linjc16/ctgov huggingface dataset:
Overactive Bladder Innovative Therapy Trial (OrBIT)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare percutaneous tibial nerve stimulation (PTNS) to drug therapy for the treatment of symptoms of overactive bladder (OAB).

Official Title
-----------------
Overactive Bladder Innovative Therapy Trial

Conditions
-----------------
Overactive Bladder

Intervention / Treatment
-----------------
* Device: Urgent PC Neuromodulation System
* Drug: Tolterodine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Is at least 18 years of age Experiences OAB with a voiding frequency of at least 8 times per day Is ambulatory and able to use a toilet independently and without difficulty Exclusion Criteria: On OAB pharmacotherapy within the previous month Primary complaint is stress urinary incontinence Has pacemaker or implantable defibrillator Has history of heart problems Has nerve damage or neuropathy Has gastric or urinary retention Has uncontrolled narrow-angle glaucoma Has known sensitivity to drug ingredients Is pregnant or planning to become pregnant during the trial

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Urgent PC treatment arm<br> | Device: Urgent PC Neuromodulation System<br>* The Urgent PC Neuromodulation System is a minimally invasive neuromodulation system designed to deliver retrograde access to the sacral nerve through percutaneous electrical stimulation of the tibial nerve. The method of treatment is referred to as Percutaneous Tibial Nerve Stimulation (PTNS).<br>Drug: Tolterodine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Voids at 12 Weeks | To demonstrate that the Urgent PC system is as effective as or more effective (noninferior) than tolterodine (Detrol LA) in changing the frequency of urinary voids per day after 12 weeks of therapy. The voiding diaries completed at 12 weeks were compared to the baseline voiding diaries. | Baseline to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urge Incontinence Episodes at 12 Weeks |  | 12 weeks | 
| Volume Voided at 12 Weeks |  | 12 weeks | 
| OAB Quality of Life at 12 Weeks |  | 12 weeks | 
| Known Side Effects Through 12 Weeks |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
OAB symptoms of urgency, frequency, and urge incontinence
A Study of Once-Monthly Subcutaneous Mircera for the Treatment of Chronic Renal Anemia in Pre-Dialysis Patients Not Currently Treated With ESA.

Study Overview
=================
Brief Summary
-----------------
This single arm study will assess the efficacy and safety of subcutaneous Mircera for the correction and maintenance of hemoglobin levels in predialysis patients with renal anemia who are not currently treated with ESA. Eligible patients will receive monthly subcutaneous injections at an initial recommended dose of 1.2 micrograms/kg. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
An Open Label Study of the Safety, Tolerability and Effect on Hemoglobin Levels of Once-monthly Subcutaneous Mircera in Predialysis Patients With Chronic Renal Anemia Not Currently Treated With ESA.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: methoxy polyethylene glycol-epoetin beta [Mircera]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients, >=18 years of age; chronic renal anemia; no ESA therapy during previous 3 months; adequate iron status; rapid chronic kidney disease progression. Exclusion Criteria: transfusion of red blood cells during previous 2 months; poorly controlled hypertension requiring hospitalization in previous 6 months; significant acute or chronic bleeding.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: methoxy polyethylene glycol-epoetin beta [Mircera]<br>* sc every month (starting dose 1.2 micrograms/kg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in Hb concentration between baseline and Efficacy Evaluation Period (EEP). |  | Week 32 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to achievement of response |  | Throughout study | 
| Percentage of patients whose Hb concentration remains within range 10.0-12.0g/dL |  | Throughout study | 
| Percentage of patients whose average Hb concentration is within range 10.0 - 12.0g/dL |  | Throughout study | 
| Mean time spent in Hb range of 10.0 - 12.0g/dL |  | Throughout study | 
| Percentage of patients requiring dose adjustments; incidence of RBC transfusions; time to initiation of renal replacement therapy. |  | Throughout study |
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Study Overview
=================
Brief Summary
-----------------
To characterize the safety and efficacy of fixed doses of MDL 28,574A administered alone and in combination with zidovudine ( AZT ) in patients with asymptomatic or mildly symptomatic HIV infection. To examine the demographic effects on population pharmacokinetics and pharmacodynamics of MDL 28,574A alone and in combination with AZT.

Official Title
-----------------
A Randomized, Double-Blind Active-Controlled, Dose-Ranging Study of the Safety and Efficacy of Chronically Administered MDL 28,574A in the Treatment of HIV-Infected Patients

Conditions
-----------------
HIV Infections

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Concurrent Medication: Allowed: Prior antiretroviral agents for up to 6 months per agent. Patients must have: HIV infection. Asymptomatic or mildly symptomatic. CD4 count 301 - 500 cells/mm3. Exclusion Criteria Co-existing Condition: Patients with the following condition are excluded: Unable or unwilling to comply with study procedures. Concurrent Medication: Excluded: Chemoprophylactic therapy for mycobacterial infection. Any nonstudy prescription medications without approval of investigator. Patients with the following prior conditions are excluded: History of grade 3 or 4 toxicity to <= 600 mg/day AZT. History of intolerance to lactose. Chronic diarrhea within 6 months prior to study entry. Unexplained intermittent or chronic fever, defined as temperature >= 38.5 C for any 7 days within the 30 days prior to study entry. Prior Medication: Excluded: Antiretroviral therapy within 2 weeks prior to study entry. Prior HIV vaccines. Biological response modifiers within 30 days prior to study entry. Prior foscarnet. Any investigational drug with a washout < 5 half-lives prior to study entry. Any medications known to alter renal, hepatic, or hematologic / immunologic function (such as barbiturates, phenothiazines, cimetidine, immunomodulators, etc.) within 14 days prior to study entry. Recent history of alcohol and/or drug abuse.

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
Masking: Double


Arms and Interventions

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

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
-----------------
Drug Therapy, Combination, AIDS-Related Complex, Zidovudine, MDL 28574
Quantitative Cardiac Parametric Mapping

Study Overview
=================
Brief Summary
-----------------
The overall goal of this project is to evaluate the clinical potential of fast quantitative myocardial tissue characterization using recently emerged Cardiac Magnetic Resonance Imaging (CMR) techniques to aid the diagnosis, treatment, and follow up of patients with myocardial diseases, such as ischemic heart disease, cardiomyopathies, and myocarditis.

Official Title
-----------------
Novel Magnetic Resonance Imaging Techniques for Quantitative Cardiac Parametric Mapping

Conditions
-----------------
Cardiomyopathy, Myocarditis, Ischemic Heart Disease

Intervention / Treatment
-----------------
* Other: Cardiac Magnetic Resonance (CMR) imaging techniques


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be 18-90 years of age. Subject must be previously diagnosed with or suspected to have one of the following conditions. Myocardial ischemia or infarction (group 1) Hypertrophic cardiomyopathy (group 2) Infiltrative cardiomyopathy (group 3) Myocarditis (group 4) Subject must have been referred for a clinically indicated CMR. Exclusion Criteria: Subject has any implanted device or condition in which an MR scan would be contraindicated. Subject has an acute psychiatric disorder or is cognitively impaired. Subject is using or is dependent on substances of abuse. Subject is unwilling to comply with the requirements of the protocol. Subject has previously entered this study. Subject has an allergy against MRI contrast agents. Subject is in acute unstable condition.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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 |
| --- | --- |
| Experimental: Additional 5 minute research MR scan of heart.<br>The purpose of this is to evaluate new, faster MR scans | Other: Cardiac Magnetic Resonance (CMR) imaging techniques<br>* Evaluation of clinical potential of fast quantitative myocardial tissue characterization using recently emerged CMRI techniques to aid the diagnosis, treatment, and follow up of patients with myocardial diseases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical value of fast T1, T2, and T2* mapping of the left ventricle for the assessment of necrosis/scar, edema, and possible intramyocardial hemorrhage in patients with heart disease. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
myocardial tissue characterization
The Long-term Results of the No-touch Vein Graft to the Left Anterior Descending Artery.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to investigate whether the no-touch saphenous vein grafts that were used in coronary artery bypass surgery between 2003-2008 had a patency rate comparable to the left internal thoracic artery when the vein grafts were anatomised to the left anterior descending artery.

Official Title
-----------------
The Long-term Results of Coronary Artery Bypass Surgery When the No-touch Vein Graft is Anastomised to the Left Anterior Descending Artery.

Conditions
-----------------
Ischemic Heart Disease, Atherosclerosis

Intervention / Treatment
-----------------
* Procedure: No-touch harvesting technique


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Coronary artery bypass grafting performed at the Department of Cardiothoracic Surgery, Örebro Universtiy Hospital between 2003-2008. Saphenous vein graft harvesting using the no-touch technique. The saphenous vein anastomised to the left anterior descending artery. Informed consent Exclusion Criteria: Allergy to contrast media. Impaired renal function. Inability to conduct the study according to protocol.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No-touch vein grafts to LAD<br> | Procedure: No-touch harvesting technique<br>* The saphenous vein is harvested with a pedicle of surrounding tissue.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total patency of the no-touch vein grafts. |  | Mean time 8 years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery bypass grafting, saphenous vein, grafts
Assessment of Tartrate-Resistant Acid Phosphatase (TRAP) as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to evaluate the usefulness of the TRAP protein as (1) an early indicator of bone destruction and (2) a tool for assessing the effect of Zometa® in treating symptoms of bone metastases due to breast cancer. Tartrate-resistant acid phosphatase (TRAP) is a protein released into the blood stream as a result of bone destruction caused by metastasis of breast cancer to the bone. Bone destruction causes pain and bone fractures. This study will measure TRAP levels in serum taken from breast cancer patients to see if TRAP levels will be able to predict the effect of Zometa® treatment on bone destruction, pain and bone fractures.

