linjc16/ctgov huggingface dataset:
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if low-dose imatinib and nilotinib combination, will improve treatment results in CML patients with failure, suboptimal response or intolerance to imatinib therapy. The hypothesis is that with low-dose imatinib and nilotinib combination, major molecular response will be achieved in patients not previously obtained with imatinib monotherapy.

Official Title
-----------------
Low-dose Nilotinib and Imatinib Combination in Chronic Myeloid Leukemia Patients, With Failure, Suboptimal Response or Treatment Intolerance.

Conditions
-----------------
Leukemia, Myeloid, Chronic, BCR-ABL Positive

Intervention / Treatment
-----------------
* Drug: Imatinib and Nilotinib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: CML patients with failure or suboptimal response to imatinib therapy according to criteria established by the European Leukemia Net (ELN) Patients with grade II or higher adverse events. CML patients not suitable for stem cell transplantation. Exclusion Criteria: Patients in blast crisis. Pregnant women Patients without a contraception method.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Imatinib and nilotinib combination<br>All patients will receive treatment as follows: imatinib 100 mg tablets, 200 mg daily for 6 months; and nilotinib 150 mg capsule, 300 mg daily for 6 months. | Drug: Imatinib and Nilotinib<br> <br> * Other names: Tasigna;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major molecular response | Major molecular response will be evaluated with quantitative Real time polymerase chain reaction assay (RT-PCR)for BCR/ABL at 6 months. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Drugs adverese effects | Patients will be evaluated every four weeks to identify possible adverse effects of drugs administered. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic myeloid leukemia, suboptimal response, imatinib, nilotinib
Diabetic Retinopathy and Sickle Trait

Study Overview
=================
Brief Summary
-----------------
To more clearly ascertain the relationship between ocular manifestations of sickle cell disease and diabetes, specifically; whether the presence of sickle cell trait exacerbates the disease progression of diabetic retinopathy.

Detailed Description
-----------------
The objective of this research study is to evaluate the relationship between sickle cell trait and the progression of diabetic retinopathy. People with diabetes have high blood sugar that damages small blood vessels. Damage to the blood vessels that supply the retina in the back of the eye is called diabetic retinopathy. Diabetic retinopathy is worse in African-Americans with diabetes, with earlier and more severe disease progression and common complications including vitreous hemorrhage - where these blood vessels in the eye leak - and retinal detachment - the separation of the nerves of the retina from the back of the eye which may lead to blindness. One explanation for this increased severity of diabetes in African-Americans is the presence of sickle cell disease, or even just sickle trait, which causes damage to red blood cells and blood vessels under conditions of stress; like low oxygen levels, or hyperglycemic acidosis.

Official Title
-----------------
Diabetic Retinopathy and Sickle Cell Trait

Conditions
-----------------
Diabetic Retinopathy, Sickle Cell Trait

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Self-identified African-American patients with diabetes will be identified from Dr Bowie's retina clinic at Storm Eye Institute. These subjects are either being screened or treated for the progression of diabetic retinopathy. Exclusion Criteria: None
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 |
| --- | --- | --- |
| We aim to screen African-American diabetic patients with retinopathy to ascertain whether sickle trait is present, and if so whether there is increased severity of diabetic retinopathy in the group with sickle trait. |  | One Year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetic Retinopathy, Sickle Cell Trait, Vision Loss, Eye disease
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to determine whether common CYP1A2 gene polymorphisms effect metabolism of theophylline in Han and Uygur Patients with chronic obstructive pulmonary disease patients.

Official Title
-----------------
Association Study Between CYP1A2 Gene Polymorphisms and Metabolism of Theophylline in Han and Uygur Patients With COPD

Conditions
-----------------
Chronic Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Drug: Theophylline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 18-75 years,Weight 40-80kg COPD patients, male or female; regularly visiting our hospital; taking a sustained-release preparation of theophylline continuously for at least 2 weeks Exclusion Criteria: Patients with renal or hepatic dysfunction; Patients with congestive heart failure; Patients with hypothyroidism or hyperthyroidism; Patients currently taking drugs likely to effect theophylline metabolism or who had taken such drugs in the preceding week; Patients with extreme obesity Patients with very severe Chronic Obstructive Pulmonary Disease(COPD)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: theophylline<br> | Drug: Theophylline<br>* After oral theophylline 200mg per day for one week, blood sample will be collected for determining plasma concentrations of theophylline and it's metabolites and the genotypes of CYP1A2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of theophylline | Blood samples will be taken after receiving oral theophylline | one week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, CYP1A2, Theophylline
Does a Safety Guidewire Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.

