linjc16/ctgov huggingface dataset:
A Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy and safety after concomitant administration of ASP1941 and metformin in patients with diabetes mellitus.

Detailed Description
-----------------
This study is to evaluate the efficacy (HbA1c change from baseline) and safety of ASP1941 in combination with metformin in subjects with type 2 diabetes mellitus (T2DM) who have inadequate glycemic control with metformin alone. The effects of ASP1941 are compared with those of placebo.

Official Title
-----------------
A Phase 3 Study to Assess the Efficacy and Safety of ASP1941 in Combination With Metformin in Patients With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin Alone

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

Intervention / Treatment
-----------------
* Drug: ipragliflozin
* Drug: Placebo
* Drug: metformin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients receiving with metformin mono-therapy for at least 6 weeks HbA1c value between 7.0 and 9.5% Body Mass Index (BMI) 20.0 - 45.0 kg/m2 Exclusion Criteria: Type 1 diabetes mellitus patients Serum creatinine > upper limit of normal Estimated GFR < 60ml/min/1.73m2 Proteinuria (albumin/creatinine ratio > 300mg/g) Dysuria and/or urinary tract infection, genital infection Significant renal, hepatic or cardiovascular diseases Severe gastrointestinal diseases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ASP group<br>ASP1941 and metformin | Drug: ipragliflozin<br>* oral<br>* Other names: ASP1941;Drug: metformin<br>* oral<br>* Other names: Glycoran;|
| Placebo Comparator: Placebo group<br>placebo and metformin | Drug: Placebo<br>* oral<br>Drug: metformin<br>* oral<br>* Other names: Glycoran;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c |  | Baseline and for 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in fasting plasma glucose |  | Baseline and for 24 weeks | 
| Change from baseline in fasting serum insulin |  | Baseline and for 24 weeks | 
| Safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) |  | for 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Metformin, ASP1941
A Efficacy and Safety Trial of Controlled Release (CR) Morphine in Cancer Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to determine the effect of Egalet® Morphine once daily compared to MST Continus twice daily on pain intensity and use of rescue medication for break through pain after 2 weeks of treatment in patients with pain due to cancer.

Official Title
-----------------
A Double-blind, Randomized, 2-way Cross-over, Phase II, Efficacy Trial in Cancer Patients to Assess the Overall Efficacy, Patient Preference, Morphine Related Side Effect Profile and Safety of the Egalet® Controlled Release Morphine Formulation 30-240 mg Once Daily Compared to MST Continus® 15-120 mg Twice Daily After 2 Weeks of Treatment

Conditions
-----------------
Pain, Cancer

Intervention / Treatment
-----------------
* Drug: Morphine Sulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient has stable strong opioid use equipotent to 30-240 mg oral morphine sulphate daily for a minimum of 2 weeks prior to entering the run-in phase. The patient has opioid-sensitive pain caused by active cancer. The patient is aged minimum 18 years. Exclusion Criteria: The patient has a life expectancy less than 2 months. The patient has received chemotherapy or radiation therapy less than 4 weeks prior to entering run-in phase Patients with medical conditions contraindicating morphine treatment The patient has hepatic disease or impaired kidney function The patient is taking monoamine oxidase inhibitors (MAOIs) or has taken a MAOI within two weeks prior to entering baseline. The patient is taking other opioid agonists or antagonists, zidovudine or cimetidine.

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Egalet® morphine<br> | Drug: Morphine Sulphate<br>* Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks<br>|
| Active Comparator: MST Continus®<br> | Drug: Morphine Sulphate<br>* Egalet® morphine, Controlled Release 30 mg Oral tablet once daily for 2 weeks and MST Continus® 15 mg twice daily for 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of rescue medication |  | 2 weeks treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity |  | 2 weeks treatment |
Drug Interaction Study to Assess the Effect of Co-Administered Miravirsen and Telaprevir in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety, tolerability, and affect on blood levels of miravirsen and telaprevir when administered together.

Official Title
-----------------
A Phase 1, Open-Label, Drug Interaction Study to Assess Safety, Tolerability, and Pharmacokinetics of Co-Administered Miravirsen and Telaprevir in Healthy Subjects

Conditions
-----------------
Hepatitis C, Chronic Hepatitis C

Intervention / Treatment
-----------------
* Drug: Miravirsen sodium
* Drug: Telaprevir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers Weight ≤ 85 kg Females of non-childbearing potential (postmenopausal or surgically sterile) or males who are surgically sterile or using an acceptable form of birth control Exclusion Criteria: Current, clinically significant illness or medical condition

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

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Miravirsen sodium<br> | Drug: Miravirsen sodium<br>* Miravirsen 7 mg/kg to be administered as single subcutaneous injections for a total of 5 doses over a 5 week treatment period.<br>* Other names: SPC3649;|
| Active Comparator: Telaprevir<br> | Drug: Telaprevir<br>* Telaprevir 750 mg to be administered as single and multiple oral doses over two 7 day treatment periods.<br>* Other names: Incivek;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of miravirsen on telaprevir pharmacokinetics as determined by AUC0-24h, Cmax and tmax. |  | Up to 24 hours after dosing. | 
| Safety and tolerability of co-administered miravirsen and telaprevir. | Safety and tolerability will be assessed by evaluation of adverse events, physical examinations, vital signs, clinical safety laboratory assessments and electrocardiograms. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effect of telaprevir on miravirsen pharmacokinetics as determined by AUC0-24h, Cmax and tmax. |  | Up to 24 hours after dosing. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Antisense, miR-122 antagonist, Safety in healthy volunteers, Hepatitis C
Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy

Study Overview
=================
Brief Summary
-----------------
To evaluate the benefit for statin use in prevention of of CI-AKI after computed tomography urogram (CTU).

Official Title
-----------------
Effects Of Combination Therapy Of Statin And Ascorbic Acid For Prevention Of Contrast-Induced Nephropathy. Randomised Controlled Study

Conditions
-----------------
Contrast-induced Nephropathy, Statin, Ascorbic Acid, AKI

Intervention / Treatment
-----------------
* Drug: Atorvastatin-Ascorbic acid
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Planned computed tomography urogram (CTU) Statin naive, or not on statin treatment for at least 14 day Exclusion Criteria: History of liver disease or elevated serum transaminases History of rhabdomyolysis or elevated creatinine kinase History of iodinated CM use within 14 days before randomization History of N-acetylcysteine, metformin or nonsteroidal anti-inflammatory drugs use within 48 hours of the procedure. History of hypersensitivity reaction to contrast media Pregnancy or lactation Acute renal failure End-stage renal disease requiring dialysis Cardiogenic shock or pulmonary edema Multiple myeloma

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Atorvastatin-Ascorbic acid<br>atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg | Drug: Atorvastatin-Ascorbic acid<br>* atorvastatin (80-mg loading dose given a mean 24 hours before procedure with another 40-mg dose approximately 2 hours before the procedure and for 3 days) plus ascorbic acid 500mg<br>|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast Induced-Acute Kidney Injury | Increase in serum creatinine ≥ 0.5 mg/dl or ≥ 25 % within 72 hours of contrast medium exposure. | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| long-term Renal function by estimated GFR | measured in ml/min/1.73m2 | 30 days |
Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
A single-center prospective study. Patients undergoing minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden are eligible. Femoral cannulation was performed percutaneously with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device (MANTA; Teleflex/Essential Medical, Malvern, PA). Data regarding preoperative clinical characteristics and operative details were obtained by medical records review.

Official Title
-----------------
Percutaneous Plug-based Arteriotomy Closure Device Use in Minimally Invasive Cardiac Surgery

Conditions
-----------------
Minimally Invasive Cardiac Surgery

Intervention / Treatment
-----------------
* Device: Percutaneous vascular closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Operated with minimally invasive cardiac surgery between 2017 and 2022 at the Karolinska University Hospital in Stockholm, Sweden, with use of percutaneous femoral cannulation with planned percutaneous arteriotomy closed using a plug-based arteriotomy closure device. Exclusion Criteria: None.

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 |
| --- |
|Device: Percutaneous vascular closure|Percutaneous arteriotomy closed using a plug-based arteriotomy closure device|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any vascular groin-related complication |  | During the first 8 weeks after surgery |
RV Function Evaluation Assessed by Strain and Validated by MRI

Study Overview
=================
Brief Summary
-----------------
Echocardiographic assessment of right ventricular function is an important diagnostic tool, and is a challenge due to the unique structure and anatomy of the right ventricle. Lately a new technique has been developed and used for evaluating both the left and the right ventricle function. This technique, called two dimensional (2D) speckle tracking, is based on detecting speckles in the myocardial tissue and using them as acoustic markers. The movement of these speckles represents the movement of the tissue, and allows us to evaluate its function, contraction and relaxation, this by calculating the strain rate, which is the speed of the speckles, and the strain, which is the distance between them. In the last few years this technique has been used to evaluate the systolic function of the right ventricle in several pathological conditions, such as pulmonary hypertension, pulmonary embolism and amyloidosis. Nonetheless, so far there has been little data on the normal RV strain and strain rate values. In this study the investigators aim to validate two dimensional (2D) speckle tracking measurements of the RV function by comparing them to strain measurements by cardiac MRI. Each patient performing cardiac MRI for any indication will perform an echocardiography examination in addition, and strain analysis performed on the cardiac MRI will be compared with two dimensional speckle tracking analysis performed on the echocardiography.

Official Title
-----------------
RV Function by Strain and MRI

Conditions
-----------------
Right Ventricular Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: More than 18 Exclusion Criteria: Age: Children Unconcious patients.

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 |
| --- | --- | --- |
| Correlation of 2D Echo and Echo strain measurements versus MRI measurements | RV dimensions, RV function, RV strain measurements compared to MRI measurements | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rehospitalization | Time from index event to timing and length of rehospitalization (based on hospital data and completed with phone interview when necessary) | 2 years |
Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

Study Overview
=================
Brief Summary
-----------------
Evaluate the accuracy of the RTVue-XR and iVue for measuring the total corneal thickness, the epithelial thickness, and the stromal thickness in normal subjects and patients with various corneal conditions.

Official Title
-----------------
Evaluation of the Accuracy of Corneal Epithelial Thickness Mapping With SD-OCT

Conditions
-----------------
Cornea

Intervention / Treatment
-----------------
* Device: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal Able and willing to provide consent. Able and willing to complete required exams. Corneal conditions Able and willing to provide consent. Able and willing to complete required exams. History of refractive surgery, contact lens, dry eye or keratoconus. Exclusion Criteria: Normal History of refractive surgery, contact lens, dry eye or pathology. Blepharitis or meibomitis Unable to complete required exams. Corneal conditions • Unable to complete required exams.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal<br>Not having any history of refractive surgery, contact lens, dry eye or pathology | Device: OCT<br>* OCT for all Arms<br>|
| Corneal condition<br>History of refractive surgery, contact lens, dry eye or keratoconus. | Device: OCT<br>* OCT for all Arms<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Epithelial thickness |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal thickness |  | Day 1 |
Observational Study of Osseotite Certain Tapered Implants in Immediate Loading Cases

Study Overview
=================
Brief Summary
-----------------
Osseotite Certain Tapered implants placed in immediate prosthesis loaded cases.

Detailed Description
-----------------
Osseotite Certain Tapered implants are placed and restored immediately (during the same visit)

Official Title
-----------------
A Prospective, Observational Study of Immediate Loading Cases Using Osseotite Certain Tapered Implants

Conditions
-----------------
Partial Edentulism, Tooth Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients of either sex and older than 18 years of age patients needing at least one dental implant to treat partial edentulism patients physically able to tolerate surgical and restorative dental procedures patients agreeing to all protocol visits Exclusion Criteria: patients with infection or severe inflammation at the intended treatment sites patients smoking greater than 10 cigarettes per day patients with uncontrolled diabetes mellitus patients with uncontrolled metabolic diseases patients who received radiation treatment to the head in the past 12 months patients needing bone grafting at the intended treatment sites patients known to be pregnant at screening visit patients with para-functional habits like bruxing and clenching

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 |
| --- | --- |
| Osseotite Certain Tapered<br>Dental implant Osseotite Certain Tapered design | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cumulative success rate | An implant will be considered successful if it is immobile at various study points in time | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
edentulism, dental implants, Osseotite Certain Tapered, randomized, clinical study, partial edentulism, immediate loading, crestal bone level
Intrathecal Mg in Gynecologic Laparoscopic Surgeries.

Study Overview
=================
Brief Summary
-----------------
The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Detailed Description
-----------------
The investigators aim to investigate the differences between intrathecal Bupivacaine + Mg sulfate in spinal anesthesia versus Bupivacaine on surgeon satisfaction, patient satisfaction and postoperative pain in gynecologic laparoscopic surgeries.

Official Title
-----------------
Effects of Addition of Magnesium Sulfate in Spinal Anesthesia on Surgeon Satisfaction and Postoperative Pain in Gynecologic Laparoscopic Surgeries.

Conditions
-----------------
Gynecologic Laparoscopic Surgery

Intervention / Treatment
-----------------
* Drug: intrathecal Mg sulfate.
* Drug: intrathecal bupivacaine 15 mg.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female patient. more than 18 years. undergoing elective gynecologic laparoscopic surgeries. Exclusion Criteria: allergy to local anesthesia. contraindication to spinal anesthesia. Significant cardiac, liver or renal dysfunction. Inability to informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: intrathecal bupivacaine + Mg sulfate<br>intrathecal bupivacaine 15 mg + intrathecal Mg sulfate 50 mg. in gynecologic laparoscopic surgeries. | Drug: intrathecal Mg sulfate.<br>* intrathecal Mg sulfate 50 mg.<br>Drug: intrathecal bupivacaine 15 mg.<br>* intrathecal bupivacaine 15 mg.<br>|
| Active Comparator: intrathecal bupivacaine<br>intrathecal bupivacaine 15 mg in gynecologic laparoscopic surgeries. | Drug: intrathecal bupivacaine 15 mg.<br>* intrathecal bupivacaine 15 mg.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| surgeon satisfaction (scale from 1 to 10) . | surgeon satisfaction (scale from 1 to 10) as 1 is worst and 10 is best. | intraoperative (from beginning of the gynecologic laparoscopic procedure till the end of the procedure). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative pain management (VAS score). | Visual Analog Scale (VAS score). | postoperative for 6 hours. |