linjc16/ctgov huggingface dataset:
Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The study will assess the glycemic variationusing continuous glucose monitoring system in type 2 diabetic patients with euglycemia control respectively when patients was treated with Basalin and one week after changing the insulin into Lantus.

Detailed Description
-----------------
The participants will take continuous glucose monitoring system for 3 days when they change the insulin into Lantus after reach euglycemia control with Basalin treatment for one week.

Official Title
-----------------
Effects of Replacing Lantus With Basalin on the Glycemic Variation in Patients

Conditions
-----------------
Type2 Diabetes

Intervention / Treatment
-----------------
* Drug: Basalin to Lantus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with T2DM, which was defined bypublished Criteria of World Health Organization in 1999; Patients were using Basalin with or without oral hypoglycemic drugs and having a stable dose of glargine for more than 3 month would be recruited into this study; Patients had relatively constant diet and exercise in 2 month before the study. Fasting blood glucose<6.1mmol/L, and postprandial (or random) blood glucose <14mmol/L Exclusion Criteria: Patients with severe cardiovascular diseases, such as stroke, transient ischemic attack, myocardial infarction, unstable angina, coronary artery bypass grafting, percutaneous coronary intervention, and heart failure; Patients with severe infectious diseases; Patients with acute complications of diabetes on admission, such as diabetic ketoacidosis, diabetic hyperosmolar nonketotic coma, and lactic acidosis; Patients with history of psychiatric disorders and were unsuitable to use CGMS; Any other situations that made patients unsuitable to participate in the study, such as alcoholism and drug abuse.
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: Basalin to Lantus<br>the patients who are using Basalin treatment will use isodose of Lantus instead | Drug: Basalin to Lantus<br>* continuous glucose monitoring system will used twice when patients are using Basalin and Lantus respectively to assess glycemic variation.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of glycemic variation | The changes of glycemic variation before and after drug change | Day 1-13 |
Post Market Registry of the CBSO

Study Overview
=================
Brief Summary
-----------------
Multi centre, international, post market registry to monitor the clinical performance and safety of an atrial septal closure device with biodegradable framework in patients with clinically significant atrial septum defect (ASD) or patent foramen ovale (PFO) in routine clinical use

Official Title
-----------------
Multi Centre, International, Post Market Registry to Monitor the Clinical Performance and Safety of an Atrial Septal Closure Device With Bioresorbable Framework in Patients With Clinically Significant Atrial Septum Defect (ASD) or Patent Foramen Ovale (PFO) in Routine Clinical Use

Conditions
-----------------
Atrial Septal Defect, Patent Foramen Ovale

Intervention / Treatment
-----------------
* Device: Septal defect closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient suffers from ASD (including ostium secundum ASD or a fenestration from a Fontan procedure) or PFO and is planned to receive the CBSO. Patient (or legal guardian) has been informed and agreed to and signed the informed consent form. A CBSO is implanted into the patient. Exclusion Criteria: Patient is known to have one or more of the contraindications listed in the instructions for use. Patient is currently participating in one or more interventional studies, with exception of a study investigating the CBSO. Patient is implanted with another product in the atrial septum.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ASD patients<br> | Device: Septal defect closure<br>* Device closure of atrial septal defect<br>|
| PFO patients<br> | Device: Septal defect closure<br>* Device closure of atrial septal defect<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effective closure by echocardiography |  | at 6 months | 
| Safety throughout the follow up duration by absence of serious incidents |  | day 0 to 3 years |
Phase II Study of Ridaforolimus (MK-8669) With Metastatic Bone or Soft-tissue Sarcoma Patients (MK-8669-030 AM1)

Study Overview
=================
Brief Summary
-----------------
The study evaluates efficacy of Ridaforolimus when administered as maintenance therapy to patients with metastatic bone or soft-tissue sarcoma in Japan.

Official Title
-----------------
A Phase II Study of MK-8669 When Administered as Maintenance Therapy to Japanese Patients With Metastatic Bone or Soft-tissue Sarcomas

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Drug: Ridaforolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented histologic diagnosis of bone or soft-tissue sarcoma that has metastasized, and who derive benefit following chemotherapy. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 Completed prior chemotherapy with last dose received at least 3 and up to 12 weeks prior to randomization Adequate organ and bone marrow function Exclusion Criteria: Presence of brain or central nervous system (CNS) metastases, unless successfully treated Prior therapy with rapamycin or rapamycin analogs Ongoing toxicity associated with prior anticancer therapy History or current evidence of any clinically significant disease that might confound the results of the study, complicate the interpretation of the study results, interfere with the patient's participation, or pose an additional risk to the patient