Detailed Description
-----------------
Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter. Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction. The forces needed to move the ureteroscope in the ureter have not been investigated properly. The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.

Official Title
-----------------
Does a Safety Guidewire Adjacent to the Ureteroscope Increase the Forces Needed to Move the Ureteroscope up and Down the Ureter?

Conditions
-----------------
Ureteroscopy

Intervention / Treatment
-----------------
* Procedure: Ureteroscopy with and without safety guidewire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients planned for endoscopic kidney stone treatment Exclusion Criteria: Known pathology in the ureter

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A - with SGW<br>Measurement of the forces needed to passage the ureteroscope in the ureter with a SGW in place. | Procedure: Ureteroscopy with and without safety guidewire<br>* In study arm A - with SGW, the force measurements are made with a safety guidewire in place. In study arm B - without SGW, the force measurements are made without SGW.<br>|
| Experimental: B - without SGW<br>Measurement of the forces needed to passage the ureteroscope in the ureter without a SGW in place. | Procedure: Ureteroscopy with and without safety guidewire<br>* In study arm A - with SGW, the force measurements are made with a safety guidewire in place. In study arm B - without SGW, the force measurements are made without SGW.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The force needed to passage the ureteroscope up and down in the ureter with and without SGW. | The force is measured by a digital force-meter device. The force measured is scaled in Newton. The results are available immediately after each measurement. | 1 day |
A Phase I, Multiple Dose Study of PF-04447943 in Healthy Elderly Volunteers

Study Overview
=================
Brief Summary
-----------------
To describe the safety, tolerability and pharmacokinetics of PF-04447943 after administration of multiple, ascending, oral doses to healthy elderly subjects.

Detailed Description
-----------------
Additional Study Purpose Details: Phase I safety and pharmacokinetics study. Detailed Description: The study was terminated on 11/12/2008. There were no safety findings in this trial that resulted in the decision to terminate the trial. The study was closed in order to change the amount of drug that subjects would take and to shorten the number of days that the drug would be taken in a new study.

Official Title
-----------------
An Investigator And Subject-Blind, Phase 1 Study To Characterize The Safety, Tolerability, Pharmacokinetics, And Pharmacodynamics Of Multiple Doses Of PF-04447943 In Healthy Elderly Subjects

Conditions
-----------------
Healthy, Elderly

Intervention / Treatment
-----------------
* Drug: PF-04447943
* Drug: PF-04447943
* Drug: PF-04447943
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Elderly 65-85 Exclusion Criteria: Evidence or history of clinically significant unstable disease

Ages Eligible for Study
-----------------
Minimum Age: 65 Years
Maximum Age: 85 Years

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

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

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: PF-04447943 05 mg dose<br> | Drug: PF-04447943<br>* 05 mg BID for 14 days<br>|
| Experimental: PF-04447943 15 mg dose<br> | Drug: PF-04447943<br>* 15 mg BID for 14 days<br>|
| Experimental: PF-04447943 45 mg dose<br> | Drug: PF-04447943<br>* 45mg BID for 14 days<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo for 14 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Safety: Adverse events, change from baseline in vital signs, triplicate ECG, clinical safety laboratory endpoints |  | 14 days | 
| Pharmacokinetic endpoints will include plasma PF 04447943 AUCt, Cmax and Tmax |  | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in cognition from baseline |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, tolerability, pharmacokinetics, cognition
The Effect of Codeine on Driving Abilities

Study Overview
=================
Brief Summary
-----------------
20 chronic pain patients using codeine are compared with 20 chronic patients not using opioids and 20 healthy volunteers with respect to driving ability measured by neurophysiological tests and driving in a car simulator.

Official Title
-----------------
The Effect of Codeine on Driving Abilities

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with chronic pain driving more than 50 000 km Exclusion Criteria: addiction eyesight disorders

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 55 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| chronic non-malignant pain codeine<br>patients having chronic non-malignant pain, living in Trondheim or the four adjacent counties and treated at the Center for Pain and Complex Disorders at St. Olav University Hospital - on long-term codeine therapy | |
| chronic non-malignant pain<br>patients having chronic non-malignant pain, living in Trondheim or the four adjacent counties and treated at the Center for Pain and Complex Disorders at St. Olav University Hospital - NOT on long-term codeine therapy | |
| healthy<br>healthy controls | |

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
-----------------
possible problems using codeine when driving
Lidocaine Patches Prior to Intravenous Insertion

Study Overview
=================
Brief Summary
-----------------
This study will determine whether application of a patch containing a topical anesthetic (numbing medicine) named lidocaine can reduce the pain of subsequent insertion of an intravenous catheter in Emergency Department patients.

Detailed Description
-----------------
Patients will be randomly assigned to an active lidocaine patch or a patch that conatins a placebo or inactive agent. Neither the patient nor the practitioner will know which patch is used since they will appear identical.

Official Title
-----------------
Phase II Study of Lidoderm Patches Prior to Intravenous Catheter Insertion.

Conditions
-----------------
Need for Intravenous Catheter

Intervention / Treatment
-----------------
* Device: Lidocaine tetracaine
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than or equal to 3, Need for non-emergent intravenous catheter Exclusion Criteria: Unstable patients, Allergy to lidocaine or tetracaine

Ages Eligible for Study
-----------------
Minimum Age: 3 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 |
| --- | --- |
| Active Comparator: 1<br>Lidocaine 70 mg/tetracaine 70 mg skin patch | Device: Lidocaine tetracaine<br>* Lidocaine 70 mg/tetracaine 70 mg<br>* Other names: Synera;|
| Placebo Comparator: 2<br> | Device: Placebo<br>* Placebo patch identical in appearance to Synera<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain on Visual Analog Scale (VAS) | Pain on 100 mm Visual Aanalog Scale from 0 (no pain) to 100 (most pain). | 0 MINUTES | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of Intravenous (IV) Insertion | Percentage of patients in whom intravenous catheter was inserted successfully | After first attempt of catheter insertion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intravenous catheter, emergency department, pain
Treating Acute MI Patients With Aggrastat on Their Way to Hospital

Study Overview
=================
Brief Summary
-----------------
Treating an AMI patient with ST elevation with Aggrastat in the ambulance on his or her way to the hospital.

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Drug: Tirofiban


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with acute Myocardial infarction with ST elevation , and moving by ambulance to Poriya hospital Exclusion Criteria: women less than 50 years old and 80 years old, bleeding tendency, stroke in the past

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 |
| --- |
|Drug: Tirofiban|pci|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality |  | immidiately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TIMI flow | feeling better | 24 hours |
Prospective Study of Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to report the intraoperative performance and postoperative outcomes of the Cionni-modified capsule tension ring implantation in eyes with subluxated lenses.

Detailed Description
-----------------
The introduction of endocapsular stabilising devices have significantly improved the management of zonular weakness, allowing for in-the-bag IOL implantation. The Cionni modified capsule tension ring (M-CTR) has an anterior eyelet that provides for fixation of the capsular bag without violating its integrity. Adult and pediatric studies have shown the usefulness of the M-CTR to manage zonular weakness. However, there are very few prospective studies that show the outcomes following implantation of the M-CTR and in-the-bag IOL on a longterm basis. Therefore, the investigators decided to carry out this study to report the intraoperative performance and postoperative outcomes on a longterm basis following M-CTR and in-the-bag intraocular lens (IOL) implantation.

Official Title
-----------------
Cionni Ring and In-the-bag IOL Implantation for Subluxated Lenses: A Prospective Case Series

Conditions
-----------------
Lens Subluxation

Intervention / Treatment
-----------------
* Device: Cionni Modified Capsule Tension Ring


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subluxated Lenses Traumatic or Non-traumatic etiology Exclusion Criteria: Dislocated Lenses
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 |
| --- |
|Device: Cionni Modified Capsule Tension Ring|Cionni ring was used to fixate the capsular bag to the sclera and IOL was implanted in-the-bag|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOL Centration |  | 4 years follow-up | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complications |  | 4 years follow-up | 
| IOP |  | 4 years | 
| Posterior Capsule Opacification |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cionni Ring, In-the-bag IOL, Subluxated lenses, Intraoperative Performance, Postoperative Outcome
Relationship of Vasoactive Peptide Levels to Portal Pressure and Patient Outcomes in Patients With Hepatic Cirrhosis

Study Overview
=================
Brief Summary
-----------------
Investigate vasoactive medicators in portal hypertension on stored sera

Official Title
-----------------
Relationship of Vasoactive Peptide Levels to Portal Pressure and Patient Outcomes in Patients With Hepatic Cirrhosis

Conditions
-----------------
Portal Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: portal hypertension Exclusion Criteria: Nil

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |