linjc16/ctgov huggingface dataset:
Brain Structure and Development in Pre-Term and Full-Term Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see how full-term and pre-term infants' brains relate to their movement and development throughout the first two years of life. All infants who participate in this study will have a magnetic resonance image (MRI) of the brain prior to discharge from the hospital. Infants will then have follow-up appointments every 3-6 months at home or at the Infant Motor Behavior Laboratory at the University of Delaware. The follow-up sessions will test how infants change their movements to respond to interesting objects or sounds in their environment. It is hoped that the results of this study will assist clinicians in developing better testing and treatment methods for those infants at risk for developmental problems.

Official Title
-----------------
The Relationship Between Early Brain Structure and Development in Full-Term and Pre-Term Infants

Conditions
-----------------
Healthy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-term infants (< 1 Kg Birthweight) Full-term infants (well)

Ages Eligible for Study
-----------------
Maximum Age: 30 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 |
| --- | --- |
| Pre-Term<br>Infants born pre-term with birthweight less than 1KG | |
| Full-Term Infants<br>Well infants who are born full-term | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age | To compare the learning and coordination impairments of extremely low birth weight infants with full term infants at 3 and 6 months of age. This is accomplished through a series of play activities. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age. | To relate the learning and coordination impairments of extremely low birth weight infants at 3 and 6 months of age to their CNS impairments at term age. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pre-term infants, full-term infants, MRI, brain structure development, pre term, full term
Effects of Metformin vs Oral Contraceptives on CV Risk Markers in PCOS

Study Overview
=================
Brief Summary
-----------------
Cardiovascular risk factors cluster in hyperandrogenic women - including those presenting with the polycystic ovary syndrome - in association with insulin resistance, obesity, and other metabolic disorders. The present clinical trial intends to compare the effects of oral contraceptives and metformin on PCOS patients, focusing on classic and non-classic cardiovascular risk markers and indexes of cardiovascular performance, in order to whether or not, as suspected by previous data obtained in non-hyperandrogenic women, oral contraceptives worsen the cardiovascular risk profile of PCOS women, favoring the use of metformin if the latter actually ameliorates such a risk.

Official Title
-----------------
The Cardiovascular Risk Profile Associated With The Polycystic Ovary Syndrome And With Ovulatory Hyperandrogenism, And Its Changes During Treatment With Metformin Or Oral Contraceptives

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: Metformin
* Drug: Ethynyl-estradiol plus cyproterone acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women of fertile age presenting with PCOS Non-hyperandrogenic women of fertile age (these women will not receive the interventions and will serve only to obtain normative data for some variables) Exclusion Criteria: Severe disease not related to the condition under study Pregnancy Medical or surgical treatment of PCOS during the previous 3 months Contraindication for the use of oral contraceptives or metformin Inability to understand the proposal of the study precluding effective informed consent Minors who are not accompanied by their legal representative

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum Age: 45 Years

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

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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Metformin|nan|
|Drug: Ethynyl-estradiol plus cyproterone acetate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum androgen levels |  |  | 
| Lipid profiles |  |  | 
| Blood pressure |  |  | 
| Cardiovascular performance |  |  | 
| Non-classic cardiovascular risk markers |  |  | 
| Indexes of insulin secretion and sensitivity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic ovary syndrome, Hyperandrogenism, Hirsutism, Cardiovascular risk, Chronic inflammation, Metformin, Cyproterone acetate, Oral contraceptives
Observational Study of Heart Valve Disease in Patients With Parkinson's Disease Treated With Pergolide

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether patients with Parkinson's disease and treated with pergolide have a higher risk of heart valve disease compared to patients with Parkinson's disease not treated with pergolide.

Detailed Description
-----------------
Pergolide is an ergot dopamine receptor agonist with demonstrated efficacy in Parkinson's disease. Last year, two studies showed that pergolide can induce unexpected heart valve disease potentially severe and frequent. The late discovery of this unknown side effect had dramatic consequences in Parkinson's disease management and the French drug agency (AFFSAPS) has recently published guidelines for its prescription. Little is known about the prevalence and the molecular mechanisms leading to this adverse event. To determine the prevalence, evolution, and potential risk factors of pergolide-induced heart valve disease, we propose an echocardiographic observational study in parkinsonian patients taking pergolide compared to matched controls. This clinical study will be performed in the Clinical Investigation Centre in collaboration with the Institute of Cardiology of the Salpétrière Hospital

Official Title
-----------------
Etude Observationnelle Des Valvulopathies Chez Les Patients Parkinsoniens Traites Par Pergolide Par Rapport a Une Population Temoin

Conditions
-----------------
Parkinson's Disease, Pergolide

Intervention / Treatment
-----------------
* Procedure: echocardiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic Parkinson's disease Hoehn and Yahr score inferior or equal to 4 treated with pergolide since more than 3 months (pergolide group) never treated by pergolide (control group) Exclusion Criteria: Parkinson + syndrome, multiple system atrophy, supranuclear palsy hoehn and yahr score equal to 5

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 |
| --- |
|Procedure: echocardiography|nan|

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
-----------------
parkinson's disease, pergolide, heart valve disease
Effect of Ginseng on Blood Pressure

Study Overview
=================
Brief Summary
-----------------
To determine the effect of ginseng on blood pressure control.

Detailed Description
-----------------
The effect of ginseng on blood pressure control is controversial, originating from an early 1970s observational study, suggesting that ginseng may adversely effect blood pressure. Despite these early findings, extensive research has since suggested that ginseng may have a positive effect on blood pressure. The current study will help clarify present uncertainty on the effect of ginseng on blood pressure control. This systematic review and meta-analysis will follow The Cochrane Handbook for Systematic Reviews of Interventions. MEDLINE, EMBASE, CINAHL and The Cochrane Central Register of Controlled Trials will be searched using appropriate search terms. Intervention trials that investigate the effect of ginseng on blood pressure in humans will be included.

Official Title
-----------------
Effect of Ginseng on Blood Pressure: A Systematic Review and Meta-Analysis of Controlled Trials

Conditions
-----------------
Blood Pressure

Intervention / Treatment
-----------------
* Dietary Supplement: Ginseng


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: clinical trials in humans randomized treatment allocation ≥ 1 month suitable control viable endpoint data Exclusion Criteria: non-human studies non-randomized treatment allocation < 1 month lack of a suitable control no viable endpoint data trials where ginseng is part of a multi-herbal treatment
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Dietary Supplement: Ginseng|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diastolic Blood Pressure |  | 1 month | 
| Mean Arterial Pressure |  | 1 month |
Is There an Allergy to Pure Metallic Gold Microparticles?

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize gold is inert and thereby there is no pure-gold allergy. The primary aim of this study is to measure the prevalence of allergy to metallic pure gold microparticles and allergy to GSTS.

Detailed Description
-----------------
TRUE test panel which includes gold sodium thiosulphate (GSTS), 1 % w/v in petrolatum, and gold microparticles, 20-micron diameter, 1 % w/v in petrolatum, will be added added to the baseline series. It will be applied to the upper back of healthy adults in aluminum Finn Chamber for 48 hours. Clinical evaluation will be performed 24 hours after removal the test according to standard procedures for evaluation of epi-cutaneous challenging (Johansen 2015).

Official Title
-----------------
Is There an Allergy to Pure Metallic Gold Microparticles?: A Epicutaneous Test of Gold Microparticles, Gold Thiosulphate and Placebo.

Conditions
-----------------
Allergic Reaction

Intervention / Treatment
-----------------
* Other: Gold microparticles
* Other: Gold thiosulphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with chronic dermatitis Exclusion Criteria: age < 18

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gold microparticles<br>Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum | Other: Gold microparticles<br>* Metallic gold microparticles, 20-micron diameter, 1 % w/v in petrolatum<br>* Other names: Patch test;|
| Active Comparator: Gold thiosulphate<br>Gold Sodium Thio Sulphate, 1 % w/v in petrolatum | Other: Gold thiosulphate<br>* Gold Sodium Thio Sulphate, 1 % w/v in petrolatum<br>* Other names: Patch test;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patch test | Test materials will be applied on the upper back of the volunteers in aluminium Finn Chambers for 48 hours. Clinical evaluation will be performed 24 hours after removal of the test substances according to standard procedures for evaluation of epicutaneous challenging according to criteria of ICDRG (International Contact Dermatitis Research Group) (Johansen 2015) | 72 hours |
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and tolerability of E5555 in Japanese patients with acute coronary syndrome.

Official Title
-----------------
A Double-Blind Study of E5555 in Japanese Patients With Acute Coronary Syndrome

Conditions
-----------------
Acute Coronary Syndrome

Intervention / Treatment
-----------------
* Drug: E5555
* Drug: E5555
* Drug: E5555
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 45 - 80 years old (at time of informed consent) Male or female (females of childbearing potential must be contracepted) Confirmed acute coronary syndrome Exclusion Criteria: Unwilling or unable to provide informed consent History of acquired or congenital bleeding disorder, coagulopathy, or platelet disorder Recent trauma or major surgery Evidence of active pathological bleeding at screening or history of gastrointestinal or genitourinary bleeding with unknown cause within 24 weeks prior to screening History of intracranial bleeding or history of hemorrhagic retinopathy History of New York Heart Association (NYHA) class III or IV congestive heart failure Pregnant or lactating women

Ages Eligible for Study
-----------------
Minimum Age: 45 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: E5555<br>* E5555, 50 mg (tablet), taken orally, once a day.<br>|
| Experimental: 2<br> | Drug: E5555<br>* E5555, 100 mg (tablet), taken orally, once a day.<br>|
| Experimental: 3<br> | Drug: E5555<br>* E5555, 200 mg (tablet), taken orally, once a day.<br>|
| Placebo Comparator: 4<br> | Drug: Placebo<br>* Placebo tablet taken orally, once a day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability: Adverse events, bleeding events, clinical laboratory tests, Coagulation tests, vital signs and 12-lead ECG. |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major cardiac adverse events, biomarkers, platelet aggregation inhibition, plasma concentration. |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Platelet Aggregation Inhibitors, Coronary Stenosis, Coronary Thrombosis
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic

Study Overview
=================
Brief Summary
-----------------
A digital problem solving tool was tailored to people in the general public with practical or emotional problems during COVID-19. Content analysis were used to account for the types of problems participants used the tool to solve. Participants were randomized to one of two versions of the problem solving tool, a simple and a more advanced graphical interface. These versions were compared on participant-rated usability, credibility and the level of actual interaction with the tool.

Official Title
-----------------
Evaluation of Two Versions of a Digital Problem Solving Tool for the General Public Specific for the COVID-19 Pandemic

Conditions
-----------------
Problem Solving

Intervention / Treatment
-----------------
* Behavioral: Digital problem solving tool


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: can use the Swedish language access to, and knowledge how to use, a digital internet-capable device Exclusion Criteria: under 16 years no practical or emotional problems during pandemic

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Traditional interface<br>Digital problem solving tool with a simple textbased graphical interface | Behavioral: Digital problem solving tool<br>* Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic<br>|
| Experimental: Advanced interface<br>Digital problem solving tool with an advanced graphical interface and automatic functions | Behavioral: Digital problem solving tool<br>* Digital problem solving tool - adapted for practical and emotional problems during the COVID-19 pandemic<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| System Usability Scale | Self-rated assessment of usability, higher score is better | immediately after the intervention | 
| Treatment Credibility Scale | Self-rated assessment of treatment credibility, higher score is better | immediately after the intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Use of intervention | How much has the participant interacted with the problem solving tool. | immediately after the intervention |
Identification of Patients at Risk of Chronic Back Pain Using Questionnaires

Study Overview
=================
Brief Summary
-----------------
Patients with acute back pain (<6 weeks) presenting at their general practitioner will be enrolled. Patients fulfilling all inclusion criteria and showing no exclusion criteria will fill out the Heidelberg short questionnaire (HKF-R10) and the Keele STarT Back Screening Tool. These two questionnaires categorize back pain patients into individuals at risk of chronic back pain and those not at risk. Furthermore, data concerning pain location, severity, duration and impairment will be collected. Study participants will receive standard care treatment prescribed by their general practitioner. Six months later, study participants will receive a questionnaire in order to collect data concerning their present pain situation. Patients with relevant impairment in their activities of daily living as a result of back pain will be categorized as individuals with chronic back pain. Categorization at six months will be compared with the categorization at presentation.

Official Title
-----------------
Identification of Patients at Risk of Chronic Back Pain Using Questionnaires

Conditions
-----------------
Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: acute (<6 weeks) back pain >20 und <60 years of age good oral and written knowledge of German language Exclusion Criteria: any treatment for back pain within the last 6 months Cauda equina tumor generalized pain severe systemic illness substance abuse pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 back pain<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| risk of chronic back pain determined by Heidelberger short questionnaire score |  | at enrolment | 
| risk of chronic back pain determined by Keele questionnaire |  | at enrolment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| numeric rating scale average pain intensity |  | at enrolment, at 6 months | 
| numeric rating scale minimal pain intensity |  | at enrolment, at 6 months | 
| numeric rating scale pain related sleep-loss |  | at enrolment, at 6 months | 
| clothepin-algometry (numeric rating scale) |  | at enrolment | 
| working days missed |  | at enrolment, at 6 months |