linjc16/ctgov huggingface dataset:
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for Care of Soft Contact Lenses

Study Overview
=================
Brief Summary
-----------------
The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.

Official Title
-----------------
Clinical Evaluation of the Safety and Efficacy of an Investigational Multi-Purpose Disinfecting Solution Compared to a Marketed Multi-Purpose Solution for Care of Soft Contact Lenses

Conditions
-----------------
Contact Lens Care

Intervention / Treatment
-----------------
* Device: FID 107027 Multi-Purpose Disinfecting Solution
* Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month. Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable). Successful lens wear for at least 8 hours per day. Vision correctable to 20/30. Normal eyes - no current ocular abnormalities that prevent successful contact lens wear. No corneal surgery within the past 12 months. No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions. No over-the-counter or prescription ocular medication. No enrollment in another clinical study within 30 days prior to enrollment. Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FID 107027<br>Contact lens solution used as instructed for 90 days. | Device: FID 107027 Multi-Purpose Disinfecting Solution<br>* Investigational, multi-purpose disinfecting solution intended for use in cleaning, rinsing, conditioning, disinfecting, and storing soft contact lenses.<br>|
| Active Comparator: ReNu MultiPlus<br>Contact lens solution used as instructed for 90 days. | Device: ReNu MultiPlus Multi-Purpose Solution No Rub Formula<br>* Commercially marketed product indicated for cleaning, rinsing, disinfecting, and storing soft contact lenses.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lens Cleanliness - Residual lens lysozyme (HPLC) at Day 90 on Group IV lenses |  | Day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average Lens Wearing Time |  | Day 90 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contact Lens Care
A Pilot Investigational Study: Treatment of Anxiety With Non-Needle Electro-Acupuncture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of non-needle electro-acupuncture on mild to moderate anxiety. The hypothesis is that this style of treatment will reduce state anxiety and not trait anxiety as measured by the Spielberger STAI test.

Detailed Description
-----------------
Persistent and unrelenting stress is defined as anxiety. Anxiety disorders are among the most common mental disorders in society. The NIH estimates that nearly 200 million Americans suffer from anxiety. Anxiety disorders are associated with a lower quality of life, functional impairment and disability, and are also associated with co-morbid physical illness. Acupuncture, one form of complementary and alternative medicine, has been used to treat anxiety. Non-needle acupuncture is one of the safest methods, with none to rare side effects. This method has been studied in China (Han 1986) and America (Ulett 1998) Pre-intervention testing, then three treatments within one week, will be followed by post intervention testing.

Conditions
-----------------
Anxiety, Mild to Moderate

Intervention / Treatment
-----------------
* Device: HANS non-needle acupuncture
* Procedure: Stimulation of two acupuncture points bi-lateral


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normally healthy persons with mild to moderate anxiety - Exclusion Criteria: Severe anxiety, depression, pregnancy, and previous experience with HANS non-needle electro-acupuncture treatment -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: HANS non-needle acupuncture|nan|
|Procedure: Stimulation of two acupuncture points bi-lateral|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spielberger STAI test |  |  |
UZ Brussel HRMC Registry of Brugada Syndrome

Study Overview
=================
Brief Summary
-----------------
The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome at UZ Brussel hospital (UZB).

Detailed Description
-----------------
The monocentric UZB registry for Brugada registry is intended to collect all data on patients affected by Brugada syndrome. These includes: demographical data: age, sex antropometric data: height, weight, BMI clinical data: comorbidities, arrhythmias, PM or ICD implantation, therapy 3) data on the families: number of family members, sudden death history. 4) data on the genetics 5) data on: ECG, echocardiography, CT scan, MRI of heart, MRI of brain, ECG imaging, 3D electroanatomical mapping and ablation

Official Title
-----------------
UZ Brussel Heart Rhythm Management Center Monocentric Registry of Brugada Syndrome

Conditions
-----------------
Brugada Syndrome

Intervention / Treatment
-----------------
* Other: No intervention because it is a patient registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Brugada syndrome diagnosis Exclusion Criteria: Other diagnosis different from Brugada syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention because it is a patient registry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular arrhythmias | Composite of: sudden cardiac death, aborted sudden cardiac death, ventricular fibrillation, sustained ventricular tachycardia, ICD appropriate therapy | through study completion, an average of 10 year | 
| Atrial fibrillation | Atrial fibrillation occurrence | through study completion, an average of 10 year | 
| Death for any cause | Death for any cause | through study completion, an average of 10 year | 
| Cardiovascular death | Death for cardiovascular cause | through study completion, an average of 10 year | 
| Genetic mutations | Genetic mutations (pathogenic and variant of unknown significance) associated with Brugada syndrome. Wide gene panel with next generation sequencing will be used: Roche SeqCap® EZ Human Exome Probes v3.0 for BrS. | Baseline |
Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision

Study Overview
=================
Brief Summary
-----------------
Hypothesis: navigated revision total knee arthroplasty results in a more precise reconstruction of preoperatively planned joint line than conventional revision total knee arthroplasty (rTKA).

Official Title
-----------------
Joint Line Reconstruction in Navigated Total Knee Arthroplasty Revision

Conditions
-----------------
Revision Total Knee Arthroplasty Because of, Loosening, Instability, Impingement, or Other Reasons Accepted as Indications for TKA Exchange., The Focus is to Determine the Precision of Joint Line Restoration in Navigated vs. Conventional Revision Total Knee Arthroplasty

Intervention / Treatment
-----------------
* Device: navigated revision knee arthroplasty
* Device: conventional revision knee arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for revision knee arthroplasty

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: navigated revision total knee arthroplasty<br>revision total knee arthroplasty with the aid of a navigation system | Device: navigated revision knee arthroplasty<br>* revision knee arthroplasty with the aid of a navigation system the navigation system is the Orthopilot System with a software specifically dedicated for revision operations (TKR 1.0). The system is from Aesculap AG (Tuttlingen).<br>|
| Active Comparator: conventional revision knee arthroplasty<br>revision knee arthroplasty using conventional instruments | Device: conventional revision knee arthroplasty<br>* revision knee arthroplasty using conventional instruments<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Restoration of Joint Line | Difference between preoperatively planned and postoperatively achieved joint line | postoperatively (6 to 12 weeks after operation, we expect a mean of 9 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
revision knee arthroplasty, navigation, joint line
Longitudinal Surveillance Registry (LSR) of ACUITY Spiral

Study Overview
=================
Brief Summary
-----------------
The primary purpose of the LSR of ACUITY Spiral is to evaluate and report on the long-term performance of the ACUITY Spiral Left Ventricular Lead.

Official Title
-----------------
Condition of Approval Study: Longitudinal Surveillance Registry of the ACUITY Spiral Lead

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: ACUITY Spiral Left Ventricular Lead


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has been or will be implanted with the ACUITY Spiral Lead within 29 days Plans to remain in the long-term care of his/her enrolling physician Is willing and capable (or appropriate legal representative) of authorizing access to and use of health information as required by an institution's institutional review board (IRB) Is willing and capable (or appropriate legal representative) of providing authorization for participation in the registry Exclusion Criteria: Is unable or unwilling to comply with the protocol requirements
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Implants<br>Patients successfully implanted with the ACUITY Spiral Lead | Device: ACUITY Spiral Left Ventricular Lead<br>* The implant of the ACUITY Spiral Lead<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Chronic Left Ventricular Lead-related Complication Free Rate |  | Date of enrollment to study completion (Date of 5 year follow-up, withdrawal or death). |
miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis (TB)

Study Overview
=================
Brief Summary
-----------------
The detection of miRNA (non-coding ribonucleic acid) in the blood in the context of active tuberculosis is an innovative approach to the detection of new disease-specific biomarkers. The primary goal of this analysis is to define, for the first time, an miRNA fingerprint for tuberculosis in sweat. Samples that were collected as part of the Sweatb Study (NCT03667742) project are examined for the occurrence of disease-specific, non-coding miRNAs to define new biomarkers in the sweat. These biomarkers can be detected non-invasively and will help in the detection of patients with active tuberculosis.

Official Title
-----------------
miRNA in Sweat, a Novel Digital Biomarker for Detection of Active Tuberculosis

Conditions
-----------------
Active Tuberculosis

Intervention / Treatment
-----------------
* Diagnostic Test: Next Generation Sequencing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients Ability to understand the purpose of the study, provide signed and dated informed consent by patient or his/her legal representative In-patients with acute tuberculosis, suspected tuberculosis or other pulmonary diseases (pneumonia, Bronchitis, COPD) Inclusion criteria Healthy Donors: negative for Quantiferon- TB Gold Plus Test or ELISpot Exclusion Criteria: Written rejection of the consent for the further use of the data

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 |
| --- |
|Diagnostic Test: Next Generation Sequencing|Next Generation Sequencing of sweat and whole blood samples for non-coding miRNAs to define biomarkers that enable to differentiate between patients with active tuberculosis, a differential diagnostic disease and healthy individuals.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Detection of miRNA (non-coding ribonucleic acid) in sweat | Analysis of sweat protein markers in patients with active tuberculosis | Sweat samples taken at baseline | 
| Detection of miRNA (non-coding ribonucleic acid) in blood | Analysis of blood protein markers in patients with active tuberculosis | Blood samples taken at baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
miRNA, Mycobacterium Tuberculosis, Next Generation Sequencing
Oral Versus Intravenous Dexamethasone

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess bioequivalence for dexamethasone administered orally versus intravenously in patients admitted to hospital for pneumonia.

Official Title
-----------------
Oral Versus Intravenous Dexamethasone in Community-Acquired Pneumonia

Conditions
-----------------
Pneumonia

Intervention / Treatment
-----------------
* Drug: Dexamethasone tablet 6 mg
* Drug: Dexamethasone injection 4 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18 years and older Presenting to the emergency room with suspected pneumonia (to be confirmed within 24 hours from admission) Pneumonia is defined as a new or progressive infiltrate on a chest X-ray plus at least two of the following criteria: cough, sputum production, temperature >38°C or <35°C, auscultatory findings consistent with pneumonia, leucocytosis or leucopenia (>10 g/l, <4 g/l or >10% rods in leucocyte differentiation), C-reactive protein >3 times the upper normal limit Corticosteroid naive at time of presentation Exclusion Criteria: Patients needing corticosteroid treatment above study medication Failure to obtain written consent to participate Patients using medication drugs that interact with dexamethasone (i.e. phenytoin, barbiturates, rifampicin, erythromycin, clarithromycin, aprepitant, colchicine, everolimus, itraconazole, ketoconazole, pazopanib, tipranavir, and vinorelbine) Moribund patients (defined as expected to die within 24 hours) Patients with proven or suspected allergy to dexamethasone Patients not capable of taking tablets orally

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Dexamethasone oral<br> | Drug: Dexamethasone tablet 6 mg<br>* Dexamethasone tablet 6 mg<br>|
| Active Comparator: Dexamethasone intravenous<br> | Drug: Dexamethasone injection 4 mg<br>* Dexamethasone injection 4 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Concentration time curve |  | 0-24 hours |
Clinical Evaluation of the SportWelding FijiAnchor® in Hand and Hand Wrist Surgery

Study Overview
=================
Brief Summary
-----------------
The SportWelding FijiAnchor is an absorbable suture anchor which is inserted by applying ultrasonic energy. This provides an intimate bond between implant and bone delivering immediate stability. The purpose of this study is to evaluate the surgical and clinical outcome of the SportWelding Fiji Anchor in ligament repair of the hand and hand wrist.

Official Title
-----------------
Prospective Clinical Evaluation of the Bioabsorbable SportWelding FijiAnchor® for Ligament Repair of the Hand and Hand Wrist

Conditions
-----------------
Lesion of Ligament of Wrist and/or Hand

Intervention / Treatment
-----------------
* Device: SportWelding Fiji Anchor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having a condition requiring (re)fixation or (re)construction of ligaments in the hand or hand wrist Being able to comprehend, sign, and date the written informed consent form (ICF)); and Being able to visit the hospital to be examined the repaired region after the procedure. Exclusion Criteria: Having serious concomitant disease Being pregnant Having the control hand not suitable to serve as comparator

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SportWelding Fiji Anchor<br> | Device: SportWelding Fiji Anchor<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Operation success | Technical success confirmed at the end of surgery by mean of an assessment form (e.g anchor insertion without breaking and suture without pulling off from the tissue during surgery). | Day 1 | 
| Procedure success | No dislodged/broken anchor nor ruptured sutures observed at 2, 6 and 12 weeks post operative evaluation | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical function | Dash (Disabilities of the Arm, Shoulder and Hand) Score, PRWE (Patient-Related-Wrist-Evaluation) Score and strength of the operated and the non-operated control hand will be recorded after 6 and 12 months. | 3 and 6 months | 
| Adverse events | All adverse events will be recorded | From Day 1 to 12 months |
Telbivudine Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Study Overview
=================
Brief Summary
-----------------
This study is being conducted to compare the effectiveness and safety of telbivudine (LdT) and lamivudine in Chinese adults.

Official Title
-----------------
A Phase III Randomized, Double Blind Trial of LdT (Telbivudine) Versus Lamivudine in Chinese Adults With Compensated Chronic Hepatitis B

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: telbivudine
* Drug: lamivudine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented clinical history compatible with chronic hepatitis B infection Other protocol-defined inclusion criteria may apply Exclusion Criteria: Patient is pregnant or breastfeeding Patient is co-infected with hepatitis C virus (HCV), hepatitis D virus (HDV) or HIV Patient has previously received lamivudine or any investigational anti-HBV nucleoside or nucleotide analog Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 70 Years

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

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: telbivudine|nan|
|Drug: lamivudine|nan|

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

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