Official Title
-----------------
Tartrate-Resistant Acid Phosphatase as a Bone Resorption Marker in Stage IV Breast Cancer Patients With Bone Metastasis During Zometa Treatment: A Pilot Study

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Zometa(drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologic or cytologic documentation of breast cancer. Stage IV Breast Cancer Patients with bone metastasis for whom Zometa treatment will be initiated. Age > 18 Written informed consent prior to study entry Patients may be currently receiving hormone therapy, chemotherapy and/or radiation therapy to the primary tumor. Life expectancy of at least 6 months. We will include patients who have had previous or current radiation therapy to breast Exclusion Criteria: Concurrent malignancy with a second primary Stage I, Stage II and Stage III ECOG Performance Status 3 or 4. Renal Failure - serum creatinine >2.O mg/dL at screening AST or ALT > ULN X 3. at screening Bilirubin > 3.0 mg/dL at screening Pregnant women Prior or current bisphosphonate therapy Any skeletal related event due to malignancy prior to study enrollment. Patients with osteoporotic fractures prior to study enrollment. Allergy to bisphosphonates Any radiation therapy for the treatment of bone metastases <4 weeks prior to study start. Any chronic medical condition which would preclude performance or adherence to protocol requirements Inability to provide informed consent -

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Zometa(drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
MR Images Variation With or Without Denture Wear

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

Detailed Description
-----------------
The magnetic resonance imaging (MRI) is useful to diagnose soft tissue morphology, especially to detect cancer and disk displacement with temporomandibular disorders. The prevalence of tongue cancer may increase with ageing population. A clear MR image is indispensable for clinical diagnosis. However, tongue motion associated with the habitual or swallowing tongue movement may cause artifacts on MRI. This occurrence of motion artifact is speculated to be prominent with the patients without the occlusal support. The objective of this pilot study was to compare level of artifact while tongue at rest and in motion of dentulous subjects.

Official Title
-----------------
MR Images Variation With or Without Denture Wear. Motion Artifacts Related With Tongue Movements

Conditions
-----------------
Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Device: denture wear.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: dentulous edentulous classified Eichner' s classfication Exclusion Criteria: involuntary motion occurs during imaging absolutely contraindicated or as a rule contraindicated of MRI examination subjects have ferromagnetic metals in the oral cavity subjects can not swallow naturally

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: dentulous<br>MR Imaging was collected with condition at the tongue at rest position. | |
| No Intervention: edentulous without denture wear.<br>MR Imaging was collected without denture wear. | |
| Experimental: edentulous with denture wear.<br>MR Imaging was collected with denture wear. | Device: denture wear.<br>* MR Imaging was collected with or without denture wear.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Luminance standard deviation value on MR image |  | MR Imaging was collected with each condition.Through study completion, an average of 2 year |
Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

Study Overview
=================
Brief Summary
-----------------
In this study, the researchers investigate the feasibility of using rapid cine MR imaging to provide both offline and online soft-tissue-based image guidance. Such images will provide a significantly more complete picture of the spatial and temporal changes in thoracic anatomy. This more complete information will lay the groundwork for better radiotherapy planning and dose delivery in the presence of respiratory motion.

Detailed Description
-----------------
Rapid MRI scans from Stage I-IV non-small-cell lung cancer (NSCLC) patients will be acquired. MR acquisition will be performed without extrinsically administered contrast, using a balanced turbo field echo (TFE) sequence and commercially available coils.

Official Title
-----------------
Investigating the Feasibility of Using Rapid Cine-MRI for Monitoring Moving and Deforming Tumors

Conditions
-----------------
Lung Cancer

Intervention / Treatment
-----------------
* Other: cine MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AJCC Stage I, II, III or IV non-small-cell lung cancer to be treated using radiotherapy will be eligible for this study. Any types and amounts of prior therapy will be allowed for this study. Subjects must be greater than or equal to 18 years of age. There are no gender or ethnic restrictions. Ability to understand and the willingness to sign a written informed consent document. Able to tolerate supine position ECOG performance status of 3 or less Exclusion Criteria: MRI-incompatible metallic implants, embedded metallic objects, implanted biomedical devices e.g., cardiac pacemakers Women who are pregnant or trying to get pregnant Pain in supine position

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Other: Cine-MRI<br>Rapid Cine-MRI | Other: cine MRI<br>* Rapid Cine-MRI for Monitoring Moving and Deforming Tumors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To measure time series of MRI imaging by the b-SSFP sequence. | To use fast acquisition sequences to obtain 2D and 3D cine MR images of moving and deforming lung tumors. The signal to noise ration (SNR) and spatiotemporal resolution of imaging sequences will be optimized into a format potentially useful for radiotherapy guidance. | 6 weeks |