linjc16/ctgov huggingface dataset:
A Study to Assess the Safety and Efficacy of Tocilizumab in Patients With Active Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
This 2 arm study will assess the safety and efficacy of tocilizumab monotherapy versus methotrexate in patients with active rheumatoid arthritis (RA). Patients will be randomized to receive tocilizumab 8mg/kg iv every 4 weeks plus placebo po weekly, or methotrexate 7.5-20mg po weekly plus placebo iv every 4 weeks. The anticipated time on study treatment is 3-12 months and the target sample size is 500+ individuals.

Official Title
-----------------
A Randomized, Double-blind Study of Safety and Reduction in Signs and Symptoms During Treatment With Tocilizumab Monotherapy Versus Methotrexate Monotherapy in Patients With Moderate to Severe Active Rheumatoid Arthritis

Conditions
-----------------
Rheumatoid Arthritis

Intervention / Treatment
-----------------
* Drug: Methotrexate
* Drug: tocilizumab [RoActemra/Actemra]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients at least 18 years of age with active RA for at least 3 months; patients of reproductive potential must be using reliable methods of contraception. Exclusion Criteria: major surgery (including joint surgery) within 8 weeks before entering study or planned major surgery within 6 months after entering study; treatment with methotrexate (MTX) within 6 months of entering study; patients who have stopped previous MTX treatment due to toxicity or lack of response; women who are 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: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: tocilizumab [RoActemra/Actemra]<br>* 8mg/kg iv every 4 weeks<br>|
| Active Comparator: 2<br> | Drug: Methotrexate<br>* 7.5-20mg po weekly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 20 response |  | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with ACR 20 response |  | Week 8 | 
| Percentage of patients with ACR 50 and ACR 70 responses |  | Week 24 | 
| Mean change in parameters of ACR core set |  | Week 24 | 
| AEs, laboratory parameters, vital signs. |  | Throughout study |
Seroprevalence Hepatitis E Infection in Healthy Blood Donors

Study Overview
=================
Brief Summary
-----------------
This is a HEV seroprevalence in the health donors in the Canton Ticino study. The pre-donation sampling pouch of each blood donor coming form the Cantone Ticino region will be collected and tested for HEV serology (IgM and IgG).

Detailed Description
-----------------
Pre-donation sampling pouch of fresh and stored frozen plasma collected within the last 5 years will be tested for HEV IgG serology at the National Reference Laboratory of the Blood Transfusion Services SRC in Berne Collected data will be used to determine HEV seroprevalence, actual and in the last 5 years, in the Canton Ticino and to investigate trend and pattern of the HEV infection (seroprevalence by different regional areas, comparison with national HEV data, and correlation with age, sex and place of residence).

Official Title
-----------------
Observational Study on Seroprevalence of Hepatitis E Infection in Healthy Blood Donors in the Canton Ticino

Conditions
-----------------
Hepatitis E

Intervention / Treatment
-----------------
* Other: Sample collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and voluntary blood donors Subjects living in the Canton Ticino Inclusion criteria for blood donation Signed informed consent of the STCRS SI for blood donation Exclusion Criteria: Exclusion criteria for blood donation
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Sample collection|Collection of one sampling pouch from each blood donor|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HEV blood incidence | HEV incidence assessed through a single periferal blood sample from each donor | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in the blood incidence of HEV | Determine the change in the incidence of HEV in the Canton Ticino region in the last 5 years analysing the blood sample of the donors. | Five years | 
| Geogarphical distribution of the HEV measured in the blood sample | Determination of the distribution of the HEV infection in different geographical areas of the Canton Ticino analysing donor blood samples | Five years | 
| Trend of the HEV infection measured in the blood sample | Evaluation of the trend of the HEV infection in the CantoneTicino compared to other Swiss cantons | One year |
Tarceva And Radiotherapy in Locally Advanced Lung Cancer Non-small Cell Lung Cancer

Study Overview
=================
Brief Summary
-----------------
The trial is a phase II study of daily Tarceva combined with definitive radiotherapy in inoperable locally advanced non small cell lung cancer (stage IIB-IIIB). The objective of the phase II trial is to examine Tarceva concomitant with curatively intended irradiation 66 Gy (2 Gy x 33 F, 5 F per week).

