linjc16/ctgov huggingface dataset:
Multicenter Study Using Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery vs. cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Detailed Description
-----------------
The purpose of this study is to evaluate the safety and efficacy of the Glaukos Trabecular Micro-Bypass Stent Model GTS400 using the G2-M-IS injector system in conjunction with cataract surgery, compared to cataract surgery only, in subjects with mild to moderate primary open-angle glaucoma.

Official Title
-----------------
A Prospective, Randomized, Single-Masked, Controlled, Parallel Groups, Multicenter Clinical Investigation of the Glaukos® Trabecular Micro-Bypass Stent Model GTS400 Using the G2-M-IS Injector System in Conjunction With Cataract Surgery

Conditions
-----------------
Primary Open-angle Glaucoma

Intervention / Treatment
-----------------
* Device: iStent inject
* Procedure: Cataract surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mild to moderate open-angle glaucoma Characteristics consistent with mild/moderate glaucoma Use of one (1) to three (3) medications at time of screening exam Exclusion Criteria: Pigmentary or pseudoexfoliative glaucoma Prior incisional glaucoma surgery

Ages Eligible for Study
-----------------
Minimum Age: 45 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 |
| --- | --- |
| Experimental: iStent inject<br>Implantation of two GTS400 stents using G2-M-IS iStent inject | Device: iStent inject<br>* Implantation of two GTS400 stents using G2-M-IS iStent inject<br>|
| Active Comparator: Cataract surgery<br>Cataract surgery alone | Procedure: Cataract surgery<br>* Cataract surgery alone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ≥ 20% Reduction in Intraocular Pressure (IOP) |  | Baseline and Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diurnal IOP Reduction from Baseline |  | Baseline and Month 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary open-angle glaucoma, POAG, Trabecular meshwork, iStent inject
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether the combination of a muscle relaxant and anti-inflammatory drug is more effective at relieving pain in patients with neck strains or whiplash than either of the two medications alone.

Detailed Description
-----------------
Muscle relaxants have been used extensively for neck and back pain since muscle spasm is thought to play a role in the cycle of pain and spasm. However, prior studies have conflicting results regarding their additive effect when given in addition to analgesics such as the NSAIDs. Because they have the potential to lead to adverse events their efficacy should be clearly demonstrated before their routine use.

Official Title
-----------------
Comparison of Ibuprofen, Cyclobenzaprine, or Both for Acute Cervical Strain: A Randomized Clinical Trial

Conditions
-----------------
Cervical Strain

Intervention / Treatment
-----------------
* Drug: Cyclobenzaprine
* Drug: Ibuprofen
* Drug: Ibuprofen plus Cyclobenzaprine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: neck pain within 24 hours of injury Exclusion Criteria: Children, allergy or contraindication to any of the study drugs

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cyclobenzaprine<br> | Drug: Cyclobenzaprine<br>* 5 mg orally every 8 hours as needed<br>* Other names: flexeril;|
| Active Comparator: Ibuprofen<br> | Drug: Ibuprofen<br>* Ibuprofen 400 mg every 8 hours as needed<br>* Other names: motrin, advil;|
| Experimental: Ibuprophen plus Cyclobenzaprine<br> | Drug: Ibuprofen plus Cyclobenzaprine<br>* Ibuprofen 400 mg plus cyclobenzaprine 5 mg every 8 hours as needed<br>* Other names: motrin or advil with flexeril;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | Daily for 1 week | 
| Use of Rescue Medications | the number of patients taking additional rescue medications beyond the study meds | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Resumption of Work |  | 1 week | 
| Resumption of Work or School | number of patients resuming regular activity the day following enrollment. | next day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cervical strain, whiplash, ibuprofen, cyclobenzaprine
Serotype Distribution of Streptococcus Pneumoniae That Causes Invasive Diseases at Children and Adults in Turkey

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to specify the serotype distribution of Streptococcus pneumoniae that causes invasive diseases at children and adults in Turkey.

Detailed Description
-----------------
Non-interventional observational study Descriptive analysis will be conducted.

Official Title
-----------------
SEROTYPE DISTRIBUTION AND ANTIBIOTIC SUSCEPTIBILITY OF STREPTOCOCCUS PNEUMONIAE CAUSING INVASIVE DISEASES IN CHILDREN AND ADULTS: A LABORATORY- BASED MULTICENTER RETROSPECTIVE STUDY

Conditions
-----------------
Pneumococcal Diseases

Intervention / Treatment
-----------------
* Other: There is no intervention in this study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Serotype distribution and antibiotic sensitivity of pneumococcal isolates that causes invasive pneumococcal diseases which are obtained from the blood, CSF, and/or all other sterile body areas (catheter, pleural fluid, parasynthesis fluid, pericardial fluid, synovial fluid, BAL) of the adults of 18 years of age or older with children that are younger than 18 years old at these centers and laboratories will be defined. Exclusion Criteria: Isolation of any other microorganism than pneumococcus at the same sample.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Serotype distribution (this is a non-interventional study)<br>Serotype distribution both in pediatrics and adults (this is a non interventional study) | Other: There is no intervention in this study<br>* This is a non-interventional study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of S. pneumoniae serotype distribution |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of antibiotic susceptibility of the isolates |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
serotype distribution, streptococcus pneumoniae, pneumonia
Microalbuminuria and Allopurinol in Type 1 Diabetes

Study Overview
=================
Brief Summary
-----------------
The objective is to determine if lowering serum uric acid by means of allopurinol in the course of kidney disease may be effective in preventing or improving albuminuria and renal function in Type 1 Diabetic patients. The study is a double blinded, randomised, placebo-controlled cross-over clinical trial.

Official Title
-----------------
A Double-blind, Randomized, Placebo Controlled Trial of Allopurinol in Patients With Type 1 Diabetes and Microalbuminuria

Conditions
-----------------
Type 1 Diabetes, Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: Allopurinol
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Albuminuria (≥30 mg/g) Uric Acid ≥ 0,265 mmol/l GFR (glomerular filtration rate) > 40 ml/min/1.73m2 Exclusion Criteria: History of gout or xanthinuria or other indications for uric acid lowering therapy such as cancer chemotherapy. Recurrent renal calculi. Current use of azathioprine, 6-mercaptopurine, didanosine, tamoxifen, amoxicillin/ampicillin, or other drugs interacting with allopurinol. Known allergy to xanthine-oxidase inhibitors. Renal transplant. Non-diabetic kidney disease. Home, 24h og clinical BP>180 or Diastolic BP >130 mmHg at screening. Cancer treatment within two years before screening. History of hepatitis B or C. History of acquired immune deficiency syndrome or human immunodeficiency virus (HIV) infection. History of alcohol or drug abuse. Breastfeeding or pregnancy or unwillingness to be on contraception throughout the trial. Poor mental function or any other reason to expect patient difficulty in complying with the requirements of the study. Serious pre-existing medical problems other than diabetes, e.g. congestive heart failure, pulmonary insufficiency.

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Allopurinol<br>400 mg once daily, tablet treatment | Drug: Allopurinol<br> <br> |
| Placebo Comparator: Placebo<br>Identical tablet treatment | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improved Albuminuria | Improvement of albuminuria will be evaluated by the collection of 24h urin collection with the measure of 24h albumine excretion rate and the measurements will be compared for the two treatment arm for each participant. | 60 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 1 diabetes, Diabetic nephropathy, Albuminuria, Allopurinol
Single Breath Hold Abdominal MRI

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a single breath hold abdominal MRI protocol and compare the image quality of respiratory triggered 3D T1-weighted images against conventional breath hold images.

Official Title
-----------------
Single Breath Hold Abdominal MRI

Conditions
-----------------
Abdominal MRI

Intervention / Treatment
-----------------
* Device: Respiratory-triggered T1w DISCO LAVA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: undergoing abdominal MRI Exclusion Criteria: none

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Breath hold Liver Acquisition with Volume Acquisition (LAVA)<br>Subjects will undergo abdominal MRI with LAVA with conventional breath holds (typically four or more breath holds) per standard of care. | |
| Active Comparator: Respiratory-triggered T1w DISCO LAVA<br>The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required. | Device: Respiratory-triggered T1w DISCO LAVA<br>* The study will acquire extra image sets using DISCO LAVA with one breath hold during the arterial imaging phase. No additional breath holds will be required. Respiratory-triggered T1w DISCO LAVA precontrast Respiratory-triggered T1w DISCO LAVA in the portal venous phase Respiratory-triggered T1w DISCO LAVA in the equilibrium phase<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motion Artifact Scores | Three investigators will independently evaluate MRI examinations. They will assign motion scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no motion artifact; 2 = minimal motion artifact, no effect on diagnostic quality; 3 = moderate motion artifact with some, but not severe, effect on diagnostic quality; 4 = severe motion artifact, images degraded but interpretable; and 5 = extensive motion artifact, images nondiagnostic. | During MRI, up to 60 minutes | 
| Noise Scores | Three investigators will independently evaluate MRI examinations. They will assign noise scores between respiratory triggered and corresponding breath hold acquisitions. 1 = no noise artifact; 2 = minimal noise artifact, no effect on diagnostic quality; 3 = moderate noise artifact with some, but not severe, effect on diagnostic quality; 4 = severe noise artifact, images degraded but interpretable; and 5 = severe noise artifact, images nondiagnostic. | During MRI, up to 60 minutes |
Spinal Anesthesia Using Lidocaine and Sufentanil and (Transient Neurological Symptoms) TNS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out whether patients receiving spinal anesthesia containing lidocaine and sufentanil get transient neurological symptoms.

