linjc16/ctgov huggingface dataset:
Viral Activation Transfusion Study (VATS)

Study Overview
=================
Brief Summary
-----------------
The purpose of the trial was to determine if transfusion of allogeneic blood to HIV-1 infected persons led to immune activation and consequent induction of HIV-1 or /or Cytomegalovirus (CMV) replication, and whether this adversely affected clinical prognosis.

Detailed Description
-----------------
BACKGROUND: The initiative was approved by the NHLBI AIDS Ad Hoc Working Group and given concept clearance by the September 1993 National Heart, Lung, and Blood Advisory Council. The initiative was released in January 1994. DESIGN NARRATIVE: Patient enrollment started in August 1995. Patients scheduled for transfusion were entered into the study at the time of their first transfusion and randomized to receive leukopoor red cells filtered within 24 hours of collection or unmanipulated blood components. Patients received blood as per their treatment arm as needed for one or two years. Patients were stratified to those with CD4 counts below 50 /MM3 (most patients) and those with CD4 counts above that level. Primary endpoints were overall survival and a change in HIV viremia after the 1st transfusion. The secondary endpoint was the occurrence of a new AIDS-defining complication. A substudy looked at donor lymphocytes in the immunosuppressed recipients to help determine why AIDS patients don't seem to get post-transfusion graft-vs-host disease. The patient recruitment time was extended for one year because of low accrual. With new drugs, especially protease inhibitors, the proportion of patients needing transfusion has decreased. The patients are less severely ill and their disease produces less anemia. Furthermore, the new drugs don't have anemia as a side effect. The trial ended in January, 2000. The study completion date listed in this record was obtained from the Completed Date entered in the Query View Report System (QVR).

Conditions
-----------------
Acquired Immunodeficiency Syndrome, Blood Transfusion, Cytomegalovirus Infections, HIV Infections

Intervention / Treatment
-----------------
* Procedure: blood transfusion


Participation Criteria
=================
Eligibility Criteria
-----------------
HIV-infected patients with CD4 counts below 250 who clinically needed red blood cell transfusions.

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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: blood transfusion|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test if the levels of AZD6244 in blood are affected by taking food at the same time as the capsules compared to taking capsules on an empty stomach

Official Title
-----------------
A Phase I, Open-Label Study to Assess the Effect of Dosing AZD6244 HydSulfate in the Presence and Absence of Food in Patients With Advanced Solid Malignancies

Conditions
-----------------
Melanoma, Malignant Melanoma

Intervention / Treatment
-----------------
* Drug: AZD6244


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to eat a high fat breakfast within a 30-minute period Advanced cancer which is refractory to standard therapies, for which no standard therapies exist WHO or ECOG performance status 0-2 (those with performance status 2 must have been stable with no deterioration for over 2 weeks) Exclusion Criteria: Any radiotherapy or chemotherapy within 21 days prior to starting the study treatment (not including palliative radiotherapy at focal sites). Any evidence of severe or uncontrolled systemic disease (eg., severe hepatic impairment, severe renal impairment, uncontrolled diabetes, acute uncontrolled infection) or current unstable or uncompensated respiratory or cardiac conditions or peripheral vascular disease including diabetic vasculopathy. Refractory nausea and vomiting, chronic GI diseases (eg., inflammatory bowel disease) or significant bowel resection that would preclude adequate absorption.

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>with food | Drug: AZD6244<br>* 75mg<br>|
| Experimental: 2<br>without food | Drug: AZD6244<br>* 75mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess whether food influences the rate and extent of AZD6244 absorption |  | Day 1 and Day 10 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the pharmacokinetics of both AZD6244 and N-desmethyl AZD6244 in the presence and absence of food |  | Day 1, 2, 3, 8, 9, and 10 | 
| To assess the safety and tolerability of AZD6244 in patients with advanced solid malignancies |  | screening to 30 day post last dose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Melanoma, Phase I, AZD6244
Cardiac AResT And GENEtic

Study Overview
=================
Brief Summary
-----------------
Sudden death is a major problem in industrially developed countries. Despite a decline in ischemic heart disease mortality and the progress has been made in resuscitation, treatment of sudden death victims is frequently unsuccessful. the ideal solution would be to prevent the disease process that causes the initial episode of cardiac arrest. Parental sudden death is an independent risk factor for sudden death. So, detect a gene predisposing to sudden death may help provide better identification of subjects at high risk of cardiac arrest. This research is a genetic study of sudden cardiac death, recruited 2000 subjects in out-of-hospital cardiac arrest.

Official Title
-----------------
Etude Multicentrique en Population de la susceptibilité génétique à Faire Une Mort Subite

Conditions
-----------------
Out-of-hospital Cardiac Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: OHCA Aged from 18 to 75 years Exclusion Criteria: Pregnant People not free Inhospital subjects Death by other disease Violent death

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>case of out-of-hospital cardiac arrest | |
| 2<br>cases of MI | |
| 3<br>controls without coronary disease | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity

Study Overview
=================
Brief Summary
-----------------
The aim of this project is to determine role for ET-1 in individuals with obesity.