Official Title
-----------------
Concomitant Tarceva® and Irradiation in Patients in Local-regionally Advanced Non-small Cell Lung Cancer. A Phase II Study

Conditions
-----------------
Non-small Cell Lung Cancer

Intervention / Treatment
-----------------
* Drug: Tarceva
* Radiation: Radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥18 years Patients with histologically or cytologically documented diagnosis locally advanced NSCLC stage IIB to IIIB without pleural effusion Performance status ≤2 on the ECOG scale Serum bilirubin must be ≤1.5 upper limit of normal (ULN) ALAT ≤2 x ULN Able to comply with study and follow-up procedures Patients with reproductive potential must use effective contraception Written (signed) informed consent to participate in the study Exclusion Criteria: Any unstable systemic disease (including active infection, unstable angina, congestive heart failure, severe hepatic, renal, or metabolic disease) Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer) Inability to take oral medication, or requirement of intravenous alimentation Nursing mothers

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Tarceva<br>* Tarceva 150 mg/day<br>Radiation: Radiotherapy<br>* 66 Gy/33 F/5 F per week for 5 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival | Progression free survival from registration according to RECIST 1.1 | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity |  | 3 years | 
| Local Tumor Control by CT-scan |  | May 2012 | 
| Overall Response Rate (CR + PR) |  | May 2012 | 
| Local Tumor Control at 9 Months Evaluated by PET-CT |  | May 2012 | 
| Overall Survival |  | May 2012 | 
| Disease Free Survival |  | May 2012 | 
| Late Toxicity |  | May 2012 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung cancer, Non-small cell lung cancer, Tarceva, Radiotherapy, Local-regionally advanced non-small cell lung cancer
This Trial is a Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators propose that the addition of rituximab will lower the risk of systemic and local relapses in patients with localized PBL. Patients will be treated with 6 cycles of RCHOP-14 or RCHOP-21. The administration of radiotherapy following chemotherapy is strongly recommended, based on the findings of the retrospective IELSG study, but will be at the discretion of the treating center.

Official Title
-----------------
A Prospective Observational Study of Newly Diagnosed Diffuse Large B Cell Primary Breast Lymphomas Treated With R-CHOP With or Without Radiotherapy

Conditions
-----------------
Diffuse Large B-Cell Lymphoma of the Breast

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated patients with DLBCL of the breast. Patients must have CD20 positive tumors. Stage IE or IIE. Must have at least one objective measurable or evaluable disease. Baseline measurements and evaluations must be obtained within 4 weeks of registration to the study. Patients must have an ECOG performance status 0-2. Patients must have adequate organ function as evidenced by the following laboratory studies ( within 2 weeks prior to registration): Creatinine Clearance > 50 ml/min Total bilirubin < 2.0 mg/dl and AST < 2 x upper limit of normal. If documented hepatic involvement with lymphoma, total bilirubin can be < 3 x ULN, and AST < 5 x ULN. Absolute neutrophil count > 1500/mm3 and platelet count > 100,000/mm3. If documented bone marrow involvement with lymphoma, absolute neutrophil count > 500/mm3 and platelet count > 50,000/mm3. Patients must be age > 18 years. Patients must have a normal left ventricular ejection fraction to be eligible. Exclusion Criteria: historical or radiographic evidence of CNS metastasis including previously treated, resected or asymptomatic brain lesions or leptomeningeal involvement. pregnant or breast feeding patients. Women of childbearing potential and sexually active males are strongly advised to use an accepted and effective method of contraception. active infection requiring parental antibiotics. known HIV infection

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 |
| --- | --- | --- |
| local and CNS relapse rate |  | 12-month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| progression free survival |  | 12-month | 
| overall survival |  | 5-year | 
| overall, complete and partial response rates following RCHOP |  | at the end of chemotherapy |
Evaluation of Domestic Hemodialysis Machine: A Multi-center Clinical Study

Study Overview
=================
Brief Summary
-----------------
An important reason for the costs of hemodialysis treatment in China are expensive is the hemodialysis machine and related products mainly rely on imports. Hemodialysis machine is the basis equipment of the hemodialysis treatment. After years of research and development, China has had the domestic hemodialysis machine. However, due to the lack of control studies of domestic and imported hemodialysis machine, thus causing the domestic hemodialysis machine promotion has been hindered. The aim of this study is to verify the quality and safety of domestic hemodialysis machine.

Official Title
-----------------
Evaluation of Domestic Hemodialysis Machine (WEGO DBB-27C) : A Multi-center Clinical Study

Conditions
-----------------
Hemodialysis

Intervention / Treatment
-----------------
* Device: domestic hemodialysis machine
* Device: imported hemodialysis machine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age≥18, male or female Maintenance hemodialysis duration>3 months Regular hemodialysis,3 times a week,4 hours per session Sign the written informed consent Exclusion Criteria: Acute kidney injury Prepare to transfer to kidney transplantation or peritoneal dialysis in a year. Positive in Hepatitis B virus, hepatitis C virus, syphilis or HIV Pregnancy or lactation Under other drug trial Acute infection, severe heart, lung, liver, nervous diseases, malignant tumor Can not be treated in accordance with the research program

