linjc16/ctgov huggingface dataset:
Trial Assessing Cooled Radiofrequency Denervation as a Treatment for Sacroiliac Joint Pain Using the Sinergy System

Study Overview
=================
Brief Summary
-----------------
to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo group

Official Title
-----------------
A Double Blind, Randomized, Controlled Trial Assessing Cooled Radiofrequency Denervation as a Treatment fr Sacroiliac Joint Pain Using the Sinergy System

Conditions
-----------------
Other Acute Pain, Chronic Pain

Intervention / Treatment
-----------------
* Device: Sinergy
* Device: Placebo sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Predominantly axial pain below L5 vertebrae greater than 75%pain relief from 2 seperate lateral branch blocks done on different days chronic axial pain lasting longer than 6 months, 3 day average VAS between 4 and 8 age greater than 18 failed to acheive adequate improvemnet with comprehensive non-operative treatments, includingbut not limited to: activity alteration, non0steriodal anti-iflammatory, physical and/or manual therap, and flurpscopically guided steriod injections in and around the area of pathology all other possible sources oflow back pain have been ruled out, including but not limited to the intervertebral discs, bone fracture. Exclusion Criteria: Beck Depression greater than 20% irreversible psychological barriers to recovery spinal pathology that may impede recovery such as spins bifida occulta, moderate to severe foraminal or central canal stenosis systemic infection or localized infection at inducer site concomitant cervical or thoracic pain greater than 2/10 on VAS uncontrolled or acute disease chronic severe condition such as rheumatoid arthritis preganancy active radicular pain immunosuppression workers compensation allergy to injectants or medications used in procedure high narcotis use greater than 30 mg hydrocodone or equivalent smokers body mass index greater than 29.9

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Treatment with Sinergy system | Device: Sinergy<br>* radiofrequency denervation<br>|
| Placebo Comparator: 2<br>placebo controlled | Device: Placebo sham<br>* sham procedure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Status Change for Sacroiliac Joint Pain Intensity | Scale ranges from 0 to 10. A score of 0 represents no pain and a score of 10 represents the highest level of pain. | Baseline and 3 months |
BlueCQ Bioavailability

Study Overview
=================
Brief Summary
-----------------
Bioavailability of methylene blue (MB) - comparison of an i.v. and two oral MB formulations - and influence of sustained release MB on chloroquine (CQ) concentrations in whole blood, plasma and urine. Intraindividual cross over open comparison in healthy male and female individuals (6:6) with different MB formulations in randomised order for the determination of the absolute bioavailability of MB (part 1), followed by an explorative randomised parallel group comparison of CQ disposition when CQ is given alone (3 males and 3 females) or in combination with 1000 mg sustained release MB (3 males and 3 females) in the participants of study part 1 (part 2).

Detailed Description
-----------------
Maximum whole blood methylene blue (MB) concentrations after i.v. and oral administration may differ in the magnitude of 100:1. For achieving MB concentrations possibly effective against malaria when using different pharmaceutical formulations, determination of oral bioavailability of MB is necessary. To investigate this 12 healthy subjects (6 females, 6 males) will receive in a randomised cross over design MB 50 mg i.v. and MB 500 mg as a oral solution. For generating this information for a planned phase II/III study in Africa, an intravenous and an oral MB preparation will be investigated. A second part of the study will explorative investigate the influence of MB on chloroquine (CQ) plasma concentrations. During this part 6 healthy subjects (3 females, 6 males) will receive either CQ alone or in combination with MB 500 mg, the design of this part will be a parallel design.

Official Title
-----------------
B l u e C Q - P r o j e c t: Bioavailability of Methylene Blue (MB) - Comparison of an Intravenous and Two Oral Formulations - and Influence of Sustained Release MB on Chloroquine (CQ) Concentrations

Conditions
-----------------
Methylene Blue, Chloroquine, Pharmacokinetics, Bioavailability

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good state of health physically and mentally Exclusion Criteria: Any regular drug treatment currently or past (within the last 2 months) except for oral contraceptives in females Treatment with a known inhibitor or inducer of drug metabolising enzymes or transport proteins within a period of less than 10 times the respective elimination half-life Any acute or chronic illness, especially: Glucose-6-phosphate dehydrogenase deficiency Allergic disposition or history of hypersensitivity reactions Smoking Alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Factors Affecting the Achievement of Glucose Monitor in the Patients on Diabetes

Study Overview
=================
Brief Summary
-----------------
To assess the effect of glucose monitors on glucose control and cardiovascular risks.

Detailed Description
-----------------
The investigators will enroll patients with diabetes. The answered questionnaire and blood samples will be collected at baseline. After change the methods or frequency of glucose monitor, the blood samples will be collected again. The investigators will analyze the factors which may affect the glucose control after changes in methods of glucose monitor.

