linjc16/ctgov huggingface dataset:
Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
To review the efficacy and the safety of ibrutinib in patients with relapsed or refractory mantle cell lymphoma (MCL).

Detailed Description
-----------------
# Background and Rationale Mantle cell lymphoma (MCL) is a rare subtype of lymphoma, accounting for about 3-6% of all non-Hodgkin's lymphoma. It is clinically prevalent in the elderly and men, commonly with gastrointestinal tract involvement. Since about 80% of patients present with advanced stage disease at diagnosis, the prognosis is very poor. Mantle cell lymphoma is less frequent in Korean than in Western countries, accounting for about 2% of all non-Hodgkin's lymphoma cases, with very poor treatment outcome as Western countries. In Korea, the clinical information about patients with MCL is very scarce so far and does not reflect recent treatment patterns. Firstly, the incidence in Korea is relatively lower than that in Western countries, with only about 100 patients a year. Secondly, due to substandard national health insurance regulations in Korea, it was not until recently that ibrutinib for relapsed/refractory MCL was approved for coverage by the National Health Insurance. In this context, the study was designed to investigate the efficacy and safety of ibrutinib in patients with relapsed or refractory MCL in Korea.

Official Title
-----------------
Ibrutinib for Relapsed or Refractory Mantle Cell Lymphoma: Multicenter Retrospective Analysis

Conditions
-----------------
Mantle Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with MCL diagnosed by a pathologist (based on the WHO 2017 classification) mantle cell lymphoma leukemic nonnodal mantle cell lymphoma in situ mantle cell neoplasia Aged ≥ 19 years Relapsed or refractory patients treated with ibrutinib, including relapse after autologous stem cell transplantation Exclusion Criteria: Patients whose clinical and pathological data are not available Patients who were not treated with ibrutinib

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival period | Progression free survival period with ibrutinib | Up to 3 years, From the date of diagnosis with MCL to the date of relapse/disease progression, or last follow-up date | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate | Overall response rate with ibrutinib | Up to 3 years, From the date of diagnosis with MCL to the date of death, or last follow-up date |
Biopsychosocial Education and Chronic Low Back Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine whether the biopsychosocial educational program could improve patients' health-related quality of life at 3-6-12-18-24-30 and 36 - month follow up.

Detailed Description
-----------------
Little information exists on biopsychosocial educational program as a multidimensional and interdisciplinary program in which Quality Of Life is as an outcome measure. Thus this educational Program designed in this study is a an outpatient program that used a health education approach to empower participants through a process of assessment, education and skill building in three dimensions of physical,mental and social that leading to improved quality of life. The purpose of this study was to examine to what extent this educational Program could improve low back pain patients' HRQOL.

Official Title
-----------------
The Effectiveness of Biopsychosocial Education on Quality of Life and Disability of Individuals Suffering From Chronic Low Back Pain

Conditions
-----------------
Chronic Low Back Pain

Intervention / Treatment
-----------------
* Behavioral: back school


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Low Back Pain lasting more than 12 weeks with or without pain radiating to the legs. age 18-70 years. Exclusion Criteria: Osteoporosis Newly operation on the back up to 2 years before the beginning of the study Fresh vertebral fracture Malignancy Infection in the back spondylolisthesis Problem in understanding Farsi Language

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Back school<br>a kind of educational program for low back pain | Behavioral: back school<br>* A kind of educational program for low back pain<br>|
| Experimental: back school<br> | Behavioral: back school<br>* A kind of educational program for low back pain<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36, Roland Morris Disability Questionnaire, Quebec back pain disability |  | before intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SF-36,Roland Morris Disability Questionnaire, Quebec back pain disability |  | 3-6-12-18-24-30-36 month after intervention |
Phase IV Comparing Rods of Yield Strengths to Correct Adolescent Idiopathic Scoliosis.

Study Overview
=================
Brief Summary
-----------------
There has been a growing trend amongst surgeons to use a construct for correction of scoliosis which involves segmental instrumentation with pedicle screws. Pedicle screw proponents cite greater curve control in all planes, which results in improved spinal curve correction. Some surgeons have noted due to the increased strength of the all screw construction that the rod is now the weak part of the spinal fixation. Although no evidence has been raised in regards to hardware failure there is a perception that a loss of balance in the sagittal plane is the result of flex in the titanium rod. A novel solution to the issue of rod flexibility is raised with the expedium super steel instrumentation which allows for greater stiffness than a 5.5 mm titanium rod with the same lower profile. This study aims to compare the new super steel technology with other established instrumentations used to correct spinal stenosis.

