linjc16/ctgov huggingface dataset:
The Influence of Storage Container and Defrost Process on Components in Breast Milk

Study Overview
=================
Brief Summary
-----------------
Breast milk is best food for neonates and preterm infants. However many handling would be done if direct breastfeeding is not feasible, and it may result in nutrients change in human milk. We investigate the influence of storage in different containers and different thawing or heating methods on human milk nutrients.

Official Title
-----------------
The Influence of Storage Container and Defrost Process on Components in Breast Milk

Conditions
-----------------
Human Milk

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy mothers lactating during first year of their babies and have sufficient milk to donate Exclusion Criteria: mothers who have insufficient milk for their babies mothers have major disease or on specific diet or drug which would affect breast milk composition

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in nutrients of human milk after several processing | we measure the changes of nutrients, including fat, protein, lactose, energy, immunoglobulins, lactoferrin, leptin, and lysozyme in human milk after several processes, such as freezing, pasteurization, storage in different containers, thawing, and heat treatments. | within first year of milk expression |
Safety and Long-term Evaluation (up to 5 Years) of First Booster Immunization With Novartis' TBE Vaccine for Adults in Adolescents and Adults

Study Overview
=================
Brief Summary
-----------------
evaluate safety and immunogenicity of first TBE booster and long-term immunogenicity up to 5 years after first TBE booster

Official Title
-----------------
A Phase IV, Uncontrolled, Open-label, Single-center Study in Adolescents and Adults: Evaluation of Immunogenicity and Safety of the First Booster Immunization With Novartis' TBE Vaccine for Adults in Participants of Study V48P7 and Long-term Evaluation of Immunogenicity up to 5 Years After First Booster Immunization

Conditions
-----------------
Tick Born Encephalitis

Intervention / Treatment
-----------------
* Biological: TBE vaccine for adults


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects who have completed study V48P7 Exclusion Criteria: acute illness at day of immunization general decrease in resistance progressive neurological disorders history of febrile or afebrile convulsions major congenital defects serious chronic illness hypersensitivity to study vaccine treatment with immunosuppressants or systemic corticosteroids, immunoglobulins, whole blood or plasma derivates

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 68 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm 1<br>Blood draw only, no vaccine | Biological: TBE vaccine for adults<br>* Serology blood draw.<br>|
| Active Comparator: Arm 2<br>Blood draw only, no vaccine | Biological: TBE vaccine for adults<br>* Serology blood draw.<br>|
| Active Comparator: Arm 3<br>Blood draw only, no vaccine | Biological: TBE vaccine for adults<br>* Serology blood draw.<br>|
| Active Comparator: Arm 4<br>Blood draw only, no vaccine | Biological: TBE vaccine for adults<br>* Serology blood draw.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| immunogenicity of TBE vaccine for adults when given as first booster dose as measured by neutralisation test and ELISA |  | On day 21, year 1, year 2, year 3, year 4, year 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of TBE vaccine for adults with respect to local and systemic reactions and adverse event reporting |  | Local and systemic reactions: up to Day 3 post vaccination; Adverse events: 21 days post vaccination; SAEs: throughout the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tick born encephalitis, TBE, adults
Samsung Medical Center-Lymphoma Cohort Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.

Detailed Description
-----------------
Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess following factors which amy probably affect the treatment outcome and the risk of treatment-related morbidity. Biologic factors associated with the aggressiveness of lymphoma molecular markers in serum, cytogenetic markers Factors associated with the risk of treatment-related morbidity comorbidity, nutrition status, performance status, quality of life at diagnosis

Official Title
-----------------
Development of a Predictive Model for Treatment Outcome and Treatment-related Morbidity in a Prospective Cohort Study of Patients With Lymphoma

Conditions
-----------------
Lymphoma

Intervention / Treatment
-----------------
* Drug: Chemotherapy with or without radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who were diagnosed as lymphoma Over 15 years old Patients who agreed the enrollment of study Informed consent for sampling Exclusion Criteria: Patients who do not want to join the study

Ages Eligible for Study
-----------------
Minimum Age: 15 Years

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

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

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: Lymphoma<br>patients diagnosed as lymphoma | Drug: Chemotherapy with or without radiotherapy<br>* Treatment regimen will be determined by the sub-type of lymphoma<br>* Other names: Chemotherapy:CHOP, RCHOP, (R)HyperCVAD;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment response |  | after completion of primary therapy | 
| Rate of occurrence of toxicity |  | 2 years from the start of the 1st therapy | 
| Treatment-related morbidity |  | within 60 days from the previous therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lymphoma, prognosis, morbidity
Efficacy Optimizing Extension Study of Chronic Hepatitis B Patients With Inadequate Response to NUC Therapy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the long-term efficacy and safety of entecavir 1.0 mg/d + adefovir 10 mg/d with entecavir 0.5 mg/d + adefovir 10 mg/d for chronic hepatitis B patients with inadequate response to NUC therapy