Ages Eligible for Study
-----------------
Minimum Age: 13 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: Ridaforolimus 40 mg<br> | Drug: Ridaforolimus<br>* Ridaforolimus, oral tablet, 40 mg once daily for 5 consecutive days followed by 2-day dosing holiday each week. Participants treated until discontinuation criteria, such as progressive disease or unacceptable toxicity, were met.<br>* Other names: MK-8669, AP23573, deforolimus; Ridaforolimus was also known as deforolimus until May 2009;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free rate (PFR) at 6 months | Progression free rate at 6 months is defined as the proportion of participants who are a complete response (CR, disappearance of all target lesions), partial response (PR, at least a 30% decrease in the sum of the longest diameter of target lesions) or stable disease (does not qualify for PR or progressive disease) at 6 months from the date of the first study drug administration. | 6 months |
Establishment and Characterization of Patient-Derived Non-Small Cell Lung Cancer Xenografts and Cell Cultures

Study Overview
=================
Brief Summary
-----------------
Xenografts and cell cultures provide sufficient material for analyses at the protein, RNA and DNA level. Patient derived NSCLC xenografts and cell lines are available but none however are Asian in origin. Given the emerging evidence to suggest inter-ethnic differences in NSCLC biology, new models of preclinical drug evaluation should be designed and validated using Asian tumors. Furthermore, such models will allow studies of biological mechanisms of sensitivity and/or resistance and also the study of dynamic regulations under standardized conditions in the Asian context.

Conditions
-----------------
Non Small Cell Lung Cancer

Intervention / Treatment
-----------------
* Procedure: Xenografts and cell cultures


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 21 years and above. Undergoing a surgical resection of tumor as part of clinical management Exclusion Criteria: Patient or legally acceptable representative unable to provide consent patient in the judgement of the study investigator, is medically unsuitable for this study

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 |
| --- | --- |
| Non-Small Cell Lung Cancer<br> | Procedure: Xenografts and cell cultures<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Etiology, Epidemiology and Prognostics of AKI

Study Overview
=================
Brief Summary
-----------------
To investigate the etiology and epidemiology of acute kidney injury (AKI). To find out risk factors associated with the occurence of AKI. To find out risk factors related to the prognosis of AKI,focusing on uremic toxins, inflammation, oxidative stress and nutritional status. To study on the relationship between gene polymorphism and prognosis of acute kidney injury.

Detailed Description
-----------------
To investigate the relationship between preexisting protein-energy wasting (PEW) and adverse outcomes in patients with AKI. To evaluate the association of serum nutritional variables and prognosis of AKI. Given the different half-lives of serum nutritional markers, we hypothesized that the utility of serum nutritional variables as prognostic predictors may differ in early death (<7 days) and late death (>7 days, <28 days) patients. To investigate the various kinds of uremic toxins in AKI, furthermore, to evaluate the relationship between uremic toxins, especially protein bound toxins, and short- or long-term mortality in AKI patients. To investigate the mineral bone disorders in AKI,and to evaluate whether these markers would role as prognostic predictors of AKI. Several risk factors of mortality in AKI,such as markers of PEW, inflammation and serum creatinine,have been used; however, no single indicator is considered to be a gold standard.

Official Title
-----------------
The Study of Etiology, Epidemiology and Prognostic Factors of Acute Kidney Injury

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age >=18 years and <= 88 years clinically diagnosed with acute kidney injury, according KDIGO criteria. Exclusion Criteria: preexisting chronic kidney failure (defined as an eGFR <60 ml/min per 1.73 m2) post-renal obstruction or rapid progressive glomerulonephritis as the main cause of AKI known acute renal dysfunction hospital stays <24 hours malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 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 |
| --- | --- |
| Hospital-acquired AKI<br>Adult patients with Hospital-acquired AKI | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all-cause mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function survival rate |  | 90 days | 
| days in hospital |  | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Acute Kidney Injury, Proteinosis, Epidemiology, Risk factors
Study of the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Study Overview
=================
Brief Summary
-----------------
To determine whether treatment with ESTRATEST® H.S. Tablets is superior to treatment with esterified estrogens tablets

Official Title
-----------------
A Multi-Center, Double-Blind Study to Determine the Efficacy of ESTRATEST® H.S. Tablets in Relieving Menopausal Symptoms in Estrogenized Postmenopausal Women

Conditions
-----------------
Menopause

Intervention / Treatment
-----------------
* Drug: esterified estrogens 0.625 mg and methyltestosterone 1.25 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Menopausal women between the ages of 30 and 65 years (inclusive) with symptoms of estrogen and/or androgen deficiency not currently controlled by estrogen therapy as determined by patient report and the Investigator's clinical judgement

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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: esterified estrogens 0.625 mg and methyltestosterone 1.25 mg|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the total score of the Menopause Rating Scale (MRS) at Week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the MRS at Week 12 & monthly change from baseline to Week 12 in the MENQOL; Comparison of changes in SHBG & testosterone & how these changes correlate with the MRS |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Menopause; Postmenopause; Estrogen; Hormone Therapy
Evaluation of Fetal Cardiac Function and Vascular Hemodynamics in Intrauterine Growth Restriction

Study Overview
=================
Brief Summary
-----------------
Intrauterine growth restriction (IUGR) is one of the major contributors to perinatal mortality and morbidity and is characterized by complex hemodynamic changes involving placental and fetal arterial, cardiac and venous circulations .However, the temporal sequence of these modifications in relation to other hemodynamic changes of the fetal arterial and venous circulations is unknown. The aim of this study was to evaluate cardiac function and other hemodynamic changes in a group of fetuses with IUGR and clinical impact on perinatal outcome .