Official Title
-----------------
The Effects of Glucose Monitor on Patients With Diabetes

Conditions
-----------------
Glucose Variability, Cognitive Decline

Intervention / Treatment
-----------------
* Device: Continue glucose monitor system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with diabetes Exclusion Criteria: Incooperative patients

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Continue glucose monitor system|The cardiovascular risks and data from continue glucose monitor system|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Glucose variability | Data from continue glucose monitor system | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| brain-derived neurotrophic factor | Biomarker of cognition | 3 months | 
| Orexin | Biomarker of cognition | 3 months | 
| Renalase | Biomarker of cognition | 3 months | 
| Vascular endothelial cell adhesion molecule 1 | Biomarker for inflammation | 3 months | 
| Health Literacy | Questionnaire of health | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Brain-derived neurotrophic factor, Vascular cell adhesion molecule 1, Renalase, Orexin, Continue glucose monitor
Vitamin D and T-Regulatory Cells in Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of Vitamin D supplementation on cardiovascular disease and certain cells (T-regulatory cells) in the body that play a role in plaque formation in arteries. This study will determine the levels of Vitamin D and T-regulatory cells in subjects with coronary artery disease and if Vitamin D supplementation will affect future events such as heart attach and stroke.

Official Title
-----------------
Vitamin D and T-Regulatory Cells in Coronary Artery Disease

Conditions
-----------------
Coronary Artery Disease, Cardiovascular Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Vitamin D
* Other: No medication


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: between the ages of 30 and 80 years have a history of medically treated coronary artery disease Exclusion Criteria: history of smoking in the past 2 years history of diabetes mellitus

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Vitamin D<br>Subject receives daily dose of Vitamin D | Dietary Supplement: Vitamin D<br>* Vitamin D 3000 IU daily<br>|
| Other: No medicine<br>Subject does not receive medication | Other: No medication<br>* No intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in T-regulatory Cells | We expect significant improvement in the suppressive capacity, with or without increase in the number, of circulating T-regs after vitamin D supplementation. This increase in T-regs function will correlate with improvement in clinical parameters. | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease pro-inflammatory cytokines & sTNFR1 and increase serum IL-10 | We also expect that vitamin D supplementation will decrease the levels of pro-inflammatory cytokines and sTNFR1 and increase the level of serum IL-10 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CAD, Vitamin D, CVD
Fasting Predictors of OGTT and MMTT Response

Study Overview
=================
Brief Summary
-----------------
To develop a database containing matched information from dynamic tests of postprandial glycemic control (OGTT or MMTT), results of a broad panel of fasting biomarkers, and clinical information related to diabetes risk obtain through subject interview. To use the database to identify fasting biomarkers and associated algorithms to best predict parameters derived from dynamic tests (OGTT or MMTT) such as Insulin Glucose Tolerance (IGT), impaired first phase insulin response, etc., controlling for clinical information such as current medication use.

Official Title
-----------------
Identification of Fasting Biomarkers That Predict Responses to the Oral Glucose Tolerance Test (OGTT) and Mixed Meal Tolerance Test (MMTT)

Conditions
-----------------
Prediabetes, Hypertension, Obesity, Cardiovascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Weight >95 Exclusion Criteria: Prior diagnosis of Diabetes

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify fasting biomarkers and associated algorithms to predict parameters | To assess relations between baseline factors and patterns of change over time due to feeding treatments. | Baseline |
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea

Study Overview
=================
Brief Summary
-----------------
The purpose of this study in patients with obstructive sleep apnoea (OSA) and concomitant patent foramen ovale (PFO) is to assess the impact of percutaneous PFO closure on nocturnal hypoxemia and apnea/hypopnea, pulmonary and systemic artery pressure, endothelial function and arterial stiffness.

Official Title
-----------------
Impact Of Closure Of Patent Foramen Ovale On Apnoea-Hypopnoea-Index, Nocturnal Hypoxemia And Systemic Vascular Function In Patients With Obstructive Sleep Apnoea

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Device: PFO Closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with newly diagnosed moderate to severe OSA Age > 17 years Written informed consent for study participation. Exclusion Criteria: Patients with other pulmonary disease associated with oxygen desaturation (other than obesity-associated pulmonary restriction) Patients with central sleep apnea syndrome Patients with other causes of pulmonary hypertension Intracardiac shunt other than via PFO Severe valvular heart disease Abnormal left ventricular (LV) systolic function (ejection fraction <50%) Obesity with BMI > 40 Contraindication to TOE Severe pulmonary arterial hypertension (mean pulmonary artery pressure > 45 mmHg)

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: OSA without PFO<br> | |
| Other: OSA with PFO<br>PFO closure | Device: PFO Closure<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea Hypopnea Index (AHI), apnea index (changes from baseline to follow-up) |  | 0, 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systemic vascular assessment |  | 0, 3 months |
Lenalidomide Adherence in Older Adults

Study Overview
=================
Brief Summary
-----------------
To describe patterns of adherence and pilot baseline measures to investigate factors associated with lower adherence to lenalidomide in older adults with myeloma.

Official Title
-----------------
Lenalidomide Adherence in Older Adults: A Pilot Prospective Cohort Study of Oral Therapy for Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Intervention / Treatment
-----------------
* Other: Medication Event Monitoring System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥65 Receiving lenalidomide for treatment of multiple myeloma. Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites Able to read and understand English. Able to understand and willing to sign an IRB-approved written informed consent document. Exclusion Criteria: Estimated life expectancy <6 months. Anticipated duration of lenalidomide therapy <3 months. Residing in a nursing facility where their medications are administered to them OR patient reports they do not self-administer their own medications.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients taking lenalidomide for multiple myeloma<br>-Patients will be seen at baseline, 1 month (+/- 1 week), 2 months (3-5 weeks following 1-month assessment), and 3 months (3-5 weeks after 2-month follow-up) | Other: Medication Event Monitoring System<br>* -Microchipped bottle cap<br>* Other names: MEMS;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate as measured by the number of days in which the lenalidomide pill bottle was open | -Participants will be given a pill diary in which they will record if they opened the pill bottle without taking a medication (e.g. to ascertain remaining supply) to adjust the adherence rate accordingly | Through completion of study (estimated to be 3 months) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence rate as measured by a modified Brief Adherence Rating Scale | Participants will fill out a brief survey about taking lenalidomide and an estimate of their adherence using a visual analog scale Scored 0-100%, 0% = lenalidomide not taken on any days and 100% = lenalidomide taken every day | Through completion of study (estimated to be 3 months) |
Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

Study Overview
=================
Brief Summary
-----------------
The aim of this long-term study is to investigate the effect of roflumilast (APTA-2217) on the long-term safety in patients with chronic obstructive pulmonary disease (COPD) who completed the 24-week evaluation of study APTA-2217-06. Roflumilast will be administered orally once daily. The present study consists of a 28 weeks treatment period, and is an extension of the 24-week study APTA-2217-06 (registered study). The study will provide further long-term safety and efficacy data of roflumilast.

Official Title
-----------------
A Long-term Study of APTA-2217 in Patients With Chronic Obstructive Pulmonary Disease

Conditions
-----------------
Chronic Obstructive Pulmonary Disease (COPD)

Intervention / Treatment
-----------------
* Drug: Roflumilast


Participation Criteria
=================
Eligibility Criteria
-----------------
Main inclusion criteria: Patients with chronic obstructive pulmonary disease (COPD) Written informed consent Patients who completed the 24-week evaluation of study APTA-2217-06 Main exclusion criteria: If patients required hospitalization or received emergency care for COPD exacerbation by the investigator (or sub-investigator) between the informed consent day and the starting day Patients with long-term oxygen therapy Serious diseases

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Roflumilast|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Long-term safety after 28 weeks treatment of Roflumilast (total 52 weeks, 24 weeks of study APTA-2217-06 followed by 28 weeks) . |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD, Phosphodiesterase 4 inhibitor, Roflumilast
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma

Study Overview
=================
Brief Summary
-----------------
The small insulinoma can not be detected by the CT or MRI. We use 68Ga-NOTA-exendin-4 positron emission tomography/computed tomography (PET/CT) to detect the insulinoma for the patient diagnosed with endogenous hyperinsulinemic hypoglycaemia. And the diagnostic value will be performed. A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. Visual and semiquantitative method will be used to assess the PET/CT images.

Detailed Description
-----------------
The glucagon-like peptide-1 receptor (GLP-1R) is an emerging target due to its high expression in benign insulinomas. 68Ga-NOTA-exendin-4 is an optimal probe targeting GLP-1R. The clinical use of 68Ga-NOTA-exendin-4 PET/CT in detecting insulinomas will be evaluated. And the comparation between PET diagnostic value and CT / MRI will be done.

Official Title
-----------------
The Clinical Application of 68Ga-NOTA-exendin-4 PET/CT in Detecting Insulinoma

Conditions
-----------------
Insulinoma

Intervention / Treatment
-----------------
* Drug: 68Ga-NOTA-exendin-4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1.age ≥6 years old 2.Patients with hypoglycaemia 3.Endogenous hyperinsulinemic hypoglycaemia 4.Enhanced CT or MRI within 1 month 5.Signed written consent Exclusion Criteria: 1. Breast feeding 2.Pregnancy or the wish to become pregnant within 6 months 3.Renal function: serum creatinine during 41-73umol/L 4.Any medical condition may significantly interfere with study compliance; 5.Known allergy

Ages Eligible for Study
-----------------
Minimum Age: 6 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Patients will undergo 68Ga-NOTA-exendin-4 PET/CT imaging<br>A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously. PET/CT imaging will be performed at 30-60 min post-injection.Visual and semiquantitative method will be used to assess the PET/CT images. | Drug: 68Ga-NOTA-exendin-4<br>* A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA-exendin-4 will be injected intravenously<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Standard uptake value (SUV) | Determination of SUV for detected lesions and discernible organs of 68Ga-NODAGA-JR11 and 68Ga-DOTATATE Standard uptake value (SUV) of the lesion will be recorded | From right after tracer injection to 1-hours post-injection |