linjc16/ctgov huggingface dataset:
Correlation Between Pupil Size and Ocular Signs of Pseudoexfoliation Syndrome

Study Overview
=================
Brief Summary
-----------------
To study possible correlation between the size of the pupil in both room light and after dilation between both eyes in bilateral pseudoexfoliation with Intraocular pressure, lens clarity and stability, Optic disc , Visual changes and glaucoma changes by optical coherence tomography

Detailed Description
-----------------
For each patient. Full preoperative ophthalmological assessment will be done using slit lamp , size of the pupil in regular room light (usually around 2000 Lux) and post dilation with tropicamide 1%. baseline IOP measurement using Goldmann applanation tonometer, UCDVA (Uncorrected Distance Visual Acuity)and CDVA (Corrected Distance visual acuity), lens opacification or clarity, stability or subluxation. corneal endothelial cell count. Fundus examination using 90 D or 78D lenses, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)

Official Title
-----------------
Correlation Between Pupil Size and Ocular Signs in Pseudoexfoliation Syndrome (PEX): a Contralateral Eye Study.

Conditions
-----------------
Pseudoexfoliation Syndrome, Pseudoexfoliation Glaucoma in Both Eyes, Pseudoexfoliation of Lens; Glaucoma

Intervention / Treatment
-----------------
* Diagnostic Test: , Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with pseudoexfoliation syndrome Exclusion Criteria: previous ocular surgery or ocular trauma affecting pupil. Any systemic or neurologic disease affecting pupil

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: , Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)|, Humphrey visual field (24-2) analysis and optical coherence tomography on retinal nerve fiber layer (RNFL) and ganglion cell complex.(GCC)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlation between pupil size and severity of Pseudoexfoliation | in each eye of the same patient we study correlation between pupil size with ntraocular pressure, lens status, corneal endothelial count and glaucomatous damage represented by (optic disc changes (cup to disc ratio) and OCT changes (RNFL and GCC) | 2-3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract, glaucoma
CNS Correlates of Extended Sleep Restriction

Study Overview
=================
Brief Summary
-----------------
Chronic sleep restriction is ubiquitous in both the general population and the military. The deleterious effects of sleep loss on human alertness and cognitive performance have been documented in numerous studies dating back to the nineteenth century. Over the past decade, evidence has emerged indicating that chronic sleep restriction may also precipitate deleterious, long lasting neuropathological changes in the brain. The purpose of this study is to determine neuropathological effects of sleep restriction and identify physiological mechanisms that correlate with sleep loss-induced performance impairment.

Official Title
-----------------
CNS Correlates of Extended Sleep Restriction

Conditions
-----------------
Sleep Restriction

Intervention / Treatment
-----------------
* Drug: [11C]ER176


Participation Criteria
=================
Eligibility Criteria
-----------------
Ages 18 to 39 (inclusive) Weigh at least 140 lbs A body mass index (BMI) below 30. Females must not be pregnant or nursing, and must be on some form of birth control, if sexually active (e.g., oral contraceptive, condom, intrauterine device, etc.) No history of sleeping problems such as insomnia or sleep apnea. Test negative for alcohol, nicotine, illegal drugs, and not take certain medications. Must not excessively consume alcohol or caffeine. Active duty and Federal employees must be on leave during participation. No history of heart disease (high blood pressure), neurologic disorder (such as seizures of epilepsy), liver disease, kidney disease, or metabolic disorder or diabetes. No history of underlying acute or chronic pulmonary disease requiring daily inhaler use.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: [11C]ER176|Brain PET with [11C]ER176. [11C]ER176 is a PET ligand that images TSPO.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positron Emission Tomography (PET) based measurement of neuroinflammation | Positron Emission Tomography (PET) is the brain imaging method and [11C]ER176 is the PET radioligand providing an index of neuroinflammation | 3 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Psychomotor Vigilance Task (PVT) | Measure of cognitive performance | 55 Days | 
| Actigraphy | Activity monitoring used to infer sleep-wake patterns | 55 Days | 
| Polysomnographic measurements of sleep and wakefulness | Measure of various aspects of sleep and wakefulness | 19 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sleep Restriction, Alertness, Performance, Neuroinflammation, Biomarker
ShearWave™ Elastography of Breast Lesions in Chinese Patients

Study Overview
=================
Brief Summary
-----------------
We aim to determine if adding ShearWave Elastography to a standard ultrasound breast exam can improve the characterization (classification) of breast lesions.

Detailed Description
-----------------
Chinese women are known to have denser breasts than women in Western countries. Mammography cannot find abnormalities easily in denser breasts, while breast ultrasound is not affected by density. Adding elastography, a stiffness measurement, to a breast ultrasound exam should improve the diagnosis of a lesion.

Official Title
-----------------
Assessment of ShearWave™ Elastography in the Ultrasonic Diagnosis of Breast Cancer in Chinese Patients

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female 18 years of age or older known breast lesion that has not been managed or treated referred for a breast ultrasound because of a breast mass found on at least one of the following examinations: physical palpation mammography ultrasound exam MRI Exclusion Criteria: Women who are unwilling or unable to provide informed consent Women with breast implants Women who are pregnant or breastfeeding Women in whom all lesions are diagnostically categorized as BI-RADS 0, 1 or 6 Women with previous ipsilateral breast surgery Women with no visible breast mass on ultrasound examination Women with axillary metastatic lymph nodes only Women with foreign body in the breast Women who are not Chinese nationality

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

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

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 |
| --- | --- | --- |
| Increase in specificity of breast ultrasound imaging when considering stiffness measurements |  | Within 18 months of the study start date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of sensitivity and negative predictive value of breast ultrasound imaging when considering stiffness measurements |  | Within 18 months of the study start date | 
| Increase in positive predictive value for biopsy of breast ultrasound when considering stiffness measurements |  | within 18 months of the study start date | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BI-RADS, ultrasound, women, malignancy, breast lesion
Correlation of PET-CT Studies With Serum Protein Analysis

Study Overview
=================
Brief Summary
-----------------
To correlate serum proteomics patterns with PET/CT findings to improve cancer diagnosis, staging, prognosis, and therapy monitoring.

Official Title
-----------------
Correlation of PET-CT Studies With Serum Protein Analysis

Conditions
-----------------
Carcinomas (Including Squamous Cell and Adenocarcinoma)

Intervention / Treatment
-----------------
* Procedure: PET/CT Scan
* Procedure: phlebotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:1. Patients must have a PET/CT study performed at the time of blood collection. 2. Patients must understand and voluntarily sign an Informed Consent form after the contents have been fully explained to them. Exclusion Criteria:1. Patients who are not eligible for a PET/CT study.

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 |
| --- |
|Procedure: PET/CT Scan|nan|
|Procedure: phlebotomy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Clinical Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Heparin in Patients Who Are on Haemodialysis

Study Overview
=================
Brief Summary
-----------------
The study will look at the safety profile (unwanted effects) of the long-lasting anticoagulant PEG-hirudin (SPP200) and compare these unwanted effects to those of unfractionated heparin, commonly used in haemodialysis to avoid clotting of the graft and of the haemodialysis machine.

Official Title
-----------------
A Randomised, Multicenter, Open-Label, Parallel Group Study to Assess the Safety of PEG-Hirudin (SPP200) Compared to Unfractionated Heparin as Anticoagulant Treatment in Patients Undergoing Haemodialysis Via an Arteriovenous Graft

Conditions
-----------------
Chronic Kidney Failure, Vascular Graft Occlusion

Intervention / Treatment
-----------------
* Drug: PEG-hirudin


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients undergoing chronic haemodialysis via an arteriovenous graft Arteriovenous graft in place for at least 3 months Duration of haemodialysis of at least 3 months, with 3 full dialysis sessions per week with a duration between 2 and 5 hours per session Women patients must be either postmenopausal for more than 1 year or, if of childbearing age, must use adequate contraception Women patients must have a negative serum pregnancy test within one week of randomisation Able to provide written informed consent prior to study participation

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PEG-hirudin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the safety and tolerability of SPP200 in patients undergoing chronic haemodialysis via an arteriovenous graft. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of PEG-hirudin compared to unfractionated heparin (UFH) on the frequency of vascular graft occlusions and on time to first graft occlusions. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Haemodialysis, PEG-Hirudin, Vascular graft occlusion, Renal replacement therapy, Hemodialysis
WelChol® and Insulin in Treating Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to see how safe and effective and tolerable the use of WelChol® is for type 2 diabetes when added to insulin alone or in combination with other anti-diabetic drugs

Official Title
-----------------
A Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel-group Study of the Efficacy and Safety of WelChol® in Type 2 Diabetes With Inadequate Glycemic Control on Insulin Therapy Alone or Insulin Therapy Combination With Other Oral Anti-diabetic Agents

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Drug: Colesevelam hydrochloride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 18 - 75 years, inclusive Diagnosed with type 2 diabetes Stable insulin therapy for 6 weeks Stable dose of any other antidiabetic medications for 90 days Hemoglobin A1c value between 7.5% to 9.5% C peptide greater than 0.5 ng/mL Prescribed ADA diet Exclusion Criteria: History of type 1 diabetes or ketoacidosis History of pancreatitis Uncontrolled hypertension Allergy or toxic response to colesevelam or any of its components Serum LDL-C less than 60 mg/dL Serum TG greater than 500 mg/dL Body mass index (BMI) greater than 45 kg/m2-

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

| Intervention/Treatment |
| --- |
|Drug: Colesevelam hydrochloride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - To assess the additional lowering of HbA1c achieved by |  |  | 
| addition of WelChol® to current antidiabetic therapy |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess: the effects on fasting plasma glucose and |  |  | 
| fructosamine; glycemic control response rate; effect on adiponectin; the effect on c-peptide; effect on c-reactive protein; effects on lipids and lipoproteins; the safety and tolerability of WelChol® as add- |  |  | 
| on therapy to patients receiving insulin alone or with |  |  | 
| other oral drugs |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus
Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of ONO-1101 in patients scheduled for multi-slice CT, in a double-blind, randomized, placebo-controlled, parallel group, multi-center study.

