linjc16/ctgov huggingface dataset:
Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
This study will compare cataract patients before and after phacoemulsification. Evaluations will be performed before and 1 and 3 months following cataract surgery, including measurement of tear film lipid layer thickness, tear film break up time, Schirmer test, corneal and conjunctival fluorescein staining, examination of lid margins and meibomian glands, and the Ocular Surface Disease Index.

Official Title
-----------------
Evaluation of Tear Film Lipid Layer Thickness Change After Cataract Surgery

Conditions
-----------------
Cataract Patients

Intervention / Treatment
-----------------
* Other: LipiView


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cataract patients with lens opacities classification higher than grade III and desire to be spectacle independence for distance and near vision Exclusion Criteria: previous ocular surgery or trauma and the presence of corneal opacities, fundus abnormalities, glaucoma, uveitis, amblyopia, systemic disease, and posterior capsule rupture during cataract surgery

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 80 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 |
| --- | --- |
| cataract patients<br>cataract patients undergoing phacoemulsification | Other: LipiView<br>* tear film lipid layer thickness measured by LipiView interferometer (TearScience Inc, Morrisville, NC)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tear film lipid layer thickness | tear film lipid layer thickness measured by LipiView interferometer | 3-month after phacoemulsification |
Enhancement and Restoring of Low Dose Abdominal CT Images

Study Overview
=================
Brief Summary
-----------------
Through the rapid growth of multislice Computer Tomography (CT) imaging, radiation protection has become a major issue in the radiological community. Optimizing CT scanning is a key task when keeping the radiation doses as low as reasonable achievable (the ALARA principle). Post processing filters can improve and restore grainy and noisy low dose CT images by enhancing structure and reducing image noise. In our study of 10 patients, the investigators perform a preliminary evaluation of a novel post processing filter, which does picture element correlations in all three spatial dimensions. By comparing normal dose pictures with unprocessed low-dose pictures and pictures processed with two dimentional (2D) and three dimentional (3D) filters,the investigators will be able to assess the possible clinical value of the 3D filter. This project is collaboration between Buskerud Hospital (BU), Buskerud University College, Norwegian Radiation Protection Authority (NRPA) and Center for Medical Image Science and Visualization (CMIV). The project is part of the PhD of Lars Borgen.

Official Title
-----------------
Enhancement and Restoring of Low Dose Abdominal CT Images by a Novel Adaptive Nonlinear 3D Post Processing Filter - a Prospective Blinded Interventional Study

Conditions
-----------------
Radiation Protection

Intervention / Treatment
-----------------
* Other: Using a 3 dimentional post processing filter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Outpatients, Male or female,Age above 60 years, Referred to our department for an abdominal CT with intravenous contrast. Exclusion Criteria: Abdominal diameter less than 80cm or larger than 100cm, Gross pancreatic pathology, Gross anatomic anomalies in the investigated region, Intolerance of intravenous contrast

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unenhanced images<br> | |
| Other: Enhanced images<br>Enhanced images | Other: Using a 3 dimentional post processing filter<br>* Using a 3 dimentional post processing filter<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rating of image quality |  | 3-6 months |
A Trial Assessing The Effectiveness and Safety of [S,S]-Reboxetine in Patients With Fibromyalgia

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of [S,S]-Reboxetine in patients with fibromyalgia.

Official Title
-----------------
An 8-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Study of [S,S]-Reboxetine Administered Once Daily in Patients With Fibromyalgia

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

Intervention / Treatment
-----------------
* Drug: [S,S]-Reboxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At screening patients must meet the ACR criteria for fibromyalgia (i.e. widespread pain for at least 3 months, and pain in at least 11 of 18 specific tender point sites). At screening and randomization, patients must have a score of >/=40mm on the Visual Analog Scale (VAS) of the Short-Form-McGill Pain Questionnaire (SF-MPQ). Exclusion Criteria: Patients with other severe pain (e.g. DPN and PHN) that may confound assessment or self-evaluation of the pain associated with fibromyalgia. Patients with severe hepatic impairment.

