linjc16/ctgov huggingface dataset:
DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
Safety and IOP (intraocular pressure) lowering effect of DE-111 ophthalmic solution will be evaluated in open-angle glaucoma or ocular hypertension patients, in an open-label, multicenter study.

Official Title
-----------------
A Long-term Open-label Study of DE-111 Ophthalmic Solution in Patients With Open Angle Glaucoma or Ocular Hypertension -Phase 3-

Conditions
-----------------
Open Angle Glaucoma or Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: DE-111 ophthalmic solution


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with open angle glaucoma or ocular hypertension Provided signed, written informed consent 20 years of age and older If a subject is a female of childbearing potential, she must utilize reliable contraceptive throughout the study, and must have a negative urine pregnancy test prior to enrollment into this study Exclusion Criteria: Females who are pregnant, nursing or planning a pregnancy, or females of childbearing potential who are not using a reliable method of contraception. Presence of any abnormality or significant illness that could be expected to interfere with the study.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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: 1<br>DE-111 ophthalmic solution | Drug: DE-111 ophthalmic solution<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in IOP (Intraocular Pressure) at End of Study |  | Treatment period: Week 0 (Baseline) and Week 52 (End of Study) |
Expanded Access for CC-2001

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants designed to provide access to CC-2001.

Official Title
-----------------
Expanded Access for CC-2001

Conditions
-----------------
Dermatologic, Other

Intervention / Treatment
-----------------
* Drug: CC-2001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: -
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CC-2001|CC-2001 will be administered orally|

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
-----------------
Expanded Access, Compassionate Use
A Clinical Trial to Explore the Safety and Efficacy of Three Different Doses of Pegaptanib Sodium in Patients With Wet Age-Related Macular Degeneration (AMD)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to compare the ability of three different doses of pegaptanib sodium to safely and effectively minimize fluid leakage within the eye, thereby stabilizing or improving vision in patients with wet AMD. The study will also examine the effects of pegaptanib sodium on the cornea and sensory retina of patients with wet AMD.

Official Title
-----------------
An Exploratory Randomized, Double-Masked, Multi-Center Comparative Trial, in Parallel Groups, to Explore the Safety and Efficacy of Three Different Doses of Intravitreous Injections of Pegaptanib Sodium (Anti-VEGF Pegylated Aptamer) Given Every 6 Weeks for 102 Weeks, in Patients With Subfoveal Neovascular Age-Related Macular Degeneration (AMD)

Conditions
-----------------
Macular Degeneration

Intervention / Treatment
-----------------
* Drug: Pegaptanib sodium


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects of either gender, aged 50 years or greater. Subfoveal choroidal neovascularization (CNV) due to AMD. Best corrected visual acuity in the study eye between 20/40 and 20/320. Normal electroretinogram, and corneal endothelial cell density of 1500 cells/mm2 or more. Exclusion Criteria: Any prior photodynamic therapy (PDT) with Visudyne or thermal laser to the study eye.

Ages Eligible for Study
-----------------
Minimum Age: 50 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: Pegaptanib sodium|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
-----------------
AMD, Age-Related Macular Degeneration, Macular Degeneration, Macugen, pegaptanib sodium, ERG, specular microscopy, Age-Related Mcular Degeneration (AMD)
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

Study Overview
=================
Brief Summary
-----------------
The objective of this sample collection study is to collect urine samples to validate the NEPHROCLEAR™ CCL14 Test in patients with KDIGO stage 2 or 3 AKI. This study is observational and will have no impact on the medical management of the subject.

Official Title
-----------------
A Sample Collection Study to Validate the NEPHROCLEAR™ CCL14 Test

Conditions
-----------------
Acute Kidney Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 21 years of age or older; Receiving care in an intensive care unit; Expected to remain in the ICU for at least 48 hours after enrollment; Use of indwelling urinary catheter as standard care at the time of enrollment; Subject must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample collection; Urine sample must be collected within 36 hours of meeting KDIGO Stage 2 criteria; Written informed consent provided by patient or legally authorized representative (LAR). Exclusion Criteria: Prior kidney transplantation; Comfort-measures-only status; Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment; Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic); Special populations, pregnant women, prisoners or institutionalized individuals.