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: Group of domestic hemodialysis machine<br> | Device: domestic hemodialysis machine<br>* WEGO, DBB-27C<br>|
| Active Comparator: Group of imported hemodialysis machine<br> | Device: imported hemodialysis machine<br>* Fresenius, 4008s<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse reactions associated with the use of dialysis machines |  | 0 to 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The results of endotoxin level of dialysate | endotoxin level of dialysis fluid at outlet | 0,1,2,3 months | 
| The results of bacterial culture of dialysate | bacterial culture of dialysis fluid at outlet | 0,1,2,3 months | 
| Clearance rate of uremic toxins |  | 0,1,2,3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodialysis machine, quality, safety, domestic
Ventricular Asynchrony in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to: assess the existence of inter-ventricular and intra-ventricular asynchrony in cardiac surgery patients before (PRE) and after cardiopulmonary bypass surgery (POST) investigate whether a modification of usual pacing practices (RA-LV pacing) can achieve inter- and intra-ventricular synchrony and improve heart function, as evaluated by hemodynamic and echocardiographic indexes, when compared with the patient's native rhythm (normal sinus rhythm (SR), or conventional pacing modes

Official Title
-----------------
Ventricular Asynchrony in Cardiac Surgery Patients

Conditions
-----------------
Ventricular Asynchrony in Cardiac Surgery Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: scheduled for cardiac surgery, in normal sinus rhythm Exclusion Criteria: atrial fibrillation, abnormal hearth rhythms

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CABG, Ventricular Asynchrony, Normal Sinus Rhythm
OLE Study to Evaluate Safety / Efficacy of ZD4522

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the long term safety of Crestor.

Official Title
-----------------
ZD4522 Long Term Extension Trial

Conditions
-----------------
Hypercholesterolaemia

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completion of previous Crestor study as listed in the protocol. Exclusion Criteria: Pregnant or breast feeding women, or not using appropriate contraception. Abnormal lab values as listed in the protocol.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Rosuvastatin | Drug: Rosuvastatin<br> <br> * Other names: Crestor;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, as determined by adverse events, laboratory data, physical examination and ECG. |  | 12 weekly | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success in achieving goals for Cholesterol levels |  | 12 weekly | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cholesterol, Hypercholesterolaemia, Statins
Mastery, Social Support and Depression of Patients With Major Depression

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to discuss the relation of mastery, social support and depression in patients with depressive disorder. Cross-sectional quantitive study and purposive sampling method were designed. Data collection and analysis was conducted through structural questionnaires (including demographics, social support scale, mastery scale, CESD scale) at a medical center in Taipei. Results showed that patients with depression whose degree of depression was negative correlated with mastery and social support, and mastery was positive correlated with social support. Regression statistics results showed that mastery, social support, age, loss of jobs can predict degree of depression up to 60 percent. The mastery was strongest independent predictable factor to degree of depression, and had partial or total mediate effects to age, loss of jobs, financial condition, and social support. The result of this study suggested that clinically the care of patients with depression should focus on their confidence in mastery and provide strategies to promote their confidence in mastery, which can effectively reduce the degree of depression of those patients.

Conditions
-----------------
Depression

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with depression Exclusion Criteria: -

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Influence of Having Breakfast on Cognitive Performance and Mood

Study Overview
=================
Brief Summary
-----------------
Breakfast is often labelled the most important meal of the day. Parents and teachers quite often stress its importance for successful learning during the morning hours. With declining numbers of children and especially adolescents eating breakfast regularly, the study examines the influence of breakfast consumption on cognition and mood of high school students.

Official Title
-----------------
The Influence of Having Breakfast on Cognitive Performance and Mood in High School Students

Conditions
-----------------
Fasting

Intervention / Treatment
-----------------
* Other: Breakfast/no breakfast


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy high school students Exclusion Criteria: Diabetes

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 20 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>Breakfast on the first day of intervention, fasting (no breakfast) on the second day of intervention | Other: Breakfast/no breakfast<br>* A: Breakfast on the first day of intervention. Fasting (no breakfast) on the second day of intervention. B: Breakfast on the second day of intervention. Fasting (no breakfast) on the first day of intervention<br>|
| Experimental: B<br>Fasting (no breakfast) on the first day of intervention, breakfast on the second day of intervention | Other: Breakfast/no breakfast<br>* A: Breakfast on the first day of intervention. Fasting (no breakfast) on the second day of intervention. B: Breakfast on the second day of intervention. Fasting (no breakfast) on the first day of intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sustained attention, immediate memory, mood |  | 2 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
High school students, Boarding school, Breakfast, Fasting, Memory, Attention, Mood