linjc16/ctgov huggingface dataset:
A Study to Assess the Efficacy and Safety of ASP1941 in Japanese Type 2 Diabetes Patients

Study Overview
=================
Brief Summary
-----------------
This study is to compare the efficacy and safety of ASP1941 with placebo in Japanese patients with type 2 diabetes mellitus.

Official Title
-----------------
Phase III Study of ASP1941 -A Phase III, Randomized, Double-Blind, Placebo-controlled, Monotherapy Study to Assess the Efficacy, Safety, and Tolerability of ASP1941 in Japanese Patients With Type 2 Diabetes Mellitus

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

Intervention / Treatment
-----------------
* Drug: ipragliflozin
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetic patients for at least 12 weeks HbA1c value between 7.0 and 10.0% Body Mass Index (BMI) 20.0 - 45.0 kg/m2 Investigator adjudicates that a subject is able to discontinue currently taking hypoglycemic agents safely during treatment Exclusion Criteria: Type 1 diabetes mellitus patients Serum creatinine > upper limit of normal 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: ASP1941 group<br>oral | Drug: ipragliflozin<br>* oral<br>* Other names: ASP1941;|
| Placebo Comparator: placebo group<br>oral | Drug: placebo<br>* oral<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in HbA1c |  | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from baseline in fasting plasma glucose |  | 16 weeks | 
| change from baseline in fasting serum insulin |  | 16 weeks | 
| safety as reflected by adverse events, routine safety laboratories, vital signs, physical examinations and 12-lead electrocardiograms (ECGs) |  | During treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Blood glucose, ASP1941, Diabetes mellitus
Optimal Prophylactic Method of Venous Thromboembolism (VTE)

Study Overview
=================
Brief Summary
-----------------
This study is to define the optimal method of prophylaxis for patients with gastrectomy in Korea and the investigators hypothesized only mechanical method would be enough for preventing VTE on perioperative period.

Detailed Description
-----------------
Venous thromboembolism (VTE) is common and often fatal complication in patients with cancer. Gastric cancer is the most frequent cancer in Korea. The incidence of VTE would be increased in patients with gastric cancer, especially associated surgery. However, the incidence and optimal prophylactic method associated with cancer surgery are not well studied in Asian patients. Most Korean surgeon concerns regarding the increased postoperative bleeding associated with low molecular weight heparin(LMWH)prophylaxis. The incidence and adverse event will be examined to define the optimal prophylactic method of VTE in surgical patients with gastric cancer.

Official Title
-----------------
Optimal Prophylactic Method of Venous Thromboembolism for Gastrectomy in Korean Patients

Conditions
-----------------
Venous Thromboembolism

Intervention / Treatment
-----------------
* Drug: low molecular weight heparin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as gastric cancer Elective and curative under general anesthesia ECOG score 0-2 ASA score 3 or less than 3 Informed consents Exclusion Criteria: 2nd primary cancer VTE history within one year Anticoagulation history Allergic to heparin Pregnancy or expected pregnancy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intermittent pneumatic compression<br>another arm include intermittent pneumatic compression plus low molecular weight heparin | Drug: low molecular weight heparin<br>* 40mg 12 hours before surgery and 12 hours later surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of VTE | The incidence of VTE between mechanical method only group and mechnical plus LMWH group. | up to 30 days after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event | The adverse event such as bleeding will also be compared. | up to 30 days after operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VTE, gastric cancer, incidence
Geneexpression as a Marker of Embryo Viability

Study Overview
=================
Brief Summary
-----------------
The aim of the post doc project is investigate which genes regulate implantation in order to analyze specific proteins and microRNA in the spent culture media with the long-term goal of developing a non-invasive method of embryo assessment and selection. This will be achieved by conducting a targeted NGS analysis, based on list obtained from a non-published pilot study. When further validated by q-PCR, the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified. The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential. If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment.

Official Title
-----------------
Geneexpression as a Marker of Embryo Viability

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: blastocyst biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: >5 oocytes retrieved Exclusion Criteria: endometriosis
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| infertile patients<br>Infertile patients with more than 5 oocytes retrieved and no endometriosis | Other: blastocyst biopsy<br>* Performed on day 5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| gene expression | the expression of specific microRNAs known to influence the final list of genes will be analyzed in the spent culture media and the protein products of the genes recovered from the media will be quantified. The level of specific microRNAs and proteins will be related to aneuploidy and implantation potential. If the level of specific microRNA and/or proteins correlates with pregnancy, the study will form the basis for developing a clinical applicable precise method of improved embryo selection and thus improved IVF treatment | 2 years |
TYSABRI Global Observational Program in Safety

Study Overview
=================
Brief Summary
-----------------
The Primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAE) in participants with multiple sclerosis (MS) treated with Tysabri (natalizumab).

