linjc16/ctgov huggingface dataset:
Ahmed Glaucoma Valve and Single-Plate Molteno Implants in Treatment of Refractory Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the efficacy and safety of the Ahmed valve implant (AVI) and the Molteno single-plate implant (MSPI) in eyes with refractory glaucoma during a follow-up period of 24 months.

Conditions
-----------------
Refractory Glaucoma

Intervention / Treatment
-----------------
* Device: Ahmed valve implant
* Device: Molteno single-plate implant (MSPI)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: refractory glaucoma, defined as uncontrolled IOP despite maximal anti-glaucoma medication, previously failed nonseton surgical treatment, or a combination thereof. Exclusion Criteria: age less than 40 years a visual acuity of no light perception lens opacity elevated IOP associated with silicone oil previous glaucoma drainage device implantation in the same eye previous cyclodestructive treatment increased risk of endophthalmitis posterior segment disorders pre-existing ocular comorbidities.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: MSPI<br>Molteno single-plate implant | Device: Molteno single-plate implant (MSPI)<br>* 134 mm2 surface area single-plate Molteno implant (Molteno Ophthalmic Limited, Dunedin, New Zealand)<br>|
| Active Comparator: AVI<br>Ahmed valve implant | Device: Ahmed valve implant<br>* 184 mm2 surface area Ahmed Glaucoma Valve (AGV Model FP7; New World Medical Inc., Rancho Cucamonga, California, USA)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular pressure (IOP) |  | Month 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intra Ocular pressure (IOP) |  | day 1,week 1, and months 1, 3, 6, 9, 12 and 18 | 
| Changes in visual acuity |  | day 1,week 1, and months 1, 3, 6, 9, 12, 18, and 24. | 
| Number of anti-glaucoma medications |  | week 1, and months 1, 3, 6, 9, 12, 18, and 24 | 
| Mean deviation of visual field, |  | week 1, and months 1, 3, 6, 9, 12, 18, and 24 | 
| Rate of intra- and postoperative complications |  | week 1, and months 1, 3, 6, 9, 12, 18, and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ahmed valve, single-plate Molteno implant, refractory glaucoma, surgical treatment
Inhaled Iloprost for the Treatment of Persistent Pulmonary Hypertension in the Term and Near Term Infants.

Study Overview
=================
Brief Summary
-----------------
Inhaled Iloprost will be administered to near term infants with Persistent Pulmonary Hypertension of the Newborn in two different doses in order to test safety and efficacy in reducing pulmonary artery pressure.

Detailed Description
-----------------
Infants eligible for the study will be divided into two arms according to oxygenation index: Infants in arm A (OI <20) will receive nebulized Iloprost in a lower dose (50 ng/kg/min) for one hour, and a higher dose (100 ng/kg/min) for another hour. Infants in arm B (OI>20) will receive NO, and in addition will receive nebulized Iloprost in a lower dose for one hour and a higher dose for another hour.

Official Title
-----------------
Pilot Study: The Effect of Inhaled Iloprost on Oxygenation in Term and Near Term Infants With Pulmonary Hypertension. Testing Two Doses.

Conditions
-----------------
Pulmonary Hypertension

Intervention / Treatment
-----------------
* Drug: Inhaled Iloprost


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Near-term infants (>34 gestational age) with evidence of persistent pulmonary hypertension and severe hypoxia(PaO2<100 mmHg with mechanical ventilation with FiO2=100%). Exclusion Criteria: Major congenital malformation Congenital diaphragmatic hernia Structural cardiac anomalies Hydrops fetalis Pulmonary hemorrhage Severe perinatal depression Patients on high frequency oscillation ventilator

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

| Intervention/Treatment |
| --- |
|Drug: Inhaled Iloprost|50 micrograms for one hour followed by 100 micrograms for one hour|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxygenation index and PaO2 after treatment with inhaled Iloprost. |  | three hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Iloprost, PPHN, Newborn, Pulmonary Hypertension, Term, Persistent Pulmonary Hypertension of the Newborn
Pulmonary Function Substudy for Subjects Enrolled in Studies MKC-TI-161, MKC-TI-162 or MKC-TI-166

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate pulmonary function test (PFT) sub-study in interested subjects from studies MKC-TI-161, MKC-TI-162 and MKC-TI-166. 100 Type I and 100 Type II diabetics will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent study.

Detailed Description
-----------------
This study is designed to evaluate and compare changes in pulmonary function (FEV1(forced expiratory volume in 1 second) FVC(forced vital capacity), TLC (total lung capacity) and DLco) in subjects enrolled in 1 of 3 parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166). Up to 100 subjects with Type I and Type II diabetes in the TI Inhalation Powder arm, and 100 subjects with Type I and Type II diabetes in the comparator arm will be enrolled. Each subject will undergo 6 PFT assessments over the course of the parent trial.