Official Title
-----------------
A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Therapy for Patients Previously Treated in Dragon Study

Conditions
-----------------
Chronic Hepatitis B, Inadequate Response, Nucleos(t)Ide Analogues Treatment

Intervention / Treatment
-----------------
* Drug: Entecavir, Adefovir


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed the 104-week Dragon study. Subjects who are willing to participate the extension study. Exclusion Criteria: Subjects who could not compliance with the protocol judged by investigators

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

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I<br>oral entecavir 1mg daily and adefovir 10mg daily for 144 weeks | Drug: Entecavir, Adefovir<br> <br> |
| Active Comparator: Group II<br>oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks | Drug: Entecavir, Adefovir<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of patients achieving HBV DNA< 300copies/mL at week 144 in each group |  | Week 144 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 in each group. |  | Week 48 & 96 | 
| The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144. |  | Week 48 & 96 &144 | 
| Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144. |  | Week 48 & 96 & 144 | 
| Percentage of patients with ALT normalization at week 48/96/144 |  | Week 48 & 96 & 144 |
Women's Health Trial: Feasibility Study in Minority Populations

Study Overview
=================
Brief Summary
-----------------
To evaluate the feasibility of recruiting women of different socioeconomic status and minority groups and to determine whether these women could achieve and maintain a modified fat-eating pattern. The full-scale trial sought to determine whether a low-fat diet could decrease the incidence of cancer and coronary heart disease in postmenopausal women. The National Heart, Lung, and Blood Institute contributed funds over a three-year period to measure lipids, lipoproteins, and other cardiovascular disease risk factors.

Detailed Description
-----------------
BACKGROUND: The Request for Proposal for the Women's Health Trial: Feasibility Study in Minority Populations was developed and released by the National Cancer Institute with assistance from the National Heart, Lung, and Blood Institute. DESIGN NARRATIVE: Randomized. Recruitment began in August 1992 and ended in February 1994. Forty percent of the subjects were randomized to a control group and 60 percent to the dietary intervention group. Dietary counseling aimed to reduce total fat to 20 percent of calories, reduce saturated fat and dietary cholesterol intakes, and to increase the intake of fruits, vegetables, and grain products. Recruitment and randomization were conducted over an 18-month period at three clinical centers. Other objectives of the trial included: development and evaluation of strategies for recruiting and retaining women of different racial and SES groups into a dietary intervention study; identification of factors affecting compliance; assessment of the effects of a modified fat eating pattern on cardiovascular disease risk factors, including fasting blood lipids and lipoproteins, glucose and insulin, body weight and blood pressure; identification and assessment of potential biochemical and/or biological markers for dietary adherence. Close-out visits began in May 1994 and ended in September 1994. These visits included six, twelve, and eighteen-month follow-up. NCI extended the coordinating center contract through January 1996 to support data analysis and publication of research results.

Conditions
-----------------
Cardiovascular Diseases, Coronary Disease, Heart Diseases, Myocardial Ischemia, Postmenopause

Intervention / Treatment
-----------------
* Behavioral: diet, fat-restricted


Participation Criteria
=================
Eligibility Criteria
-----------------
Postmenopausal women, aged 50 to 69 years, who consumed 38 percent or more of total calories as fat at baseline.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 69 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: diet, fat-restricted|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain target blood glucose levels when taking a single oral drug. The purpose of this study is to assess the long term safety and effectiveness of vildagliptin, an unapproved drug, compared to that of glimepiride in lowering overall blood glucose levels when added to metformin in people with type 2 diabetes not at target blood glucose levels on metformin alone.

Official Title
-----------------
Vildagliptin Compared to Glimepiride in Combination With Metformin in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin
* Drug: glimepiride
* Drug: Metformin
* Drug: Vildagliptin matching placebo
* Drug: Glimepiride matching placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: On a stable dose of metformin as defined by the protocol Body mass index (BMI) in the range 22-45 Blood glucose criteria must be met Exclusion Criteria: Pregnancy or lactation Type 1 diabetes Evidence of significant diabetic complications Evidence of serious cardiovascular complications Laboratory value abnormalities as defined by the protocol Other protocol-defined exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 73 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: Vildagliptin<br> | Drug: vildagliptin<br> <br> * Other names: LAF237, Galvus;Drug: Metformin<br> <br> Drug: Glimepiride matching placebo<br> <br> |
| Active Comparator: Glimepiride<br> | Drug: glimepiride<br> <br> Drug: Metformin<br> <br> Drug: Vildagliptin matching placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to HbA1c >8% |  | 2 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in HbA1c at 5 years |  | 2 years (amended) | 
| Adverse event profile after 5 years of treatment |  | 2 years (amended) | 
| Coefficient of failure for HbA1c from week 24 to 5 years |  | 2 years (amended) | 
| Change from baseline in fasting plasma glucose at 5 years |  | 2 years (amended) | 
| Change from baseline in body weight at 5 years |  | 2 years (amended) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
type 2 diabetes, vildagliptin
Tack Optimized Balloon Angioplasty (TOBA) Study

Study Overview
=================
Brief Summary
-----------------
A multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Detailed Description
-----------------
Intact Vascular intends to conduct a prospective, single arm, multi-center, post-CE Mark study designed to evaluate the performance of the Intact Vascular Tack-IT Endovascular Stapler™ in subjects with vascular flaps (e.g.; post-angioplasty dissection) resulting from percutaneous transluminal balloon angioplasty (PTA) of superficial femoral or popliteal artery(ies).

Official Title
-----------------
Tack Optimized Balloon Angioplasty (TOBA) Study for Femoropopliteal Arteries Using the Tack-IT Endovascular Stapler

Conditions
-----------------
Peripheral Vascular Disease

Intervention / Treatment
-----------------
* Device: Tack-It Endovascular Stapler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Rutherford clinical category 2, 3 or 4 ABI less than or equal to 0.90 Reference vessel diameter is between 2.5mm and 5.5mm Target lesion has stenosis greater than or equal to 70% or is occluded Target lesion is less than or equal to 10cm in length Exclusion Criteria: Previously implanted stent in the ipsilateral superficial femoral or popliteal artery Target treatment area is severly calcified (e.g. circumferential calcification or calcium plaque visible on plain fluoroscopy that extends far more than 5.0cm continuously)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group<br>Treatment with Tack-IT Endovascular Staple | Device: Tack-It Endovascular Stapler<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Composite of new-onset major device-related adverse events. | 30 days |
Open-label Study to Investigate the Safety, Tolerability, PK, and Pharmacodynamics of the AKT Inhibitor GSK690693

Study Overview
=================
Brief Summary
-----------------
This study is a first time in human, Phase I, open-label study to determine recommended doses and schedules, based on maximum tolerated doses and biologically active doses, for the AKT inhibitor GSK690693.

Official Title
-----------------
An Open-label Study to Investigate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of the AKT Inhibitor GSK690693 Given on Various Schedules in Subjects With Solid Tumors or Lymphoma

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Drug: GSK690693


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed diagnosis of solid tumor malignancy or lymphoma that is not responsive to standard therapies or for which there is no approved therapy Female patients of child-bearing potential must be willing to abstain from intercourse from 2 weeks prior to administration of the first dose of study medication until 28 days after the final dose of study medication or be willing to consistently and correctly use an acceptable method of birth control. Exclusion Criteria: Prior anti-cancer therapy within the prior 28 days. History of diabetes. Coronary artery disease/myocardial infarction, acute coronary syndromes within the past 6 months. Use of theophylline and warfarin within 14 days prior to the first dose of study drug. Current use of oral corticosteroids (note: Inhaled corticosteroids are permitted.) Participation in an investigational study within the prior 28 days. Pregnant or breast-feeding.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: GSK690693|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the maximum tolerated dose of GSK690693 given weekly or twice weekly over 1 - 4 hours. |  | given weekly or twice weekly over 1 - 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure and heart rate every 8 hours. |  | every 8 hours. | 
| 12-lead ECGs will be conducted at 4, 8, 10, 12, 14, 24hrs |  | 4, 8, 10, 12, 14, 24hrs | 
| Pharmacokinetics and Pharmacodynamics via blood draws before, during, and after the infusion. |  | draws before, during, and after the infusion | 
| Urinalysis samples while the patient is hospitalized |  | while the patient is hospitalized | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GSK690693,, Solid Tumors,, Lymphoma,, AKT