linjc16/ctgov huggingface dataset:
AZD9164 Single Ascending Dose Study in Healthy Male Subjects

Study Overview
=================
Brief Summary
-----------------
The aims of the study are to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of AZD9164 following single ascending dose administrations to healthy male subjects.

Official Title
-----------------
A Phase I, Single Centre, Double-blind, Randomised, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Inhaled AZD9164 After Single Ascending Doses in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: AZD9164
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Provision of signed, written and dated informed consent prior to any study specific procedures Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and no more than 100 kg Be non-smoker or ex-smoker who has stopped smoking (or using other nicotine products) for >6 months prior to study start Exclusion Criteria: Any clinically significant disease or disorder Any clinically significant abnormalities at screening examinations Use of any prescribed or non-prescribed medication

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

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Solution for nebulisation, inhaled | Drug: AZD9164<br>* Each subject will receive a single-dose starting dose 4µg (lung deposited dose) with up to 8 dose escalations not exceeding AstraZeneca pre-defined exposure limits.<br>|
| Placebo Comparator: 2<br>Solution for nebulisation, inhaled | Drug: Placebo<br>* Each subject will receive a single-dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety variables (ECG, adverse events, blood pressure, pulse, body temp, safety lab) |  | up to 48 hours post-dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics |  | up to 48 hours post-dose. | 
| Local and extrapulmonary effects |  | up to 48 hours post-dose. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
safety, tolerability, healthy, inhalation, Healthy males
The Effect of tDCS on Motor Performance and Cortical Excitability

Study Overview
=================
Brief Summary
-----------------
In this study the effect of tDCS intensity on motor performance and corticospinal (CS) excitability is evaluated. The investigators expect that a positive relationship between current intensity and motor performance/CS excitability.

Conditions
-----------------
Cortical Excitability, Motor Performance, tDCS

Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Healthy subjects Exclusion Criteria: Contraindications for tDCS/TMS TMS measurements have to be possible

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Low intensity anodal tDCS<br>tDCS will be administered for 10 min at 1mA | Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)<br>* The anode is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region.<br>* Other names: NeuroConn DC-stimulator;|
| Experimental: High intensity anodal tDCS<br>tDCS will be administered for 10 min at 2.5mA | Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)<br>* The anode is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region.<br>* Other names: NeuroConn DC-stimulator;|
| Sham Comparator: Sham tDCS<br>Sham will be administered for 10 min at 0 mA | Device: transcranial direct current stimulation (tDCS) (NeuroConn DC-stimulator)<br>* The anode is fixed on the primary cortex and the cathode will be fixed on the contralateral supraorbital region.<br>* Other names: NeuroConn DC-stimulator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in motor performance | motor performance is assessed using different reaction time paradigms (simple reaction time, choice reaction time). This is done at baseline and immediately after the intervention (30 min after baseline) | Baseline and POST (30 min after baseline) intervention | 
| Change in cortical excitability | Cortical excitability is measured using trancranial magnetic stimulation (TMS) measuring muscle evoked potentials (MEPs) at baseline and POST (30 min after baseline). | Baseline and POST (30 min after baseline) intervention |
NHANES 2003-2014 and Sugar-sweetened Beverages in Children

Study Overview
=================
Brief Summary
-----------------
The study uses data from the NHANES surveys to evaluate trends in SSB intakes among US children. The goal was to determine whether recent declines in intake may have been less marked in the more vulnerable groups with a persistently high burden of obesity, including race/ethnic minorities and low-income groups.

Detailed Description
-----------------
Recent studies suggest sugar-sweetened beverage (SSB) consumption has been declining among US children 2-18y. However, most studies focus on changes in mean intake and little is known about trends in the high SSB consumers who are most at risk of excess weight gain. There is also limited understanding of whether and how these changes over time may have influenced disparities in intake among vulnerable groups of children with persistently high levels of obesity, including children from low-income households, and several race-/ethnic minorities. This analysis of six cycles of US National Health and Nutrition Examination Survey (NHANES) dietary surveillance data from 2003-2014 examined shifts over time in SSB intake at both the median and 90th percentile among US children. The study evaluated the extent to which disparities in intake of total SSBs, as well as major SSB subtypes (regular sodas, fruit drinks and other), may have persisted in vulnerable groups, for both median and heavy intake. The analysis presents data for three age groups: 2-5y, 6-11y and 12-18y by gender, and focus on three race-ethnic groups: Non-Hispanic White, Non-Hispanic Black, and Mexican-American. Household income is used as the primary socioeconomic status variable.

Official Title
-----------------
Analysis of National Health and Nutrition Examination Survey (NHANES) 2003-2014 Data to Evaluate Trends in Sugar-sweetened Beverage (SSB) Intakes in Children

Conditions
-----------------
Sugar Sweetened Beverage Intakes in US Children

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All U.S. children aged 2-18y in US NHANES diet surveys from 2003-2014 Exclusion Criteria: missing socio-economic data: parental education or household income as a percentage of the Federal Poverty Level; n=1841 missing or implausible dietary data, defined as: energy intake of zero kcal or more than four standard deviations beyond individual estimated energy requirements, or no report on whether data represents usual intake (more, same or less than usual); n=236

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 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 |
| --- | --- | --- |
| Sugar Sweetened Beverage Intake in Children | All non-alcoholic, non-diet beverages sweetened with sugars of any type, either as purchased or added after purchase | 2003-2014 |
Hemodynamic Changes After Anesthesia With Propofol: Study of Biomarkers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate biomarkers affecting the hemodynamic responses to propofol. Particularly, the investigators will assess the effects of polymorphisms in NOS3 and PRKCA genes on hemodynamic responses to propofol and the effects of these polymorphisms on biomarkers related to nitric oxide after propofol anesthesia. In addition, the investigators will evaluate the effects of propofol anesthesia on biomarkers related to nitric oxide in hypertensive patients chronically treated with angiotensin-converting enzyme inhibitors.

Conditions
-----------------
Hemodynamic Responses to Propofol

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA I or II BMI lower 30 kg/m2 Exclusion Criteria: Severe hypertension Previous stroke Previous infarction Uncontrolled respiratory, renal, hepatic and hematological diseases.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 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 |
| --- | --- |
| Normotensive<br> | |
| Hypertensive taking ACEi<br> | |
| Hypertensive not taking ACEi<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic blood pressure |  | 10 minutes | 
| Diastolic blood pressure |  | 10 minutes | 
| Mean blood pressure |  | 10 minutes | 
| Heart rate |  | 10 minutes | 
| Plasma nitrite levels |  | 10 minutes | 
| Plasma nitrate levels |  | 10 minutes |
Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Study Overview
=================
Brief Summary
-----------------
Single-center, prospective, randomized, open-label clinical trial to evaluate the 1-year efficacy and safety of rATG 3mg/kg compared to 6mg/kg in low to moderate immunological risk patients receiving low exposure tacrolimus plus everolimus (EVL) in a steroid-free protocol.

Official Title
-----------------
Prospective Randomized Study to Evaluate the Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg vs. 6mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive Regimen

Conditions
-----------------
Thymoglobulin Dose

Intervention / Treatment
-----------------
* Drug: Thymoglobulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary kidney transplant recipients, adults Exclusion Criteria: PRA > 50% DSA > 1500 MFI Retransplantation Patients who are planning to receive mycophenolate instead of everolimus Patients who have planning for follow-up in another center

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: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 3mg/kg Group<br>Patients will received Thymoglobuline 3mg/Kg (reduced dose) | Drug: Thymoglobulin<br>* reduced dose (3mg/Kg)<br>|
| Active Comparator: 6mg/kg Group<br>Patients will received Thymoglobuline 6mg/Kg (standard dose) | Drug: Thymoglobulin<br>* reduced dose (3mg/Kg)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute rejection | Biopsy proven and all treated acute rejection episodes | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Infection | All infections requiring hospitalization | 1 year |
Fluvoxamine Maleate in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents

Study Overview
=================
Brief Summary
-----------------
This study is to verify the efficacy of fluvoxamine maleate given for 10 weeks in treatment of children and adolescents with obsessive-compulsive disorder

Official Title
-----------------
SME3110 (Fluvoxamine Maleate) in the Treatment of Obsessive-Compulsive Disorder: A Post-marketing Clinical Study in Children and Adolescents (8 Through 18 Years of Age) -A Double-blind, Randomized, Placebo-controlled Study

Conditions
-----------------
Obsessive Compulsive Disorder

Intervention / Treatment
-----------------
* Drug: Fluvoxamine maleate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Have a minimum total score of 16 on the JCY-BOCS, Weight is within the standard weight ± 2S.D. based on the standard weight for each age in the School Health Statistical Survey Exclusion Criteria Have the following predominant psychiatric diagnosis -Schizophrenia Have previously been treated with fluvoxamine maleate

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: F<br> | Drug: Fluvoxamine maleate<br>* Test product: Fluvoxamine maleate 25mg tablet. In case that the daily dose is one tablet, the study medication will orally be administered once daily, at bedtime. In case that the daily dose is two tablets or higher (maximam:6 tablets), the study mmedica<br>|
| Placebo Comparator: P<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the time of onset of 25% decrease from baseline in the Japanese Version of the Children's Yale-Brown Obsessive Compulsive Scale (JCY-BOCS) 10-item total score |  | 10 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The Clinical Global Impression(CGI) improvement at Week 10 |  | 10 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluvoxamine Maleate, OCD, Children and Adolescents
Vestibular Evoked Myogenic Potential: A New Device Propose

Study Overview
=================
Brief Summary
-----------------
The bioelectrical responses of muscle, evoked by sound, obtained with a device considered the gold standard (widely used in clinics and hospitals) are similar to those obtained with a new device developed

Official Title
-----------------
Vestibular Evoked Myogenic Potential: A New Device Propose

Conditions
-----------------
Evoked Potentials, Motor, Vestibular

Intervention / Treatment
-----------------
* Device: Vestibular myogenic evoked potential analyzer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hearing thresholds equal to or less than 20 dB HL with differences between the ears, by frequency, equal to or less than 10 dB. Exclusion Criteria: Occupational noise exposure Ear surgeries More than three ear infections in the current year Use of ototoxic medication Tinnitus, vertigo, dizziness or other vestibular-cochlear diseases Systemic diseases that may contribute to cochlear-vestibular pathologies, such as hypertension and dyslipidemia Hormonal diseases

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 50 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 |
| --- | --- |
| Normal subjects<br>Adults normal hearing and vestibular function subjects | Device: Vestibular myogenic evoked potential analyzer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Adductor Strength in Roller Hockey Athletes

Study Overview
=================
Brief Summary
-----------------
Roller hockey athletes will be recruited along the season and will be examined for adductor strength and other potential groin pain risk factors.

Detailed Description
-----------------
Roller hockey athletes will be recruited and assess through the season. The assessment consist of an adductor, abductor strength measurement, Hip and Groin Outcome Score (HAGOS) completion and will be screened for other risk factors which are believed to cause groin pain (Age, previous injury)

Official Title
-----------------
Risk Factors for the Development of Groin Pain in Roller Hockey Athletes

Conditions
-----------------
Groin Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participate in the roller hockey bronze division from spain Exclusion Criteria: Deny participation

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 35 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active hockey players<br>Observational study on 180 Hockey players | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adductor Strength | Adductor strength will be measured with a dynamometer | November 2021-March 2022 | 
| Abductor strength | Abductor strength will be measured with a dynamometer | November 2021-March 2022 | 
| Adductor to abductor ratio | Ratio between adductor and abductor strength will be calculated | November 2021-March 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip and Groin Outcome Score | a questionnaire will be given to every participant to obtain information on groin pain symptoms in the last week | November 2021-March 2022 | 
| 5 seconds squeeze test | While measuring adductor and abductor strength, pain will be assess during the test | November 2021-March 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Roller hockey, Groin Pain, Risk factors
Nitric Oxide, Endothelin-1, and the Patency of Ductus Arteriosus in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
BACKGROUND Patent ductus arteriosus (PDA) is a frequent clinical event in preterm infant. The cardiopulmonary functions of these preterm babies may be adversely affected by the patency of ductus arteriosus. Ductal tissues are sensitive to the constricting effect of endothelin-1 and the dilating effect of prostaglandins, inflammatory mediators, and concentration of oxygen. OBJECTIVE To examine the role of endogenous nitric oxide (NO) and endothelin-1 (ET-1) in the pathogenesis of patent ductus arteriosus of the preterm infants. We hypothesize that the patency of ductus arterious in preterm infants is probably due to inappropriate production of endogenous nitric oxide and the interaction with various inflammatory mediators and prostaglandins, which is different from those of term infants. In addition, the secretion of endothelin is probably decreased. The purpose of this study is to monitor the changes of these substance sequentially, and to evaluate the relationship among endothelin-1, endogenous nitric oxide, and inflammatory mediators in the pathophysiology of patent ductus arteriosus in preterm infants. METHODS AND MATERIALS Inclusion criteria: Preterm infants with gestational age less than 32 weeks or birth weight less than 2000 gm. Informed consent Numbers of study population: With 80-100 evaluable infants (40-50 patients in PDA and non-PDA groups, respectively) Blood sample, collecting on day 1,3,7 after regular echocardiographic evaluation, is assessed for inflammatory mediator (IL-8, IL-10), nitric oxide metabolites (nitrite and nitrate), endothelin-1, and cGMP Statistical analysis: Student t-test testing the differences of clinical data, Wilcoxon signed rank test for comparing data obtained between the PDA and non-PDA patients, the PDA patients before and after intravenous indomethacin, and those who are responsive or refractory to the therapy.

Official Title
-----------------
The Role of Nitric Oxide, Endothelin-1, and Inflammatory Mediators in the Patency of Ductus Arteriosus in Preterm Infants

Conditions
-----------------
Patent Ductus Arteriosus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of the patency of ductus arteriosus Exclusion Criteria: Congenital anomalies

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 1 Year

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
-----------------
Preterm infant, Patent ductus arteriosus, Nitric oxide,Endothelin-1