linjc16/ctgov huggingface dataset:
Evaluation of Outcome Metrics in Alexander Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to define the natural history of Alexander Disease, a leukodystrophy that causes neurological dysfunction. Investigators will obtain clinical outcome assessments to measure how the disease affects a patient's gross motor, fine motor, speech and language function, swallowing, and quality of life. Specimens are collected to measure glial fibrillary acidic protein (GFAP) levels in cerebrospinal fluid (CSF) and blood. The data obtained from this study will be used for the design of future treatment trials.

Detailed Description
-----------------
Participants will be asked to complete physical examinations including physical therapy, occupational therapy, speech and language therapy, neurocognitive and swallowing assessments. Patients (or caretakers) may be asked to complete questionnaires as well. Specimen collection is an optional procedure. The study asks for participants to return at least once yearly to repeat assessments.

Official Title
-----------------
Evaluation of Outcome Metrics in Alexander Disease

Conditions
-----------------
Alexander Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with Alexander Disease Exclusion Criteria: Other Leukodystrophies will not be enrolled
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 |
| --- | --- | --- |
| Change in Gross Motor Function Over Time | Total score and dimensional scores (rolling/supine, crawling/traveling, sitting, standing, and walking/running) will be calculated at each visit. Change in total and dimensional scores over time will be assessed. | Up to 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Bruininks-Oseretsky Test of Motor Proficiency Over Time | Composite score and scores for the 4 sub-scales will be calculated at each visit. Change in composite and subscale scores over time will be assessed. | Up to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Alexander Disease
Internet-delivered Cognitive Behavioral Therapy (CBT) for Health Anxiety

Study Overview
=================
Brief Summary
-----------------
Hypochondriasis (health anxiety) is common, has many negative consequences for the afflicted individual and is associated with high societal costs. Cognitive Behavioural Therapy (CBT) has proven to be effective when administered in live-sessions. The aim of this study is to investigate whether CBT remains effective when administered via a self-help programme on the Internet.

Official Title
-----------------
Internet-delivered Cognitive Behavioural Therapy for Health Anxiety - a Randomized Controlled Trial

Conditions
-----------------
Hypochondriasis

Intervention / Treatment
-----------------
* Behavioral: Internet-delivered CBT.
* Behavioral: On line discussion group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary diagnosis of hypochondriasis At least 18 years old Able to read and write in swedish Computer access Exclusion Criteria: Drug abuse Concurrent severe depression No serious somatic illness Previous treatment with CBT for hypochondriasis

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: 1<br>Internet-delivered CBT. Contact with therapist thru an e-mail system. 12 weeks. | Behavioral: Internet-delivered CBT.<br>* 12 weeks. Therapist contact through e-mail.<br>|
| Placebo Comparator: 2<br>On line discussion group. | Behavioral: On line discussion group<br>* Placebo. On line discussion group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Anxiety Inventory |  | 3 days before treatment start | 
| Health Anxiety Inventory |  | 12 weeks after pre asessment | 
| Health Anxiety Inventory |  | 6 months after post assessment | 
| Health Anxiety Inventory |  | 12 months after post assessment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IAS |  | Immediately pre and post treatment,and 6 and 12 month follow up | 
| BAI |  | Immediately pre and post treatment, and 6 and 12 month follow-up | 
| MADRS-S |  | Immediately pre and post treatment, and 6 and 12 month follow-up | 
| QOLI |  | Immediately pre and post treatment, and 6 and 12 month follow-up | 
| WI |  | Immediately pre and post treatment, and 6 and 12 month follow-up |
Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

Study Overview
=================
Brief Summary
-----------------
Oxidative stress is seen in children with asthma, but is hard to measure. The investigators exploring the utility of using a commercially available assay to measure oxidative stress in the urine in asthmatics. Additionally, the investigators will attempt to prove that oxidative stress is higher in children with acute asthma compared to those with stable asthma and that this stress is also higher in children with more severe clinical asthma exacerbations compared to less severe ones.

Official Title
-----------------
Urinary 8-isoprostane is Elevated in Acute Childhood Asthma

Conditions
-----------------
Childhood Asthma, Oxidative Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Group 1 Patients aged 4-18 years Known stable asthmatics on no medications or with no medication changes in 3 weeks prior to enrollment No asthma hospitalizations in past 3 months Parent available to consent Group 2 Patients aged 4-18 Known asthmatic, admitted to Stony Brook University Hospital for status asthmaticus Parent available to consent Exclusion Criteria: Any child with documented fever within 24 hours of study entry Any child with a known current history of tracheo- or bronchomalacia Any child with known clinical or laboratory evidence of shock (see below) Any child with history of documented immunodeficiency, rheumatologic disease, cystic fibrosis, or renal dysfunction (see below) Any child with a current or recent (less than 1 year) history of tracheostomy Any child with a known genetic abnormality Any pregnant child Any child with a history of autism Any child whose parent/caregiver is unable to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 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 |
| --- | --- |
| acute asthmatic children<br>Children hospitalized with a diagnosis of acute asthma exacerbation | |
| stable asthmatic children<br>Children with a history of asthma currently asymptomatic | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We expect to see increased urinary 8-isoprostane in acute pediatric asthmatics |  | Urinary 8-isoprostane levels were measured at the end of subject recruitment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| We expect urinary 8-isoprostane levels to be higher with increased pediatric asthma severity. |  | This was calculated at the end of patient recruitment, after urinary 8-isoprostane levels were obtained | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Childhood Asthma, Oxidative stress, Urinary 8-isoprostane
A Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia

Study Overview
=================
Brief Summary
-----------------
This is a clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Detailed Description
-----------------
This is a multicenter, randomized, double-blind comparative clinical study to evaluate the efficacy between Helicobacter pylori Eradication therapy and Motilitone in Functional Dyspepsia

Official Title
-----------------
A Multicenter, Randomized, Double-blind Comparative Study to Evaluate the Efficacy Between Helicobacter Pylori Eradication Therapy and Motilitone in Functional Dyspepsia

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: Motilitone®
* Drug: A-Cilin®, Clari® and Pantoline®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Roman III criteria One or more conditions are applied: epigastric pain, epigastric burning, bothersome, postprandial fullness or early satiety No organic lesion Helicobacter pylori infection Exclusion Criteria: has taken prokinetics, H2 antagonists, PPIs, NSAIDs, anticholinergics, antibiotics, antidepressants, anticoagulants within a month had a surgery that might affect gastrointestinal motility

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: H.Pylori eradication therapy<br>A-cillin®, Pantoline® and Clari® is administered with a tablet of placebo (Motilitone®) | Drug: A-Cilin®, Clari® and Pantoline®<br> <br> |
| Experimental: Motilitone®<br>30 mg is administered with 3 tablets of placebo (Patoline®, Clari® and A-cilin) | Drug: Motilitone®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volunteer global assessment of improvement rate of functional dyspepsia by using 5-Likert scale | 5-Likert scale deteriorated not changed moderately improved markedly improved symptom-free | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Volunteer global assessment by using 5-Likert scale |  | 6 weeks | 
| The improvement rate of 4 types of dyspepsia symptoms |  | 12 weeks | 
| The change of each score and total score of dyspeptic symptoms |  | 6, 12 weeks | 
| Assessment of NDI-K Quality of Life |  | 6,12 weeks | 
| The proportion of the patients who answered yes for the question about symptom improvement |  | 6, 12 weeks |
Partial Breast Versus Whole Breast Irradiation in Elderly Women Operated on for Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this trial is to investigate the difference in late radiation morbidity between partial breast irradiation and whole breast irradiation given to women operated on with breast conservation surgery for early breast cancer with a low risk of local recurrence.

Detailed Description
-----------------
The study is 2-armed. In both treatment arms the radiotherapy consists of 40 Gy in 15 fractions, 2.67 Gy per fraction. The primary endpoint in the trial is late radiation morbidity evaluated as fibrosis, secondary endpoints are other types of late morbidity, rate of local recurrence and an attempt to establish a genetic risk profile for development of late radiation morbidity. The hypothesis is that women operated with breast conservation for a breast carcinoma with low risk of local recurrence can be offered partial breast irradiation without risking more late radiation morbidity compared to whole breast irradiation.

Official Title
-----------------
Partial Breast Versus Whole Breast Irradiation to Women ≥ 60 Years Operated With Breast Conservation for Early Breast Cancer: a Randomized Fase II Trial

Conditions
-----------------
Breast Carcinoma

Intervention / Treatment
-----------------
* Radiation: Partial breast irradiation
* Radiation: Whole breast irradiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women 60 years or older operated for unilateral, unifocal early breast cancer pT1, pN0, M0, grade I or II, positive estrogen and/or progesterone receptor, HER2 negative Exclusion Criteria: lobular carcinoma

Ages Eligible for Study
-----------------
Minimum Age: 60 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Partial breast irradiation<br>40 Gy/15 fractions, 3 weeks | Radiation: Partial breast irradiation<br>* 40 Gy/15 fractions, 3 weeks<br>|
| Active Comparator: Whole breast irradiation<br>40 Gy/15 fractions, 3 weeks | Radiation: Whole breast irradiation<br>* 40 Gy/15 fractions, 3 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade 2 and/or 3 fibrosis after radiotherapy |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Any other late morbidity after adjuvant radiotherapy, genetic risk profile for late morbidity, recurrence/survival | morbidity and recurrences | 10 years |
Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to expand access to buprenorphine using a mobile health care system among marginalized populations with or at high risk for HIV and observe longitudinal effects of treatment.

Official Title
-----------------
Prospective Cohort of Opiate Dependent Patients on Buprenorphine/Naloxone for Maintenance

Conditions
-----------------
Opiate Dependence

Intervention / Treatment
-----------------
* Other: Mobile Access


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV + At high risk for HIV (IV drug use, commercial sex worker, partner of HIV+) Mental Health (unmanaged or diagnosed mental illness) Exclusion Criteria: Benzodiazepine use Opiate use due to pain management issues only (present or past) Non-IDU

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mobile Access to Buprenorphine<br>High risk populations accessing a mobile health care system can obtain Buprenorphine for treatment. | Other: Mobile Access<br>* Subjects would access buprenorphine through mobile access. On day 1: 8 mg of buprenorphine, then on Day 2: 16 mg daily of buprenorphine sublingually.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance | To assess the feasibility and efficacy of the use of buprenorphine to treat opioid dependence in high risk populations accessing a mobile health care system using tracked attendance. | 10/1/03-9/30/08 | 
| Opioid free urine toxicology | To assess the feasibility and efficacy of the use of buprenorphine to treat opioid dependence in high risk populations accessing a mobile health care system using incidence of opioid free urine toxicology. | 10/1/03-9/30/08 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Access to other health care, incarceration, hospitalization acceptability of the site of care from both patient and provider perspectives, and attendance and adherence to counseling. |  | 10/1/03-9/30/08 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
opiate dependence, buprenorphine
Shanghai Epidemiology Study for Adolescents and Children With Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the morbidity, mortality, disability and survival rate in Shanghai adolescents and children with cancer diagnosed since January 2002.

Detailed Description
-----------------
The investigators collected information of all the adolescents and children diagnosed cancer in Shanghai since January 2002, including their name, gender, the date of birth, the diagnosis date, disease diagnosis, residence address and the last follow-up time status (survival/death). The type of cancer included all malignant tumors such as Acute Lymphocytic Leukemia, Acute Myeloid Leukemia, Non-Hodgkin Lymphoma, Hodgkin Lymphoma, central nervous system tumors, Neuroblastoma, Wilms tumor and so on. Then the investigators would analyze the morbidity, mortality, disability and survival rate.

Official Title
-----------------
Shanghai Epidemiology Study for Adolescents and Children With Cancer

Conditions
-----------------
Childhood Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 0-19 year-old children and adolescents. Diagnosed cancer in Shanghai since January 2002. Exclusion Criteria: Patients who were lost of follow-up. Patient's death wasn't caused by cancer or complications but by other accidents such as car accident, fell from a great height and so on.

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 19 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 |
| --- | --- |
| 1<br>Patients were diagnosed since January 2002. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival for the whole cohort |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality for the whole cohort |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epidemiology, Shanghai, Cancer, Adolescents, Children
A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population

Study Overview
=================
Brief Summary
-----------------
To determine the prevalence and the prognosis in a corhort of patients with familial hypercholesterolemia (FH).

Detailed Description
-----------------
This study aims to achieve the following goals through prospective cohort study and statistical analysis: (1) to determine the prevalence of familial hypercholesterolemia (FH) in healthy people with hypercholesterolemia.（2) Compared with non FH population, the relative risk of atherosclerotic cardiovascular disease (ASCVD) in FH patients in China was calculated, and the risk prediction model of ASCVD in FH patients was constructed by using biochemical results, imaging data, biomarkers and other indicators.（3) To evaluate the benefits of different lipid-lowering strategies for FH patients in China.（4) To analyze the gene carriers of FH patients in China.

Official Title
-----------------
A Prospective Cohort Study on Familial Hypercholesterolemia in Health Examination Population

Conditions
-----------------
Familial Hypercholesterolemia

Intervention / Treatment
-----------------
* Other: familial hypercholesterolemia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) Patients with definite diagnosis of hyperlipidemia. Exclusion Criteria: Age < 18. Do not agree to participate in this study. secondary hypercholesterolemia. Phytosteronemia.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| non-FH Group<br> | |
| FH Group<br> | Other: familial hypercholesterolemia<br>* Among the selected patients with hyperlipidemia, those who met the diagnostic criteria of FH were included in the study cohort as FH group.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with atherosclerotic cardiovascular disease (ASCVD) events | 1) Fatal or non-fatal myocardial infarction; 2) Fatal or non-fatal ischemic stroke; 3) Coronary artery revascularization; 4) Peripheral artery revascularization; 5) Cardiogenic death | 2 years from enrollmet | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
familial hypercholesterolemia, prognosis