linjc16/ctgov huggingface dataset:
Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Study Overview
=================
Brief Summary
-----------------
Proliferative diabetic retinopathy is a serious complication of diabetes mellitus, partly consecutive to upregulation of vascular endothelial growth factor (VEGF) as a consequence of retinal ischemia leads. Aflibercept has been approved by FDA and European medicine agency for treatment of exudative age-related macular degeneration, another retinal disease characterized by choroidal new vessels. The aim of this pilot study is to evaluate the efficacy and the safety of Aflibercept intravitreal injections compared to panretinal photocoagulation for proliferative diabetic retinopathy.

Official Title
-----------------
Phase 2 Study of Safety and Efficacy of Aflibercept in Proliferative Diabetic Retinopathy.

Conditions
-----------------
Naive Patients With Uncomplicated Proliferative Diabetic Retinopathy

Intervention / Treatment
-----------------
* Procedure: panretinal photocoagulation
* Drug: Aflibercept intravitreal injections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with diabetes mellitus type 1 or type 2 complicated by PDR Male or female over 18 years HbA1c <11.6% at study entry Systolic blood pressure <160 mmHg and diastolic blood pressure <105 mmHg at study entry Backgrounds clear eye, pupil dilation and patient cooperation sufficient to allow examination or fundus photographs of good quality Exclusion Criteria: Hypersensitivity to aflibercept or to any of the excipients History of retinal laser (macular or panretinal photocoagulation), of intravitreal injections, of vitrectomy in the eye studied PDR associated with tractional retinal detachment in the eye studied PDR associated with fibrovascular proliferation in the eye studied Florid diabetic retinopathy Eye infection or periocular active or suspected Unbalanced glaucoma in the eye studied Other eye disease in the eye studied Patients with significant medical problems that may interfere with the evaluation of the safety or efficacy of the treatment studied

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Panretinal photocoagulation<br> | Procedure: panretinal photocoagulation<br> <br> |
| Experimental: Aflibercept intravitreal injections<br> | Drug: Aflibercept intravitreal injections<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with regression of retinal neovascularization between baseline and 12th month. |  | 12 months |
A Study of First Line Treatment With Tarceva (Erlotinib) in Combination With Gemcitabine in Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy and safety of Tarceva + gemcitabine in patients with locally advanced, unresectable or metastatic pancreatic cancer. Patients will receive Tarceva 100mg po daily, in combination with gemcitabine 1000mg/m2 iv weekly for 8 weeks, followed by weekly for 3 weeks of each 4 week cycle. The anticipated time on study treatment is until disease progression, and the target sample size is <100 individuals.

Official Title
-----------------
An Open Label Study to Evaluate the Effect of First Line Treatment With Tarceva in Combination With Gemcitabine on Overall Survival and Disease Progression in Patients With Locally Advanced, Unresectable or Metastatic Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer

Intervention / Treatment
-----------------
* Drug: erlotinib [Tarceva]
* Drug: gemcitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; pancreatic cancer, surgically unresectable or with metastases; no previous chemotherapy (except concomitant with radiotherapy); ECOG 0-2. Exclusion Criteria: pancreatic cancer without histologic or cytologic confirmation; surgical resection possible; previous chemotherapy not concomitant with radiotherapy; ECOG 3-4.

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: 1<br> | Drug: erlotinib [Tarceva]<br>* 100mg po daily<br>Drug: gemcitabine<br>* 1000mg/m2 iv weekly for 8 weeks, then weekly for 3 weeks of each 4 week cycle<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival; time to progression |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of response; disease-free survival |  | Event driven | 
| AEs, lab parameters |  | Throughout study |
Study With a Topical Gel to Treat Common Warts in Adults

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to evaluate the effectiveness in adults of 2 different strengths of resiquimod gel applied to common wart(s) five times a week for up to 12 weeks. A second purpose is to evaluate the safety of the drug.

Official Title
-----------------
A Two-Stage, Single-Blind, Dose-Escalating Study to Assess Efficacy and Safety of Resiquimod Gel Applied 5 Times Per Week for up to 12 Weeks for the Treatment of Common Warts in Adults

Conditions
-----------------
Warts

Intervention / Treatment
-----------------
* Drug: Resiquimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of common warts Two forms of birth control Exclusion Criteria: Pregnant or breast feeding Other types of warts, ie. plantar Currently participating in another clinical study Chronic viral hepatitis B or 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?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Resiquimod|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clearance of treated wart(s) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Partial clearance of treated wart(s) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Warts, Adults, Common Warts, Resiquimod
Clinical Application and Validation of Innovative Tourniquet

