linjc16/ctgov huggingface dataset:
Angioplasty of Left Main - lAriboisiere Registry

Study Overview
=================
Brief Summary
-----------------
In patients with unprotected left main disease (ULMD), angioplasty is emerging as an alternative technique. The investigators aimed to determine the rate of major cardiovascular events in patients treated by angioplasty for ULMD in a real world registry.

Detailed Description
-----------------
Current guidelines recommend coronary artery bypass graft surgery as the gold standard treatment in patients with unprotected left main disease. However, patients with ULMD and high surgical risk score or favourable anatomy are still referred for angioplasty. Recently, several studies and registries comparing surgery and percutaneous intervention with drug eluting stents report similar results regarding cardiovascular death and myocardial infarction in patients with multivessel coronary artery disease including unprotected left main disease. The aim of the study is to evaluate major cardiovascular events in a real world registry.

Official Title
-----------------
Prospective Registry in Patients With Unprotected Left Main Disease Treated by Percutaneous Coronary Intervention: The ALMA (Angioplasty of Left Main - lAriboisiere) Registry

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: stable or unstable angina and/or documented ischemia 50% de novo ULMD referred for angioplasty Exclusion Criteria: acute coronary syndrome with ST elevation, cardiogenic shock or out of hospital cardiac arrest

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 |
| --- | --- |
| Angioplasty of left main<br>Patients with: stable or unstable angina and/or documented ischemia de novo ≥50% stenosis in the left main stem referred for angioplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiovascular events (MACCE) | Major cardiovascular events (MACCE)were measured after 1 year follow-up. MACCE included all-cause of death, stroke, myocardial infarction, and repeat revascularizations. Non-Q-wave myocardial infarction was defined using universal definition with troponin I. Stent thrombosis was defined according to the Academic Research Consortium definition as definite, probable, or possible and as early or late after the index procedure. Repeat revascularization was composed of any repeat percutaneous intervention or surgical bypass. | One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
left main, stent,angioplasty
Screening Questionnaire for Depression

Study Overview
=================
Brief Summary
-----------------
Depression is common in primary care and general medical settings, but is often unrecognized and untreated by physicians working in those settings. The Patient Health Questionnaire for depression (PHQ-9) is well validated and widely used screening instrument.

Official Title
-----------------
Validation of a Hebrew Version of a Brief Screening Questionnaire for Depression in General Medicine

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >18 yrs Primary care and general medical patients Understand the IC Speaks Hebrew No significant cognitive impairment

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?
-----------------
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
-----------------
depression, screening, primary care, validity, Hebrew, Primary care and general medical patients
Safety and Effectiveness of NXY-059 for the Treatment of Patients Who Have Suffered From a Stroke

Study Overview
=================
Brief Summary
-----------------
This study will determine if NXY-059 will reduce functional disability from an acute stroke. The study is designed to look at both overall recovery and recovery of motor function, for example muscle strength and coordination.

Official Title
-----------------
SAINT I (Stroke - Acute Ischemic - NXY Treatment) A Double Blind, Randomized, Placebo Controlled, Parallel Group, Multicenter, Phase IIb/III Study to Assess the Efficacy and Safety of Intravenous NXY-059 in Acute Ischemic Stroke.

Conditions
-----------------
Cerebral Stroke, Ischemic Attack, Transient

Intervention / Treatment
-----------------
* Drug: NXY-059


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females Acute ischemic stroke with limb weakness, onset of symptoms within 6 hours Full functional independence prior to the present stroke Exclusion Criteria: Unconsciousness Subjects who are unlikely to complete the infusion of investigational product and/or are unlikely to undergo active medical management during that period due to a severe clinical condition Severe illness with life expectancy less than 6 months Known severe kidney disorder Current known alcohol or illicit drug abuse or dependence Pregnant or breast-feeding Treatment with acetazolamide and methotrexate is not permitted during the infusion Participation in a previous clinical study within 30 days

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: NXY-059|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global disability on modified Rankin scale at 90 days. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| NIH stroke scale (termed co-primary in study protocol), Barthel Index, Stroke Impact Scale, EQ-5D all at 90 days, Safety outcomes. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke, Acute, Cerebrovascular Stroke
Bed Rest for Threatened Preterm Labor. Pilot Study

Study Overview
=================
Brief Summary
-----------------
The aim of the pilot trial is to assess at what extend women with arrested threatened preterm labor change their activity patterns at home in response to bed rest prescription. An area of concern for the design of a trial is the strength of health provider's recommendation to change women's behaviors, and their compliance with bed rest recommendations. The study was a randomized parallel design. The intervention group consisted of total bed rest for four days (with allowance to go to the toilet). The control group consisted in the restriction of activities during four days.

