linjc16/ctgov huggingface dataset:
Ensure Cardiac Resynchronization Therapy Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information on how doctors program particular settings on cardiac resynchronization therapy implantable cardiac defibrillators (CRT-Ds), to analyze how these settings affect the amount of cardiac resynchronization therapy (CRT) patients receive and to evaluate the therapy approach for converting abnormally fast heartbeats into normal heartbeats. There are no experimental devices or procedures involved in this study.

Official Title
-----------------
Ensure Cardiac Resynchronization Therapy Study

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: Cardiac Resynchronization Therapy Device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is indicated for a Medtronic CRT-D system Patient is willing to sign Permission for Access to and Use of Health Information form Patient is willing and able to comply with follow-up visits through six months Exclusion Criteria: Patient has a life expectancy of less than 6 months Patient is participating in any concurrent study that could confound the results for either study

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

| Intervention/Treatment |
| --- |
|Device: Cardiac Resynchronization Therapy Device|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
-----------------
Observational, Heart Failure, Continuous Cardiac Resynchronization Therapy
Biomarkers in Tissue Samples From Older Women With Breast Cancer

Study Overview
=================
Brief Summary
-----------------
This research trial studies phosphatidylinositol-4,5-bisphosphate 3-kinase, catalytic subunit alpha (PIK3CA) mutation analysis in tissue samples from older patients with stage I breast cancer. Studying samples of tissue from patients with stage I breast cancer in the laboratory may help doctors learn more about changes that occur in deoxyribonucleic acid (DNA) and identify biomarkers related to cancer.

Detailed Description
-----------------
PRIMARY OBJECTIVES: To assess the relapse free-survival difference between patients with PIK3CA mutated and wild-type (WT) tumors and therefore validate PIK3CA mutation status as an important biomarker in women 70 years or older diagnosed with breast cancer. OUTLINE: Previously collected tissue samples are analyzed via mutation analysis of PIK3CA.

Official Title
-----------------
PIK3CA Mutation Status as a Biomarker in Elderly Women With Breast Cancer

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

Intervention / Treatment
-----------------
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants with stage I breast cancer (T1N0M0) and estrogen-receptor status positive or unknown Patients underwent lumpectomy with negative margins and were clinically node-negative

Ages Eligible for Study
-----------------
Minimum Age: 70 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: laboratory biomarker analysis|Correlative sciences|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast cancer-free interval for patients with PIK3CA-mutated tumors |  | baseline | 
| Tumor size |  | baseline | 
| Estrogen receptor status |  | baseline | 
| Lymph node status |  | baseline | 
| Treatment group associated with PIK3CA expression |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival associated with PIK3CA |  | baseline | 
| Breast cancer specific survival associated with PIK3CA expression |  | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stage IA breast cancer, stage IB breast cancer, estrogen receptor-positive breast cancer
Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic Benign Prostatic Hyperplasia (BPH)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy and safety of tamsulosin 0.4mg (Harnal® D. 0.2mg, 2T) with tamsulosin 0.2mg (Harnal® D 0.2mg, 1T) in patients with severe symptomatic benign prostatic hyperplasia as a first line therapy.

Official Title
-----------------
The Effects of Tamsulosin 0.4mg on Clinical Outcomes in Korean Men With Severe Symptomatic BPH

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Tamsulosin 0.4mg
* Drug: Tamsulosin 0.2mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe LUTS : IPSS ≥ 20 Exclusion Criteria: Post voided residual urine ≥ 150mL Patients performing catheterization Urinary tract infection patients Patients taking 5 alpha reductase inhibitor Known hypersensitivity to tamsulosin History of postural hypotension or syncope Hypertension patients treated with other alpha1-blockers Patients newly taking anticholinergic medication within 1 month Hepatic insufficiency (AST/ALT ≥ 2 times of normal range) Renal insufficiency (s-Cr ≥ 2mg/dL)

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
Male

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tamsulosin 0.4mg<br> | Drug: Tamsulosin 0.4mg<br>* Treatment: tamsulosin 0.2mg (2T) /day Posology: two 0.2 mg tablet to be taken after an evening meal.<br>|
| Active Comparator: tamsulosin 0.2mg<br> | Drug: Tamsulosin 0.2mg<br>* tamsulosin 0.2mg (1T) /day Posology: one tablet to be taken after an evening meal.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of the total International Prostate Symptom Score (IPSS) score from baseline to 12 weeks of treatment in patients with severe symptomatic BPH refractory to tamsulosin 0.2mg (Harnal® 0.2mg, 1T) |  | 12 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of maximal flow rate and post-voided residual urine volume after 4 and 12 weeks treatment. |  | 4 weeks and 12 weeks of treatment | 
| Changes of parameters in voiding diary after 4 and 12 weeks treatment. |  | 4 weeks and 12 weeks of treatment |
Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer

Study Overview
=================
Brief Summary
-----------------
An Expanded Access Program for IMM-101 for patients with advanced pancreatic cancer.

Detailed Description
-----------------
IMM-101 is a suspension of heat-killed whole cell Mycobacterium obuense. Since it is a heat-killed preparation, treatment is not associated with the potential side-effects of delivering live or attenuated organisms. Five studies with IMM-101 have been completed including a 110-patient randomised Phase II study in pancreatic cancer and exploratory studies in other solid tumours (melanoma, colorectal cancer and advanced melanoma).

Official Title
-----------------
Expanded Access Program Using IMM-101 for Patients With Advanced Pancreatic Cancer

Conditions
-----------------
Pancreatic Cancer, Pancreas Cancer, Pancreatic Cancer Stage IV, Pancreatic Cancer Stage III

Intervention / Treatment
-----------------
* Biological: IMM-101


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: This Expanded Access Program is available for patients of 18 years or older with advanced pancreatic cancer for whom, in the opinion of their treating physician, other treatment options or clinical trials in this indication are unsuitable. Exclusion Criteria: Female patient of child-bearing potential who is not, in the opinion of the physician, using an approved method of birth control (e.g., physical barrier [patient and partner], contraceptive pill or patch, spermicide and barrier, or intrauterine device [IUD]).

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: IMM-101|IMM-101 10mg/mL, a suspension of heat-killed whole cell M. obuense in borate-buffered saline. The treatment regimen with IMM-101 is one dose given every 2 weeks for three doses followed by 4 weeks rest, then one dose is given every 2 weeks for a further three doses. Subsequent doses are given every 4 weeks.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
HPV Screening (Human Papilloma Virus)

Study Overview
=================
Brief Summary
-----------------
Examination of cervical &urine samples for HPV

Detailed Description
-----------------
500 females attending colposcopy kasrelaini unit are included. History including age and parity is taken.urine samples are taken. Colposcopy will be done. Pap smear will be taken and sent for pathology.

Official Title
-----------------
Screening for Human Papilloma Virus in Urine and Pap Smear.A Comparative Study.

Conditions
-----------------
HPV Testing

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all females attending colposcopy kasrelaini unit aging 18_45 years Exclusion Criteria: females with known cervical cancer females less than 18 or more than 45

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Number of patients with positive urine test for HPV Number of patients with positive pap smear. |  | 3 months |
Impact of Pelvic Floor Musculature on Peripartum Outcomes

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand the effect of the pregnancy on the muscles in the pelvis. The purpose of this study is to evaluate the pelvic muscle changes related to pregnancy; to assess if the ability to squeeze and relax these muscles has any effect on delivery mode and if there are any injuries to the pelvic muscles.

Detailed Description
-----------------
Healthy women who are pregnant with their first child will be included in the study. Information about their general health will be gathered. These women will be screened for pelvic disorders at the start and end of study. Three-dimensional ultrasound will be performed three times: 12-24 weeks, 34-39 weeks and 4-6 weeks after delivery. Fetal measurements will be included in the third trimester ultrasound for prediction of estimated birth weight. The relationship of the predicted fetal weight and the likelihood of having a successful vaginal delivery will be studied. Images will be analyzed for pelvic muscles function and injuries. Information regarding the length of labor, types of delivery and vaginal tears will be gathered. The information obtained will be analyzed to look for the strength of correlation of variables to the outcomes.

Official Title
-----------------
Impact of Pelvic Floor Musculature on Peripartum Outcomes: A Prospective Study

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primiparous or should not have given birth to a fetus older than 12 weeks. Singleton pregnancy. Age more than or equal to 18 years. Basal mass index between 18 - 40 kg/m2. Must plan to deliver at Strong Memorial Hospital at the University of Rochester Medical Center. Exclusion Criteria: Basal mass index more than 40 kg/m2. Presence of current or prior history of cervical incompetence. Presence of diabetes mellitus (type I or type II). Presence of connective-tissue disorders such as Systemic lupus erythematosus, Rheumatoid Arthritis, or Sjogren's disease. Presence of neuromuscular disorders such as myasthenia gravis and neuropathies.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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 |
| --- | --- | --- |
| Serial changes in pelvic floor anatomy and function | To evaluate the serial changes in pelvic floor anatomy and function during the second, third trimester of pregnancy and in the postpartum period. | 12-24 weeks, 34-39 weeks gestation, and 4-6 weeks postpartum |
Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)

Study Overview
=================
Brief Summary
-----------------
This study is a research and development initiative established to explore the use of magnetic resonance imaging (MRI) as a tool for managing organ motion of the liver in cancer patients planning procedures for stereotactic body radiation therapy (SBRT).

Detailed Description
-----------------
There is a potential role to systematically implement MRI to establish appropriate workflow of the implementation for tumor motion management in liver SBRT. Compared to CT, MRI has many significant advantages for radiotherapy planning, including superior tumor and soft-tissue contrast, flexible imaging orientation, freedom from radiation exposure and real-time imaging. MRI solely based liver SBRT will allow for more precise delineation of target volume, less uncertainties in treatment planning, better motion management, and potentially better treatment outcome

Official Title
-----------------
Magnetic Resonance Imaging (MRI) Solely For Liver Stereotactic Body Radiation Therapy (SBRT)

Conditions
-----------------
Primary Liver Cancer, Metastatic Liver Cancer From Any Cancer Site

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 21 Patients with primary stage I, II, III liver cancer or metastatic tumor in the liver from any cancer site Signed, specific informed consent prior to study entry Women of child bearing potential must have a negative serum pregnancy test Exclusion Criteria: Any condition for which a MRI procedure is contraindicated including presence of metallic material in the body, such as pacemakers, non- MRI compatible surgical clips, shrapnel. Pregnant or breast-feeding women are excluded. Subjects who have difficulty lying flat on their back for extended periods of time

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| Single arm cohort study<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure average motion trajectories |  | During MRI approx 1 hour | 
| Image quality, as measured by image rating | Image quality will be measured on a scale of 1 to 5, 1 being the best. | During MRI approx 1 hour | 
| Image quality, as measured by tumor volume |  | During MRI approx 1 hour | 
| Image quality, as measured by tumor-to-live contrast to noise ratio |  | During MRI approx 1 hour | 
| Planning target volume (PTV) | PTV is defined as PTV=internal target volume (ITV) + safety margin (M) | During MRI approx 1 hour |
Total Body Albumin Measurement Utilizing a Modification of the BVA 100 Blood Volume Analyzer

Study Overview
=================
Brief Summary
-----------------
The DAXOR Corporation manufactures and distributes a blood volume analyzer. The analysis is based on the tracer dilution principle utilizing radioiodine labeled human serum albumin. In addition to calculating human blood volume it is hypothesized that measurement of the dilution of the tracer can also yield an accurate measurement of total body albumin.

Detailed Description
-----------------
Twenty adult individuals underwent a standard blood volume measurement. The specimens for this determination are normally collected over a period of approximately 40 minutes. For the determination of total body albumin, additional specimens were collect over a three to four day period until the counts in the blood specimens were stable. Calculation of the degree of dilution over this time interval is thought to represent dilution of the tracer in albumin in both the intra and extravascular space. The ratio of albumin in the intravascular to the extravascular space is available in the medical literature. The total volume in which the tracer is distributed can be determined from the dilution determined. A calculation of total body albumin is therefore possible. Computation of the total body albumin for the test subjects (all normal individuals) was consistent with values for total body albumin in the literature. The purpose of the development of this method is to permit clinicians to determine albumin status in patients with disturbances in albumin such as burn patients, cirrhotic patients, nephrotic patients as well as patients with protein losing gastroenteropathies.

Official Title
-----------------
Pilot Research Study to Asses Total Body Albumin Levels

Conditions
-----------------
Hypoalbuminemia, Heart Failure, Nephrosis, Cirrhosis, Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal adult males and females. Females in the childbearing age group to have test to exclude pregnancy Exclusion Criteria: Children, pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Total Body Albumin | The study demonstrated that total body albumin can be determined utilizing modified software designed for this purpose with the BVA 100 blood volume analyzer |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BVA-100 Blood volume analyzer, Human serum albumin labeled with Iodine 131
ACEIs and ARBs Treatment in Diabetic Patients -Drug Interactions and Adverse Drug Effects

Study Overview
=================
Brief Summary
-----------------
Proteinuria is an expression of diabetic nephropaty in type 1 and type 2 patients. Hypertenshion treatment and decreasing urine protein excretion, slow down renal deterioration. Treating diabetic ,hypertensive patients with Angiotensin Converting Enzyme inhibitors (ACEi), Angiotensin receptor blockers (ARBs)is common practice. The aim of our work is to examine 1.The prevalence of ACE and ARB treatment in diabetic patients with or without hypertension.2. Adverse drug reactions of ACEi and ARBs alone or in combination.

Detailed Description
-----------------
The study group- men and women with diabetes mellitus type 2,who were hospitalized in the department of internal medicine in Assaf- Harofeh Medical Center. During hospitalization, data regarding the clinical history,chronic diseases and drugs were collected from the medical files. Blood tests results were recorded during hospitalization .The patients were asked about adverse drug effects.

Official Title
-----------------
Angiotensin Converting Enzyme Inhibitors & Angiotensin Receptor Blocker in the Treatment of Type 2 Diabetic Patients Adverse Drug Effects and Drug Interactions- a Survey in an Internal Medicine Department.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients admitted to department of Internal Medicine in Assaf Harofeh Medical Center Exclusion Criteria: Type 1 diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 90 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
-----------------
Diabetes Mellitus type 2, ACE Inhibitors, ARBs, Adverse drug effect
Clinical Study of the HeartLight X3 Endoscopic Ablation System With Excalibur Balloon

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to demonstrate the improved ablation and procedure times of the HeartLight X3 compared to the current HeartLight catheter in the treatment of atrial fibrillation.

Official Title
-----------------
Clinical Study of the HeartLight X3 Endoscopic Ablation System (EAS) With Excalibur Balloon Compared to HeartLight System in the Treatment of Symptomatic Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Device: HeartLight X3


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: paroxysmal atrial fibrillation failure of at least one AAD others Exclusion Criteria: overall good health as established by multiple criteria

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HeartLight X3<br>Pulmonary vein isolation using HeartLight X3 | Device: HeartLight X3<br>* Pulmonary vein isolation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ablation time | Ablation time | Acute - at the end of the index procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Procedure time | Procedure time | Acute - at the end of the index procedure | 
| PV Isolation | Percent of isolated pulmonary veins | Acute - at the end of the index procedure | 
| PAE Rate | Primary Adverse Event rate | 30 Days | 
| AF Free Rate | 6- and 12-month chronic results | 6 and 12 months |