Official Title
-----------------
Study of ONO-1101 in Patients Scheduled for Multi-Slice Computed Tomography (CT), a Double-Blind, Randomized, Placebo-Controlled, Parallel Group, Multi-Center Study

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

Intervention / Treatment
-----------------
* Drug: ONO-1101
* Drug: ONO-1101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ≥ 20 years old Heart rate ≥ 70beats/min and ≤ 90beats/min at entering the CT room and just before dosing organic nitrates. Exclusion Criteria: Previous allergic reactions to contrast agent Renal failure Asthma

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: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: P<br> | Drug: ONO-1101<br>* Placebo for one minute IV<br>|
| Experimental: E<br> | Drug: ONO-1101<br>* 0.125 mg/kg for one minute IV<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Image quality |  | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  | 5 days maximum |
12-week Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the efficacy and safety of ropinirole CR-RLS in the treatment of patients with Restless Legs Syndrome and associated sleep disturbance and period limb movements during sleep.

Official Title
-----------------
A 12-Week, Multi-Center, Double-Blind, Placebo-Controlled, Parallel Group, Flexible Dose Polysomnography Study of Ropinirole Controlled Release for Restless Legs Syndrome (RLS) in RLS Patients With Sleep Disturbance and Periodic Limb Movements (PLM) During Sleep

Conditions
-----------------
Restless Legs Syndrome (RLS), Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: ropinirole CR-RLS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: provided written informed consent. Diagnosed with primary RLS using the International RLS Study Group Diagnostic Criteria with a total score of 20 or greater on the International RLS (IRLS) Rating Scale and significant sleep disturbance indicated on Item 4 of the IRLS rating scale. Have evening and nighttime symptoms of RLS, significant sleep impairment due to RLS symptoms, and symptoms requiring treatment prior to bedtime, but no earlier than 5:00PM. Sleep efficiency <85% OR Latency to persistent sleep >20 minutes. Exclusion criteria: Secondary RLS Primary sleep disorder Have any medical conditions that may impact efficacy assessments or that may present a safety concern. Pregnant or lactating or women of child-bearing potential who are not practicing an acceptable method of birth control. Use of any prohibited medication.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 79 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: ropinirole CR-RLS|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the Periodic Limb Movements in Sleep associated with Arousal/hour of sleep (PLMAI) at Week 12 Change from baseline in sleep Latency at Week 12. |  | 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess safety, tolerability, polysomnography efficacy measures, and patient reported outcomes. |  | 12 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RLS, Restless Legs Syndrome, ropinirole, polysomnography, PSG
A Study Of Rosiglitazone Plus Insulin To Treat Type 2 Diabetes Mellitus Patients

Study Overview
=================
Brief Summary
-----------------
This study is designed to demonstrate that addition of rosiglitazone (4mg) to insulin in Type 2 diabetes mellitus subjects who have not achieved glycemic goals on insulin injections alone is efficacious in terms of improving glycemic control.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Control, Clinical Evaluation of Insulin Plus Rosiglitazone Compared to Insulin Plus Placebo for 24 Weeks in Subjects With Type 2 Diabetes Mellitus Who Are Inadequately Controlled On Insulin

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

Intervention / Treatment
-----------------
* Drug: Rosiglitazone 4 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Patients with type 2 Diabetes mellitus on a minimum dose of 30 units/day insulin monotherapy continuously for at least 8 weeks If Patients are taking another oral antidiabetic agent may stop their oral agent and adjust their insulin dose properly over 8 weeks prior to screening if they are asked by doctor who considers him/her suitable for study in all other respects, and the HbA1c level>7.5%. Exclusion: Fasting plasma glucose >13 mmol/L at screening Ongoing edema or history of peripheral edema requiring pharmacological treatment within 12 months Drug abuse Women pregnant or lactating Use any rosiglitazone like drug in 3 months Use more than one oral antidiabetic agent in 2 months Uncontrolled hypertension Chronic heart failure Anemia

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Rosiglitazone<br>4mg | Drug: Rosiglitazone 4 mg<br> <br> * Other names: Insulin;|
| Placebo Comparator: Rosiglitazone placebo<br>4mg | Drug: Rosiglitazone 4 mg<br> <br> * Other names: Insulin;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control at treatment 24-week measured by HbA1c (Glycosylated hemoglobin) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycemic control at treatment 24-week measured by fasting plasma glucose and daily insulin dose, proportion of subjects who reduce total daily insulin dose after treatment of 8, 16, and 24 weeks |  | 8, 16, and 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Insulin, BRL49653 /rosiglitazone, Type 2 Diabetes Mellitus