Official Title
-----------------
Bed Rest for Arrested Threatened Preterm Labor. Pilot Study for the Design of a Randomized Controlled Clinical Trial.

Conditions
-----------------
Bedrest, Premature Labor

Intervention / Treatment
-----------------
* Behavioral: Bed rest
* Behavioral: Activity restriction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Every woman admitted to hospital during the antenatal period because of an episode of TPL. If the attending physician decides that the woman is ready for hospital discharge the woman will be eligible for the study. Exclusion criteria: Multiple pregnancy Premature rupture of membranes Cervical cerclage and whenever the attendant physician considers that the woman is not eligible to be randomized to bed rest or activity restriction.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bed rest<br> | Behavioral: Bed rest<br>* The woman assigned to the bed rest group, will be instructed to keep in bed for the study period of four days and will be allowed to go to the toilet<br>|
| Placebo Comparator: Activity restriction<br> | Behavioral: Activity restriction<br>* Women assigned to activity restriction group will do the restriction of activities during four days.During the activity restriction phase the women will be allowed to ambulate at home, work at home (home office), child care, household tasks, meal preparation or any forceless activities.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The outcome was the amount of activity. In order to measure the outcome, we used: a) an accelerometer which was delivered to the woman at home and b) a diary record that the woman fulfilled during the study. |  | Four days |
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the effect of the timing of treatment completion in two-staged selective laser trabeculoplasty therapy on intraocular pressure lowering effect.

Detailed Description
-----------------
SLT therapy is used as an IOP lowering agent in patients with glaucoma. It is unknown whether the timing of a 2-staged approach to the laser therapy will result in better IOP lowering effect. This study will evaluate the timing (early vs. late completion of SLT therapy) and determined the IOP lowering effect following the interventions. Arm 1: Early Completion SLT 180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees on Day 2 Arm 2: Late Completion SLT 180 degrees of SLT on Day 1, 180 degrees of SLT on the other 180 degrees at the 1 month follow up visit. Primary Outcome: IOP (mmHg).

Official Title
-----------------
Timing of Treatment Completion in Staged Selective Laser Trabeculoplasty (SLT): Early vs. Late Completion

Conditions
-----------------
Glaucoma

Intervention / Treatment
-----------------
* Procedure: selective laser trabeculoplasty - early completion
* Procedure: Selective laser trabeculoplasty - late completion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age primary open angle glaucoma or pseudoexfoliation glaucoma Exclusion Criteria: Unable to give 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SLT Early Completion (Arm 1)<br>Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degree on Day 2 | Procedure: selective laser trabeculoplasty - early completion<br>* 180 degrees of laser on day 1 and other 180 degrees on day 2.<br>|
| Active Comparator: SLT Late Completion (Arm 2)<br>Intervention: 180 degrees of laser on Day 1, 180 degrees of laser on the other 180 degrees at 1 month follow up appointment. | Procedure: Selective laser trabeculoplasty - late completion<br>* 180 degrees of laser on day 1 and other 180 degrees at 1 month follow up point.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure lowering |  | 1 month following procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| intraocular pressure lowering |  | 3, 6, 12 and 24 months following procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, laser, trabeculoplasty
Effect of Liraglutide on Glucagon Secretion in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to examine the effect of NNC 90-1170 on the hypoglycaemic counterregulation in subjects with type 2 diabetes.

Official Title
-----------------
Effect of NNC 90-1170 on Hypoglycaemic Counterregulation During Stepwise Hypoglycaemic Clamp in Type 2 Diabetic Subjects. A Double-blind, Placebo-controlled, Randomised, 2-period Cross-over Trial

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

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


Participation Criteria
=================

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years


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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NNC 90-1170<br> | Drug: liraglutide<br>* Single dose of 7.5 mcg/kg, injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement<br>* Other names: NNC 90-1170;|
| Placebo Comparator: Placebo<br> | Drug: placebo<br>* Single dose injected subcutaneously followed by a hypoglycaemic clamp by concentration measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the Curve (AUC) glucagon |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin secretion |  |  | 
| Glucose |  |  | 
| Cortisol |  |  | 
| Growth hormone |  |  | 
| Adrenaline |  |  | 
| Noradrenaline |  |  | 
| Adverse events |  |  |
How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.

Study Overview
=================
Brief Summary
-----------------
This study evaluated the practice before and after the introduction of a particular model pulsoxymeter giving, in addition, information on the state of fluid responsiveness of the patient.