Study Overview
=================
Brief Summary
-----------------
Background: Tourniquets are the basic equipment for nurses to perform blood draws, and venous indwelling needles for congestion, or for hemostasis. Therefore, forgetting to remove the tourniquet is a common problem that leads to blood circulation being blocked, and even severe tissue necrosis occurred. Purpose: The study aimed to evaluate whether this innovative tourniquet could prevent forgetting to remove the tourniquet, and improve the satisfaction of care. Research design: This clinical research trial was a quasi-experimental study designed for a single group with pre-and post-test. We will recruit 160 nurses in high-risk units of the hospital. The delay in removing the tourniquet as our study outcome is defined as the removing time delay of one minute. Expected results: The research results will provide some evidence of the efficacy of intelligent tourniquets.

Official Title
-----------------
Clinical Application and Validation of Innovative Tourniquet

Conditions
-----------------
Compartment Syndrome of Forearm

Intervention / Treatment
-----------------
* Device: Innovative tourniquet (Acusense Nonpneumatic tourniquet)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nurse group: We included nurses who have working experience of more than 3 months, and are willing to use an innovative tourniquet.
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: We will recruit 160 nurses in high-risk units of the hospital.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nurse group<br>Using an innovative tourniquet (Acusense Nonpneumatic tourniquet) for the standard of care | Device: Innovative tourniquet (Acusense Nonpneumatic tourniquet)<br>* To use this innovative tourniquet before collecting blood samples, and setting IV catheter. We also use this innovative tourniquet to occlude the flow of blood.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preventing the forgetting to remove the tourniquet | Forgetting to remove the tourniquet is defined as the optimal removing time to delay of one minute. | A three months period | 
| Enhancing nurses' satisfaction | The Likert Scale asks how much a person agrees or disagrees with a particular statement or question. It is usually made up of a 5-point rating scale ranging from 1 and 5 with 10-item. | A three months period |
Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care

Study Overview
=================
Brief Summary
-----------------
Early fixation of unstable fractures of the femur, pelvis, and acetabulum reduces some complication rates. However, in patients with multiple injuries, the optimal treatment of skeletal trauma may be affected by severe injury to the head, chest, or abdomen. The relationship between associated injury severity and the timing of definitive management of unstable fractures is not well-understood. The practice of early total care, early definitive fracture management, has been criticized by some, who have suggested that additional hemorrhage with surgery may be associated with a deleterious systemic inflammatory response. The alternative extreme of damage control orthopedics (DCO) has been recently proposed as a means of providing provisional stability of major skeletal injury, generally through external fixation. It is speculated that DCO will diminish the potential for systemic compromise. However, the need for further (definitive) surgery on a delayed basis, and the potential additional complications and costs associated with this strategy are controversial. The investigators' goals are to define which injuries or parameters warrant delay of definitive orthopaedic care, and to determine what time interval for fracture fixation promotes optimal patient outcome. The investigators will assess the effects of fracture fixation on head injury, chest injury, abdominal injury, mortality, complications, patient outcomes, and costs.

Official Title
-----------------
Timing of Orthopaedic Surgery in the Multiply-injured Patient: Development of a Protocol for Early Appropriate Care

Conditions
-----------------
Unstable Pelvic Ring Fracture, Unstable Acetabulum Fracture, Femur Fracture

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients at least 16 years of age treated at a major urban level 1 trauma center between the years 2000 and 2006, who had any of the following musculoskeletal injuries: unstable pelvic ring fracture unstable acetabulum fracture, or femur fracture Patients will be included regardless of race or gender. Isolated fractures will be included Exclusion Criteria: Low-energy pelvis and hip fractures will be excluded Patients younger than 16 years of age will be excluded

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- | --- |
A Study of Lumigan® in Patients With Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT)

Study Overview
=================
Brief Summary
-----------------
This is an observational study of Lumigan® 0.01% (bimatoprost) treatment in clinical practice for patients with Primary Open Angle Glaucoma (POAG) or Ocular Hypertension (OHT).