Detailed Description
-----------------
The TYSABRI Global Observational Program in Safety (TYGRIS) is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with natalizumab in a clinical practice setting in the United States or Canada.

Official Title
-----------------
TYGRIS: TYSABRI® Global Observational Program in Safety

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: MS patients in the US and Canada receiving TYSABRI under standard clinical care for less than or equal to 3 infusions are eligible to participate in TYGRIS. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
| --- | --- | --- |
| Number of participants with serious infections, malignancies, and other SAEs |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
natalizumab, MS, Tysabri, Multiple Sclerosis, TYGRIS
CARES Lumbar Artificial Disc Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the registry is to assess outcomes following treatment with lumbar total disc replacement (TDR) in patients outside the clinical trial setting.

Detailed Description
-----------------
The purpose of this study is to capture outcomes associated with use of total disc replacement (TDR) in patients treated with either the CHARITE™ Artificial Disc or the PRODISC®-L Total Disc Replacement may be included in the registry.

Official Title
-----------------
The Centers for Arthroplasty Research and Education in Spine (CARES) Lumbar Artificial Disc Registry Protocol

Conditions
-----------------
Lumbar Degenerative Disc Disease

Intervention / Treatment
-----------------
* Device: Total Disc Replacement


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Treated with the lumbar TDR. Signed IRB approved consent document. Key Exclusion Criteria: None known.

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: Total Disc Replacement|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Oswestry Disability Index (ODI) Score | The ODI assesses several domains of function affected by low back pain. A change of 15 points from baseline is considered a clinical meaningful difference for the individual. The change from pre operative baseline to each follow-up assessment will be calculated. | 3, 6, 12, 24, 36, 48, and 60 months post operative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
arthroplasty, spinal, CHARITE, PRODISC-L, PRODISC, disc, replacement, lumbar
A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the investigators ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer.

Official Title
-----------------
A Pilot C11-Choline PET-CT Imaging Study in Patients With Locally Advanced Esophageal Cancer

Conditions
-----------------
Esophageal Cancer

Intervention / Treatment
-----------------
* Drug: C11-Choline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly diagnosed or recurrent patients with locally advanced esophageal cancer with either squamous or adenocarcinoma histology. Ability to tolerate PET imaging Prior malignancy is allowed, but the expectation of survival must be that beyond that expected for patients with locally advanced esophageal cancer. Exclusion Criteria: Pregnant or lactating females are not eligible for this pilot study. Patients having received chemotherapy in the 3 months prior to registration for any reason Patients with metastatic disease requiring chemoradiation for palliation are not allowed.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: C11-Choline<br> | Drug: C11-Choline<br>* 15 mCi 11C-choline will be administered intravenously as a bolus. The whole body emission scans will be acquired immediately following the tracer injection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate our ability to obtain reliable and meaningful 11C-Choline PET-CT images of esophageal cancer (pre- and post- chemotherapy). |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Perform semi-quantitative analysis of tracer uptake using standard uptake values (SUV) and qualitative analysis using pure visual analysis. |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET Positron emission tomography, CT X-ray computed tomography, Patients with Locally Advanced Esophageal Cancer
E-nose Utility in the Diagnosis of Bacterial Infection in COPD

Study Overview
=================
Brief Summary
-----------------
Hypothesis: A commercial e-nose (Cyranose 320) is able to detect specific breathprints from patients with COPD and bacterial infection

Detailed Description
-----------------
Thirty to 50% of COPD patients have airway colonization with potentially pathogenic bacteria. This is associated with worse prognosis. Currently, diagnosis of bacterial colonization relies mainly upon quantitative sputum culture. However, this method lacks good sensitivity. The electronic nose is a novel device made up of nanosensors capable of detecting specific volatile organic compounds (VOCs). OBJECTIVES: Main 1) To assess the usefulness of the electronic nose in the diagnosis of bacterial colonization in COPD. Secondary 1) To define the VOCs pattern associated with bacterial colonization. 2) To study the pattern of pulmonary and systemic inflammation associated with bacterial colonization as well its relationship with the aforementioned VOCs patterns.