Official Title
-----------------
A Phase 3b, Multicenter, Clinical Trial to Evaluate Pulmonary Function in a Subset of Subjects With Type 1 or Type 2 Diabetes

Conditions
-----------------
Type 1 Diabetes Mellitus, Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Comparator administered in parent trial
* Drug: Technosphere Insulin Inhalation Powder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment in one of three parent trials (MKC-TI-161, MKC-TI-162 or MKC-TI-166) Exclusion Criteria: Subjects who are unable to perform PFTs that meet American Thoracic Society/European Respiratory Society (ATS/ERS) quality recommendations for acceptability and repeatability will be excluded from this study

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Technosphere Insulin Inhalation Powder<br> | Drug: Technosphere Insulin Inhalation Powder<br>* Pulmonary delivered inhaled insulin formulation containing human insulin and Technosphere Inhalation Powder (administered in parent trial)<br>|
| Comparator<br>Based on parent trial | Drug: Comparator administered in parent trial<br>* Comparator arm may be different for each parent trial, consisting of some sort of usual care for diabetes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of change from baseline to final treatment visit in pulmonary function (FEV1 FVC, TLC and DLco) between treatment Groups (TI vs comparator arms) using ANCOVA models. |  | Baseline values are the average of Visit 1 (Week -7) and Visit 4 (Week 0). |
Radiofrequency of Breast Cancers in Non Surgical Patients

Study Overview
=================
Brief Summary
-----------------
To treat breast tumors in non surgical patients with percutaneous technique (radiofrequency). Prospective evaluation of treatment efficiency and tolerance based on clinical and radiological evaluation

Official Title
-----------------
Radiofrequency of Breast Cancers : Pilot Study in Non Surgical Patients

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

Intervention / Treatment
-----------------
* Procedure: Radiofrequency


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients more than 70 years old Breast tumors with estrogen receptors Non surgical patients Life expectancy more than 6 months Exclusion criteria: Presence of a pace maker Tumors measuring more than 30 mm on ultrasound evaluation, located less than 10 mm from skin, nipple, or pectoral muscle Coagulation disorders Contra indications to magnetic resonance imaging or computed tomography with contrast medium injection Non visible lesions on magnetic resonance imaging or computed tomography with contrast medium injection

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

Sexes Eligible for Study
-----------------
Female

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

| Intervention/Treatment |
| --- |
|Procedure: Radiofrequency|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To know at 6 months the efficacy of radiofrequency based on |  |  | 
| - no local recurrence (detected with magnetic resonance imaging) |  |  | 
| - no palpable mass on clinical examination |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate every 2 months, until 6 months : |  |  | 
| - the late complications of the percutaneous technique |  |  | 
| - the pain felt by the patients, during and after the radiofrequency |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Radiofrequency, Percutaneous technique, breast cancer, tolerance
Prevention of Venous Thromboembolism in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

Study Overview
=================
Brief Summary
-----------------
The study objective is to evaluate the efficacy and safety of oral YM150 for prevention of venous thromboembolism in subjects undergoing hip fracture surgery or surgery in the lower extremities.

Official Title
-----------------
YM150 Phase III Study - An Open-label, Multi-center Study in Subjects Undergoing Hip Fracture Surgery or Surgery in the Lower Extremities

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: YM150


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects undergoing hip fracture surgery or patients undergoing surgery in the lower extremities other than hip fracture surgery Written informed consent obtained before screening Exclusion Criteria: Subject has history of deep vein thrombosis and/or pulmonary embolism Subject has a hemorrhagic disorder and/or coagulation disorder Subject has had clinically important bleeding occurred within 90 days prior to the screening visit Subject has an acute bacterial endocarditis Subject has uncontrolled severe or moderate hypertension, retinopacy, myocardial infarction or stroke Subject is receiving anticoagulants/antiplatelet agents Subject has a body weight less than 40 kg

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: YM150 group<br> | Drug: YM150<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of venous thromboembolism |  | Until day 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of deep vein thrombosis |  | Until day 35 | 
| Incidence of pulmonary embolism |  | Until day 35 | 
| All cause mortality |  | Until day 35 | 
| Incidence of bleeding event |  | Until day 35 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
YM150, Bleeding, Anticoagulant, Venous thromboembolism, FXa inhibitor
A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.

Conditions
-----------------
AMD

Intervention / Treatment
-----------------
* Drug: Anecortave acetate 30 mg
* Drug: Anecortave Acetate 15 mg
* Drug: Anecortave Acetate 3 mg
* Other: Anecortave Acetate Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 50 years and over Other protocol-defined inclusion and exclusion criteria may apply.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anecortave Acetate 30<br> | Drug: Anecortave acetate 30 mg<br>* 0.5ml administered onto the sclera once every six months for 24 months<br>|
| Experimental: Anecortave Acetate 15<br> | Drug: Anecortave Acetate 15 mg<br>* 0.5ml administered onto the sclera once every six months for 24 months<br>|
| Experimental: Anecortave Acetate 3<br> | Drug: Anecortave Acetate 3 mg<br>* 0.5ml administered onto the sclera once every six months for 24 months<br>|
| Placebo Comparator: Anecortave Acetate Vehicle<br> | Other: Anecortave Acetate Vehicle<br>* 0.5ml administered onto the sclera once every six months for 24 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in logMAR visual acuity at 12 months from baseline. |  | 12 months |
Effect of Wide Pulse Pressure on the Predictability of Stroke Volume Variation for Fluid Responsiveness in Patients Undergoing Off-pump Coronary Artery Bypass Graft

