linjc16/ctgov huggingface dataset:
Retinal Nerve Fibres Layers Thickness Study in Glaucomatous Patients

Study Overview
=================
Brief Summary
-----------------
In this study the investigators are going to study the retinal nerve fibers layers (RNFL) modification of two groups of patients, one taking no drugs, the other taking forskolin, rutin and vitamins B1 and B2.

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

Intervention / Treatment
-----------------
* Drug: forskolin, rutin and vitamins B1 and B2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age (30-80 years); Baseline Intraocular pressure (IOP) (20-32 mmHg): average untreated Intra Ocular Pressure (IOP) for both eyes as determined from 2 to 4 visits within a 6-months period; Central Corneal Thickness (CCT) (475-650 µm): average of 3 different measurements from both eyes during the same visit; Pattern standard deviation (PSD) (0,50-3,00 dB) average of both eyes as stated on the most recent visual field index report Vertical Cup/Disk ratio (0,00-0,80): average of both eyes All these data were entered into a calculator specially designed for STAR (Scoring Tool for assessing risk) II parameter. The patients were divided into low-, moderate- and high risk groups according to the result given by the calculator. Exclusion Criteria: -other ocular pathologies than glaucoma

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: forskolin, rutin and vitamins B1 and B2|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| retinal nerve fibres layer thickness |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| global risk threshold for glaucoma progression |  |  |
Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa Mental

Study Overview
=================
Brief Summary
-----------------
Body Image distortion is a key diagnostic feature for Anorexia Nervosa. Patients suffering from Anorexia Nervosa tend to perceive themselves as fatter than they are. This bias might be at the origin of a reinforcement of anorectic behavior which might alter medical care. The objective of this study is to identify neural correlates of self-recognition in Anorexia Nervosa. Patients are hypothesized to activate the self-recognition network when seeing images of a fatter body shape than their own.

Detailed Description
-----------------
Patients suffering from Anorexia Nervosa and control subjects (matched by age and study level) are recruited in medical care facilities in Lille's Metropolis. They are asked to identify their body shape when being presented with 3 different stimuli, i.e.real (RBS), estimated (EBS) and neutral body shape (NBS), in a functional magnetic resonance imaging or functional MRI (fMRI) machine. While answering to this identification paradigm, we hoped to identify modifications in the self body-recognition network.

Official Title
-----------------
Neural Correlates of Self Body-shape Recognition in Anorexia Nervosa, an fMRI Activation Study

Conditions
-----------------
Anorexia Nervosa

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Providing informed, dated and signed consent (for minors, consent must be signed by both parents) With medical insurance With normal vision Only for the AN Group : Diagnosis of Anorexia Nervosa (AN) restrictive for at least one year and with a Body Masse index (BMI) between 14 and 18 Only for the control Group : BMI between 18 and 25 and without any psychiatric disorder Exclusion Criteria: Pregnant or breast-feeding women With antecedent or current neurologic disease With antecedent or current ophthalmologic disease Contraindication for IRMf

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 45 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients suffering from Anorexia Nervosa<br>Subjects with a diagnostic of anorexia nervosa disorder | |
| Control group<br>Healthy subjects with no psychiatric disorder | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of the activation brain areas in self body-recognition network | Level of activation areas in the self body-recognition network measured during fMRI | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anorexia nervosa, functional MRI (fMRI), self body-shape recognition
Cross -Over Study to Prove Bioequivalence Between Two Oral Formulations of Levonorgestrel

Study Overview
=================
Brief Summary
-----------------
A single dose, two treatments (Postday and Opxion), two periods, two sequences, crossover, randomized, prospective design was chosen with a washout of 21 days between the two study periods. Treatment groups were balanced with the same number of male healthy volunteers who were randomly assigned to the study drug administration sequences.

Official Title
-----------------
Open-label, Randomized, Crossover Study to Prove Bioequivalence Between Opxion® (Levonorgestrel 0.75 mg From Bayer de Mexico) and Postday® (Levonorgestrel 0.75 mg From Investigacion Farmaceutica), in Healthy Volunteers

