linjc16/ctgov huggingface dataset:
The Effect of Epidural Steroid Use in Patients With Continous Epidural Block in PHN Patients.

Study Overview
=================
Brief Summary
-----------------
The efficiency of epidural steroid injection in patients who has postherpetic neuralgia is well known. In this study, the purpose is whether the continous epidural steroid injection is effective or not.

Detailed Description
-----------------
Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days. Continous epidural injection will be done during 10 days N group will be injected a 0.19% ropivacaine 8mL only every other day during 10 days

Official Title
-----------------
The Effect of Epidural Steroid Use on Pain Relief in Patients With Continuous Epidural Nerve Block in Postherpetic Neuralgia Patients.

Conditions
-----------------
Neuralgia,Postherpetic

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who has herpes zoster Patients has a period (at least 1month) after onset of herpes zoster Patients has a definite symptom along dermatome ASA class I - II Age : 18 - 80 years Exclusion Criteria: Patients who has a cancer Patients who has a neurologic, psychologic, renal, hepatic and hematologic disease Patients who has a other dermatologic disease Patients who has major operation & procedure history Patients who has a other pain origin Patients who can not be inserted epidural catheter

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: D group<br>0.19% Ropivacaine 8mL + Dexametasone 1mg every other day injection during 10 days | Drug: Dexamethasone<br>* Continous epidural injection will be done during 10 days. D group will be injected a 0.19% ropivacaine 8mL and dexametasone 1mg every other day during 10 days. .<br>* Other names: DEXA-S;Drug: Ropivacaine<br>* Continous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days<br>* Other names: Rocaine;|
| Placebo Comparator: N group<br>0.19% Ropivacaine 8mL only every other day injection during 10 days | Drug: Ropivacaine<br>* Continous epidural injection will be done during 10 days Both group will be injected a 0.19% ropivacaine 8mL every other day during 10 days<br>* Other names: Rocaine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VAS score | The investigator set the primary outcome If there is a 50% reduction of VAS score. | up to 10 days |
Safety of Ciclesonide Nasal Spray Administered With Inhaled Fluticasone Dipropionate/Salmeterol in Adults With Perennial Allergic Rhinitis (BY9010/M1-409)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and tolerability of combined ciclesonide nasal spray administered along with a fixed combination of inhaled fluticasone dipropionate/salmeterol.

Official Title
-----------------
Investigation of Potential Additive Inhibitory Effects on HPA-Axis of Ciclesonide Nasal Spray When Administered Concomitantly With Orally Inhaled Fluticasone Propionate/Salmeterol (FP/SAL) in Patients (18-60 Years) With Perennial Allergic Rhinitis (PAR)

Conditions
-----------------
Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever

Intervention / Treatment
-----------------
* Drug: Ciclesonide


Participation Criteria
=================
Eligibility Criteria
-----------------
Main Inclusion Criteria: General good health, other than perennial allergic rhinitis History and diagnosis of perennial allergic rhinitis by skin prick Normal body weight as defined by the study protocol Main Exclusion Criteria: Pregnancy, nursing, or plans to become pregnant or donate gametes (ova or sperm) for in vitro fertilization during the study period or for 30 days following the study period Participation in any investigational drug trial within the 30 days preceding the Screening Visit A known hypersensitivity to any corticosteroid or any of the excipients in the formulations Use of any prohibited concomitant medications as defined by the study protocol Previous participation in an intranasal ciclesonide study Non-vaccinated exposure to or active infection with, chickenpox or measles within the 21 days preceding the Screening Visit

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety and tolerability. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Allergy, Perennial Allergic Rhinitis, Allergic Rhinitis, Hay Fever
Carotid Atherosclerotic Plaque Study

Study Overview
=================
Brief Summary
-----------------
First, to establish a comparison of the pathophysiology of carotid atherosclerosis and the genetic and environmental variables that cause those plaques to become symptomatic. Second, to differentiate between vulnerable plaque and other types of plaque using ultrasound elastography, MRI data, trans-cranial doppler along with RF (radio frequency) analysis of back-scattered ultrasonic echoes.

Detailed Description
-----------------
This is a multi-investigator study based on the pathophysiology of carotid atherosclerosis and the variables that cause certain plaques to become symptomatic.Patients enrolled in this study will be those patients undergoing a carotid endarterectomy. This will include both symptomatic and asymptomatic patients, and there are a variety of atherosclerotic risk factors representing this patient population.Patients may or may not have had strokes or transient ischemic attacks (TIAs).Pre-operatively patients will be reviewed for their medical history and atherosclerotic risk factors. Plaque removed during routine carotid endarterectomy will be examined for study purposes.

Official Title
-----------------
Carotid Atherosclerotic Plaque Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and Female patients aged 18-80 presenting for carotid endarterectomy Exclusion Criteria: Patients not felt suitable for carotid endarterectomy and those with impaired decision-making capacity

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Lipid protein analysis and cognitive status comparison | Comparison studies will be done using the lipid protein analysis and imaging studies. The primary comparison will be between those that are symptomatic and those that are asymptomatic. Secondary comparisons will be done using the lipid protein analysis and patient history. Comparison of cognitive status between groups will be made using analysis of covariance in which the difference in follow-up score between groups (symptomatic/asymptomatic) is adjusted for baseline score. The baseline adjusted standard error is 6.4, which with 36 subjects per group will yield 90% power to detect a difference between groups of approximately 4.9 points at a significant level of 5%. We need 36 subjects per group to achieve the power stated. We have built in another 15% for projected dropout to insure we meet the final target. | 2008-2011 |
Effect of Moisturizing Creams on Skin Barrier Function

Study Overview
=================
Brief Summary
-----------------
This study is a randomized, double-blind, placebo-controlled bilateral study on the effect of moisturizing creams on skin barrier function. The hypothesis is that a new active emulsion has a better influence on skin barrier function comapred to its placebo.

Conditions
-----------------
Atopic Eczema

Intervention / Treatment
-----------------
* Drug: urea/lactic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dry skin barrier disorders such as atopic dermatitis or Malassezia eradicated head and neck dermatitis. Rough or clinically normal skin on the volar aspect of the forearm. Either gender Age between 18 and 65 years Written Informed Consent Exclusion Criteria: Possible allergy to ingredients in the study medications. Use of any concomitant medication that may interfere with the study related activities or assessment of efficacy. Any patient related factor suggesting potential poor compliance with study procedures (e.g. psychiatric disorders, history of alcohol or substance abuse). Any serious medical condition which, in the opinion of the investigator, may interfere with the evaluation of the results. Pregnancy or breast feeding, or patients who plan to become pregnant during the course of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Active Comparator: new emulsion<br> | Drug: urea/lactic acid<br>* new emulsion type<br>|
| Placebo Comparator: new emulsion placebo<br> | Drug: Placebo<br>* only emulsion base<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Use of Fiber-optic Probe for Non-invasive Diagnosis of Melanoma and Assessment of Impact of Ultraviolet (UV) Exposure on Skin

Study Overview
=================
Brief Summary
-----------------
This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique used routinely as a non-invasive device during subjects' skin examination to aid dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of the skin. Alternatively, this technique would, in the future, also be used to screen patients at risk for melanoma.

Official Title
-----------------
Optical Spectroscopy for Non-invasive Diagnosis of Melanoma and Assessment of Impact of UV Exposure on Skin

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female above 18 years of age; Subjects who are planned to undergo skin examinations with and without atypical nevi, with and without personal or family history of melanoma and potentially with pigmented lesions to be removed for medical care or cosmetic purposes. Exclusion Criteria: Individuals whose pathology cannot be obtained or retrieved. Inability to provide informed consent.

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia | To correct for skin color effect and heterogeneity, the readings of the pigmented lesion will be normalized by the readings taken from the corresponding normal skin around the lesion. | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi; |  | 3 years | 
| To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure |  | 3 years | 
| To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fiber Optic, Melanoma, UV Exposure
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Study Overview
=================
Brief Summary
-----------------
The investigators are trying a combination vaginal product of higher dose metronidazole combined with miconazole to see if it is effective in treating vaginal trichomonas.

Official Title
-----------------
Neo-Penotran Forte Vaginal Suppository for Vaginal Trichomoniasis

Conditions
-----------------
Trichomonas Vaginitis

Intervention / Treatment
-----------------
* Drug: oral metronidazole
* Drug: neo penotran forte
* Drug: neo penotran forte once a day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: presence of trichomonas Exclusion Criteria: pregnant or nursing known immunodeficiency allergy to study drugs concurrent yeast infection history of seizures or peripheral neuropathy unwillingness to abstain from alcohol during treatment period and for 48 hrs after concurrent lithium anticoagulation therapy, and abuse patient expected to have menses within 8 days of enrollment