Study Overview
=================
Brief Summary
-----------------
The investigators examined the predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure undergoing off-pump coronary artery bypass graft

Conditions
-----------------
Stroke Volume Variation

Intervention / Treatment
-----------------
* Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1. Age ≥ 20 2. elective off-pump coronary artery bypass graft Exclusion Criteria: 1. arrhythmia 2.EF <40% 3.valvular heart dz 4.pul HTN 5.PAOD 6.lung dz 7.NYHA IV 8.ESRD

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

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

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

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

Design Details

Primary Purpose: Screening
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Normal pulse pressure<br>pulse pressure <60mmHg | Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading<br>* HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia<br>|
| Other: Wide pulse pressure<br>pulse pressure ≥60mmHg | Other: HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading<br>* HES 130/0.4 (VoluvenⓇ, Fresenius Kabi, Graz, Austria) 500mL loading during 15 minutes after induction of anesthesia<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The predictability of stroke volume variation for fluid responsiveness in patients with wide pulse pressure |  | 30 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cut off value of stroke volume variation for predicting fluid responsiveness in patients with wide pulse pressure |  | 30 min |
The Tap Block Technique Via the Anterior Approach in Elective Surgery of the Spine

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-centre, randomised, double-blind trial, comparing TAP block with continuous infiltration of ropivacaine versus placebo. Procedure: Once consent has been obtained, patients will be randomised into one of the two groups: Ropivacaine or Placebo. At the end of the operation, the TAP block will be implemented via a catheter inserted by the anaesthetist.

Official Title
-----------------
THE TAP BLOCK TECHNIQUE VIA THE ANTERIOR APPROACH IN ELECTIVE SURGERY OF THE SPINE: Prospective, Randomised, Double Blind Trial, Comparing TAP BLOCK With Continuous Infiltration of Ropivacaine Versus Placebo

Conditions
-----------------
Elective Surgery of the Spine by Laparotomy

Intervention / Treatment
-----------------
* Drug: Ropivacaine 0.2%
* Drug: Chlorure de sodium 0.9%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 yo who have provided written informed consent Patients with an indication for elective spinal surgery using laparotomy Patients with national health insurance cover Exclusion Criteria: Adults under guardianship Pregnant or breast-feeding women allergies or contra-indication for paracetamol, morphine-based drugs Contra-indication for ropivacaine Contra-indication for sodium chloride inability to understand PCA (patient-controlled anaesthesia) Hypersensitivity to ropivacaine or to other aminoamide local anaesthetics Hypovolemia

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br> | Drug: Chlorure de sodium 0.9%<br> <br> |
| Placebo Comparator: control<br> | Drug: Ropivacaine 0.2%<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Consumption of morphine in mg |  | First 48 hours following the surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intensity of pain |  | First 48 hours following the surgery |
Development of the General Scale Observance for Chronic Diseases

Study Overview
=================
Brief Summary
-----------------
The main objective is to assess the measurement characteristics (validity, reproducibility) and the invariance of EGOMAC scale in a population of consultants in diabetology, cardiology and rheumatology hospital and liberal and hospital oncology and Infectious disease, by following the evolution of patient compliance at D0 and D15. The second objective is to assess the sensitivity to change of scale EGOMAC following developments compliance 3 months.

Detailed Description
-----------------
During a routine appointment (D0), the patient filled a newsletter and a questionnaire to complete. The doctor collects medical informations for the case report form. At the end of the first consultation (D0), an additional EGOMAC scale and a stamped envelope is delivered to the patient by asking him to fill that scale to 15 days and return it by Post Office (reproducibility study). Finally, a new scale will be addressed to the patient at the end of 3 months, which will return by Post Office too (stability study).

Official Title
-----------------
Development of the General Scale Observance for Chronic Diseases (EGOMAC)

Conditions
-----------------
Chronic Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient age of 18 years from routine patient counseling with at least one of these diseases : heart failure, hypertension, coronary disease, type 2 diabetes, osteoarthritis of the knee or hip, osteoporosis, inflammatory rheumatism (rheumatoid arthritis, spondyloarthropathy), cancer ( with only non-hormonal oral anti cancer treatments) and HIV. patient can read the French language in order to complete the self -administered questionnaire patient agreeing to participate in the study Exclusion Criteria: patient treated for more than 3 conditions mentioned in the inclusion criteria ( patient receiving no drug prescription or recommendation of lifestyle or diet (for example consultationpurely diagnostic ).

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 |
| --- | --- | --- |
| EGOMAC questionnaire |  | baseline | 
| Change in EGOMAC questionnaire |  | 15 days |