linjc16/ctgov huggingface dataset:
Endocan in Ventilator-associated Pneumonia

Study Overview
=================
Brief Summary
-----------------
In this study; in patients undergoing mechanical ventilation, making the day series Endocan measurements during the first 5 day to look at whether there is a relationship between the levels of VAP with Endocan. This relationship, if any, aimed to investigate whether correlated with clinical and laboratory findings [presence of fever, pathological lung X-ray, the number of white blood cells (WBC), procalcitonin (PCT), C-reactive protein (CRP)] .

Official Title
-----------------
Endocan; Can be a New Biomarker in Ventilator-associated Pneumonia?

Conditions
-----------------
Serial Endocan Measurements

Intervention / Treatment
-----------------
* Biological: endocan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 18 age Patients whether intubated and connected to a mechanical ventilator Exclusion Criteria: patients intubated due to lung problems such as COPD, asthma, pulmonary embolism , etc. Patients with brain tumors patients with acute and chronic renal failure Patients with hypertension Patients with previously diagnosed infection Patients with extubated patients using antibiotics or corticosteroids before bronchoalveolar lavage fluid samples taken

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

| Intervention/Treatment |
| --- |
|Biological: endocan|to look series Endocan level for 5 days in intubated patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relationship between the level of Endocan and development of VAP |  | 9 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation with the level of Endocan and clinical and laboratory findings |  | 9 month |
LIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS)

Study Overview
=================
Brief Summary
-----------------
Evaluate burden of disease in Patients with newly occurred upper GI symptoms related to GERD (symptom frequency & severity, QoL, lifestyle modifications, self-medication) - baseline data according to GERD impact scale presenting to specialists, especially internists - Evaluate effect of treatment with a acid suppressive therapy on these parameters: looking for improvement of symptom burden and quality of life according to the GERD impact sca

Official Title
-----------------
LIFE NIS, GERD-Patients - Evaluation of Burden of Disease Determined by GERD Impact Scale (GIS)

Conditions
-----------------
GERD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly occured upper GI symptoms related to GERD
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
-----------------
GERD, NIS
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas (2)

Study Overview
=================
Brief Summary
-----------------
To evaluate the efficacy of ultraviolet-A (UVA)-induced cross-linking of corneal collagen (CXL) as a method to increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within or between collagen fibers using UVA light and the photo- mediator riboflavin. The purpose of this study is to generate data for presentation at medical meetings and for peer-review publication

Official Title
-----------------
Collagen Crosslinking With Ultraviolet-A in Asymmetric Corneas

Conditions
-----------------
Keratoconus, Ectasia, Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 8 years of age or older Diagnosis of keratoconus, post-LASIK ectasia, or pellucid marginal degeneration or forme fruste pellucid marginal degeneration. Diagnosis of FFKC History of Radial Keratotomy with fluctuating vision. Ability to provide written informed consent Likely to complete all study visits Minimum corneal thickness of at least 300 measured by ultrasound or Pentacam Exclusion Criteria: Severe corneal scarring that markedly affects vision Contraindications to any study medications or their components Pregnancy or breast feeding Active Herpes Corneal Disease

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- |
| Ciprofloxicine or Vigamox or other<br>up to qid till epithelialized. | |
| Topical Nonsteroidal (Acular, Acuvail, Voltaren Xibrom<br>up to qid for up to 5-10 days postop | |
| Topical steroid (FML, Pred Forte, Flarex<br>qid for up to 8 weeks | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase the biomechanical and biochemical stability of the cornea by inducing additional cross-links within |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase the biomechanical and biochemical stability of the cornea between collagen fibers using UVA light and the photo- mediator riboflavin |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnosis of keratoconus, post-LASIK ectasia, FFKC, or pellucid marginal degeneration
Neural Indices Associated With Relapse in Cannabis Dependence

Study Overview
=================
Brief Summary
-----------------
The aim of this fMRI study is to investigate neural indices of relapse in cannabis dependence. The development and maintenance of drug addictions have been associated with deficits in cognitive control, craving and impaired stress regulation. Therefore, neural markers of brain processes underlying the beforementioned components will be studied. Subsequent follow-up drug use interviews will reveal associations between relapse in cannabis dependence and alterations in brain networks of cognitive control, craving and stress.

Official Title
-----------------
Altered Neural Activation Patterns of Emotional Processing in Dependent Cannabis Users Associated With Relapse

Conditions
-----------------
Cannabis Dependence

Intervention / Treatment
-----------------
* Other: fMRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cannabis Dependence 24 hours abstinence Exclusion Criteria: other DSM-4 diagnosis neurological disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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 |
| --- | --- |
| Cannabis Dependence<br>ages 18-40 | Other: fMRI<br> <br> |
| Healthy control subjects<br>socio-demographically matched | Other: fMRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fMRI neural activation patterns of emotional processing | Activation patterns associated with emotion processing, emotion regulation, craving and stress are determined in addicted cannabis users compared to non-using matched control subjects | one time point = fMRI assessment after minimum 24 hours of abstinence | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Timeline Followback Interviews | Association between fMRI correlates and drug use during follow up preiod as predictor for relapse | one time point = 12 months after fMRI data acquisition | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cannabis, fMRI, addiction, relapse
To Demonstrate the Relative Bioequivalency of Generic Haloperidol Tablets Versus Haldol in Normal Volunteers

Study Overview
=================
Brief Summary
-----------------
To demonstrate the relative bioequivalency of generic Haloperidol tablets versus Haldol in normal volunteers.

Official Title
-----------------
An Open-Label, Single-Dose, Crossover Study to Determine the Bioequivalency of Generic Haloperidol Tablets vs. Haldol in Normal Volunteers.

Conditions
-----------------
Psychosis

Intervention / Treatment
-----------------
* Drug: Haloperidol 10 mg Tablets (Cord Laboratories)
* Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. Exclusion Criteria: Positive test results for HIV or hepatitis B or C. Treatment for drug or alcohol dependence.

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Haloperidol 10 mg Tablets (Cord Laboratories) | Drug: Haloperidol 10 mg Tablets (Cord Laboratories)<br> <br> |
| Active Comparator: 2<br>Haldol 10 mg Tablets (McNeil Pharmaceuticals) | Drug: Haldol 10 mg Tablets (McNeil Pharmaceuticals)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence based on AUC and Cmax |  | 17 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Typical Antipsychotic
Short-Term Prognosis Evaluation of Transient Ischemic Attack Patients Using ABCD2 Score

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the ABCD2 score can be used in patients with transient ischemic attack, admitted to Beijing anzhen hospital, to evaluate the prognosis, risk factor of those patients.

Detailed Description
-----------------
The feasibility of risk stratification of patients with acute transient ischemic attack admitted to Beijing anzhen hospital by the ABCD2 score system is yet to be determined. The aim of this paper was to evaluate and validate the short-term prognosis of TIA patients in Peking area using this new score system.

Official Title
-----------------
Phase 1 of Clinical Trial of Risk Factor, Prognosis, Imaging and Standard Management of Transient Ischemic Attack.

Conditions
-----------------
Ischemic Attack, Transient

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every patient admitted to Beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour. Magnetic resonance imaging negative on DWI(no fresh infarction). Old infarction or not the criminal infarction. Exclusion Criteria: Patients with hemorrhage stroke were excluded.
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>Dept. of Neurology, Beijing Anzhen Hospital, Capital Medical University Beijing 100029, P.R.China Every patient admitted to Beijing anzhen hospital with transient ischemic attack will be enrolled in this study, from 06/2007 to 12/2008. duration of the symptom not larger than 1 hour. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end points are defined as follow: transient ischemic attack, stroke, angina, myocardial infraction, peripheral vascular disease, intracerebral hemorrhage and other vascular death. |  | two year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TIA, prognosis, evaluation, management
Dinoprostone vs Misoprostol Before LNG-IUD Insertion

Study Overview
=================
Brief Summary
-----------------
the aim of this study is to compare the safety and efficacy of vaginal dinoprostone vs vaginal misoprostol administration prior to IUD insertion in multiparous women regarding reduction in iud insertion pain

Official Title
-----------------
Comparative Study Between Vaginal Dinoprostone and Vaginal Misoprostol Prior to IUD Insertion in Multiparous Women

Conditions
-----------------
IUD Insertion Pain

Intervention / Treatment
-----------------
* Drug: vaginal dinoprostone
* Drug: vaginal misoprostol
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: multiparous women requesting IUD insetion Exclusion Criteria: active genital infection,uterine anomalies, and contraindication or allergy to dinoprostone or misoprostol
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: vaginal dinoprostone<br>vaginal dinoprostone 6 mg (two tablets) 3 hours prior to IUD insertion | Drug: vaginal dinoprostone<br>* two tablets of vaginal dinoprostone (6 mg) 3 hours prior to IUD insertion<br>|
| Active Comparator: vaginal misoprostol<br>vaginal misoprostol 400 mcg (two tablets) 3 hours prior to IUD insertion | Drug: vaginal misoprostol<br>* two tablets of vaginal misoprostol (400 mcg) 3 hours prior to IUD insertion<br>|
| Placebo Comparator: placebo<br>two tablets of placebo similar in shape ,color, odor to the study drugs | Drug: placebo<br>* two tablets of placebo given 3 hours prior to IUD insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain during IUD insertion: visual analog scale | pain during IUD insertion assessed by the visual analog scale from 0=no pain to 10 = the worst pain imaginable | 2 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of IUD insertion | duration of IUD insertion measured in minutes | 5 minutes |
Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

Study Overview
=================
Brief Summary
-----------------
This is a comparative, open label, parallel group, non interventional study to further demonstrate the effectiveness and tolerability of Ectoin® Rhinitis Nasal Spray. In addition the effectiveness and safety shall be compared to a Sinupret forte. The patient applies Ectoin® Rhinitis Nasal Spray or takes Sinupret forte according to the instructions for use. The observation takes place over a period of 14 days. Response to treatment is recorded at day 7 and day 14 by the physician and in daily by the patient in a dairy.

Official Title
-----------------
Non-interventional Study: Application of Ectoin® Rhinitis Nasal Spray in Patients With Acute Rhinosinusitis

Conditions
-----------------
Sinusitis

Intervention / Treatment
-----------------
* Other: Medical Device, Drug-like
* Drug: Sinupret forte


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female or male individuals ≥ 18 years Patients with acute Rhinosinusitis which are treated with Ectoin® Rhinitis Nasal Spray or Sinupret forte during the observational period Exclusion Criteria: Contra indications according to the label

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

| Intervention/Treatment |
| --- |
|Other: Medical Device, Drug-like|Ectoin Rhinitis Nasal Spray|
|Drug: Sinupret forte|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in the symptoms of acute Rhinosinusitis assessed by the EPOS- Sinusitis-Symptom-Score |  | day 1, day 7, day 14 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life questionnaire (Rhino QoL) |  | day 1, day 7, day 14 | 
| Rhinoscopy |  | day 1, day 7, day 14 | 
| Patient's and physician's judgment of efficacy |  | day 7, day 14 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sinusitis, rhinosinusitis, ectoin, ectoine, bitop, SNS, SNS01
Zilver PTX Post-Market Study in Japan

Study Overview
=================
Brief Summary
-----------------
Japanese post market clinical study of the Zilver PTX device.

Official Title
-----------------
Zilver PTX Post-Market Surveillance Study of Paclitaxel-Eluting Stents for Treating Femoropopliteal Artery Disease in Japan

Conditions
-----------------
Peripheral Arterial Disease (PAD)

Intervention / Treatment
-----------------
* Device: Zilver PTX Drug-Eluting Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic peripheral arterial disease (PAD) involving the above-the-knee femoropopliteal arteries
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zilver PTX<br> | Device: Zilver PTX Drug-Eluting Stent<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of stent fracture |  | 5 years | 
| Rate of adverse events |  | 5 years |
Evaluation of Treatment With Fixture Microthread™ in Patients Missing All Teeth in the Upper Jaw, When Using One-Stage Surgery

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the long-term survival rate of implants and prostheses when treating totally edentulous upper jaws with Fixture MicroThread (Micro-Macro) using a one-stage surgical procedure. Clinical study recruitment was stopped in year 2000 due to a decision to modify the product under study. This was a result of feedback regarding the subjective feeling during the installation procedure. There were no safety concerns w/r to the study products. Patients already included and treated in the study were monitored for the full duration of the study in accordance with the clinical study protocol.

Official Title
-----------------
An Open, Prospective, Multicenter Study to Evaluate Treatment of Edentulous Upper Jaws With Fixed Detachable Bridges Retained by Astra Tech Dental Implants, Fixture Micro-Macro

Conditions
-----------------
Jaw, Edentulous

Intervention / Treatment
-----------------
* Device: Fixture MicroThread (Micro-Macro)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-75 years of age Sufficient amount of bone to give good support for implants of at least 9 mm length. Willing to give signed informed consent Exclusion Criteria: Any systemic disease or condition that would compromise post-operative healing and/or osseointegration Systemic corticosteroids or any other medication that would compromise post-operative healing and/or osseointegration Unable or unwilling to return for follow-up visits

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Fixture MicroThread (Micro-Macro)<br>* Fixture MicroThread (Micro-Macro) Ø 3.5 and 4.0 mm in lengths of 9, 11, 13, 15 and 17 mm.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant survival |  | Continuously during 5,5 years after implant placement |