Ages Eligible for Study
-----------------
Minimum Age: 19 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: oral metronidazole<br>control arm | Drug: oral metronidazole<br>* 2 gm oral once<br>|
| Experimental: neo penotran forte<br>neo penotran forte vaginal suppository twice a day for 7 days | Drug: neo penotran forte<br>* neo penotran forte intravaginal twice a day for 7 days<br>|
| Experimental: neo penotran forte once a day<br>neo penotran forte vaginal suppository once a day for 7 days | Drug: neo penotran forte once a day<br>* neo penotran forte intravaginally once a day for 7 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants Cured of Vaginal Trichmonas | percentage of participants achieving microbiological cure of trichomonas | day 12-15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tolerability of the Study Product as Measured by Participant Self-report | Number of participants with any side effects | day 12-15 day 30-35 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
trichomonas
Jena Sepsis Registry

Study Overview
=================
Brief Summary
-----------------
Despite the burden of severe sepsis and septic shock deficiencies in the quality of sepsis management are recognized. Investigators present a population-based registry with easy feasibility as part of German Center for Sepsis Control & Care (CSCC). All ICU patients of the Jena University Hospital, Germany will be screened for inclusion (severe sepsis or septic shock). Baseline data on ICU- and hospital care will be extracted from patient records at ICU discharge. The primary outcome is change in all-cause mortality from baseline to follow up at 6, 12, 24, 36, 48 and 60 months after diagnosis of sepsis. Follow-up data will be collected from the primary care provider of the patient. The registry may provide valid data on quality in sepsis care.

Official Title
-----------------
Jena Sepsis Registry - a Sepsis-registry for Long Term Outcomes

Conditions
-----------------
Severe Sepsis or Septic Shock (ICD-10-GM, R65.0, R65.1)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients treated in one of the ICUs will be enrolled if they were 18 years or older and fulfill the diagnostic criteria of severe sepsis or septic shock (ICD-10-GM, R65.0, R65.1) (19), (20). Diagnosis of severe sepsis or septic shock requires the following criteria: a microbiologically documented and/or clinically evident infection, at least two of the four criteria of the systemic inflammatory response syndrome (SIRS) and at least one new organ dysfunction, remote from the site of infection. Exclusion Criteria: -

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 |
| --- | --- | --- |
| all cause mortality | based on data from hospital records as well as patient records of the primary care provider. | change from baseline to 6,12, 24, 36, 48 and 60 months after ICU discharge |
The Effect of Cold Storage Solutions on Ischemic Injury in Lung Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare 2 different cold storage solutions, used to preserve donor lungs for lung transplantation, and their effect on cytokine activation related to ischemic reperfusion injury. Primary endpoint is 30 day survival.

Detailed Description
-----------------
The length of ischemic time in harvesting lung allografts is associated with graft survival. It is further thought that ischemic changes in early post-transplantation bronchoscopic biopsies has a direct correlation with later development of chronic rejection.

Official Title
-----------------
A Prospective, Controlled, Randomized Study on the Effect of Cold Storage Solutions on Complement Activation and Other Mediators of Ischemic Injury in Lung Transplantation

Conditions
-----------------
Lung Transplant Recipients

Intervention / Treatment
-----------------
* Device: Celsior Cold Storage Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient undergoing a lung trasnplant at Johns Hopkins Hospital - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Celsior Cold Storage Solution|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
-----------------
Cytokines in lung transplantation, Cold storage solutions, Ischemic reperfusion injury
Preemptive Low-dose Epidural Ketamine for Preventing Chronic Post-thoracotomy Pain

Study Overview
=================
Brief Summary
-----------------
Chronic post-thoracotomy pain is the most common long-term complication that occurs after a thoracotomy with a reported incidence of up to 80%. While thoracic epidural analgesia has become the mainstay for managing acute post-thoracotomy pain, its effect on the chronic post-thoracotomy pain seems questionable. The objective of this prospective, double-blinded, randomized, controlled trial was to assess the effect of preemptive low-dose epidural ketamine in addition to preemptive thoracic epidural analgesia on the incidence of chronic post-thoracotomy pain.

Conditions
-----------------
Chronic Post-thoracotomy Pain

Intervention / Treatment
-----------------
* Drug: Ketamine
* Drug: ketamine free


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing surgery with a thoracotomy incision Exclusion Criteria: history of previous thoracic surgery, chronic pain, psychiatric disease, cardiac or vascular disease, neurologic deficits, or contraindications to epidural catheterization such as coagulopathy, or localized or systemic infection

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 81 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketamine<br>epidural ketamine added to the patient controlled epidural analgesia regimen | Drug: Ketamine<br> <br> |
| Active Comparator: ketamine free<br>epidural ketamine NOT added to the patient controlled epidural analgesia regimen | Drug: ketamine free<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of pain 3 months after surgery |  | 3 months after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preemptive epidural ketamine, prevention of chronic post-thoracotomy pain