Detailed Description
-----------------
This study aims to qualify the capability of general anesthesiologist to adopt Pleth Variability Index (PVI) into their practice. It also seeks to establish whether the introduction of the PVI in the clinical practice is associated with a modification of the practice. In this scope, the intent is to see the impact of introduction of PVI monitoring on anesthesiologist practices, and to do this by comparing their survey response both before and after use of PVI in their surgeries, and to see how clinical practices for GDT and outcomes may have changed. To that end, the intent is to conduct this at sites with no current experience in use of PVI parameter, so that one can closely follow the change in clinician practice as PVI is adopted.

Official Title
-----------------
How Are Changing the Practices After the Introduction of the Pleth Variability Index? A Before/After Survey.

Conditions
-----------------
Fluid Management

Intervention / Treatment
-----------------
* Device: PVI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years ASA 1 to 3 Exclusion Criteria: ASA 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Before introduction of PVI<br>Physicians' practices | |
| After introduction of PVI<br>Physicians' practices | Device: PVI<br>* Pleth Variability Index<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Practice concerning fluid management | Amounts and type of fluids administered. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fluid management by center | Amounts and type of fluids administered. | One day | 
| Mortality after the introduction of Pleth Variability Index | mortality is higher in one of the two groups? | 30 days after surgery |
Analysis of Implantation Failure and Establishment of Therapy for Implantation Failure

Study Overview
=================
Brief Summary
-----------------
Impaired endometrial growth (thin endometrial thickness) is a critical factor for implantation failure. In this study, effects of vitamin E on endometrial growth are studied.

Conditions
-----------------
Infertility

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Endometrial thickness < 8 mm Exclusion Criteria: Women with fibroids Women receiving hormone therapy
Sexes Eligible for Study
-----------------
Female

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
-----------------
infertile women, thin endometrial thickness, implantation failure
Evaluation of Outcomes Following LASIK Surgery Using CustomVue

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate visual outcomes, contrast sensitivity, glare and induced high order aberrations induced by the new CustomVue software use for wavefront-guided LASIK.

Official Title
-----------------
Evaluation of Visual Outcomes, Contrast Sensitivity, Glare, and Induction of High Order Aberrations Following LASIK Surgery Using CustomVue

Conditions
-----------------
Myopia, Astigmatism, Myopic Astigmatism

Intervention / Treatment
-----------------
* Device: Wavefront-guided LASIK using CustomVue platform


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopia 0.00 to -6.00 D Astigmatism 0.00 up to -3.00 D Manifest refraction spherical equivalent (MRSE) up to -6.00 D. Exclusion Criteria: History of ocular pathology Previous ocular surgery Large pupils (greater than 8mm diameter, infrared measurement) Thin corneas (preoperatively calculated minimal residual bed < 250 um) Irregular astigmatism Asymmetric astigmatism Unstable refraction Any other condition that precludes the patient from undergoing LASIK

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

| Intervention/Treatment |
| --- |
|Device: Wavefront-guided LASIK using CustomVue platform|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  |  | 
| Induction of high order aberrations |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast sensitivity & glare |  |  | 
| Patient satisfaction |  |  |
Therapy With Topotecan and Carboplatin by Patients With Relapsed Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
Compatibility of the topotecan therapy in combination with carboplatin.

Official Title
-----------------
Multicenter, Prospective Phase-I/II-study: Topotecan and Carboplatin in the Therapy of Patients With Relapsed Ovarian Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Drug: Hycamtin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >= 18 years patient with ovarian cancer after primary therapy bone marrow function leukocytes >= 4,0 x 109/ l, platelets >= 100 109/l, hemoglobin >= 9 g/dl renal function creatinin <= 1,5 mg% or creatinin clearance >= 60 ml/min liver function bilirubin <= 2,0 mg/dl, SGOT, SGPT and AP within 3 fold of the reference laboratory's normal range ECOG <= 2 Intention of regular follow-up visits for the duration of the study written informed consent Exclusion Criteria: any known hypersensitivity against topotecan isomerase-I-inhibitor other medication included in the study protocol ECOG > 2 patients with radiotherapy within the last 4 weeks

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

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

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: Hycamtin<br> | Drug: Hycamtin<br>* Topotecan: 1,0 mg/m²/d, day 1-3; q21d Carboplatin: AUC 5 on day 3 after Topotecan, q21d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity | hematological adverse events and non-hematological adverse events grade 3/4 | after each cycle for up to one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free Survival | progression-free survival according to kaplan-meier-estimator | after every third cycle, for up to one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
platin-resistant