linjc16/ctgov huggingface dataset:
Myocet, Docetaxel & Trastuzumab as 1st Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
To study the pharmacokinetic profile of the therapeutic schedule in order to demonstrate absence of negative interactions among the 3 drugs administered

Detailed Description
-----------------
To assess the maximum tolerated dose (MTD) of Myocet at different dosages in combination with Taxotere at the fixed dose of 35 mg/m2 on day 2 and 9 every 21 days and weekly Herceptin as first line therapy in patients affected by HER-2/neu positive metastatic breast cancer To enhance the proportion of complete remission To allow the feasibility of the combination of Herceptin with both Myocet and Taxotere without an enhanced risk of cardiotoxicity

Official Title
-----------------
Phase I-II Study of Liposomal Doxorubicin (Myocet®), Docetaxel and Trastuzumab as First-Line Treatment of Patients With HER-2/Neu Positive Metastatic Breast Cancer

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

Intervention / Treatment
-----------------
* Drug: Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HER-2/neu overexpression assessed by FISH test or with immunohistochemical methods: Dako(the result must be 3+ with dakotest); if the immunohistochemical test results 2+ it is needed a positive FISH test Female < 70yrs Histologically or cytologically proven breast cancer. Metastatic or locally advanced breast cancer (clinical stage: III-IV) Adequate hematological, hepatic, renal and cardiac function, the latter confirmed by echocardiography with FEVS ≥50% Prior adjuvant chemotherapy if doxorubicin total dose ≤300 mg/m2, epirubicin total dose ≤450 mg/m2 Exclusion Criteria: History of cardiopathy Severe hepatic and renal diseases Brain metastases as the only parameter of disease Contraindication to the use of corticosteroids as premedication Acute infectious diseases Insulin-dependent diabetes History of other cancers except for adequately treated basal cell skin cancer or in situ carcinoma of the cervix Concurrent treatment with any other cancer therapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

| Intervention/Treatment |
| --- |
|Drug: Liposomal Doxorubicin (Myocet), Docetaxel and Trastuzumab|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Detection of Coronary Vulnerable Plaque With Contrast-enhanced Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
MRI has the ability to visualize the arterial vessel wall. Wall thickening and atherosclerotic plaque components can be visualized in the carotid arteries and the aorta. Previous studies also demonstrated the ability of MRI to visualize the coronary vessel wall. The ultimate goal of coronary vessel wall imaging is to detect vulnerable atherosclerotic plaque thereby. This might prevent complications, e.g., chest pain (angina) or myocardial infarction. The goal of this study was to validate MRI of the coronary vessel wall by comparing it to intravascular ultrasound (IVUS), to detect atherosclerotic plaque in the coronary vessel wall and to look at the uptake of the albumin-binding contrast agent gadofosveset in atherosclerotic plaques. The main hypothesis is that due to the albumin binding characteristics, uptake of the contrast agent will take place in the more vulnerable plaques compared to less vulnerable plaques. MRI will be compared to X-ray coronary angiography and intravascular ultrasound, two techniques currently considered as the standard of reference for imaging of the coronary arteries and vessel wall.

Official Title
-----------------
Detection of Vulnerable Plaque With Coronary Vessel Wall MRI: Contrast Enhanced MRI With Gadofosveset MS-325.

Conditions
-----------------
Coronary Artery Disease, Stable Angina, Unstable Angina

Intervention / Treatment
-----------------
* Other: Contrast enhanced MRI with Gadofosveset


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled X-ray angiography for known coronary artery disease, valvular disease or chest pain with unknown origin age > 18 yrs and < 90 yrs Informed consent Exclusion Criteria: arrhythmia hemodynamic unstable patients contra-indications for (contrast-enhanced) MRI age < 18 yrs or > 90 yrs

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

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

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

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

Design Details

Primary Purpose: Diagnostic


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Contrast enhanced MRI with Gadofosveset|0.03 mmol/kg bodyweight of gadofosveset will only once be administered during MRI procedure via an intravenous catheter|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validation of MRI: comparison with IVUS. Can plaque be detected? |  | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| uptake contrast agent gadofosveset in atherosclerotic plaque in the coronary vessel wall? |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
coronary artery, MRI, vessel wall imaging
Observational Study in Type 2 Diabetes Treated by an Intensive Insulin Treatment (ICT) Containing Once Daily Levemir® (Insulin Detemir)

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to gain practical experience with once-daily Levemir administration in type 2 diabetes patients who were previously treated with Insulatard®, Humulin® N (NPH insulins) as basal insulin as part of their ICT under normal clinical practice conditions in Hungary.

Official Title
-----------------
Evaluation on Glycaemic Control and Weight Change of Once Daily Levemir® (Insulin Detemir) in Type 2 Diabetes Mellitus Treated by an Intensive Insulin Treatment (ICT)

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

Intervention / Treatment
-----------------
* Drug: insulin detemir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic subjects on intensive insulin treatment (ICT) Eligibility for once daily insulin detemir administration Informed consent obtained before any observation-related activities Exclusion Criteria: Known or suspected allergy to insulin detemir Subjects previously enrolled in the observation Women who are pregnant, breast feeding or have the intention of becoming pregnant within 6 months.

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 |
| --- | --- |
| A<br> | Drug: insulin detemir<br>* observational study - dose and frequency to be prescribed by the physician as a result of standard clinical practice.<br>* Other names: Levemir®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy (HbA1c) |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight |  | 24 weeks | 
| Hypoglycaemia frequency |  | 24 weeks | 
| FBG variability |  | 24 weeks | 
| Insulin dose change |  | 24 weeks |
The Effect of Clove Oil on Labor Pain

Study Overview
=================
Brief Summary
-----------------
The study has two groups. one of them is experimental group that is given massage with clove oil. The other one is control group that is given standard midwifery care. Each group consists of 30 women. We will evaluate their labor pain scores by using Visual Analogue Scale before and after massage application.

Detailed Description
-----------------
Labor is a painful process. That's why there are lots of nonpharmacological methods to reduce labor pain. Especially most clinical guide suggests giving massage to pregnant who has labor pain. In the literature, there are a lot of study examining effectiveness of massage techniques. However there is no study about massage application with clove oil on labor pain. The investigators would like to give a massage with clove oil to pregnants to reduce their labor pain. Hereby the investigators will evaluate effectiveness of clove oil.

Official Title
-----------------
The Effect of Massage Applied With Clove Oil on Perceived Labor Pain

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Other: Massage Application with clove oil
* Other: Massage Application without any oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of volunteer and pregnant women is 18-35 years old. Exclusion Criteria: The pregnant women has any obstetrical complications.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: There are two groups as experimental and control.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>The pregnant women in the experimental group are given a massage with clove oil. | Other: Massage Application with clove oil<br>* The experimental group is given a massage with clove oil,<br>|
| Other: Control Group<br>The pregnant women in the control group are given a massage without any oil as standard midwifery care | Other: Massage Application without any oil<br>* The control group is given a massage without any oil as a standard midwifery care.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | The scale has 0-10 points. As the point increases the pain score increases | during labor process, until the labor process is done. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor pain, midwifery, pregnant women, massage
Magnetic Resonance Imaging of Atrial Septal Defects

Study Overview
=================
Brief Summary
-----------------
An atrial septal defect (ASD) is a hole in the heart that can lead to heart failure. Depending on the size and severity of the ASD, They can be treated during a heart catheterization with a special device that can permanently seal the ASD, but knowing the exact size and severity of the ASD is crucial. Newer MRI techniques may provide a better way at diagnosing the size and severity of an ASD. We compared MRI to other standard clinical ways for evaluating an ASD.

Detailed Description
-----------------
Background: Atrial septal defect (ASD) flow can be measured indirectly by velocity-encoded cardiovascular magnetic resonance (veCMR) of the pulmonary artery and aorta (Qp/Qs). Imaging the secundum ASD en face could potentially enable direct flow measurement and, additionally, provide valuable information regarding ASD size, shape, location, and proximity to other structures. Methods: Patients referred for possible transcatheter ASD closure underwent a comprehensive standard evaluation including transesophageal and/or intracardiac echocardiography (ICE), and invasive oximetry. CMR was performed in parallel and included direct en face veCMR after an optimal double-oblique imaging plane was determined accounting for ASD flow direction and cardiac-cycle interatrial septal motion. We hypothesized that En face veCMR using an optimized imaging plane can accurately determine ASD flow, size, and morphology, and that it would provide information incremental to comprehensive standard evaluation.

Official Title
-----------------
Imaging of Atrial Septal Defects by Velocity Encoded Cardiovascular Magnetic Resonance

Conditions
-----------------
Atrial Septal Defect

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Suspected Atrial Septal Defect (ASD) undergoing evaluation for possible transcatheter closure Exclusion Criteria: Contraindications to magnetic resonance imaging known sinus venosus or primum defects

Ages Eligible for Study
-----------------
Minimum 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 |
| --- | --- | --- |
Fenofibrate in Dyslipidemia and Metformin-Controlled Diabetes

Study Overview
=================
Brief Summary
-----------------
The primary objective was to assess the effect of 3-month treatment of low and standard doses of fenofibrate in combination with stable dose of metformin on fasting triglycerides levels in patients with type 2 diabetes and dyslipidemia.

Official Title
-----------------
A Randomized, Double-Blind Trial Assessing the Efficacy and Safety of Low and Standard Doses of Fenofibrate in Combination With Metformin on the Lipid Profile in Patients With Type 2 Diabetes and Dyslipidemia.

Conditions
-----------------
Dyslipidemia/Glucose Metabolism Disorder

Intervention / Treatment
-----------------
* Drug: fenofibrate and metformin combination (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes mellitus Exclusion Criteria: Type 1 diabetes, uncontrolled type 2 diabetes, - HbA1c ≥ 10 % - Fasting plasma glucose > 300 mg/dL - Triglycerides > 500 mg/dL

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: fenofibrate and metformin combination (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in fasting triglycerides. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of lipid and glucose metabolisms. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Treatment of Dyslipidemia and of Type 2 Diabetes Mellitus
Randomised Controlled Trial Comparing Tension-Free Vaginal Tape (TVT), Pelvicol & Autologous Slings for Stress Urinary Incontinence(SUI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial was to discover which type of operation for stress urinary incontinence in women offered better results: autologous slings, TVT or Pelvicol slings.

Official Title
-----------------
A Randomised Controlled Trial Comparing TVT, Pelvicol and Autologous Fascial Slings for the Treatment of Stress Urinary Incontinence in Women

Conditions
-----------------
Stress Urinary Incontinence

Intervention / Treatment
-----------------
* Procedure: Autologous fascial sling
* Procedure: TVT
* Procedure: Pelvicol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women requiring surgery for SUI following failed conservative treatment Exclusion Criteria: Under 18 years of age Previous surgery for SUI Evidence of neurological disease Pelvic Organ Prolapse (POP) greater than Grade 2 Women with any evidence of Detrusor Overactivity or bladder hypocompliance on urodynamic assessment

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

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

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Autologous Fascial Sling<br>Retropubic, bottom up autologous sling | Procedure: Autologous fascial sling<br>* Retropubic bottom up mid urethral sling made using autologous rectus sheath fascia<br>|
| Active Comparator: TVT<br>Standard retropubic TVT | Procedure: TVT<br>* Standard TVT as described by Ulmsten 1996<br>|
| Active Comparator: Pelvicol<br>Retropubic mid urethral sling made from Pelvicol | Procedure: Pelvicol<br>* retropubic mid urethral sling made from Pelvicol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate at improving symptom of stress urinary incontinence |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| completely dry rates |  | 1 year | 
| quality of life scores |  | 1 year | 
| intra & post-operative complications |  | 1 year | 
| re-operation rates |  | 1 year | 
| hospital stay |  | 5 days | 
| operative time |  | hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stress urinary Incontinence, autologous slings, slings, tvt, grafts, surgery
iStent Inject New Enrollment Post-Approval Study

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the rate of clinically relevant complications associated with iStent inject placement in the post-market setting.

Detailed Description
-----------------
To evaluate the rate of clinically relevant complications associated with iStent inject placement and stability, as determined at 36 months in the postmarket setting.

Official Title
-----------------
iStent Inject Trabecular Micro-Bypass System New Enrollment Post-Approval Study

Conditions
-----------------
Glaucoma, Open-Angle, Glaucoma

Intervention / Treatment
-----------------
* Device: iStent Inject Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female ≥ 22 years of age Mild to moderate primary open-angle glaucoma Scheduled to undergo cataract surgery Able and willing to attend scheduled follow-up exams for three years postoperatively Able and willing to provide written informed consent on the IRB approved Informed Consent Form Operative Inclusion Criterion: Successful, uncomplicated cataract surgery Exclusion Criteria: Angle closure glaucoma Traumatic, malignant, uveitic, or neovascular glaucoma or discernible congenital anomalies of the anterior chamber angle Retrobulbar tumor, thyroid eye disease, Sturge-Weber Syndrome or any other type of condition that may cause elevated episcleral venous pressure

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Implantation<br>Subjects will undergo cataract surgery and then implantation of the iStent Inject trabecular micro-bypass device. | Device: iStent Inject Implantation<br>* Subjects will be implanted with the iStent Injection Micro-Bypass device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| iStent inject placement and stability | The rate of clinically relevant complications associated with iStent inject placement and stability | 36 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sight-threatening adverse events | Rate of occurrence of sight-threatening adverse events | 36 Months |
The Effects of Cervical Spine Manipulation On Postural Control

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test the effect of high velocity low amplitude (HVLA) chiropractic cervical manipulation on the patient's postural control as measured by a force plate.

Conditions
-----------------
Posture

Intervention / Treatment
-----------------
* Procedure: HVLA chiropractic manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Students Normal healthy adults Exclusion Criteria: Previous or ongoing foot, ankle, or hip problems Experiencing vertigo, visual difficulties and other disorders that would make it difficult to balance for a set period of time. Anyone with high risk for injury due to cervical manipulation Anyone with training in areas of activity that require superior balance Body mass index over 30

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

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: HVLA chiropractic manipulation|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
-----------------
To determine the effects of cervical spine manipulation on postural control.