linjc16/ctgov huggingface dataset:
Safety Study of Passive Immunization for Patients With Mild to Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
This research study will assess whether AAB-001 is safe, well tolerated and effective for use in patients with Alzheimer's Disease. AAB-001 is a new drug that is not available outside this study. AAB-001 is an antibody (a type of protein usually produced by white blood cells to destroy other substances in the body). In Alzheimer's disease a protein called amyloid gathers in the brain and is thought to cause symptoms like memory loss and confusion. It is hoped that AAB-001 will attach to the amyloid protein in your brain and help your body to remove it.

Official Title
-----------------
A Phase IIA, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose, Safety, Tolerability, Pharmacokinetic, Pharmacodynamic, and Immunogenicity Trial of AAB-001 in Patients With Mild to Moderate AD

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: AAB-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of probable AD Age from 50 to 85 years, inclusive Rosen Modified Hachinski ischemic score less than or equal to 4 Magnetic Resonance Imaging (MRI) scan consistent with the diagnosis of AD Fluency in English Stable doses of medications Exclusion Criteria: Significant neurological disease other than AD Major psychiatric disorder Significant systemic illness History of stroke or seizure Weight greater than 120kg (264 lbs.) History of autoimmune disease Smoking more than 20 cigarettes per day Anticonvulsants, anti-Parkinson's, anticoagulant, or narcotic medications Prior treatment with experimental immunotherapeutics or vaccines for AD Presence of pacemakers or foreign metal objects in the eyes, skin, or body

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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: AAB-001|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessments |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood levels of administered study drug |  |  | 
| Cognitive and functional assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alzheimer's Caregivers, Alzheimer disease
A Study of Epoetin Beta (NeoRecormon) in Predialysis Patients With Renal Anemia

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the tolerability, and effect on quality of life, in patients receiving multi-dose NeoRecormon administered by RecoPen in predialysis patients with chronic renal anemia. The anticipated time on study treatment is 10 months, and the target sample size is 60 individuals.

Official Title
-----------------
An Open-Label Study of the Tolerability and Flexibility of Multi-Dose NeoRecormon Administered by Reco-Pen in Pre-Dialysis Patients With Chronic Renal Anemia.

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Drug: Epoetin Beta


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18-65 years of age Chronic renal failure (Stages I-III) No previous epoetin therapy Exclusion Criteria: Poorly controlled hypertension History or evidence of malignancy Relevant acute or chronic bleeding (requiring therapy) within 3 months before study drug Women who are pregnant or breastfeeding

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epoetin Beta<br>Patients will be administered 3 times (X) 30 International unis per kilogram(IU/Kg body weight per week of eopetin beta subcurtaneously using the device RecoPen. The dosage could be increased every 4 weeks by 3 X20 IU/Kg. | Drug: Epoetin Beta<br>* Initial dose: 3X30 IU/Kg body weight administered subcutaneously using RecoPen. Dosage could be increased by 3X20 IU/Kg every 4 weeks up to a maximum of 720 IU/Kg per week.<br>* Other names: NeoRecormon;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of participantss who change to once weekly NeoRocormon |  | 10 months | 
| Percentage of participants with local intolerabilities (pain/allergic reactions) |  | 10 months | 
| Percentage of participants who withdrew due to inability to use RecoPen |  | 10 months | 
| Percentage of participants who changed dose during treatmnent |  | 10 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life evaluated by the Short Form 36 |  | 10 months |
CMR-Lupus Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

Study Overview
=================
Brief Summary
-----------------
In systemic lupus erythematosus (SLE), cardiac manifestations, e.g. coronary artery disease (CAD) and myocarditis are leading causes of morbidity and mortality. The prevalence of subclinical heart disease in SLE is unknown. We studied whether a comprehensive cardiovascular magnetic resonance (CMR) protocol may be useful for early diagnosis of heart disease in SLE patients without known CAD

Official Title
-----------------
The Heart in Systemic Lupus Erythematosus - a Comprehensive Approach by Cardiovascular Magnetic Resonance Tomography

Conditions
-----------------
Lupus Erythematosus, Systemic, Coronary Artery Disease, Myocardial Disease

Intervention / Treatment
-----------------
* Diagnostic Test: Cardiovascular magnetic resonance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of SLE, as defined by the American College of Rheumatology Classification Criteria for Systemic Lupus Erythematosus Exclusion Criteria: age under 18 years known coronary artery disease impaired renal function with an estimated glomerular filtration rate less than 30 ml/min, estimated by the Modification of Diet in Renal Disease Study Group (MDRD) formula (45) devices as pacemakers, implantable cardioverter-defibrillators, insulin pumps and others metallic foreign bodies in the eyes, ferromagnetic implants labeled MR unsafe allergy against CMR contrast media or adenosine presence of chronic atrial fibrillation, 2nd or 3rd degree Atrioventricular (AV)-block, trifascicular block, asthma and severe chronic obstructive pulmonary disease

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 |
| --- |
|Diagnostic Test: Cardiovascular magnetic resonance|CMR including cine, late gadolinium enhancement (LGE) and stress perfusion sequences|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of cardiovascular pathologies identified by CMR in patients with SLE |  | at baseline |
The Fifth-year Follow-up Study for the Phase IV Clinical Trial of Hepatitis A Vaccine in Healthy Children

Study Overview
=================
Brief Summary
-----------------
The purpose of this follow-up study is to evaluate the five-year immune persistence of one injection of inactivated and attenuated alive hepatitis A vaccine in healthy children.

Detailed Description
-----------------
In the previous double-blind, randomized, phase IV clinical trial in 2008, 300 healthy Chinese children aged 18 to 35 months old were administered with one dose of inactivated and attenuated alive hepatitis A vaccine. Series of serum samples were taken for immunogenicity and immune persistence evaluation. Safety observations were performed after vaccination. This trial was also approved by Tianjin CDC Biomedical Ethics Committee in 2008. This study is the fifth-year follow-up research for the previous clinical trial.

Official Title
-----------------
The Phase IV, Open-labelled, Follow-up Study to Evaluate the Five-year Immune Persistence of One Injection of Inactivated or Attenuated Alive Hepatitis A Vaccine in Healthy Chinese Children

Conditions
-----------------
Hepatitis A

Intervention / Treatment
-----------------
* Biological: Inactivated HAV vaccine
* Biological: Attenuated alive HAV vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All subjects who received inactivated or attenuated alive HAV vaccine in the previous trial Exclusion Criteria: Subjects who refused to continue in the follow-up study

Ages Eligible for Study
-----------------
Minimum Age: 18 Months
Maximum Age: 35 Months

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 |
| --- | --- |
| Inactivated HAV vaccine<br>Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose | Biological: Inactivated HAV vaccine<br>* Inactivated vaccine: 0.5 ml per dose containing 250 u antigen, one dose<br>|
| Attenuated alive HAV vaccine<br>Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose | Biological: Attenuated alive HAV vaccine<br>* Attenuated alive vaccine: 1.0 ml per dose containing 6.50 lgCCID50 alive virus, one dose<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The geometric mean concentration (GMC) of anti-hepatitis A virus (HAV) antibodies in serum 60 months after vaccination | to evaluate the immune persistence of anti-HAV antibodies in serum | 60 months after vaccination | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hepatitis A, inactivated hepatitis A vaccine, attenuated alive hepatitis A vaccine, immune persistence
Study Comparing Pharmacokinetics, Safety and Immunogenicity of CT-P6 and US-licensed Herceptin

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, two-arm, parallel-group, single-dose study.

Detailed Description
-----------------
This is a double-blind, two-arm, parallel-group, single-dose study. A total of 70 healthy male subjects will be enrolled.

Official Title
-----------------
A Randomized, Double-blind, Two-arm, Parallel-group, Single Dose Study to Compare the Pharmacokinetics, Safety and Immunogenicity of Two Formulations of Trastuzumab (CT-P6 and US-licensed Herceptin) in Healthy Subjects

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: Trastuzumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male subject Subject voluntarily agrees to participate in this study Exclusion Criteria: Female. Subject has a medical condition of disease including one or more. Smoker

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CT-P6<br>Trastuzumab | Drug: Trastuzumab<br>* Each patient may receive single dose by intravenous infusion<br>|
| Active Comparator: US-licensed Herceptin<br>Trastuzumab | Drug: Trastuzumab<br>* Each patient may receive single dose by intravenous infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics will be assessed by AUC | Pharmacokinetics will be assessed by AUC. | up to week 10 |
Muscle Strength, Physical Work Capacity and Functional Performance in Individuals With Down Syndrome

Study Overview
=================
Brief Summary
-----------------
This project will evaluate muscle strength and its relationship to everyday function in individuals with Down Syndrome.

Official Title
-----------------
Muscle Strength, Physical Work Capacity and Functional Performance in Individuals With Down Syndrome

Conditions
-----------------
Down Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Down Syndrome Mild or moderate mental retardation Able to tolerate exercise testing Exclusion Criteria: Uncontrolled cardiovascular disease orthopedic limitations to exercise

Ages Eligible for Study
-----------------
Minimum Age: 17 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
-----------------
Muscle Strength
Gait Evaluation in Multiple Sclerosis Patients Treated With Glatiramer Acetate

Study Overview
=================
Brief Summary
-----------------
Hypothesis: Treatment with Glatiramer acetate prevents deterioration of gait in multiple sclerosis (MS) patients. During the study patients will undergo a 3 dimensional gait analysis before starting treatment with glatiramer acetate and after 1 year of treatment.

Detailed Description
-----------------
Patients with a definite diagnosis of relapsing remitting multiple sclerosis (MS) will undergo a 3 dimensional gait analysis before initiation of treatment with glatiramer acetate. The gait analysis will include kinematic evaluation using a Charnwood Dynamics CODA CX-1 system, 4 AMTI force plates and a Noraxon telemetric EMG system. Patients will be videotaped and will also undergo a detailed physical examination by a physical therapist. Treatment with Glatiramer acetate will be initiated after the gait analysis. Therapy will be observed and controlled by a neurologist fromn the staff of the Multiple Sclerosis Center. Repeat gait analysis will be performed after one year of treatment.

Official Title
-----------------
Three Dimensional Gait Evaluation in Relapsing Remitting Multiple Sclerosis Patients Treated With Glatiramer Acetate

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

Intervention / Treatment
-----------------
* Drug: Glatiramer acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of multiple sclerosis EDSS less than 5.5 No cognitive disability Exclusion Criteria: EDSS over 5.5 Inability to cooperate with gait analysis

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: Glatiramer acetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Computerized gait analysis: at the beginning of treatment and after 1 year |  |  |
Fish, Polyunsaturated Fatty Acids Intake and Mortality

Study Overview
=================
Brief Summary
-----------------
Data linking fish, polyunsaturated fatty acids intake and mortality are lacking and conflicting. We aim to use data from the China Health and Nutrition Survey (CHNS) and National Health and Nutrition Examination Survey (NHANES) to investigate the associations of fish and polyunsaturated fatty acids (PUFA) intake with mortality in Chinese and US populations. The study findings will be informative for addressing the role of fish and specific PUFA in human health and improve basis for dietary recommendations.

Detailed Description
-----------------
Data from the China Health and Nutrition Survey (CHNS, from 1989 to 2011) and National Health and Nutrition Examination Survey (NHANES), including NHANES III conducted in 1988-1994 and continuous NHANES 1999-2010 were used to investigate the associations of fish and polyunsaturated fatty acids intake with mortality.The following variables were used: Demographics: age, sex, race/ethnicity, residence Socioeconomic variables: education, marital status, Dietary variables: Intakes of fish, polyunsaturated fatty acids, total energy, vegetables, fruits, red meat and saturated fat Clinical assessments: hypertension, diabetes, cancer, cardiovascular disease (CVD), family history of CVD

Official Title
-----------------
Fish, Polyunsaturated Fatty Acids Intake and Mortality: Analysis of CHNS and NHANES

Conditions
-----------------
Mortality, Polyunsaturated Fatty Acids

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged ≥20 with complete data on diet and follow-up time Exclusion Criteria: Missing information for mortality Cardiovascular disease Cancer

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| CHNS<br> | |
| NHANES<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Mortality | Total Mortality from All Causes | From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cause-specific mortality | Cause-specific mortality from diseases | From baseline until death or censoring on 31 December 2011, whichever came first, assessed up to an average of 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fish, Polyunsaturated fatty acids, Mortality, CHNS, NHANES
A Study for Small Cell Lung Cancer (SCLC) in Extensive Disease Stage

Study Overview
=================
Brief Summary
-----------------
Comparison of two combination chemotherapies in the treatment of patients with SLCL

Detailed Description
-----------------
Comparison of two combination chemotherapies in the treatment of patients with SLCL The combination chemotherapies for this study are Carboplatin plus Irinotecan versus Carboplatin plus Etoposide.

Official Title
-----------------
A Randomised Phase II/III Study to Compare the Combination of Carboplatin Plus Irinotecan Vs. the Combination of Carboplatin Plus Etoposide for SCLC in Extensive Disease Stage

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

Intervention / Treatment
-----------------
* Drug: Carboplatin plus Irinotecan vs Carboplatin plus Etoposide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cytological or histological proven SCLC Stage I or II at 1st diagnosis no prior chemotherapy measurable tumor disease karnofsky performance 70 Exclusion Criteria: second malignancy ( except basal cell carcinoma, CA in situ Cervix uteri) NYHA III chronic diarrhea, obstructive bowel syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Carboplatin plus Irinotecan vs Carboplatin plus Etoposide|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint: |  |  | 
| Documentation of the remission rate ( Phase II) |  |  | 
| Determination of progress free time (Phase III) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary Endpoint: |  |  | 
| Documentation of progress free time (Phase II) |  |  | 
| Documentation of objective remission rate ( Phase III) |  |  | 
| Documentation of 1-year survival rate |  |  | 
| Documentation of safety of the drug combination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
SCLC