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Patients with KDIGO stage 2 or 3 AKI<br> | Diagnostic Test: Urine collection for NEPHROCLEAR CCL14 Test<br>* Urine will be collected and banked for future analysis with the NEPHROCLEAR CCL14 Test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Persistent Severe Acute Kidney Injury as Determined by Physician Adjudication |  | Within 5 days |
Insulin Glulisine, Diabetes Mellitus Type 1

Study Overview
=================
Brief Summary
-----------------
To provide local data on efficacy and safety of insulin glulisine in patients with Type 1 Diabetes Mellitus receiving insulin glargine as basic insulin therapy

Official Title
-----------------
Multicenter, Open, Non-randomised Phase III Clinical Study of Efficacy and Safety of Insulin Glulisine Injected Subcutaneously in Patients With Type 1 Diabetes Mellitus Using Also Insulin Glargine

Conditions
-----------------
Diabetes Mellitus, Type 1

Intervention / Treatment
-----------------
* Drug: Insulin glulisine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus, Type 1 HbA1c 6.5-11.0% BMI <35 kg/m² Exclusion Criteria: Diabetes mellitus, Type 2 The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Insulin Glulisine<br> | Drug: Insulin glulisine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | 26 weeks | 
| Fasting Blood Glucose |  | 26 weeks | 
| Fasting Blood Glucose |  | 52 weeks | 
| Post-prandial glycemia (2 hour after breakfast) |  | 26 weeks | 
| Post-prandial glycemia (2 hour after breakfast) |  | 52 weeks |
Topera E-FIRM Registry

Study Overview
=================
Brief Summary
-----------------
This is a registry to assess the safety and effectiveness of FIRM guided procedures for the treatment of symptomatic any type of atrial fibrillation. FIRM (Focal Impulse and Rotor Modulation) guided ablation is defined as ablating rotors identified by the FIRMap® basket catheter for visualising of rotors with the RhythmView® mapping system. In addition to the FIRM guided ablation any other ablation method could be applied.The acute success of FIRM ablations is defined as elimination of rotors defined by absence of rotors. Data items will be collected, if available, consistent and applicable with routine and standard clinical care at each participating site.

Detailed Description
-----------------
Prospective and retrospective enrollment is possible.

Official Title
-----------------
EU Focal Impulse and Rotor Modulation Registry -Topera E-FIRM Registry-

Conditions
-----------------
Atrial Fibrillation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: reported incidence of at least 2 documented episodes of symptomatic AF (paroxysmal, persistent or long standing persistent) during the 3 months preceding the initial AF ablation attempt of at least one Class I or III anti-arrhythmia drug with failure defined as recurrence of symptomatic AF or adverse drug effect resulting in stopping medication Exclusion Criteria: women who are pregnant As this is a registry only data of patients will be included who have been treated according to the current AF guidelines.
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 |
| --- | --- | --- |
| Number of Participants With Acute Success | Acute Success was defined as the elimination (by ablation) of all identified rotors | day of procedure | 
| Number of Participants With 12-Month Success | Single procedure freedom from atrial fibrillation recurrence | 12-months after index procedure | 
| Number of Participants With Acute Safety Success | Acute safety success was defined as freedom from Serious Adverse Events at 7 days after index procedure | 7 days after index procedure | 
| Number of Participants With 12-Month Safety Success | Success was defined as freedom from Serious Adverse Events at 12-months after index procedure | 12-months after index procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FIRM procedure
Minimally Invasive Fixation for Distal Radius Fractures

Study Overview
=================
Brief Summary
-----------------
Minimally invasive surgery avoids the tissue damage and impairment of physiological function caused by open surgery because of its precise location techniques and can effectively promote the early recovery of wrist function. Under conditions of no cutting of fracture fragments, no blood supply compromise in the fracture fragments

Detailed Description
-----------------
Distal radial fracture is common fracture and internal fixation needed in many cases so we use minimally invasive fixation in this study to minimize open surgery compilations

Official Title
-----------------
Minimally Invasive Surgical Fixation for Unstable Fractures of the Distal End Radius in Adults

Conditions
-----------------
Distal Radius Fracture

Intervention / Treatment
-----------------
* Device: Minimal invasive surgical fixation of distal radius Fractures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with unstable distal radial fracture skeletally mature Patients. Acute fractures within one weeks of injury Exclusion Criteria: contaminated open fractures. fractures associated with vascular injury requiring repair, and suspected pathologic Fracture

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Minimally invasive fixation<br>Minimally Invasive Surgical Fixation for Unstable Fractures of the distal end Radius in Adults | Device: Minimal invasive surgical fixation of distal radius Fractures<br>* Fixation of distal radius Fractures by minimal invasive technique<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture healing | Rate of fracture healing | 6 minths | 
| Wrist function | Percentage of restoration of wrist function | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fracture compilations | Percentage of fracture healing compilations | One year |
Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study