Conditions
-----------------
Contraception, Contraception, Postcoital

Intervention / Treatment
-----------------
* Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)
* Drug: Levonorgestrel (Postday)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male volunteers age between 18 and 55 years old with normal vital signs, electrocardiogram (ECG), blood chemistry, liver function profile and urinalysis Exclusion Criteria: History of illnesses or any organic abnormalities that could affect the results of the study. History of abuse tobacco or alcohol or regular use of recreational or therapeutic drugs. Subjects that have taken any medication within 14 days or that are in an elimination period of less than 7 half-lives (whichever is longest) before study startup.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br> | Drug: Levonorgestrel Emergency Pill (BAY86-5028/Opxion)<br>* Single dose of one 0.75 mg coated tablet<br>|
| Active Comparator: Arm 2<br> | Drug: Levonorgestrel (Postday)<br>* Single dose of one 0.75 mg tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Least square estimator of average maximum plasmatic concentration (log transformed) |  | After 2 months | 
| Least square estimator of area under the pharmacokinetic curve (log transformed) |  | After 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time at which maximum concentration is reached |  | After 2 months | 
| Area under the pharmacokinetic curve from time=0 to last blood sample |  | After 2 months | 
| Half life of plasmatic concentration of study drug |  | After 2 months | 
| Clearance constant of plasmatic concentration of study drug |  | After 2 months | 
| Adverse event collection |  | Up to 8 weeks |
Excimer Laser Trabeculostomy Glaucoma Treatment Study

Study Overview
=================
Brief Summary
-----------------
Evaluation of the safety and effectiveness of the ELIOS System procedure to reduce intraocular pressure (IOP) in adult subjects with mild to moderate primary open-angle glaucoma (POAG) undergoing cataract surgery

Official Title
-----------------
A Prospective, Multicenter Clinical Trial Designed to Evaluate the Safety and Effectiveness of the ELIOS System to Reduce Intraocular Pressure in Patients With Primary Open-Angle Glaucoma Undergoing Cataract Surgery

Conditions
-----------------
Glaucoma, Primary Open Angle

Intervention / Treatment
-----------------
* Device: ELIOS Procedure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of mild to moderate POAG Operable cataract, eligible for phacoemulsification with a BCVA of 20/40 or worse Medicated IOP of <=24 mmHg Unmedicated diurnal IOP of >=22 mmHg and <=34 mmHg Shaffer angle grade of III or IV CD ratio <=0.8 At least 45 years old Exclusion Criteria: Closed-angle and secondary glaucomas Prior incisional glaucoma surgery, intraocular surgery, or corneal surgery Cannot undergo medication washout in the study eye Diagnosis of degenerative visual disorders Non-study eye with BCVA worse than 20/80 Known corticosteroid responder Pregnant or nursing women; or women of childbearing potential not using medically acceptable birth control

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: ELIOS Procedure<br>ELIOS Procedure | Device: ELIOS Procedure<br>* Treatment with the ELIOS System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% | Proportion of subjects who achieve a decrease in medication-free mean diurnal IOP (DIOP) from baseline of at least 20% | 24 Month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in medication-free DIOP from baseline | Mean change in medication-free DIOP from baseline | 24 Month |
Comparison of POC-test-equipment With the Laboratory

Study Overview
=================
Brief Summary
-----------------
We compare two POC-tests (INRario2 and CoaguChek) for the INR with the laboratory. Therefore, we take bloodsamples (capillary and venous blood) and put it on the tool. After the measuring, a number is shown = INR. We develop a Bland-Altman-plot for the correlation between the tool value and the laboratory value to illustrate the applicability in the clinical daily routine.

Detailed Description
-----------------
Including criteria: ICU-patients from 18-99 years

Official Title
-----------------
Comparison of POC-test-equipment With the Standard Method (Laboratory) at ICU-patients

Conditions
-----------------
INR-POC-testing

Intervention / Treatment
-----------------
* Device: INRatio2 and CoaguChek


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-99 years, ICU patients Exclusion Criteria: Lupus erythematodes Anti-Phospholipid-Antikörper

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: INRatio2 and CoaguChek<br>one measuring per tool, in case of error: one repetiton | Device: INRatio2 and CoaguChek<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of POC-test-equipment with the standard method (laboratory) at ICU-patients | outcome measure: Bland Altman plot | 12 months |
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Study Overview
=================
Brief Summary
-----------------
Efficacy and Safety of Bromfenac Ophthalmic Solution in Cataract Surgery

Conditions
-----------------
Cataract

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for cataract surgery Exclusion Criteria: Known hypersensitivity to bromfenac and salicylates

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bromfenac<br>Bromfenac ophthalmic solution 0.09%, dosed 1 drop daily | Drug: Bromfenac<br>* sterile ophthalmic solution<br>|
| Placebo Comparator: Placebo<br>Placebo, dosed 1 drop daily | Drug: Placebo<br>* sterile ophthalmic solution<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Summed Ocular Inflammation Score (SOIS) of Zero | Participants with SOIS of 0. Scale: 0=0 cells (complete absence); 0.5=1-5 cells; 1=6-15 cells (very slight); 2=16-25 cells (moderate); 3=26-50 cells (marked); 4=>50 cells (intense) | Day 15 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants That Are Pain Free | Participant description of being pain free (Score of none)taken from patient questionnaire, Ocular Comfort Grading Assessment with multiple possible responses | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract extraction, intraocular lens implantation
Traction Assisted Polypectomy of the Intestine

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to verify if the ablation of lesions (polyps, adenomas) in the large (and small) intestine can be facilitated by using a traction on the lesions.

Detailed Description
-----------------
We want to facilitate the ablation of lesions (polyps, adenomas) in the large (and small) intestine by using a traction assisted technique. The traction will be performed by using a haemoclip connected to surgical suture materials. The haemoclip will be fixed to the intestinal mucosa next to the lesion and a loop will be mounted to perform an endoscopic mucosal resection. The aim of the study is to show the feasibility of this technique.

Official Title
-----------------
Traction Assisted Endoscopic Mucosa Resection (TAEMR)

Conditions
-----------------
Colonic Polyps, Adenomatous Polyps

Intervention / Treatment
-----------------
* Device: traction assisted endoscopic mucosa resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: benign lesions in the large and small intestine diameter of lesion smaller than 3cm Exclusion Criteria: malign lesions of the large and small intestine diameter of lesions larger than 3cm

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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: mucosa resection<br> | Device: traction assisted endoscopic mucosa resection<br>* A haemoclip is connected to suture material and will be fixed (next) to a polyp to allow traction and lifting the lesion in order to facilitate its resection with a loop.<br>* Other names: endoscopic polypectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ablation of lesion in toto |  | 1 week after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications after resection |  | within one week after intervention |
A Study to Analyze the Occurrence of Transformation From Myelodysplastic Syndrome to Acute Myeloid Leukemia in Patients With Myelodysplastic Syndrome Who Received Revlimid® 5 mg Capsules and Who Are Continuing or no Longer Continuing Revlimid Treatment

Study Overview
=================
Brief Summary
-----------------
To analyze the occurrence of transformation from myelodysplastic syndrome (MDS) to acute myeloid leukemia (hereinafter referred to as transformation from MDS to AML) in patients with myelodysplastic syndrome with a deletion 5q cytogenetic abnormality (hereinafter referred to as del(5q)MDS) who received Revlimid® 5 mg Capsules (hereinafter referred to as Revlimid) and who are continuing or no longer continuing Revlimid treatment. Planned registration period This period started on the date of initial marketing of Revlimid and will end on the day when the appropriateness of enrollment is assessed for all del(5qMDS) patients in the all-case surveillance. Planned surveillance period This period started on the date of initial marketing of Revlimid and will end 3 years after the last enrolled patient begins receiving Revlimid.

Official Title
-----------------
Revlimid 5 mg Capsules Special Use-results Surveillance of Transformation to Acute Myeloid Leukemia

Conditions
-----------------
Myelodysplastic Syndromes, Leukemia, Myeloid, Acute

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All del(5q)MDS patients in the all-case surveillance in whom transformation to acute myeloid leukemia (hereinafter referred to as AML) has not been documented at the end of the observation period of the all-case surveillance. Exclusion Criteria: N/A

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 |
| --- | --- |
| Patients with myeloid leukemia<br>All del(5q) Myelodysplastic syndrome (MDS) patients in the all-case surveillance in whom transformation to acute myeloid leukemia has not been documented at the end of the observation period of the all-case surveillance. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events (AEs) | Number of participants with adverse events | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Leukemia, Acute Myeloid Leukemia, Revlimid
Role of Calcium Channels in Vascular Function

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the role of T-type calcium channels in endothelial dysfunction observed with ageing.

Official Title
-----------------
Role of T-type Calcium Channels in Vascular Function

Conditions
-----------------
Endothelium, Vascular

Intervention / Treatment
-----------------
* Drug: Efonidipine
* Drug: Nifedipine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 20 - 30 and 60-70 BMI < 30 Exclusion Criteria: Hypertension (>150/90 mmHg) Smoking Physical activity >2 hours/week Known chronic diseases Pregnancy or birth within 3 month Alcohol misuse

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 Years

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: L + T-type<br>8 weeks treatment with efonidipine (1 week 1x20mg, 7 weeks 2x20mg) | Drug: Efonidipine<br>* 8 weeks treatment with either efonidipine<br>* Other names: Landel (efonidipine);|
| Active Comparator: L-Type<br>8 weeks treatment with nifedipine (1 week 1x20mg, 7 weeks 2x20mg) | Drug: Nifedipine<br>* 8 weeks treatment with either nifedipine<br>* Other names: Adalat (nifedipine);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular function | Hemodynamic response to femoral arterially infused vasoactive substances | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Receptors, Calcium Channel Blocker