Detailed Description
-----------------
screw purchase was to be recorded but study has been withdrawn.

Official Title
-----------------
A Multi-Centre Randomized Phase IV Clinical Trial Comparing Rods of Varying Yield Strengths and Their Ability to Hold Correction of Adolescent Idiopathic Scoliosis.

Conditions
-----------------
Scoliosis

Intervention / Treatment
-----------------
* Device: titanium rod
* Device: ultra strength stainless steel rod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aged 10-20; presenting with a progressive lenke type 1A, N; or type idiopathic adolescent scoliosis measuring greater than 45 degree cobb angle Exclusion Criteria: rigid scoliosis requiring a three column release or osteotomy; patients that can not have pedicle screw instrumentation due to technical concerns

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: titanium rod|comparison of rods of varying yield strengths and their ability to hold correction of scoliosis.|
|Device: ultra strength stainless steel rod|interventions involving rods of various strength to treat scoliosis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent correction in both frontal and sagittal planes for idiopathic scoliosis |  | pre-op, 3, 6, 12, 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| screw purchase |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
scoliosis correction rod strength adolescent
Ketorolac vs. Steroid in the Prevention of CME

Study Overview
=================
Brief Summary
-----------------
Evaluate if the incidence of sub clinical CME can be significantly reduced by use of peri-operative Acular LS plus Pred Forte when compared with Pred Forte alone in normal cataract patients.

Official Title
-----------------
A Masked Comparison of Acular LS Plus Steroid Versus Steroid Alone for the Prevention of Macular Leakage in Cataract Patients

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

Intervention / Treatment
-----------------
* Drug: Ketorolac, Prednisolone Acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: · Male or female > 18 years of age scheduled to undergo cataract surgery with surgeon expectation of 20/20 BCVA postoperatively Must be in good general health. Patients with systemic diseases will be enrolled only if there are no ocular manifestations of their disease (ie diabetics with normal retinal exams) Ability to provide informed consent and likely to complete all study visits Exclusion Criteria: · Known contraindication to any study medication or any of their components Uncontrolled systemic disease Required use of ocular medications other than the study medications during the study Abnormal pre-operative OCTs if obtainable Diabetic patients with a history of macular edema or diabetic retinopathy AMD patients with less than a 20/20 surgical outcome expectation, epi-retinal membranes, retinal vein occlusion, or any pre-existing macular disease

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ketorolac, Prednisolone Acetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Pilot Trial of the Non-invasive H.G.R Glucometer

Study Overview
=================
Brief Summary
-----------------
A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes. The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.

Official Title
-----------------
A Pilot Trial to Evaluate the Precision and Accuracy of the Non-invasive H.G.R Glucometer

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

Intervention / Treatment
-----------------
* Device: H.G.R (GWave) non-invasive glucometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study. Male or female. Age above or equal to 18 years at the time of signing informed consent. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening. HbA1c of 6.0-8.0% . Exclusion Criteria: Participants under the age of 18 years pregnant women or patients with normal blood glucose.

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 |
| --- | --- |
| Other: Non invasive glucose monitor<br>Single arm. All subjects will have glucose levels measured both by non invasive glucometer and by core lab | Device: H.G.R (GWave) non-invasive glucometer<br>* Glucose tolerance test<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| difference between core lab and non invasive glucose measurements | difference between core lab and non invasive glucose measurements | 3 HOURS |
Effects of Ursodeoxycholic Acid on Graft Recovery Early After Adult Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate the possible beneficial effects of UDCA on liver graft recovery early after adult liver transplantation.

Conditions
-----------------
Liver Transplantation, Ischemia-reperfusion Injury, Cholestasis

Intervention / Treatment
-----------------
* Drug: ursodeoxycholic acid
* Drug: identical-appearing placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All liver transplant patients in our center between May 2005 and April 2008 were potentially eligible for enrollment Exclusion Criteria: Age less than 18 years Treatment with UDCA within one month before operation Inability to provide written informed consent prior to study entry Non-liver organ(s) failure prior to entry

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: ursodeoxycholic acid<br> | Drug: ursodeoxycholic acid<br>* 13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation<br>|
| Placebo Comparator: identical-appearing placebo<br> | Drug: identical-appearing placebo<br>* 13-15mg/kg/day, 250mg/capsule, given twice per day, within the first 4 weeks after liver transplantation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum liver tests | Serum liver tests include serum levels of alanine aminotransferase (ALT), aspartate aminotransferase (AST), gamma glutamyl transpeptidase (GGT), alkaline phosphatase (ALP) and total bilirubin (TB) | within the first 4 weeks after liver transplantation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | Postoperative complications include rates of acute cellular rejection (ACR), drug-induced hepatotoxicity, vascular or biliary complications, recurrence of primary liver disease and death | within the first 4 weeks after liver transplantation |
Ultrasound Findings of Finger, Wrist and Knee Joints in Mucopolysaccharidosis

Study Overview
=================
Brief Summary
-----------------
Hardly any imaging studies specifically addressing the articular and periarticular structures in MPS patients are available at this point. The investigators propose to do for the first time a pilot study using musculoskeletal ultrasound in patients with various types of MPS.

Official Title
-----------------
Ultrasound Findings of Finger, Wrist and Knee Joints in Mucopolysaccharidosis

Conditions
-----------------
MPS I, MPS IV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Diagnosis of Mucopolysaccharidosis Ability to collaborate with the ultrasound assessment Written informed consent from parents and patients over 14 years of age, assent from children 7 to 14 years Exclusion Criteria Inability to collaborate with the ultrasound assessment Acute trauma to a joint that will be assessed in the 3 months preceding the study Coexistence of other pathology that is known to affect the respective joints

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Power Doppler | The primary objective is to determine whether patients with various types of MPS and at various stages of the disease exhibit abnormalities of the finger, wrist and knee joints as assessed by grey scale and Power Doppler ultrasonography. | one time exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ultrasound scanning technique | To determine the optimal ultrasound scanning technique for MPS patients given the potentially advanced joint contractures | one time scan | 
| Findings of synovitis or tenosynovitis | To determine whether there are ultrasound findings indicative of synovitis or tenosynovitis | one time scan | 
| Differences between MPS I and IV | To determine whether differences exist between MPS I and MPS IV | one time scan | 
| Differences between ERT and BMT | To determine whether differences exist between patients with or without Enzyme Replacement Therapy (ERT) or Bone Marrow Transplants | one time scan | 
| Differences between severe and attenuated phenotypes | To determine whether differences exist between severe and attenuated phenotypes | one time scan |
Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to verify whether extensive flushing of the port catheter in patients with catheter related blood stream infection will lead to correct vancomycin trough levels, taken via the port catheter and compared with simultaneously taken peripheral samples.

Detailed Description
-----------------
In this study, extensive flushing of the port catheter prior to blood sampling to determine vancomycin trough levels, will be compared with normal flushing. To ascertain correctness of the trough levels taken via the central catheter, sampling will occur through a peripheral catheter simultaneously. Flushing will be done with sodium chloride 0.9 % solution.

Official Title
-----------------
Optimization of Therapeutic Drug Monitoring of Vancomycin in Pediatric Patients With an Implanted Port Catheter

Conditions
-----------------
Catheter Related Blood Stream Infections

Intervention / Treatment
-----------------
* Procedure: Extensive flushing of the port catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients with a port catheter Treated with systemic vancomycin and/or vancomycin lock Exclusion Criteria: Age > 18 years Active downgrading of care

Ages Eligible for Study
-----------------
Maximum Age: 18 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: Patients with port catheter: flushing<br>In patients with a catheter-related blood stream infection (CRBSI) and a port catheter, being treated with vancomycin intravenously, we will flush the catheter with 30 ml of sodium chloride 0.9 % prior to blood sampling to determine vancomycin concentrations, in order to decrease residuel vancomycin in the port. | Procedure: Extensive flushing of the port catheter<br>* The port catheter will be flushed extensively with sodium chloride 0.9% before blood sampling. Blood sampling will occur through the central catheter and peripherally simultaneously.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vancomycin trough levels via port catheter and peripheral vein | Vancomycin trough levels will be determined, both on peripheral blood and blood taken via the port catheter and will be compared. | At steady state i.e. approximately 36 hours after initation of the treatment or a change in dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vancomycin, Therapeutic drug monitoring, Catheter related blood stream infections
Emergency/Compassionate Use PFO Occluder

Study Overview
=================
Brief Summary
-----------------
Emergency/compassionate use for the AMPLATZER PFO Occluder

Conditions
-----------------
Patent Foramen Ovale, PFO

Intervention / Treatment
-----------------
* Device: Device closure with the AMPLATZER PFO Occluder


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Emergency/compassionate use for patients not meeting the inclusion criteria for the AMPLATZER PFO Access Registry.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Device closure with the AMPLATZER PFO Occluder|Device closure with the AMPLATZER PFO Occluder|

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
-----------------
patent, foramen, ovale, PFO