Official Title
-----------------
Evaluation of Non Invasive Fetal Cardiac Functions and Fetal Arterial&Venous Doppler Study in Intrauterine Growth Restriction as Predictive Parameters of Perinatal Outcome

Conditions
-----------------
Fetal Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton fetus with normal fetal anatomy documented a detailed sonogram. Fetal abdominal circumference <5th percentile for gestational age. Evidence of placental insufficiency documented by an elevated umbilical artery pulsatility index (UA-PI) by reference ranges. Exclusion Criteria: evidence of fetal infection chorioamnionitis fetal anomalies abnormal fetal karyotype patient withdrawal from the study and/or unavailability for follow-up.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myocardial performance index | Ratio between isovolumetric time to ejection time | 5 minutes | 
| Aortic isthmus flow index | Aortic isthmus flow index = Ratio of (systolic velocity time integral+diastolic velocity time integral) / systolic velocity time integral | 5 minutes | 
| Cerebroplacental ratio | cerebroplacental ratio = Rtio middle cerebral artery pulsatility index / umbilical artery pulsatility index | 5 minutes | 
| Preload Index in inferior vena cava | Preload Index in inferior vena cava = ratio of peak systolic velocity in atrial contraction /peak systolic velocity ventricular systole | 5 minutes |
Validation of a Multimodal Indicator of Depth of Anesthesia

Study Overview
=================
Brief Summary
-----------------
The present study is designed to validate an multimodal indicator of anesthetic depth (Schneider G et al. 2014, Anesthesiology 120, 819-28). The indicator previously developed shall now be tested on an independent set of data. The investigators will include 250 patients undergoing general anesthesia in 3 German tertiary care centers. The design is strictly observational - the anesthetic regime is at the discretion of the clinician and will not be influenced.

Official Title
-----------------
A Multicenter Validation Study of a Multimodal Indicator of Anesthesia Calculated From the Electroencephalogram and Standard Monitoring Parameters

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Other: the study is observational


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years elective surgery under general anesthesia anticipated operating time of about one hour or longer ASA physical status I-III written informed consent Exclusion Criteria: chronic intake of CNS affecting drugs alcohol or drug abuse in the last three months CNS or psychiatric disease hardness of hearing or deafness abnormal gastrointestinal motility non-adherence to fasting guidelines, emergency surgery anticipated difficult airway pregnancy cardiac surgery and surgery involving the head and/or neck postoperatively prolonged intubation pre- and/or postoperative intensive care treatment

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 |
| --- |
|Other: the study is observational|the study is observational|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ability of the multimodal indicator of anesthetic depth to discriminate between consciousness and unconsciousness |  | 1 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the indicator's ability to discriminate between consciousness, surgical anesthesia and deep anesthesia |  | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
electroencephalogram, hemodynamic monitoring, respiratory monitoring
An Evaluation Of The Novel TRAMINER Sequence By Comparison To Late Gadolinium Enhancement Images

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to show that the novel TRAMINER (T(Rho) and Magnetization Transfer and Inversion Recovery) sequence provides at least as good visualization and detection of sub-endocardial scarring, fibrosis, and acute infarction as the current gold standard Inversion Recovery (IR) Turbo-Flash sequence. The hypothesis is that the TRAMINER sequence has the same or higher sensitivity in detecting small sub-endocardial scarring than the inversion recovery segmented gradient echo sequence known as IR-Turbo Fast low angle shot (IR Turbo-Flash), which is the accepted current gold standard for the detection of myocardial viability.

Official Title
-----------------
Establishing the Clinical Usefulness Of Dark Blood Late Gadolinium Enhancement Images For The Detection Of Small Subendocardial Left Ventricular Infarcts - An Evaluation Of The Novel TRAMINER Sequence By Comparison To Late Gadolinium Enhancement Images

Conditions
-----------------
Myocardial Fibrosis, Cardiovascular Disease

Intervention / Treatment
-----------------
* Other: Traminer MRI Sequence


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥18 years of age referred for a cardiac MRI with Gadolinium enhancement only at Advocate Lutheran General Hospital Exclusion Criteria: <18 years old, Adults unable to consent Adults for whom the MRI has not been previously scheduled Adults with an order for any MRI other than cardiac MRI with Gadolinium enhancement

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: Traminer MRI Sequence<br>The TRAMINER MRI sequence implementation to be tested allows the acquisition of high resolution MR images in the free-breathing patient, by combining multiple averages and motion correction with the TRAMINER preparation. | Other: Traminer MRI Sequence<br>* The Traminer MRI sequence will be added to the standard IR Turbo-Flash sequence and last 2-5 minutes.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the TRAMINER sequence in detecting myocardial fibrosis or acute infarction compared to the gold standard sequence will be measured. | The method of assessment is through a score using the 17 segment model of myocardial map. | 6-12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction in clinical Magnetic Resonance (MRI) procedure time. |  | 6-12 months |