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [S,S]-Reboxetine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weekly Average Pain Score from the Daily Pain Diary. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fibromyalgia Impact Questionnaire (FIQ) Total Score |  |  | 
| Patient Global Impression of Change |  |  | 
| Short-Form 36 Health Survey (SF 36) |  |  | 
| Sheehan Disability Scale |  |  | 
| Medical Outcomes Study - Sleep Scale (MOS-Sleep Scale) |  |  | 
| Quality of Sleep Score from the Daily Sleep Diary |  |  | 
| Multidimensional Assessment of Fatigue (MAF) |  |  | 
| Hospital Anxiety and Depression Scales (HADS) |  |  | 
| Short-Form McGill Pain Questionnaire (SF-MPQ) |  |  | 
| Fibromyalgia Health Assessment Questionnaire (F-HAQ) |  |  | 
| Safety and Tolerability |  |  | 
| Exposure Response Relationship Between Daily Dose and Daily Pain Score |  |  |
Post-licensure Department of Defense (DOD) Screening Accuracy Study in Military Personnel

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study of the Department of Defense (DoD) Smallpox Screening Form 600s (SF600s) generated during screening of service members for possible immunization with the ACAM2000® smallpox vaccine. Primary Objective: To evaluate the accuracy of the DoD smallpox vaccination screening process in military personnel. Secondary Objective: To describe the number of subjects who are excluded from vaccination, stratified by the pre-defined categories for exclusion (separately for the Screened and Evaluable Populations).

Detailed Description
-----------------
Please note that we elected to post this study on the registry (clinicaltrials.gov) in the interests of transparency and because the study represented a post-licensure commitment to FDA for ACAM2000® smallpox vaccine. However, this study was not a clinical trial and did not involve the administration of any vaccine product nor the collection of any product performance or adverse event data. Rather, the purpose of the study was to determine the success rate for proper completion and use of Department of Defense (DoD) Screening Form 600s (SF600s). The SF600 is a form required to be completed prior to smallpox vaccination of DoD staff and is used to guide decision-making by DoD vaccination staff regarding offering, postponing, or denying vaccination. The study evaluated both the extent to which the SF600s were completed correctly and the extent to which they were correctly used to guide vaccination decision-making.

Official Title
-----------------
A Phase IV Post-licensure DOD Screening Accuracy Study in Military Personnel

Conditions
-----------------
Smallpox

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Military personnel ≥17 years of age. Completion of the DoD Smallpox Screening Form 600 (2-part format). Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 17 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 |
| --- | --- |
| Study Group<br>DoD Smallpox Screening Form 600 (2 part format) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percent of SF600 forms that did not clearly support the subsequent decision to vaccinate. | ACAM2000® Screening Accuracy Review Committee (SARC) consensus that SF600 form did not support the decision to vaccinate divided by all subjects in the Evaluable Population. | 1 year post-screening | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Smallpox, ACAM2000®, Smallpox vaccine
Phase III Randomized, Double-Blind, Placebo-Controlled Study of Acellular and Whole-Cell Pertussis Vaccines

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare the safety and efficacy of acellular 2-component vs. acellular multicomponent vs. whole-cell pertussis vaccine vs. placebo in infants living in Sweden. II. Compare the relative protection of each vaccine against atypical or subclinical pertussis infection. III. Analyze possible laboratory correlates to vaccine protection.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double-blind study. Patients are stratified by participating institution. The first group of infants receives a vaccine composed of inactivated pertussis toxin (iPT) and filamentous hemagglutin (FHA). The second group receives a vaccine containing iPT, FHA, pertactin, agglutinogen 2, and agglutinogen 3. The third group receives a whole-cell pertussis vaccine. The fourth group receives a diphtheria-tetanus vaccine as the control. All vaccines are given as an intramuscular injection, at 2-3, 4, and 6 months of age. Close surveillance of infants and families continues for 2-3 years.

