linjc16/ctgov huggingface dataset:
A Double Blind Crossover Study on the Effect of Methylphenidate on Decision-making Ability of Adults With ADHD Compared to Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The study assesses the effect of Ritalin on working memory,attention,and decision-making measures in adults with ADHD and compares it to its effect on healthy adults, in a double-blind crossover design.We hypothesize that Ritalin will result in better performance in all measures,and that the improvement will be greater in the ADHD group.

Conditions
-----------------
ADHD

Intervention / Treatment
-----------------
* Drug: methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adults in the age of 21-50 Exclusion Criteria: People diagnosed with a clinical disorder other than ADD/ADHD that may impair their performance in the tasks used in the study. People for whom there is a contra-indication for consuming Ritalin. Pregnant women and nursing women;

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 50 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 |
| --- | --- |
| Experimental: ADHD adults<br> | Drug: methylphenidate<br>* a capsule containing 20 mg<br>|
| Experimental: healthy adults<br> | Drug: methylphenidate<br>* a capsule containing 20 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TOVA score |  | assessed twice, separated by 1-2 weeks. | 
| IGT score |  | assessed twice, separated by 1-2 weeks | 
| FPGT score |  | assessed twice, separated by 1-2 weeks | 
| SWM score |  | assessed twice, separated by 1-2- weeks | 
| digit span score |  | assessed twice, separated by 1-2- weeks |
Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions

Study Overview
=================
Brief Summary
-----------------
To verify the occurrence of Spontaneous Otoacoustic Emissions (SOAE) in neonates at term and preterm infants who had transient otoacoustic emissions and verify if the presence of response is related to gestational age, gender or risk factors for hearing loss.

Official Title
-----------------
Interrelations Between Spontaneous Otoacoustic Emissions and Transient Evoked Emissions: Indication of Cochlear Damage in Newborn.

Conditions
-----------------
Cochlear Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: born in this institution have presence of transient otoacoustic emission Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 4 Days
Maximum Age: 5 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 |
| --- | --- |
| preterm newborn<br> | |
| term newborn<br> | |

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
-----------------
otoacoustic emissions in newborns
Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Study Overview
=================
Brief Summary
-----------------
Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry. High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques. The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.

Official Title
-----------------
Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Conditions
-----------------
Gastrointestinal Motility Disorder

Intervention / Treatment
-----------------
* Diagnostic Test: High resolution intestinal manometry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients: digestive symptoms Healthy subjects: asymptomatic Exclusion Criteria: Patients: organic disorders Healthy subjects: organic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients<br>Patients with chronic digestive symptoms in whom intestinal dysmotility is suspected | Diagnostic Test: High resolution intestinal manometry<br>* Evaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contractile activity | Number of contractions | 10 minutes |
Assessment of Suspected Intracranial Malignancy Using 3'-Deoxy-3'18 F-flourothymidine PET

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to detect and quantify tumor cells of high grade malignant gliomas and metastatic brain lesions both before and after initial surgical resection in a cohort of newly diagnosed patients.

Detailed Description
-----------------
In this study, 35 patients will be selected to undergoing sequential imaging with FLT-PET. Prior to surgical resection, patients will undergo a preliminary FLT-PET. Additional FLT scans for a maximum of four scans.

Official Title
-----------------
Assessment of Suspected Intracranial Malignancy Using 3'-Deoxy-3'18 F-fluorothymidine Positron Emission Tomography

Conditions
-----------------
Brain Tumor

Intervention / Treatment
-----------------
* Procedure: FLT-PET scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Women must not be pregnant or breast feeding Histologic or strong radiologic suspicion of high grade malignant glioma or ogliometastatic tumor(s) Exclusion Criteria: May not have received previous therapy for their malignancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Brain tumor FLT-PET<br>Those diagnosed with a brain tumor and are to undergo surgery | Procedure: FLT-PET scan<br>* Imaging test<br>|

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
-----------------
Brain scan
An 8 Week Study Of Depression In Adults Diagnosed With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
A Placebo Controlled Study Evaluating Efficacy, Safety and Tolerability of Medication in Patients with Major Depressive Disorder (MDD)

Official Title
-----------------
A Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, Flexible-Dose Study Evaluating Efficacy, Safety, and Tolerability of Once-Daily Oral GW353162 (20-40-60mg) Versus Placebo in Subjects With Major Depressive Disorder Over an Eight-Week Treatment Period.

Conditions
-----------------
Depressive Disorder, Major

Intervention / Treatment
-----------------
* Drug: Radafaxine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Major Depressive Disorder (MDD) Duration of current depressive episode 12 weeks - 24 months Patients can read and write at a level sufficient to provide a signed consent If female, patients must be practicing an acceptable method of birth control Exclusion Criteria: Patients have other psychiatric disorders that would affect patient's response to treatment Patients have not responded to two or more adequate courses of antidepressant therapy Patients cannot be currently abusing illicit drugs or alcohol Patients are not currently receiving psychotherapy Patients have received electroconvulsive therapy within 6 months prior to screening Patients are pregnant or lactating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the Montgomery-Asberg Depression Rating Scale (MADRS) after 8 weeks of treatment |  | 8 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the MADRS score at other timepoints; change in Clinical Global Impression; percentage of remitters and responders based on the MADRS; change in disability, motivation, energy, fatigue and pain;incidence of adverse events over course of study; |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Major Depressive Disorder (MDD),, Flexible, GW353162,
Sustiva Levels With Use of a Gel Capsule

Study Overview
=================
Brief Summary
-----------------
We are studying if putting a gel capsule over a standard HIV drug changes the ability of the body to absorb the drug. This is important because we want to be able to study new HIV drugs against the most common drugs used today and the most common is Sustiva, which is also called efavirenz. We will give you Sustiva every day for 5 days and draw blood to see how much is absorbed. Then we will give you Sustiva that has a gel capsule over it for 5 days and we will draw blood to see how much is absorbed.

Official Title
-----------------
Effect of Encapsulation Upon Efavirenz Pharmacokinetics

Conditions
-----------------
HIV Infections, HIV

Intervention / Treatment
-----------------
* Drug: Efavirenz
* Drug: Over-encapsulated efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-negative, proven by ELISA Age: ≥ 18 years old Exclusion Criteria: Psychiatric or psychological illness that would make adherence to protocol procedures unlikely.

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: efavirenz<br> | Drug: Efavirenz<br>* Subject will take efavirenz for 5 days.<br>* Other names: Sustiva;|
| Experimental: over-encapsulated efavirenz<br> | Drug: Over-encapsulated efavirenz<br>* Subject will take efavirenz that has been over-encapsulated with a gel capsule for 5 days.<br>* Other names: Over-encapsulated Sustiva;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Levels of Efavirenz | Serum levels of efavirenz were measured on the fifth day of taking efavirenz (tablet) and the fifth day of taking an overencapsulated efavirenz. | 5th day of taking drug | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
efavirenz, Sustiva, pharmacokinetics
Specimen Stability Study

Study Overview
=================
Brief Summary
-----------------
To collect and process urine samples from critically ill subjects for use in assessing the effects of various urine sample freezing and storage conditions on biomarker test results.

Official Title
-----------------
Urine Sample Processing Study:Analysis of Fresh Versus Frozen Urine Samples From Critically Ill Subjects

Conditions
-----------------
Acute Kidney Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 21 years of age or older Subjects must be enrolled (first study-specific sample collection) within 24 hours of ICU admission Subjects enrolled from ED or Floor must be admitted to the ICU within 24 hours of enrollment Subjects enrolled in the ICU must have been admitted to the ICU or transferred into the study ICU from another ICU no more than 24 hours prior to enrollment Expected to remain in the ICU for at least 48 hours after enrollment Use of indwelling urinary catheter as standard care expected for at least 48 hours after enrollment Subject (or authorized representative)able and willing to provide written informed consent for study participation Exclusion Criteria: Special populations including children, pregnant women, and prisoners Previous renal transplantation Already receiving dialysis (either acute or chronic) or in imminent need of dialysis at the time of enrollment Known infection with human immunodeficiency virus (HIV) or active hepatitis (acute or chronic) Subjects with a history of chronic kidney disease (CKD) without a baseline serum creatinine value (baseline within 6 months of enrollment) Previously provided a urine sample and enrolled in this study

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Specimen handling and stability, for example, effect of temperature on biomarker results. There are no primary clinical outcomes. |  | 6 months |
Early Detection of Breast Cancer Using Tomosynthesis Imaging

Study Overview
=================
Brief Summary
-----------------
The purpose is to develop digital tomosynthesis to improve the detection of breast cancers. The aims are optimizing digital mammography and tomosynthesis acquisition, creating visualization tools, prospective pilot studies to evaluate radiologist performance, and computer-aided detection.

Detailed Description
-----------------
Finding breast cancer early has been shown to improve the chance of survival. Mammography (x-ray imaging of the breast) helps find breast cancer early. Some breast cancers, however, are not seen on mammography, which creates two-dimensional images for the radiologist to see. The goal of this study is to make a breast tomosynthesis or tomosynthesis 3D (three-dimensional) x-ray system by taking x-ray images from many angles. This is similar to a CAT (computerized axial tomography) scan for the breast and can give radiologists 3D information so that they can find breast cancers which might otherwise be hidden from view.

Official Title
-----------------
Early Detection of Breast Cancer Using Tomosynthesis Imaging

Conditions
-----------------
Breast Neoplasms

Intervention / Treatment
-----------------
* Radiation: Mammography and tomosynthesis imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All Subjects accepted for this clinical study must: Be already scheduled to undergo screening mammography, diagnostic mammography, or breast biopsy for standard clinical indications Provide written informed consent Be able to communicate effectively with clinical study personnel. Exclusion Criteria: Subjects with any of the following conditions will be excluded from this clinical study: Childbearing potential and subject refuses serum pregnancy test or test result is positive.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Tomosynthesis scans<br>This is a case-only study with only one group/cohort. All women receive both mammography and tomosynthesis imaging. | Radiation: Mammography and tomosynthesis imaging<br>* All subjects receive the same radiation dose associated with mammography and tomosynthesis imaging (which is comparable to mammography).<br>* Other names: film-screen mammography;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiologist ROC (receiver operating characteristic) area under curve (AUC) |  | at imaging review by the end of the study, approximately 9 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diagnostic Imaging, Mammography, Breast Tomosynthesis
Long-term Outcome of Patients Treated With Extracorporeal Membrane Oxygenation

Study Overview
=================
Brief Summary
-----------------
Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane Oxygenation are not known in china.A cross-section survey will be performed to assess the long-term outcome of these patients.

Detailed Description
-----------------
Patients admitted to ICUs and treated with extracorporeal membrane oxygenation from March 1,2011 to March 1,2017 were screened . Pre-Ecmo clinical parameters(diagnose,APACHE-II, SOFA,indications,expected mortality) and related treatment conditions(duration of ICU stay, duration of ECMO,duration of mechanical ventilation,ventilation conditions,prone ventilation,ECMO complications )will be used to assess the severity and curative effect of these patients.Short Form-36 Health Status Questionnaire,EuroQol-5 Dimensions and St. George's Respiratory Questionnaire(SGRQ) will deliver in these survivors ,which are used to assess the physical and mental health ,as well as the social adaptation. Finally a comprehensive assessment will be obtained to describe the outcomes and long-term quality-of-life of patients treated With ECMO.

Official Title
-----------------
Outcomes and Long-term Quality-of-life of Patients Treated With Extracorporeal Membrane Oxygenation

Conditions
-----------------
Long-term Outcome, Extracorporeal Membrane Oxygenation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients treated with ECMO Exclusion Criteria: non-survivors of patients treated with ECMO，declined or lost to follow up
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ECMO mode<br>ECMO mode includes Venovenous- ECMO and Venoarterial- ECMO | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short Form-36 Health Status Questionnaire | SF-36 is now widely utilized by managed care organizations and by Medicare for routine monitoring and assessment of care outcomes in adult patients. | June,2017-May,2018 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EuroQol-5 Dimensions | The health-related quality of patients' life was rated with use of the EQ-5D index | June,2017-May,2018 | 
| the St. George's Respiratory Questionnaire(SGRQ) | a fixed-format self-complete questionnaire for measuring health in chronic airflow limitation.Three component scores were calculated: symptoms, activity, and impacts (on daily life), and a total score. | June,2017-May,2018 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
outcome,ECMO,Respiratory Failure,Circulatory Failure