Official Title
-----------------
Role of Endothelin-1 Modulating Insulin-stimulated Blood Flow and Sympathetic Nervous System Activity in Obesity

Conditions
-----------------
Insulin Resistance, Autonomic Dysfunction, Obesity

Intervention / Treatment
-----------------
* Drug: Hyperinsulinemic, euglycemic infusion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-55 years of age Male sex Obese (BMI ≥30 kg/m2) Exclusion Criteria: Female sex Current smoking/Nicotine use Nerve/neurologic disease Cardiovascular, hepatic, renal, respiratory disease Blood pressure ≥140/90 mmHg Diabetes Vigorous exercise >3 times/week Communication barriers taking any medications known to affect metabolic, respiratory, cardiovascular, and/or autonomic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oral Bosentan<br> | Drug: Hyperinsulinemic, euglycemic infusion<br>* 60 minute infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amount of muscle sympathetic nerve activity (MSNA) | MSNA burst incidence (bursts/100 heart beats) | Change from baseline at minute 60 | 
| Amount of leg blood flow | Measured with Doppler ultrasound (mL/min) | Change from baseline at minute 60 |
Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota

Study Overview
=================
Brief Summary
-----------------
Oropharyngeal administration of mother's colostrum to premature infants has been proposed as a stimulus to the oropharyngeal lymphatic tissues to decrease the incidence of pneumonia and sepsis, particularly in intubated babies. We propose to study the impact of this intervention on the composition of the oral microbiota.

Official Title
-----------------
Oral Administration of Colostrum to Premature Babies: Impact on the Oral Microbiota

Conditions
-----------------
Changes in the Oral Microbiota

Intervention / Treatment
-----------------
* Other: Colostrum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature infant with birth weight < 1500 intubated in the first 48 hours of life available maternal colostrum Exclusion Criteria: lethal condition

Ages Eligible for Study
-----------------
Minimum Age: 12 Hours
Maximum Age: 7 Days

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Colostrum<br>Colostrum administration | Other: Colostrum<br>* Mother's own colostrum (0.2 ml) will be administered into the mouth of the infant every 2 hours for 48 hours.<br>|
| No Intervention: Control<br>Routine care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oral microbiota | Changes in the composition of the community of microbes inhabiting the oral-cavity after administration of oropharyngeal maternal colostrum. | Difference between enrollment, 48 hours and 96 hours |
A Study to Investigate the Safety, Tolerability and Pharmacokinetics of MT-7117 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of MT-7117 in healthy subjects.

Official Title
-----------------
A Randomised, Double Blind, Placebo Controlled Phase I Study to Investigate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Single and Multiple Ascending Doses of MT-7117 in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: MT-7117
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy and free from clinically significant illness or disease Male or female subjects aged 18 to 55 years or elderly male subjects aged ≥65 A body weight of ≥60 kg for males and ≥50 kg for females, and a body mass index ranging from 18 to 30 kg/m2 Exclusion Criteria: Participated in more than three clinical studies involving administration of an IMP in the previous year, or any study within 12 weeks Clinically significant endocrine, thyroid, hepatic, respiratory, gastro intestinal, renal, cardiovascular or skin disease, or history of any significant psychiatric/psychotic illness disorder Clinically relevant abnormal medical history, physical findings or laboratory values

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single ascending dose, MT-7117 or Placebo<br> | Drug: MT-7117<br> <br> Drug: Placebo<br> <br> |
| Experimental: Multiple ascending dose, MT-7117 or Placebo<br> | Drug: MT-7117<br> <br> Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability as measured by number of participants with adverse events |  | up to Day56 | 
| Safety and Tolerability as measured by vital signs |  | up to Day56 | 
| Safety and Tolerability as measured by physical examination |  | up to Day56 | 
| Safety and Tolerability as measured by ECG |  | up to Day21 | 
| Safety and Tolerability as measured by laboratory safety assessments |  | up to Day21 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration (Cmax) |  | 96 hours post dose | 
| Area under the plasma concentration-time curve (AUC) |  | 96 hours post dose | 
| Time to maximum plasma concentration (Tmax) |  | 96 hours post dose | 
| Apparent elimination half-life in plasma |  | 96 hours post dose |
Tailored Messages to Increase Eye Examination Behavior

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to test two different types of health messages, one that is developed for a specific group (targeted) and the other that is more personalized to individuals (tailored), to see which is better at changing how often people have their eyes examined. We hypothesize that people who get the tailored messages will be more likely to get a dilated eye exam than people who receive the targeted messages.

Detailed Description
-----------------
Studies have shown that people are not getting their eyes examined on a regular basis, even though dilated eye exams can detect eye diseases like glaucoma and diabetic retinopathy early, before significant vision loss has developed. Early detection can lead to earlier treatment, which can save sight by preventing or slowing the progression of these eye diseases. In this project we designed, implemented, and are now evaluating tailored and targeted print health messages to increase eye examination behavior in an African-American population 65 years of age and older, a group at increased risk of glaucoma and diabetes.

Official Title
-----------------
Tailored Messages to Increase Eye Examination Behavior

Conditions
-----------------
Eye Disease, Eye Care

Intervention / Treatment
-----------------
* Behavioral: tailored newsletter
* Behavioral: targeted newsletter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: African-American 65 years of age or older no dilated fundus exam in past 2 years Exclusion Criteria: appointment for dilated fundus exam scheduled no access to phone

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>tailored print messages to encourage eye examination behavior | Behavioral: tailored newsletter<br>* Tailored newsletter that addresses each person's stage of change, barriers to getting eye exams, and knowledge of eye exams and eye disease<br>|
| Active Comparator: 2<br>targeted print messages to encourage eye examination behavior | Behavioral: targeted newsletter<br>* Targeted newsletter that contains messages about barriers to getting eye exams and presents facts about glaucoma and African-Americans.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| doctor-confirmed dilated eye examination |  | 3 and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tailored health messages, glaucoma, diabetic retinopathy, dilated fundus exams, health behavior
Social Web Mining for Suicide Prevention

Study Overview
=================
Brief Summary
-----------------
According to a recent and alarming WHO (World Health Organisation) report (September 4, 2014), one person dies of suicide every 40 seconds in the world. Suicide is the third-leading cause of death for 15- to 24-year-olds, according to the Centers for Disease Control and Prevention , after accidents and homicide. This major public health issue need prevention strategies especially directed to at-risk populations. Since 2013, more than 2 billion users are enrolled in social networks such as Twitter or Facebook. Young adults (ages 18 to 29) are the most likely to use social media - fully 90% do. Consequently, in this project, we focus on suicide prevention in social media network.. The aim of this project is the validation of the algorithm. This algorithm build a decision support system that monitor young people at-risk based on large volume of heterogeneous data collected through social media to improve suicide prevention.

Detailed Description
-----------------
This study is composed of two steps : 9 subjects were recruited. After patients agreement, computer scientists were accessing to patient social network profile. Computer scientists were not able to visualize the content of publications, just run the algorithm that will analyse the content of messages (text, frequency, emoticons…) The algorithm defines the 3 most at-risk periods of suicide behaviors, on the next month. This result were compared to periods found by psychiatric interview. The psychiatrist then confirmed or not to LIRM whether periods found by the algorithm conrrespond to those defined by the psychitrist. No data of the social network were collected. the 2nd step aim to improve the algorithm by collecting sociodemographic and clincal data related to patients included.

Official Title
-----------------
Social Web Mining for Suicide Prevention of Young People

Conditions
-----------------
Suicidal Behaviors

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Major patient Minor patient with parents approval Patient hospitalized due to suicide attempt or suicide ideations Frequent active user of social netword (Facebook, Instagram, Youtube, Twitter) Exclusion criteria: - Patient's refusal to participate

Ages Eligible for Study
-----------------
Minimum Age: 15 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 |
| --- | --- | --- |
| sensitivity of the algorithm | baseline | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Suicide, Prevention, Social network
Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate choroidal thickness and volume during the third trimester of pregnancy by comparison with a group of age-matched non-pregnant healthy group of women

Detailed Description
-----------------
Pregnant women in the last trimester and age-matched healthy controls have an Optical Coherence Tomography (OCT) image taken on the OCT Spectralis® device. A map of the choroid in the macular area is constructed automatically. Choroidal thickness and volume are calculated for the 9 subfields defined by the Early Treatment Diabetic Retinopathy Study (ETDRS). A comparative analysis between the two groups will be performed. As a secondary outcome measure, the change in choroidal thickness of the pregnant group of women will be assessed at 6 months postpartum by comparison to the 3rd trimester of pregnancy. The OCT is a non-invasive examination that poses no risk to the mother or the fetus.

Official Title
-----------------
Evaluation of Choroidal Thickness During Pregnancy Using Enhanced Depth Imaging Optical Coherence Tomography

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Other: OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women: uncomplicated pregnancy in the third trimester (from 28 weeks of gestation) For both groups: no systemic or ocular disease absence of systemic medication other than prenatal vitamins no smoking habits emmetropia or a small refractive error (spherical equivalent <1.5 diopters) Exclusion Criteria: any of the above
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pregnant<br>OCT | Other: OCT<br>* Optical coherence tomography in enhanced depth imaging mode<br>|
| Control<br>OCT | Other: OCT<br>* Optical coherence tomography in enhanced depth imaging mode<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Choroidal thickness | Comparison of choroidal thickness between the pregnant group of women and the age-matched group of control subjects | 3rd trimester of pregnancy (from 28 weeks gestation to delivery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in choroidal thickness | Change in choroidal thickness in the third trimester of pregnancy and at 6 months post partum | During the 3rd trimester (from 28 weeks gestation to delivery) and at 6 months post partum | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pregnancy, OCT, Enhanced depth imaging, Choroid