Conditions
-----------------
Pertussis

Intervention / Treatment
-----------------
* Biological: whole-cell pertussis vaccine
* Biological: diphtheria-tetanus vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Population Characteristics-- Infants aged 2 months at planned date of first vaccination No prior pertussis confirmed by culture The following do not exclude: Down syndrome Prematurity Healthy babies vaccinated according to chronological age Recent pertussis exposure Seizures in parent or sibling Sudden infant death in sibling Close relative with history of anaphylaxis or allergy Close relative with history of strong reaction to vaccination --Patient Characteristics-- Age: Under 3 months Renal: No renal failure Other: No prior gammaglobulin No requirement for immunosuppressives, e.g., HIV infection No manifest immunosuppression No serious chronic illness associated with failure to thrive No cardiac disease No progressive neurologic disease No uncontrolled epilepsy or infantile spasms No parental language or communication barrier

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 3 Months

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: whole-cell pertussis vaccine|nan|
|Biological: diphtheria-tetanus vaccine|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
-----------------
bacterial infection, immunologic disorders and infectious disorders, pertussis, rare disease
Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess diagnostic performance of urinary markers of detrusor overactivity (Nerve Growth Factor (NGF), Brain-Derived Neurotrophic Factor (BDNF), adenosine triphosphate (ATP), Prostaglandine E2) in detected high pressure bladder un spina bifida patients.

Official Title
-----------------
Urinary Markers of Detrusor Overactivity in Spina Bifida Patients

Conditions
-----------------
Spina Bifida, Multiple Sclerosis, Spinal Cord Injury, Overactive Bladder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Study arm: Spina bifida patient Seen consecutively in outpatient clinics Age > 18 years-old Control arm: Patients with multiple sclerosis or spinal cord injury or overactive bladder Seen consecutively in urodynamics with lower urinary tract symptoms Age > 18 years-old Exclusion Criteria: Positive urine culture History of urologic neoplasms History of interstitial cystitis

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 |
| --- | --- |
| Spina bifida patient<br> | |
| Patients with multiple sclerosis<br> | |
| Patients with spinal cord injury<br> | |
| Patients with overactive bladder<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of urinary markers will be evaluated by area under the curve (AUC) |  | through study completion, an average of 1 year |
Duloxetine Compared With Placebo in Patients With Generalized Anxiety Disorder

Study Overview
=================
Brief Summary
-----------------
This is a clinical trial assessing duloxetine compared with placebo in patients who have generalized anxiety disorder.

Official Title
-----------------
Duloxetine Hydrochloride 60 mg or 120 mg Once Daily Compared With Placebo in Patients With Generalized Anxiety Disorder.

Conditions
-----------------
Anxiety Disorders

Intervention / Treatment
-----------------
* Drug: duloxetine hydrochloride
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female outpatients at least 18 years of age Exclusion Criteria: Have previously completed or withdrawn from this study or any other study investigating duloxetine or have previously been treated with duloxetine Patient diagnosed with major depressive disorder within the past 6 months Patient diagnosed with panic disorder, post-traumatic stress disorder, or an eating disorder within the past year History of alcohol or any psychoactive substance abuse or dependence within the past 6 months

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: duloxetine hydrochloride|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess duloxetine 120 mg once daily is superior to placebo in the treatment of GAD, defined as statistically greater reduction on the mean change anxiety symptoms as measured by the HAMA total score. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported anxiety symptomatology;Pain;Quality of Life;Clinical Global Improvement;HAMA factor scores |  |  |
Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

Study Overview
=================
Brief Summary
-----------------
Patients with surgically altered anatomy receiving Motorized Spiral Eneroscopy (MSE)-assisted ERCP at a single endoscopic reference center for various indications are planned to be retrospectively enrolled

Detailed Description
-----------------
All consecutive patients with altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery and indication for ERCP with biliary and/or pancreatic indication, who underwent routine Enteroscopy-assisted ERCP using MSE, at the study center during the study period, will be enrolled in the analysis. Primary endpoint of the study will be efficacy and safety of MSE-assisted ERCP. Retrospective epidemiologic Study (not interventional) was approved by local IRB and ethical committee of the North-Rhine Chamber of Physicians (Düsseldorf, Germany), Reference Number: 177/2021.