Study Overview
=================
Brief Summary
-----------------
Correlate the implant stability quotient values measured by ostell device with radiographic bone density measured on CBCT by bluesky software pre-operatively

Detailed Description
-----------------
Dental implants have been widely used in the field of dental rehabilitation. Nowadays implant sucess rate is very high but to keep faliure rate as low as possible patient selection is very important especially regarding bone density to achieve high primary stability. Primary stability plays an important role in successful osteointegration of dental implants. This study was done to correlate between the bone density pre operatively measured on CBCT represented by HF unit and implant stability measured post operatively by ostell device represented by ISQ unit

Official Title
-----------------
Correlation Between Radiographic Bone Density in CBCT and Implant Stability Quotient Value: Clinical Observational Study

Conditions
-----------------
Dental Implantation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients receiving dental implants in both arches patients should be free from any systemic diseases that may affect normal healing of bone, and predicated outcome no intra-oral soft tissue defect that would render primary closure of the intra-oral wound Exclusion Criteria: patients with systemic diseases _ patients with ridge augmentation such as ridge expansion, ridge splitting and bone grafting patients with sinus lifting done to place implants immediate extraction sockets

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- | --- |
| Bone density | Measuring bone density on CBCT by bluesky software representing by hounsfield unit pre operatively | Baseline | 
| Implant stability | Post oprative measurements of implant stability by ostell device (ISQ) | Immediate post operative |
A Prospective Longitudinal Breast Cancer Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to obtain sufficient specimens and correlating clinical data from a well-controlled prospective clinical trial collecting longitudinal specimens from subjects diagnosed with any stage of breast cancer.

Detailed Description
-----------------
The study objectives are described below: Obtain serum and plasma specimens longitudinally collected from a minimum of 130 subjects diagnosed with breast cancer and are about to or are currently undergoing treatment and follow-up. Specimens will be used to evaluate CA 15-3 assays, currently under development, as an aid for monitoring recurrence or progressive disease. To store any remaining specimens for use in future cancer research and to evaluate as yet undetermined biomarkers for the development of IVDs, including additional CA 15-3 assays, for monitoring the course of disease and therapy in subjects diagnosed with breast cancer.

Official Title
-----------------
A Prospective Longitudinal Study of CA 15-3 as an Aid in Monitoring Recurrence or Progressive Disease in Patients With Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: CA 15-3 Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, age≥ 18 years Histologic/pathologic confirmation of breast cancer Any stage of disease: Newly diagnosed, stable, disease progression, surveillance Any treatment time point: Treatment naïve, currently receiving or completed therapy for breast cancer including active monitoring. Individuals with a history of malignant disease other than breast cancer that was resected greater than 5 years ago and are currently in remission are eligible. Able to understand and willing to provide informed consent Exclusion Criteria: Males and females, age <18 years No histologic/pathologic confirmation of breast cancer Any concurrent malignancy other than basal or squamous cell skin cancers, in-situ cervical cancer, or breast cancer. Treatment plan with fewer than three visits expected in 3 years' time Unable to provide informed consent

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 |
| --- |
|Device: CA 15-3 Assay|Physicians use the CA 15-3 test result to manage their patients|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure CA 15-3 in Breast Cancer Patients | 130 patients with Recurrence or Progressive Breast Cancer. | 3 years |
Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and effectiveness of vildagliptin, an unapproved drug, compared to metformin in lowering overall blood glucose levels in people with type 2 diabetes who have not been previously treated with drug therapy to lower their blood sugar.

Official Title
-----------------
Efficacy and Safety of Vildagliptin Compared to Metformin in Drug Naive Patients With Type 2 Diabetes

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: Metformin Comparator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Not currently on durg therapy for type 2 diabetes Body mass index (BMI) in the range 22-45 Blood glucose criteria must be met Exclusion Criteria: Type 1 diabetes Pregnancy or lactation Evidence of serious diabetic complications Evidence of serious cardiovascular conditions Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vildagliptin<br> | Drug: vildagliptin<br> <br> * Other names: LAF237A;|
| Active Comparator: Metformin<br> | Drug: Metformin Comparator<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Adverse event profile after 52 weeks of treatment |  |  | 
| Change from baseline in body weight at 52 weeks |  |  | 
| Change from baseline in fasting lipids at 52 weeks |  |  | 
| Change from baseline in HOMA B at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin