linjc16/ctgov huggingface dataset:
Pitavastatin on Carotid Intima-media Thickness

Study Overview
=================
Brief Summary
-----------------
This study is aimed to analyze the effects of aggressive and conventional lipid lowering therapy with Pravastatin on carotid intima-media thickness (IMT) in patients with hyperlipidemia and abnormal thickening of IMT.

Official Title
-----------------
Pitavastatin Evaluation of Atherosclerosis Regression by Intensive Cholesterol-Lowering Therapy

Conditions
-----------------
Hyperlipidemia, Carotid Artery Diseases

Intervention / Treatment
-----------------
* Drug: Pitavastatin
* Drug: Pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as having hyperlipidemia LDL-C at the time of enrollment is no less than 100 Common carotid IMT is 1.1 mm and over Exclusion Criteria: Received or planned to receive intervention on carotid arteries during the study period Overt liver dysfunction (ALT; 100 IU/L and over) Overt renal dysfunction (serum creatinine; 2.0 mg/dL and over) Receiving Cyclosporin Hyperreactive to Pitavastatin During pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months. After administration, serum LDL-cholesterol should be kept between 100 and 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. | Drug: Pitavastatin<br>* comparison of different target levels of lipid lowering using Pitavastatin Subjects are receiving Pitavastatin, starting at 2 mg, for 12 months.<br>|
| Active Comparator: 2<br>Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months. After administration, serum LDL-cholesterol should be kept under 80 mg/dL by controlling the dose of Pitavastatin or adding other anti-hyperlipidemia agents other than statins. | Drug: Pitavastatin<br>* Subjects are receiving Pitavastatin, starting at 4 mg, for 12 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| absolute changes in carotid intima-media thickness from baseline to final visit |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| relative change in carotid intima-media thickness |  | 12 months | 
| change in LDL-C, HDL-C, TG and RLP-C |  | 12 months | 
| change in hs-CRP and IL-6 |  | 12 months | 
| new onset or recurrence of ischemic heart disease, heart failure, stroke and atherosclerosis obliterans |  | 12 months | 
| sudden death |  | 12 months | 
| side effects |  | 12 months |
Bupropion SR for Treating Smokeless Tobacco Use

Study Overview
=================
Brief Summary
-----------------
To determine the efficacy and safety of bupropion SR for quitting tobacco in smokeless tobacco users.

Detailed Description
-----------------
CONTEXT: No pharmacotherapies have been shown to increase long-term (&#8805; 6 month) tobacco abstinence rates among smokeless tobacco (ST) users, although bupropion SR has demonstrated potential efficacy in pilot studies. OBJECTIVE: To determine the efficacy and safety of bupropion SR for tobacco abstinence among ST users compared with placebo. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted between August 2003 to May 2005 at two research centers with a 12-week treatment period and follow-up of smoking status to week 52. INTERVENTION: Bupropion SR titrated to 150 mg twice daily or placebo for 12 weeks plus weekly behavioral interventions. Main Outcome Measures: The primary endpoint was 7-day point-prevalence tobacco abstinence rate at week 12. Secondary outcomes included the prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52.

Official Title
-----------------
Bupropion SR for Treating Smokeless Tobacco Use

Conditions
-----------------
Smokeless Tobacco

Intervention / Treatment
-----------------
* Drug: Bupropion SR


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older used ST daily for at least one year in good general health willing to complete all study procedures

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

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

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

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: Bupropion SR|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point-prevalence tobacco abstinence rate at week 12 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prolonged and continuous tobacco abstinence rates at weeks 12, 24, and 52 |  |  |
Health Benefits of Alpine Skiing for the Elderly

Study Overview
=================
Brief Summary
-----------------
Older people tend to live a sedentary lifestyle which causes a loss of cardiorespiratory fitness, impaired postural stability and a increased risk of falls. Social isolation of older people leads to depression and other mental diseases. However, numerous studies show that age-related degradation processes and functional limitations can be counteracted by physical activity. Various studies show that alpine skiing is a complex sport that places demands on the cardiorespiratory, neuromuscular and sensorimotor systems. With studies providing evidence to suggest alpine skiing is an appropriate activity for elderly as a health-enhancing sport, perhaps Alpine skiing could provide the physical activity needed to counteract age-related degradation processes and loss of function. To date, there is a lack of long-term intervention studies devoted to this topic. The aim of this study was to monitor the long-term effects of skiing on the health of older people, as to age-related muscle breakdown, cardiorespiratory fitness, body stability, general mobility and the overall psychological state of the subjects.

Official Title
-----------------
SASES: SAlzburg Skiing in the Elderly Study: Health Benefits of Alpine Skiing for the Elderly

Conditions
-----------------
Elderly, Strength, Exercise Capacity, Postural Control

Intervention / Treatment
-----------------
* Behavioral: Alpine Skiing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 60-75 years of age at average or above average skiing ability average physical activity level willingness to ski regularly (2-3 days per week) for 12 weeks ability to give written informed consent Exclusion Criteria: serious health problems that would make alpine skiing unjustifiable

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 75 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Alpine Skiing<br> | Behavioral: Alpine Skiing<br> <br> |
| No Intervention: Control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Spread and Course of COVID-19 Infections

Study Overview
=================
Brief Summary
-----------------
The overall goal is to study the immune response to SARS-CoV-2 infection over the period of one year in the blood of a representative cohort of ETH students/employees.

Official Title
-----------------
Longitudinal Serological Study on the Spread and Course of COVID-19 Infections

Conditions
-----------------
Covid-19, Virus Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ETH employee or ETH student and their family members living in the same household at the start of the study Between 18 and 64 years of age at the start of the study Signed informed consent Exclusion Criteria: Age over 64 years at the start of the study In quarantine or self-confinement at the start of the study Active COVID-19 infection at the start of the study: Diagnosed with a laboratory test Suspected based on typical symptoms such as fever (>38°C), acute pulmonary ex-acerbation or sudden loss of gustatory taste The following medical condition With continuous steroid therapy/ chemotherapy/immunsuppressive therapy In treatment for cancer With severe autoimmune disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| ETH cohort<br>employees or students at ETH Zurich, Switzerland | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| seroprevalence as well as the titer of serum antibodies (IgM, IgG and IgA) targeting SARS-CoV-2 antigens |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the property of peripheral blood mononuclear cells before and after an infection with SARS-CoV-2 as opposed to other pathogens |  | 12 months | 
| the property of IgM and IgA antibody titers against the nucleocapsid protein of SARS-CoV-2 in symptomatic as well as asymptomatic COVID-19 infections over the course of time following an infection |  | 12 months | 
| the immune response to common-cold (corona)virus and influenza virus infections in patients with COVID-19 infections |  | 12 months |
Bone Lead Levels and College Achievement Scores

Study Overview
=================
Brief Summary
-----------------
This project studies the relationship between lead exposure and academic achievement in college students. Most studies of the neurobehavioral effects of lead have focused on performances at the low end of the distribution. There is evidence that lead affects outcome across the entire distribution. This is a retrospective cohort study of subjects whose cognitive function is adequate to gain admission to college. We will use x-ray fluorescence to measure bone lead concentrations in undergraduate college students and test the hypothesis that achievement scores are related to early lead exposure. Early lead exposure has been shown to have measurable effects on academic performance and neurobehavioral outcomes at 18 years of age. Should an effect be found in this study, the spectrum of lead toxicity would be expanded to include subjects with above average function.

Conditions
-----------------
Lead Poisoning

Participation Criteria
=================
Eligibility Criteria
-----------------
Current undergraduate student at the University of Pittsburgh who have taken the Scholastic Aptitude Test (SAT).

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lead exposure, Bone lead, Cognitive function, Academic achievement, Neurobehavior
Excimer Light(308) Therapy for Resistant Alopecia Areata

Study Overview
=================
Brief Summary
-----------------
This study aimed to evaluate the efficacy and safety of the 308-nm excimer lamp in resistant AA treated with topical minoxidil .

Detailed Description
-----------------
Alopecia areata (AA) is a chronic, nonscarring, T-cell mediated autoimmune disease, presenting with localized or diffuse hair fall in hair-bearing areas. Approximately 1.7% of the population experience an episode of AA during their lifetime. Both sexes are equally affected, and most new cases are recorded below the age of 30 years . Excimer laser using high-dose monochromatic UV radiation can trigger apoptosis and induce immunological suppression through altering cytokine production such as IL-4, IL-10, prostaglandin E2, platelet-activating factor, and cis-urocanic acid. Benefits have only been seen with localized patches of AA, and regrowth of hair occurs only in treated areas .

Official Title
-----------------
Efficacy of Excimer Light(308) Therapy for Resistant Alopecia Areata

Conditions
-----------------
Alopecia Areata

Intervention / Treatment
-----------------
* Device: excimer light


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ● Having multiple patches of AA. Duration of alopecia >1 year No topical or systemic treatment for the last 4 months Agreement to regular visits for treatment and follow-up. Exclusion Criteria: ● A single form of AA. Alopecia for <1 year. Being on other modalities of treatment. Treatment within the last 4 months. Photosensitive disorders. Pregnancy or breastfeeding.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: excimer light|Excimer laser using high-dose monochromatic UV radiation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| alopecia areata with ecimer light | evulate patients monthly during treatment with excimer light and minoxidil gel for three months With 20 patients who should completely recovered from alopecia areata. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
excimer light
Bio-ADM as a Biomarker of Refilling in Chronic Hemodialysis Patient

Study Overview
=================
Brief Summary
-----------------
Aim of this study is to evaluate in a population of chronic kidney disease patients on dialysis (Stage 5D) the predictive value of bio-adrenomedullin (bio-ADM) level on vascular refilling rate.

Official Title
-----------------
Bio-adrenomedullin (Bio-ADM) as a Biomarker of Refilling in Chronic Hemodialysis Patient

Conditions
-----------------
Chronic Kidney Disease 5D

Intervention / Treatment
-----------------
* Biological: BioADM determination in plasma


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Chronic Kidney Disease patient on dialysis (stage 5D) for more than 1 month Anuric patient Exclusion criteria: Patient protected by law Patient under guardianship ou curatorship Patient deprived of liberty

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 |
| --- | --- |
| All patients receive conventional dialysis treatment at inclusion<br>All patients receive conventional dialysis treatment at inclusion | Biological: BioADM determination in plasma<br>* BioADM determination in plasma<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship between bio-ADM level and vascular refilling rate | The refilling rate will be assessed by the ratio of relative blood volume and UF max | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bio-ADM value according to comorbidity factors | Bio-ADM value according to comorbidity factors (diabetes, heart failure and low-grade inflammation) | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic kidney disease, Extracorporeal purification, Bio-ADM, Vascular refilling rate
AneuRx Post Market Study in the Treatment of AAA

Study Overview
=================
Brief Summary
-----------------
The aorta is a large blood vessel that carries blood away from the heart to the organs in the rest of the body. An aneurysm is a weakening in the artery wall that will become a bulge in the aorta. If left untreated, this bulge may continue to grow larger and may rupture (break open) with fatal consequences. Abdominal aortic aneurysm (AAA) is a life-threatening lesion that has been treated in recent year via endovascular repair. The purpose of this study is to monitor the long term performance of the AneuRx Stent Graft Systems.

Official Title
-----------------
AneuRx Post Market Surveillance Registry

Conditions
-----------------
Abdominal Aneurysm

Intervention / Treatment
-----------------
* Device: AneuRx Stent Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients implanted with an AneuRx Stent Graft per Instructions for Use Patients must provide written informed consent and agree to be accessible for follow-up at the study center.

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 |
| --- | --- |
| Other: Lifeline Registry<br>All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by the Foundation of Society for the Vascular Surgery (SVS) | Device: AneuRx Stent Graft<br>* Abdominal Aortic Aneurysm Repair<br>|
| Other: PS Registry<br>All comers registry for the on-label treatment of AAA with the AneuRx Stent Graft sponsored by Medtronic | Device: AneuRx Stent Graft<br>* Abdominal Aortic Aneurysm Repair<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Occurrence of Death, Aneurysm Rupture, and Surgical Conversion | Number of patients that had an occurrence of death, aneurysm rupture or surgical conversion | 5 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the Occurance of Endoleak, Stent Graft Migration, Aneurysm Enlargement, Device Integrity and Adverse Events |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal Aneurysm, Endovascular Aortic Repair (EVAR), Endovascular Stent Graft, Endograft
Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
A total of 41 adults with perennial allergic rhinitis were enrolled in a first double-blind placebo-controlled phase for six months, and treated on a weekly basis with sublingual doses of single individualized homeopathic medicines or placebo. After this closed initial phase, all patients were invited to participate in an long-term open-label controlled phase, in that they would receive homeopathic treatment for the maximum period of 36 months, and the results were compared with the improvement of initial phase. Signs and symptoms scores, rescue medication requirements and quality of life were assessed by questionnaires and personal clinical evaluation by a same independent researcher, before and after each phase. Primary and secondary clinical outcome were, respectively, specific and general allergic signs and symptoms scores. Total IgE titles were performed before and after each phase.

Official Title
-----------------
Quantitative-Qualitative Clinical Trial to Evaluate the Effectiveness of Individualized Homeopathic Treatment in Perennial Allergic Rhinitis

Conditions
-----------------
Rhinitis

Intervention / Treatment
-----------------
* Drug: homeopathic medicine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate rhinitis to assign written informed consent Exclusion Criteria: other chronic diseases corticosteroid use pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: 1<br>This arm received individualized homeopathic medicine during 6 months (initial phase), and completed three years (second phase) | Drug: homeopathic medicine<br>* individualized homeopathic medicine<br>|
| Placebo Comparator: 2<br>This arm received placebo during 6 months. After this period, all patients received individualized homeopathic medicine for three years. | Drug: homeopathic medicine<br>* individualized homeopathic medicine<br>Drug: placebo<br>* placebo - 6 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| specific allergic signs and symptoms score |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| general allergic symptoms score |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
allergy, rhinitis, homeopathy, double-blind