linjc16/ctgov huggingface dataset:
Efficacy and Safety of Oxycodone/Naloxone (Targin®) in Persistent Moderate to Severe Low Back Pain Following NSAIDs Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of the study drug (Targin®) after 8 weeks of treatment in patients with moderate to severe low back pain who are uncontrolled* by NSAIDs.

Official Title
-----------------
An 8-week, Prospective, Interventional, Single-arm, Multi-centre, Phase IV Study to Evaluate the Efficacy and Safety of Controlled-release Oxycodone/Naloxone (Targin®) in Moderate to Severe Low Back Pain Patients Who Are Not Adequately Controlled by NSAIDs

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

Intervention / Treatment
-----------------
* Drug: Brand Name: Targin®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Korean patients age ≥ 19 years old Patients having moderate to severe low back pain (NRS pain score ≥4) for ≥ 7 days and ≤ 90 days not satisfactorily controlled with NSAIDs Patients showing average NRS pain score ≥4 over the last 1 week at screening point In case of previous opioids medication history, opioids wash-out period > 30 days before enrolment Patients who is willing to voluntarily sign informed consent Exclusion Criteria: Patients with any history of hypersensitivity to oxycodone, naloxone or related products Low back pain coming from cancer, infectious disease, psychiatric issue or congenial cause Pregnant or lactating women

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Brand Name: Targin®<br>Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral | Drug: Brand Name: Targin®<br>* Brand Name: Targin® Generic name: Oxycodone/Naloxone dosage form: Oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of NRS average score from week 0 to week 8 | reduction of pain intensity of week 8 average NRS score | week 8 |
Palliative Care of Children With End-Stage Heart Failure

Study Overview
=================
Brief Summary
-----------------
Palliative care in pediatric oncology and neurology is well described in the literature. There is a lack of information on the care of children terminally ill due to heart failure. A significant number of children are diagnosed with terminal heart failure for which palliative care is required. Objective: To describe palliative care of children over one year of age with end-stage heart failure, including need for and types of pain control, hospice use, need for and use of home nursing and quality of life issues.

Detailed Description
-----------------
Methods: Retrospective chart review of all children over one year of age diagnosed with end-stage heart failure between January 1, 1995 and December 31, 2005 at Children's Healthcare of Atlanta, Egleston Hospital, followed by Sibley Heart Center Cardiology. Patient variables taken from the medical charts will include: Diagnosis Age, gender Medications Prior surgery or transplantation Associated conditions such as muscular dystrophy, renal failure Practice variables taken from the medical charts will include: Hospice care provided Home inotropic infusions Medications administered for pain Social work/psychology evaluation DNR status Statistics: Number of patients receiving home nursing, involved in hospice, treated with pain medications, home oxygen or home inotropes.

Official Title
-----------------
Palliative Care of Children With End-Stage Heart Failure

Conditions
-----------------
Congenital Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any patient between 1 - 18 years of age (inclusive) Any patient with end stage heart disease Treated at Egleston Hospital, Children's Healthcare of Atlanta Followed by Sibley Heart Center Cardiology Exclusion Criteria: Those who do not meet inclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 18 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, palliative care, end stage heart failure
Double-blind Comparative Study of SYR-472

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of treatment with SYR-472 in diabetic patients.

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: SYR-472
* Drug: Alogliptin 25 mg
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The participant is an outpatient. The participant signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures. Exclusion Criteria: The participant has any serious cardiac disease, serious cerebrovascular disorder, or any serious pancreatic or hematological disease.（e.g., subjects who require hospitalization or subjects who were hospitalized within 24 weeks prior to the commencement of the observation period) The participant is considered ineligible for the study for any other reason by the investigator or subinvestigator.

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

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

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

Design Details

Primary Purpose: Treatment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYR-472 100 mg<br> | Drug: SYR-472<br> <br> |
| Active Comparator: Alogliptin 25 mg<br> | Drug: Alogliptin 25 mg<br> <br> * Other names: SYR-322;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glycosylated hemoglobin (HbA1c) | Measurement of change in HbA1c (ratio of hemoglobin bound to glucose). | 24 weeks. |
The Effect and Mechanism of Hyaluronan on the Mucociliary Differentiation of Human Respiratory Epithelial Cells

Study Overview
=================
Brief Summary
-----------------
The mucociliary system of nasal mucosa, which is composed of the ciliated respiratory epithelium, the mucous blanket, and the mucus-producing glands, is an important defense component of the respiratory system. Therefore, it is important to maintain intact inner respiratory mucociliary epithelium in reconstruction of large respiratory defect and in the development of tissue engineering trachea. Hyaluronan derivatives, which are biodegradable and non-immunogenic, have already proved to be effective as a scaffold for chondrocytes. However, the feasibility of use as a scaffold for respiratory epithelial cells remained unexplored. The aim of the study is to investigate the effect of hyaluronan including concentrations and molecular weight on the mucociliary differentiation of human respiratory epithelial cells (HREC). If hyaluronan is able to promote mucociliary differentiation of HREC, the investigators can synthesize hyaluronan derivatives serving as ideal biomaterials for respiratory tissue engineering and tissue-engineered trachea in the future.

Official Title
-----------------
The Effect and Mechanism of Hyaluronan on the Mucociliary Differentiation of Human Respiratory Epithelial Cells

Conditions
-----------------
Respiratory System Defect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PATIENTS UNDERWENT SEPTOMEATOPLASTY
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hyaluronan including concentrations, molecular weight, mucociliary differentiation, human respiratory epithelial cells
Predictive Factors and Complications of Delirium

Study Overview
=================
Brief Summary
-----------------
The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.

Detailed Description
-----------------
Delirium is a transient and fluctuating course syndrome of acute onset that is characterized by reduced level of consciousness, global cognitive dysfunction, and disorder in the sleep-wake cycle. In patients undergoing cardiac surgery, delirium is a complication that affects 2-57% of the patients, reaching as high as 73% in older subjects. The identification of patients at high risk for delirium is important to deliver proper care and avoid the consequences of this complication. However, previous studies published on the subject have not delivered definitive results in the cardiac surgery setting. Low educational level has also been studied as a risk factor for delirium after surgery but never in a group of cardiac surgery patients that includes a significant rate of illiteracy. The objective of this research was to determine the incidence, predisposing and triggering factors of delirium following cardiac surgery and its consequences within 30 days of surgery and during a 12-18-month follow-up in older adult patients.

Official Title
-----------------
Incidence, Predictive Factors and Complications of Delirium in Postoperative Cardiac Surgery Elderly Patients

Conditions
-----------------
Delirium, Surgery--Complications, Age Problem

Intervention / Treatment
-----------------
* Procedure: Cardiac surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Elective cardiovascular surgery Exclusion Criteria: Blindness, deafness, previous stroke dementia delirium at inclusion, preoperatively creatinine clearance < 30 ml/min emergency surgery

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Cardiac surgery|Coronary bypass, heart valve replacement|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delirium | Delirium was assessed using the Confusion Assessment Method for the Intensive Care Unit | Until hospital discharge or 30 days after surgery, and for up to 18 months. |
Long Term Study of Fingolimod in MS Patients From the FTY Clinical Program

Study Overview
=================
Brief Summary
-----------------
The purpose of this observational study is to collect long-term data on safety and effectiveness of fingolimod, particularly including clinical disease and patient outcome related parameters such as relapse and disability, in patients who have participated in prior trials within the fingolimod clinical development program. Furthermore, this study explores the incidence of selected safety related outcomes of fingolimod treatment during follow-up visits within the context of routine medical practice.

Official Title
-----------------
A Long Term, Multicenter, Non-interventional, Observational Study Monitoring Long-term Safety and Effectiveness of Fingolimod 0.5 mg in Patients With Multiple Sclerosis Who Have Participated in the Fingolimod Clinical Development Program

Conditions
-----------------
Multiple Sclerosis

Intervention / Treatment
-----------------
* Drug: fingolimod


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are prescribed fingolimod as part of their routine medical care Patients who have participated in a prior fingolimod clinical trials Exclusion Criteria: Restrictions regarding the use of fingolimod while pregnant or nursing in accordance with the local prescribing label Any patient who has prematurely discontinued from the previous fingolimod trial Other protocol-defined inclusion/exclusion criteria may apply

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 |
| --- | --- |
| Prescribed fingolimod 0.5 mg/day<br> | Drug: fingolimod<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety data in patients with relapsing forms of multiple sclerosis who have participated in clinical trials with fingolimod and who are now taking prescribed fingolimod under the conditions of routine medical practice |  | Throughout the entirety of the study up to a maximum of 8 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term effectiveness data, particularly including clinical disease and patient outcome related parameters such as relapse and disability |  | Throughout the entirety of the study up to a maximum of 8 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fingolimod, FTY720, Relapsing forms of multiple sclerosis, Multiple sclerosis, MS, Safety, Efficacy
Effects of Gene Polymorphism After Transcranial Cranial Direct Current Stimulation on the Corticobulbar Excitability

Study Overview
=================
Brief Summary
-----------------
This study aims to examine the effects of transcranial direct current stimulation at corticobulbar excitability in individuals with different gene polymorphism.

Detailed Description
-----------------
The effects of TDCS on corticobulbar excitability of the brain after inhibitory pre-conditioning will be compared in patients with different BDNF phenotypes

Official Title
-----------------
Role of Genetic Polymorphism in Neuroplasticity Involved in Dysphagia Recovery- Part 2

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

Intervention / Treatment
-----------------
* Device: tdcs


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19-40 years Informed consent Exclusion Criteria: History of epilepsy Presence of cardiac pacemaker previous brain surgery previous swallowing problems current use of medication which acts on the central nervous system presence of implanted metal intracranially

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 40 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 |
| --- | --- |
| Healthy<br>Healthy adults - Participants will receive single session of tdcs after application | Device: tdcs<br>* application of optimised parameters of tDCS (anodal stimulation, 1.5 mA, 10 min) over the unconditioned hemisphere reverses the brain and behavioural consequences of inhibitory pre-conditioning<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain corticobulbar excitability | Change of Brain corticobulbar excitability by motor evoked potentials | Immediately after single conditioning the brain | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tongue pressure measurement- | Change of tongue pressure measurement by Intra oral pressure assessment | Immediate after single conditioning the brain | 
| Electrophysiological responses of swallowing - | Change of Electrophysiological responses of swallowing - With the use of a laryngeal transducer, will measure the mylohyoid amplitude | Immediate after single conditioning the brain |
Safety and Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to evaluate the safety and intraocular pressure (IOP)-lowering efficacy of anecortave acetate for treatment of elevated IOP in patients with open-angle glaucoma.

Official Title
-----------------
A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma

Conditions
-----------------
Open-angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL
* Other: Anecortave Acetate Vehicle


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of open-angle glaucoma; Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Pseudoexfoliation; Pigment dispersion component; Other protocol-defined exclusion criteria may apply.

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: Anecortave Acetate Depot<br> | Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL<br>* Administered by anterior juxtascleral depot (AJD) in study eye, either 0.25 mL or 0.5 mL. One injection, 24 months.<br>|
| Placebo Comparator: Anecortave Acetate Vehicle<br> | Other: Anecortave Acetate Vehicle<br>* Administered by anterior juxtascleral depot (AJD) in study eye, 0.5 mL. One injection, 24 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure (IOP) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Treatment Failures |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma
Outcomes of Bariatric Surgery/UMMMC Bariatric Surgery Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to monitor and evaluate the efficacy, as well as safety, of bariatric surgery performed at UMass Memorial Medical Center, including laparoscopic gastric bypass surgery and laparoscopic gastric banding, in the surgical treatment of morbid obesity and associated co-morbidities such as type 2 diabetes, sleep apnea and cardiovascular disease.

Detailed Description
-----------------
See brief Summary

Official Title
-----------------
Outcomes of Bariatric Surgery (UMMMC Bariatric Surgery Registry)

Conditions
-----------------
Morbid Obesity

Intervention / Treatment
-----------------
* Other: Observational Study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be scheduled for Bariatric Surgery @ UMMMC Exclusion Criteria: Not scheduled for Bariatric Surgery @ UMMMC

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Bariatric Surgery Patients<br>Bariatric Surgery patients at UMass Memorial Medical Center | Other: Observational Study<br>* This is an Observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight Loss after surgery | Baseline weight is recorded preoperatively. Time points after surgery when weight is recorded are two weeks, six weeks, 6 months, 1 year, 18 months, 2 years, then annually on the anniversary date of surgery. | Preop, Postop, Six Months, and Annually | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of Co-morbidities, such as Type 2 Diabetes, Sleep Apnea, Hypertension | Preoperatively co-morbidities of morbid obesity are recorded as well as treatment (ie: medications, CPAP machine). Resolution of co-morbidities postoperatively is measured/recorded for example by blood tests, sleep study, as well as changes or discontinuation of medications &/or interventions. | Preop, Postop, Six Months, Annually | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Morbid Obesity, Obesity, Weight Loss, Bariatric Surgery