Official Title
-----------------
Spinal Anesthesia Using Lidocaine and Sufentanil and TNS (=Transient Neurological Symptoms)

Conditions
-----------------
Transient Neurologic Symptoms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults over the age of seventeen years Exclusion Criteria: patient refuse spinal anesthesia spinal anesthesia is contraindicated pregnancy patient is incapable of giving consent diabetes neurological disorders chronic pain chronic use of analgesics spinal anesthesia within five days before the actual surgery

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 |
| --- | --- | --- |
| Symptoms of transient neurological symptoms |  | 5 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TNS, Spinal anesthesia, Lidocaine
Vistakon Investigational Multi-purpose Contact Lens Care Solution.

Study Overview
=================
Brief Summary
-----------------
This study compares an investigational contact lens care multi-purpose solution to a currently marketed multi-purpose solution.

Conditions
-----------------
Contact Lens Wear

Intervention / Treatment
-----------------
* Device: Vistakon Investigational Multi-Purpose Solution II
* Device: ReNu MultiPlus Multi-Purpose Solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: must be an adapted contact lens wearer best corrected distance visual acuity must be 20/25 or better in each eye must be wearing their habitual lenses on a daily wear basis must be willing to refrain from swimming during the study Exclusion Criteria: any systemic diseases that may interfere with contact lens wear any clinically significant ocular disease any ocular infection use of certain medications any grade 2 or greater slit lamp findings any know sensitivity to marketed contact lens care solutions currently pregnant or lactating monovision corrected

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Multi-Purpose Solution<br>contact lens care solution | Device: Vistakon Investigational Multi-Purpose Solution II<br>* contact lens care solution<br>|
| Active Comparator: ReNu MultiPlus Multi-Purpose Solution<br>contact lens care solution | Device: ReNu MultiPlus Multi-Purpose Solution<br>* contact lens care solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Slit Lamp Findings (SLF) | Slit Lamp Findings were assessed for each subject eye at baseline, 1-day, 1-week, 2-week, 1-month and 3-month follow-up evaluations. SLF consisted of Edema, Corneal Neovascularization, Cornela Staining, Injection, Tarsal Abnormalities and Other findings; each was graded on a 5-likert Scale (Grade: None, Grade 1: Trace, Grade 2: Mild, Grade 3: Moderate and Grade 4: Severe). The number of eyes with Grade 2 or higher across all time points for each SLF variable was reported. | Up to 3 months Post Lens Wear | 
| Distance Visual Acuity (LogMAR) | Distance Visual Acuity (LogMAR) was assessed for each subject eye at 1-week, 2-week, 1-month and 3-month follow-up evaluations. The average Visual Acuity (LogMAR) for each time point and lens was reported. | Up to 3 Months Post Lens Wear |
The Physiological Response to Routine Head and Neck Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
The main objective of this pilot study is to observe and document the range of changes in the blood concentrations of certain hormones, inflammatory chemicals and immune chemicals in response to the stimulus of Head and Neck cancer

Detailed Description
-----------------
This project is in keeping with the strategy of the anaesthetic and intensive care departments to push towards greater understanding of the immune, metabolic and inflammatory changes associated with surgery and how these may be modified through use of different anaesthetic and intensive care techniques. Through increased understanding of the stress, inflammatory and immune responses to surgery we may be able to modulate peri-operative care to reduce cytotoxic(Natural Killer and Cytotoxic T cell) immunosuppression and hence micrometastatic spread at the time of surgery in future studies.

Official Title
-----------------
The Neuroendocrine, Metabolic, Inflammatory and Immune Responses to Routine Head and Neck Surgery. An Observational Pilot Study

Conditions
-----------------
Head and Neck Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective unilateral neck dissections (Levels I-V) and/or Hemithyroidectomy surgery. Royal Marsden Hospital patients with head and neck cancer - all histological sub-types. Capable of providing informed consent Age >17 American Society of Anaesthesiologists Classification I-III. Exclusion Criteria: Past history of ipsilateral neck dissection. Bilateral neck dissection A recent course of systemic steroids (< 3 months) Pregnancy Involvement in drug trials On following medications: Interleukins, Interferons, Immunosuppressants and long term opiates Recent Synacthen Test (within 48 hours) Emergency surgery American Society of Anaesthesiologists Classification IV-V.

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 |
| --- | --- | --- |
| The maximum increase (from baseline to day 3 post-op) in cortisol, IL1 and IL6 will be calculated together with their standard deviations. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The area under the curve for insulin concentration. |  |  | 
| Maximum change in IL2, IL3, IL8 and IL10 from baseline to day 3 post-op. |  |  | 
| Description of other blood parameters related to stress response. |  |  |