Official Title
-----------------
Motorized Spiral Enteroscopy-assisted ERCP in Surgically Altered Anatomy

Conditions
-----------------
Ercp in Altered Anatomy

Intervention / Treatment
-----------------
* Device: MSE-ERCP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: altered upper gastrointestinal anatomy after Billroth-II- or Roux-en-Y reconstructive surgery indication for ERCP with biliary and/or pancreatic indication Enteroscopy-assisted ERCP using MSE, at the study center during the study period Exclusion Criteria: - due to the retrospective design of the study, no exclusion criteria are defined

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 |
| --- | --- |
| MSE-ERCP<br>Group of patients, that received motorized spiral enteroscopy assisted ERCP in altered anatomy at the single study center | Device: MSE-ERCP<br>* No interventional study, MSE-ERCP performed within routine treatment, (approved indication of device)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of MSE-ERCP | rate of subjects with successfull MSE-assisted ERCP | intraprocedural | 
| Adverse event rate of MSE-ERCP | rate of adverse events during and early after MSE-ERCP | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of enteroscopy | rate of subjects with successful enteroscopic access to the papilla | intraprocedural | 
| Procedural duration | overall time for MSE-ERCP (scope in to scope out) | intraprocedural | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
endoscopy, enteroscopy, ercp in altered anatomy
Treatment of Patients With Chronic Hepatitis C With PegIntron as Monotherapy or in Combination With Ribavirin (Study P04437)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
In February 2002, a French Consensus Conference on the management of patients with chronic hepatitis C in France was organized. The jury issued several recommendations on pegylated alpha interferon/ribavirin treatment strategy. Three years after these recommendations, it is of interest to understand the evolution of hepatitis C management in France in real clinical practice. This observational study will permit the identification of patients who are treated and will provide information on the use of PegIntron/ Ribavirin.

Detailed Description
-----------------
To assure a good representation of participants treated for hepatitis C, participants who meet the inclusion criteria will be enrolled on a consecutive basis.

Official Title
-----------------
Real Situation Observational Study of VIRAFERONPEG® in Patients With Chronic Hepatitis C

Conditions
-----------------
Hepatitis C, Chronic, Hepacivirus

Intervention / Treatment
-----------------
* Biological: Peginterferon alfa-2b (SCH 54031)
* Drug: Ribavirin (SCH 18908)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult participants starting a treatment with PegIntron for the treatment of chronic hepatitis C. Exclusion Criteria: Concomitant participation in a clinical trial for the treatment of hepatitis C.

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 |
| --- | --- |
| PegIntron as monotherapy or in combination with Ribavirin.<br>Adult participants with chronic hepatitis C treated with PegIntron as monotherapy or in combination with ribavirin. | Biological: Peginterferon alfa-2b (SCH 54031)<br>* Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.<br>* Other names: PegIntron;Drug: Ribavirin (SCH 18908)<br>* Peginterferon alfa-2b as monotherapy or in combination with ribavirin will be administered according to the products' labeling.<br>* Other names: Rebetol;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Number of Participants Receiving the Recommended Treatment Duration (24 Weeks for Genotypes 2 and 3 and 48 Weeks for Genotype 1 According to the French 2002 Consensus Meeting). |  | Physicians will complete a questionnaire at these visits: treatment initiation; 12 and 24 weeks after treatment initiation and 24 weeks after the end of treatment; and 36 and 48 weeks after treatment initiation for participants treated for 48 weeks. |