Conditions
-----------------
Glaucoma, Open-Angle, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: bimatoprost 0.01%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open angle glaucoma or ocular hypertension Prescribed Lumigan® Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| POAG or OHT<br>Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry | Drug: bimatoprost 0.01%<br>* Patients with POAG or OHT prescribed Lumigan® (bimatoprost 0.01%) treatment in a dose determined by the physician prior to study entry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Intraocular Pressure (IOP) | IOP is a measurement of the fluid pressure inside the eye. A negative change from baseline indicates an improvement. | Baseline, 14 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Assessment of Tolerability Using a 4-Point Scale | Patient assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. | 14 Weeks | 
| Physician Assessment of Tolerability Using a 4-Point Scale | Physician assessment of tolerability using a 4-point scale (very good, good, moderate, and poor). The number of patients assessed as good and very good combined are reported. | 14 Weeks | 
| Patients Who Discontinued Use of Lumigan® Prior to 14 Weeks | Patients who discontinued Lumigan® prior to 14 weeks was assessed as Yes or No. | 14 Weeks | 
| Patients Who Will Continue Use of Lumigan® After 14 Weeks | Patients who will continue use of Lumigan® after 14 weeks was assessed as Yes or No. | 14 Weeks |
Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

Study Overview
=================
Brief Summary
-----------------
To define a rational pharmacological management of pain for the subjects under opioid maintenance therapy (methadone or buprenorphine), it is first of all necessary to estimate the efficiency of the current practices on pain management as well as their potentially noxious consequences, in particular on the long term opioid maintenance therapy. The objective of the study is to compare the efficiency of the opioid maintenance therapy according to the arisen of an acute painful phenomenon requiring an analgesic management for these patients. At first, this work will allow to determine the results on acute pain of the current practices for these patients. The comparison of the long term consequences on opioid maintenance therapy between the patients that presented an acute painful phenomenon and the control patients should help to improve acute pain management for these patients while limiting the risk of relapse in the abused consumption of psychoactive substances.

Official Title
-----------------
Acute Pain Episodes in Patients Under Opioid Maintenance Therapy : Clinical Management and Long Term Effects

Conditions
-----------------
Acute Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 or more. Patients under opioid maintenance therapy (buprenorphine or methadone) Patients treated by the same drug (buprenorphine or methadone) since at least 3 months Exclusion Criteria: Refusal of the patient to take part in the study Absence of possible follow-up

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 |
| --- | --- |
| Group P<br>Exposed to an acute painful phenomenon requiring an analgesic management | |
| Group C<br>Control, not exposed to acute pain | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retention rate under buprenorphine or methadone treatment defined as the percentage of patients still under treatment during the follow-up |  | 1, 3, 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain, anxiety, drugs, alcohol and other substances abuse and dependence, drug prescription (included for pain treatment and opioid maintenance) |  | 1, 3, 6 and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Analgesics, Opioid, Opioid maintenance therapy, Acute pain
Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

Study Overview
=================
Brief Summary
-----------------
The main purpose of this study is to assess the efficacy of early oseltamivir treatment (started within 24 hours of the onset of influenza symptoms) in preventing the development of acute otitis media as a complication of influenza in children aged 1-3 years.

Official Title
-----------------
A Double-Blind, Randomized, Placebo-Controlled Study of Early Oseltamivir Treatment of Influenza in Children 1-3 Years of Age

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Drug: oseltamivir
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-3 years Fever = or > 38.0 C and at least one respiratory symptom OR fever = or > 38.0 C and a positive influenza rapid test Exclusion Criteria: Confirmed infection with any other respiratory virus than influenza. Suspicion of invasive bacterial infection requiring immediate admission to hospital Evidence of a poorly controlled underlying medical condition Known immunosuppression (malignancy, transplant, drugs) Known allergy to oseltamivir or paracetamol Received oseltamivir within 4 weeks Participation in another clinical trial with an investigational drug

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 3 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Oseltamivir | Drug: oseltamivir<br>* Body weight: ≤ 15 kg, 30 mg twice daily; 15 - ≤ 23 kg, 45 mg twice daily; 23 - ≤ 40 kg, 60 mg twice daily; > 40 kg, 75 mg twice daily, for 5 days<br>* Other names: Tamiflu;|
| Placebo Comparator: 2<br>Placebo | Drug: placebo<br>* The dosage of placebo will be similar to the active drug<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of influenza-infected children in whom acute otitis media develops after the start of study medication |  | 1-8 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to resolution of fever and other clinical symptoms |  | 1-21 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, children, acute otitis media, oseltamivir
A Study of Ultrasonography With Elastography in Skin Neoplasms

Study Overview
=================
Brief Summary
-----------------
This study will look at high frequency ultrasound as a medical imaging modality and apply it to skin lesions. Elastography is an ultrasonic method of looking at the hardness of an area. We will use this to try and differentiate between benign and cancerous skin lesions.

Conditions
-----------------
Benign and Malignant Skin Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with skin lesions undergoing biopsy for diagnosis. Exclusion Criteria: Patients with skin lesions which do not require biopsy for diagnosis.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Elastography, Cutaneous, Imaging