner as well as on a 7 Tesla (T) scanner. Images acquired on the 7T allow to visualize anatomical structures that are not easily identified on standard clinical images. SIS software will be used to visualize selected anatomical features on the clinical image and the results will be compared with the images of the same subject obtained from the 7T MRI.

Official Title
-----------------
Accuracy Evaluation for Software-based Visualization of Anatomical Brain Structures Using Surgical Information Sciences Inc. Algorithms

Conditions
-----------------
Software Evaluation for Visualizing Anatomical Structures That Are Not Typically Identified on Clinical MR Images

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all subject that are willing to be scanned on a 3T and 7T MRI scanners and are not excluded by the exclusion criteria below. Exclusion Criteria: MRI exclusion criteria for 7T scans: presence of any metallic clip(s) or implantable medical devices (e.g., heart valve, aneurysm clip, coils or surgery, renal or aortic clips, shunts, stents or stent grafts, metal mesh/coil implants, neurostimulator, insulin pump, IVC filter, artificial knee or hip, metal plates, pins, screws or wires anywhere in the body, any other metal implants, etc.). Pregnant women. Subject under the age of 18

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 |
| --- | --- |
| MRI data collection<br>A group of 30 subjects will be scanned on a 3 Tesla (T) and on a 7T MRI scanners. The images will be compared. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of the accurate visualization of brain structures based on SIS algorithms |  | one year |
Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the concentration of omega-3 fatty acids in plasma, blood and abdominal fat before and after bariatric surgery to provide guidance for future studies.

Detailed Description
-----------------
The omega-3 fatty acids are essential for human growth, development and well-being. Numerous studies have shown that a relatively high intake of the omega-3 fatty acids are beneficial in brain and visual development, psychiatric disorders, rheumatic disorders, inflammatory responses and cardiovascular disease. As an example, low levels of tissue omega-3 fatty acids are associated with a markedly higher rate of death from cardiac causes compared to patients with relatively high concentrations of the omega-3 fatty acids. Obese patients often have an unhealthy dietary intake and evidence of increased inflammatory processes. After a gastric bypass patients will have decreased absorption of fats from the gastrointestinal tract and may become fatty acid deficient. While gastric bypass may decrease death from cardiovascular disease in morbidly obese patients, cardiovascular disease is still the most common cause of death after a gastric bypass. There are numerous nutritional deficiencies which occur after gastric bypass and many of these are well documented. However, there are no data concerning the plasma and tissue levels of omega-3 fatty acids in morbidly obese patients either before or after operation.

Official Title
-----------------
Omega-3 Fatty Acid Status in Morbid Obesity Before and After Surgical Treatment

Conditions
-----------------
Morbid Obesity, Cardiovascular Disease, Fatty Acid Levels

Intervention / Treatment
-----------------
* Procedure: Bariatric Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Surgical group candidates must be undergoing surgery for morbid obesity, abdominoplasty or other abdominal operation. Must have adequate venous access. Exclusion Criteria: Insufficient venous access
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical<br>Those subjects undergoing bariatric surgery or abdominal surgery following a previous bariatric surgery. | Procedure: Bariatric Surgery<br>* Open roux-en-Y gastric bypass, open banded sleeve gastrectomy, abdominoplasty, other abdominal surgery<br>|
| Control<br>Volunteers who have dietary habits similar to the subjects. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Omega-3 Fatty acid levels in whole blood, plasma and abdominal fat sample |  | Within 3 months of surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid obesity, Omega-3 fatty acid levels
Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
The aim of the investigators analysis is to identify the neural correlates of quality of life scores in schizophrenia. For this, the investigators will constitute group of patients according to their quality of life scores and the investigators will analyze their differences in patterns of brain structures and activations.

Official Title
-----------------
Morphological, Structural and Functional Neural Substrates of Quality of Life in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Device: Magnetic Resonance Imaging
* Other: EVALUATION NEUROPSYCHOLOGICAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of schizophrenia according to the Diagnostic and Statistical Manual of Mental Disorders (DSM-IV) criteria (American Psychiatric Association(APA), 1994), age over 18 years, informed consent to participate in the studies French as native language Exclusion Criteria: diagnosis other than schizophrenia on Axis I of DSM-IV, decompensated organic disease and mental retardation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: schizophrenia PATIENTS<br> | Device: Magnetic Resonance Imaging<br> <br> Other: EVALUATION NEUROPSYCHOLOGICAL<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to study the relationships between quality of life and the morphologic, structural and functional substrates in schizophrenia |  | 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine whether quality of life is correlated with brain modifications using functional Magnetic Resonance Imaging |  | 36 months |
Follow-up Survey of Patients Who Were Treated for Medulloblastoma or Primitive Neuroectodermal Tumors of the Central Nervous in Norway

Study Overview
=================
Brief Summary
-----------------
Clinical follow-up survey of the Norwegian material of paediatric patients who received therapy for medulloblastoma and CNS-PNET from 1974 - 2013 with a focus on quality of life, education, work, family and children, delayed effects of tumour disease and treatment, endocrine evaluation, existence of auditory neuropathy, and neuropsychological testing.

Conditions
-----------------
Brain Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Whose who has been treated for medulloblastoma og CNS-PNET between 1974 and 2013 Exclusion Criteria: Other brain tumours

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 51 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 |
| --- | --- | --- |
| SF 36 for those older than 18 years | Questionnaire | 1 year | 
| PedsQL for those younger than 18 years | Questionnaire | 1 year |
Vaginal Infection Study

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the efficacy and safety of a vaginal product compared with that of other vaginal products in the treatment of vaginal infections.

Conditions
-----------------
Vulvovaginitis, Vaginitis

Intervention / Treatment
-----------------
* Drug: clindamycin phosphate/butoconazole nitrate
* Drug: clindamycin phosphate
* Drug: butoconazole nitrate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must have a clinical diagnosis of vaginal infection. Patients must be post-menopausal, surgically sterilized or using an acceptable form of birth control. Exclusion Criteria: Patients must not have any other infections May not be pregnant or nursing May not be receiving any other antimicrobial therapies or any medications that would interfere with the outcome of the study.

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>clindamycin phosphate/butoconazole nitrate | Drug: clindamycin phosphate/butoconazole nitrate<br>* semi solid, single dose<br>|
| Active Comparator: 2<br>clindamycin phosphate | Drug: clindamycin phosphate<br>* semi solid, single dose<br>|
| Active Comparator: 3<br>butoconazole nitrate | Drug: butoconazole nitrate<br>* semi solid, single dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical symptom resolution. |  | baseline, 7 to 10 days and 21 to 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Yeast Culture for Candida | Negative Yeast Culture for Candida result=response, Positive Yeast Culture for Candida result=no response | baseline, 7 to 10 days and 21 to 30 days | 
| Gram stain Nugent score | Gram stain Nugent score of less than 4= resolution, Gram stain Nugent score of greater than 4= no resolution | baseline, 7 to 10 days and 21 to 30 days | 
| Saline wet mount for clue cells | Saline wet mount negative for clue cells=resolution, Saline wet mount positive for clue cells=no resolution | baseline, 7 to 10 days and 21 to 30 days |
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures

Study Overview
=================
Brief Summary
-----------------
This is a study to compare the new nail INTERTAN with a Sliding Hip Screw in treating a specific group of hipfractures (trochanteric and subtrochanteric fractures). Are there differences in terms of pain, early and late functional mobility and complications between the to implants (and methods of operation)?

Official Title
-----------------
A Prospective Randomised Multicenter Study Comparing the Sliding Hip Screw and the Intertan Nail in Trochanteric and Subtrochanteric Femoral Fractures

Conditions
-----------------
Trochanteric and Subtrochanteric Hip Fractures, Treatment With a New Nail or a Sliding Hip Screw

Intervention / Treatment
-----------------
* Procedure: Intertan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 60 years with a trochanteric or subtrochanteric hip fracture. Exclusion Criteria: Patients with pathologic fractures, patients already included with a fracture on the opposite side.

Ages Eligible for Study
-----------------
Minimum Age: 60 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 |
| --- | --- |
| Active Comparator: Intertan<br> | Procedure: Intertan<br>* Operations performed either with a Sliding Hip Screw or a nail (Intertan)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early postoperative pain (VAS)(and functional mobility (TUG-test)) |  | 1 week postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain, functional mobility (TUG-test), Harris Hip Score, quality of life (EQ-5D) and complications at discharge from hospital,and at 6 weeks,3 and 12 months postop. |  | 1 year follow up |
Alfuzosin Versus Placebo in Acute Urinary Retention

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to investigate if 14 days of treatment with Alfuzosin compared to placebo, will increase the number of patients with satisfying spontaneous voiding after acute urinary retention treated with Clean Self-Catheterization. Furthermore is investigated the safety of the medical treatment and self-catheterization.

Official Title
-----------------
Does Alfuzosin OD vs. Placebo in Male Patients Facilitate Spontaneous Voiding During Clean Intermittent Self-Catheterization Following Acute Urinary Retention?

Conditions
-----------------
Urinary Retention

Intervention / Treatment
-----------------
* Drug: Alfuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men with acute urinary retention and catheterized Benign hypertrophia of prostate Patient is diagnosed in Emergency room or at a acute hospitalization Exclusion Criteria: Known prostate cancer Prior urinary retention within 30 days Urinary retention occurring in relation to surgery Blood in urine Difficult or impossible catheterization Fever > 38 degree Celsius Decreased kidney function Permanent catheter > 14 days Treatment with alfa 1 blocker within 30 days Meeting contraindications to treatment with Alfuzosin Treatment with other drugs for urinary problems The above information is not intended to contain all considerations relevant to a patients potential participation in a clinical trial.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with satisfying spontaneous voiding after 14 days measured by bladder scan at day 14. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of days until termination of self catheterization |  |  | 
| Number of patients with urinary infection requiring treatment |  |  | 
| Pressure of voiding, volume of voiding, residual urine after voiding, measured by urine culture and bladder scan at day 14. |  |  |
Impact of Computerized Reminders on Blood Pressure Documentation and Control

Study Overview
=================
Brief Summary
-----------------
Numerous studies have examined potential causes for the racial differences in HTN prevalence and severity including baseline insulin levels, sympathetic nervous activity, intracellular calcium levels and intracellular sodium levels.[21-23] However, to our knowledge, there have been no studies examining the relationship of physician adherence to JNC guidelines to racial disparities in outcomes from HTN; nor have there been published studies examining the use of interventions such as computerized decision support tools or case-management to improve JNC adherence with the goal of reducing racial differences in blood pressure control. The aims of this study are: 1) To determine if physician's prescribing practices for HTN medications adhere to JNC guidelines for drug therapy. 2) To determine if there are variations in adherence to JNC guidelines based on patient race. 3) To determine if adherence to JNC guidelines improves blood pressure control. 4) To determine if the use of computerized medical reminders improves adherence to JNC guidelines.

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Behavioral: Computerized reminders about treatment guidelines to providers who care for hypertensive patients


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We examined data obtained from the electronic medical record review of patients older than 20 years with a diagnosis of hypertension, with at least one hypertension-related outpatient visit to one of fourteen general medicine clinics in community health centers, community-based practices, and hospital-based practices affiliated with a large urban academic medical center during the one-year period prior to the beginning of the intervention trial. Exclusion Criteria: Patients without documented hypertension-related primary care visits or less than 20 years of age

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Computerized reminders about treatment guidelines to providers who care for hypertensive patients|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |