linjc16/ctgov huggingface dataset:
Platelet Aggregation Inhibition in Children on Clopidogrel (PICOLO)

Study Overview
=================
Brief Summary
-----------------
PICOLO is a double blind placebo controlled phase II dose ranging, dose escalating study in patients of Blalock-Taussig age categories (neonates and infants/toddlers), to determine the dose providing inhibition of platelet aggregation similar to adults.

Detailed Description
-----------------
There will be 3 blinded dose groups of 12 patients each (9 active, 3 placebo), central randomization, stratified by age (< 1 month ;1 to 24 months). There will be a comparison of ADP-induced platelet aggregation at steady state.

Official Title
-----------------
Dose-Ranging Pharmacodynamic Assessment of Platelet Aggregation Inhibition With Clopidogrel in Children of Blalock-Taussig Shunt Age Categories (Neonates and Infants/Toddlers)

Conditions
-----------------
Congenital Heart Defects, Blood Platelet Disorders

Intervention / Treatment
-----------------
* Drug: Clopidogrel (SR25990)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neonates or infants/toddlers (up to 24 months) at risk for thrombosis (e.g., Blalock-Taussig shunt or any systemic to pulmonary artery shunt, Kawasaki disease, vascular stent or any condition requiring antiplatelet therapy). Exclusion Criteria: Ongoing bleeding or increased risk of bleeding Weight < 2 kg; gestational age < 35 weeks Allergy to drugs Current or planned anticoagulant treatment Unable to receive drug enterically Platelet transfusion < 7days Thrombocytopenia Hepatic or renal failure

Ages Eligible for Study
-----------------
Maximum Age: 24 Months

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

| Intervention/Treatment |
| --- |
|Drug: Clopidogrel (SR25990)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent inhibition of maximum extent and rate of aggregation of 5 µM ADP-induced platelet aggregation |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
THROMBOSIS, PLATELET AGGREGATION, Pediatrics
A Prospective Study of the Disease Characteristics of Adult Patients With Long Chain Fatty Acid Oxidation Disorders

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect information on disease characteristics from adult patients diagnosed with fatty acid oxidation disorders (FAOD).

Detailed Description
-----------------
In this study there will be no drug intervention. The study will include a Baseline visit and a follow up visit scheduled at Month 4. At these visits medical history, safety assessments, concomitant medications, exercise tests and quality of life questionnaire data will be collected.

Official Title
-----------------
A Prospective, Multicenter, Non-interventional Study to Investigate the Disease Characteristics of Adult Patients With Long Chain Fatty Acid Oxidation Disorders (FAOD)

Conditions
-----------------
Fatty Acid Oxidation Disorder

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A genetically confirmed diagnosis of one of the following: Carnitine palmitoyltransferase 2 deficiency Very long-chain Acyl-CoA dehydrogenase deficiency Long-chain 3-hydroxyacyl-CoA dehydrogenase deficiency Trifunctional protein deficiency A stable treatment regimen for at least 30 days Ambulatory and able to perform the study exercise test, using walking aids if necessary Willing and able to personally sign and date an informed consent document indicating that the subject has been informed of all pertinent aspects of the study Exclusion Criteria: Unstable or poorly controlled disease as determined by one or more of the following: Presence of symptoms of acute rhabdomyolysis with clinically significant elevations in serum CK Evidence of acute crisis from their underlying disease Currently taking a PPAR agonist Have motor abnormalities other than those related to the fatty acid oxidation disorder that could interfere with the study procedures, as determine by the investigator Evidence of significant concomitant medical or psychiatric disease that in the opinion of the Investigator may interfere with the conduct or safety of this study Pregnant or nursing females

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 |
| --- | --- | --- |
| To evaluate change in function as measured by 12 minute walk test in adult subjects with long chain FAOD | Change from baseline in 12MWT | Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate change in symptoms related to FAOD using a newly developed muscle symptom questionnaire specifically designed for adult patients with long chain FAOD | Change from baseline in FAOD-Muscle Symptom Inventory | Week 16 |
Phone Call in Type 2 Diabetes Patient

Study Overview
=================
Brief Summary
-----------------
To assay the influence of personality profile to promote behavior change adherence for physical activity using a pedometer. The investigators also studied the metabolic profile, diagnosis of depression, intention to change behavior, physical activity referred and the quality of life. Casuistic and Methods: a randomized quasi-experimental enrolling 48 T2DM patients using a pedometer for 6 weeks. The intervention group received phone calls stimulating them to increase their walking activity. The control group received only one telephone call to explain pedometer use. The investigators also analyzed the personality profile, quality of life, and metabolic and anthropometric indexes.

Official Title
-----------------
Phone Call as an Intervention for Improving Walking Practice in Type 2 Diabetes: Influence of Personality Profile in This Response

Conditions
-----------------
Behavior Change

Intervention / Treatment
-----------------
* Behavioral: phone call support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: to assign written informed consent to have a phone call number to agree to use a pedometer for 6 weeks to be able to write the data concerning their number of steps per day Exclusion Criteria: don´t agree to assign written informed consent don´t have phone number don´t have conditions to answer all the questionnaire don´t agree to use pedometer for 6 weeks

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>This group received call phone support to incentive the increase of the number of steps during 6 weeks | Behavioral: phone call support<br>* The intervention group received a phone call support for 6 weeks to incentive to increase the number of steps/day.<br>* Other names: couselling to behavior change;|
| No Intervention: 2<br>This group just received a pedometer to register the number of steps for 6 weeks but this group don´t received a phone call. | |

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
-----------------
type 2 diabetes, physical activity, behavior change, profile personality, phone call support
Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device

Study Overview
=================
Brief Summary
-----------------
Single blinding study comparing FDA cleared device for prevention of medically diagnosed migraine pain to placebo.

Detailed Description
-----------------
In order to determine if nocturnal jaw clenching can be an influence on chronic migraine pain, the FDA cleared NTI (Nociceptive Trigeminal Inhibition) device with the Indications for Use of for prophylactic treatment of medically diagnosed migraine pain was compared to a similar device that had no influence on jaw clenching.The HIT-6 (Headache Impact Test) score was selected as the outcome measure, as the goal was to focus on improving disability in sufferer's lives, as in chronic migraine, changes in headache days may not be as helpful as improving disability.

Official Title
-----------------
Adjunctive Treatment of Chronic Migraine Using an Oral Dental Device: Overview and Results of a Placebo-Controlled Crossover Study

Conditions
-----------------
Chronic Migraine, Headache

Intervention / Treatment
-----------------
* Device: NTI-tss
* Device: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with chronic migraine at a neurology clinic - Exclusion Criteria: none -

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: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Single blinded cross-over study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Device<br>Subjects receiving the FDA-cleared device | Device: NTI-tss<br>* FDA cleared device for prophylactic treatment of medically diagnosed migraine pain<br>|
| Placebo Comparator: Placebo<br>Subjects receiving the sham device | Device: Placebo<br>* Similar to Device, but having no influence on clenching intensity<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of negative impact on life | At least a one-category improvement in subject's HIT-6 score | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
single blinded study
The Effect of Stimulating Substances on Brain Activity of Preterm Infants

Study Overview
=================
Brief Summary
-----------------
Introduction: Methylxanthines and doxapram have been widely used for the treatment of apneas of prematurity. Both substances have effects on the central nervous system. While there are data available concerning the use of caffeine (the methylxanthine used at our NICU) even proposing a positive effect on neurodevelopmental outcome of very preterm infants, there are data which suggest a negative effect of the central stimulants doxapram on longterm outcome in this group of infants. Nevertheless concerning both medications only few studies have been published and only scarce data are available concerning the effect of these medications on brain activity of very preterm infants until now. The aim of this study: is the assessment of the effect of stimulating substances on brain activity of preterm infants born below 30 weeks of gestation and their longterm neurodevelopmental follow-up. Methods: This study is a prospective study including preterm infants born below 30 weeks of gestational age. Brain activity is measured by one-channel amplitude-integrated EEG (aEEG). The first aEEG measurement is performed without caffeine and/or doxapram medication. At least one hour of brain activity is registrated. The second measurement is done at least 24 hours after the start of caffeine and/ or doxapram treatment. The percentage of different background patterns, the occurrence and duration of sleep-wake-cycling, and the occurrence and duration of seizures is assessed and analysed. Neurodevelopmental outcome is assessed at one and two years of corrected age by assessment of the Bayley Scales of Infant Development II and standardized clinical neurological examination.

Official Title
-----------------
The Effect of Stimulating Substances on Brain Activity Measured by Amplitude-integrated EEG and Long-term Neurodevelopmental Outcome of Preterm Infants Born Below 30 Weeks of Gestation

Conditions
-----------------
Apneas of Prematurity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: see above Exclusion Criteria: intraventricular hemorrhage posthaemorrhagic hydrocephalus cerebral infection cerebral malformation

Ages Eligible for Study
-----------------
Minimum Age: 23 Weeks
Maximum Age: 30 Weeks

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 |
| --- | --- |
| Caffeine group<br>Premature infants below 30 weeks of gestation who receive Caffeine treatment | |
| Caffeine and Doxapram group<br>Premature infants below 30 weeks of gestation who receive Caffeine and Doxapram treatment | |
| Group with no treatment<br>Premature infants below 30 weeks of gestation with no stimulating treatment | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Modafinil as a Cocaine Treatment Medication and Interactions With Cocaine - 1

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate modafinil, a cocaine treatment medication, and its interactions with intravenous (IV) cocaine.

Detailed Description
-----------------
Placebo-controlled, escalating dose drug interaction study using a total of 12 cocaine users at a single site. Study duration will include four infusion sessions: 1) screening/baseline; 2) baseline; 3) 400mg/day steady-state modafinil; 4) 800 mg/day steady state modafinil. Infusion session will be 2 days in duration.

Official Title
-----------------
Safety Evaluation of Cocaine Treatment Medication Modafinil: Interactions With Intravenous Cocaine

Conditions
-----------------
Cocaine-Related Disorders, Drug Administration Schedule, Infusions, Intravenous

Intervention / Treatment
-----------------
* Drug: Modafinil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Dependent on cocaine; non-treatment seeking; male or female; DSM-4 criteria for cocaine abuse or dependence; at least 18 years of age but no older than 45 non-pregnant females using adequate birth control; capable of providing written informed consent; able to comply with protocol requirements. Exclusion Criteria: Additional criteria available during screening at the site

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Modafinil|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pharmacokinetic parmaters at steady state |  |  | 
| BP, HR |  |  |
Feasibility of Collateral Information Review and Its Impact on Clinical Decision-Making

Study Overview
=================
Brief Summary
-----------------
This project will investigate how review of collateral information sources (CIS) may impact clinical decision-making across the lifespan.

Detailed Description
-----------------
This study aims to explore how reviewing collateral information sources (CIS) may affect clinical decision-making for clinicians treating participants with varied mood disorders. Investigators will assess the types of collateral information used in the clinical setting and treatment decisions made after a clinical session. We will gather this information from interested clinicians who will provide this information after each patient visit over the course of one week.

Official Title
-----------------
Feasibility of Collateral Information Review and Its Impact on Clinical Decision-Making

Conditions
-----------------
Depressive Disorder, Anxiety Disorders

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Credentialed to provide psychopharmacology or psychotherapy at McLean and Licensed by the State of Massachusetts Practice pharmacotherapy and either adjunctive or stand-alone evidence-based psychotherapy (e.g., CBT, DBT, supportive psychotherapy, etc.) Fluent in English Exclusion Criteria: Clinicians who do not meet the inclusion criteria detailed above

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| McLean Treatment Tracking Survey | Clinicians will find the McLean Treatment Tracking Survey easy to use in their clinical care and we will measure rate of use and completion. | Over the course of 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Outcome - Increased treatment decisions made | Investigators will explore whether reviewing more collateral information sources leads to more clinical actions taken for treatment. | Over the course of 1 week |
Investigation of Vascular Relaxing Effects of Candesartan and Pioglitazone.

Study Overview
=================
Brief Summary
-----------------
The study is designed to test the hypothesis in healthy subjects that candesartan and pioglitazone provide additional vascular relaxing or modulating effects in addition to their blood-pressure and blood glucose level reducing ability, respectively.

Detailed Description
-----------------
The aim of the study is to investigate the effect of oral candesartan and/ or rosiglitazone therapy on the vascular responsiveness of different vasoactive compounds (angiotensin II, insulin, histamine and glyceroltrinitrate) in healthy subjects. Pioglitazone will be given orally (4 weeks 30mg/d, titrated to 45 mg/d for another 4 weeks). Candesartan will be given orally (4 weeks 8mg/d, titrated to 16 mg/d for another 4 weeks) as treatment. Every subject will receive intravenous stimulation with phenylephrine, angiotensin II, histamine, insulin and glyceroltrinitrate before and after an 8 weeks treatment interval with study medication or placebo. In addition, pulse wave velocity will me measured non-invasively before and after treatment.

Official Title
-----------------
Characterization of Vascular Effects of Candesartan and Pioglitazone.

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: Pioglitazone (drug) and/or candesartan (drug)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male healthy 18 - 40 years old non-smoker no additional medication Exclusion Criteria: any relevant disease smokers elevated liver enzymes body weight different from Broca Norm > 20% allergies

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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: Pioglitazone (drug) and/or candesartan (drug)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vascular reactivity |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse wave velocity |  |  | 
| Changes in Angiotensin metabolites |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vascular reactivity, venodilation, pulse wave velocity
Influence of Vitamin D Deficiency on the Development of Autism

Study Overview
=================
Brief Summary
-----------------
The investigators wish to study the effect of Vitamin D on the development of autism in children. The investigators will also investigate the environmental and genetic influences on the level of Vitamin D in children with autism.

Conditions
-----------------
Autism

Intervention / Treatment
-----------------
* Other: Blood Samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Autistic children Healthy children Children with ADD Exclusion Criteria: All others

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 12 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 |
| --- | --- |
| Autistic Children<br>Children diagnosed with autism spectrum disorder according to the criteria of the Diagnostic Statistical Manual-V will have blood samples taken for laboratory analysis. | Other: Blood Samples<br> <br> |
| Healthy Children<br>Children with no developmental or physical diseases will have blood samples taken for laboratory analysis. | Other: Blood Samples<br> <br> |
| Children with Attention Deficit Disorder<br>Blood samples from children with Attention Deficit Disorder will be measured for Vitamin D and oxidative stress markers. | Other: Blood Samples<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Vitamin D | Blood samples of patients with and without autism with be taken and the level of vitamin D in their serum will be determined (international units). | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of environment on Vitamin D level | All participant blood samples will be measured for levels of oxidative stress markers and antioxidants. | One week |