Official Title
-----------------
E-nose Utility in the Diagnosis of Bacterial Infection in Chronic Obstructive Pulmonary Disease (COPD)

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

Intervention / Treatment
-----------------
* Device: enose


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD patients Exclusion Criteria: Exacerbation in the last 4 weeks

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: enose<br> | Device: enose<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathprint in exhaled breath from patients with COPD | Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breathprint in exhaled breath from COPD patients with bacterial colonization | Breathprints will be assessed by discriminant analysis on principal component reduction, resulting in cross-validated accuracy values | Day 1 |
Ertapenem Versus Meropenem/Imipenem for ESBL+ Gram-negative Infections

Study Overview
=================
Brief Summary
-----------------
Adult patients with ESBL-producing Gram negative infections are randomized to receive ertapenem or meropenem/imipenem. Clinical and microbiological responses between both groups are compared.

Detailed Description
-----------------
Ertapenem is active against ESBL-producing Gram negative bacteria. This study is conducted to determine if ertapenem is effective against ESBL-producing Gram negative infections similar to meropenem/imipenem.

Official Title
-----------------
An Open-label, Randomized Equivalence Trial and Cost-effectiveness Analysis of Ertapenem Versus Other Carbapenems for Treatment of Extended -Spectrum Beta-Lactamase (ESBL)-Producing Gram-negative Bacterial Infections

Conditions
-----------------
Drug Safety

Intervention / Treatment
-----------------
* Drug: Ertapenem
* Drug: Meropenem or Imipenem


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hospitalized patients aged >18 years with documented ESBL +ve GNB infection Receive meropenem or imipenem/cilastatin as empiric antibiotic therapy Exclusion Criteria: Having been treated with meropenem or imipenem/cilastatin for longer than 72 hours Have active P. aeruginosa co-infection Pregnancy or breast feeding Allergy to carbapenems

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: Ertapenem<br>Ertapenem 1 gram per day for 7 to 14 days | Drug: Ertapenem<br>* Ertapenem 1 gram per day for 7 to 14 days<br>* Other names: Invanz;|
| Active Comparator: Meropenem or Imipenem<br>Meropenem or Imipenem o.5 or 1 gram 3 to 4 times a day for 7 to 14 days | Drug: Meropenem or Imipenem<br>* Meropenem or Imipenem 0.5 to 1 gram 3 to 4 times per day for 7 to 14 days<br>* Other names: Tienam;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with cure or improvement | Cure Improvement Persistence Death from Infection | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with eradication of the causative bacteria | Eradication Persistence Superinfection | 14 days |
The Effect of Eprosartan on Hormones and Kidney Function in Patients With Essential Hypertension

Study Overview
=================
Brief Summary
-----------------
We, the investigators at Holstebro Hospital, want to test the hypothesis that eprosartan reduces the activity of the sympathetic nervous system in patients with essential hypertension - during baseline conditions and after activation of the sympathetic nervous system.

Official Title
-----------------
The Effect of Eprosartan in Patients With Essential Hypertension on Renal Tubular Function and Vasoactive Hormones During Baseline Conditions and After Activation of the Sympathetic Nervous System.

Conditions
-----------------
Essential Hypertension

Intervention / Treatment
-----------------
* Drug: Eprosartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 - 65 years. Body mass index less or equal to 30 kg/m2. Women must use oral hormonal anticonceptive drugs, use intrauterine anticonceptive device, be sterilized / hysterectomized or be postmenopausal. Arterial hypertension, defined by 24 hour ambulatory blood pressure above 125 mmHg systolic or above 80 mmHg diastolic. Exclusion Criteria: History of myocardial infarction. History of stroke. Heart failure. Endocrine organ disease. Lung disease. Clinically significant abnormal biochemical screening of the blood regarding: B-hemoglobin, P-sodium, P-potassium, P-creatinine (under 200 µmol/L will be accepted), P-albumin, p-bilirubin, p-alaninaminotransferase, P-alkaline phosphatase, p-cholesterol and B-glucose. Clinically significant abnormal screening of the urine regarding: albumin and glucose (protein excretion below 0.5 g/L will be accepted). Renovascular hypertension. Malignant disease. Alcohol abuse. Usage of medical drugs besides antihypertensives or statins. Drug abuse. Pregnancy or breast feeding. Known intolerance or allergic to eprosartan or sodium nitroprusside. Blood donation within 1 month of the start of the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Eprosartan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate |  |  | 
| Fractional sodium excretion |  |  | 
| Plasma levels of noradrenaline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional lithium excretion |  |  | 
| Glomerular filtration rate |  |  | 
| plasma levels of renin, angiotensin II, aldosterone, vasopressin, atrial natriuretic peptide and brain natriuretic peptide |  |  | 
| free water clearance |  |  | 
| urinary excretion of aquaporin 2 |  |  |