linjc16/ctgov huggingface dataset:
Biomarkers in Samples From Patients With Down Syndrome and Acute Megakaryoblastic Leukemia

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying samples of blood or tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. PURPOSE: This research study is studying biomarkers in samples from patients with Down syndrome and acute megakaryoblastic leukemia.

Detailed Description
-----------------
OBJECTIVES: Determine whether megakaryocyte differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor can lead to proliferation arrest, polyploidization, and terminal differentiation of blasts in specimens from patients with Down syndrome and acute megakaryoblastic leukemia. OUTLINE: Cryopreserved specimens are cultured and treated in vivo (in mice) and in vitro with megakaryocytic differentiation agents comprising a Rho kinase inhibitor and a JAK3 inhibitor.

Official Title
-----------------
Development of Novel Therapeutics for AMKL

Conditions
-----------------
Leukemia

Intervention / Treatment
-----------------
* Other: cell culture procedure
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Diagnosis of acute megakaryoblastic leukemia Diagnosis of Down syndrome Cryopreserved specimens available PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: cell culture procedure|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proliferation arrest |  |  | 
| Polyploidization |  |  | 
| Terminal differentiation |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
adult acute megakaryoblastic leukemia (M7), childhood acute megakaryocytic leukemia (M7), recurrent adult acute myeloid leukemia, recurrent childhood acute myeloid leukemia, untreated adult acute myeloid leukemia, untreated childhood acute myeloid leukemia and other myeloid malignancies
Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

Study Overview
=================
Brief Summary
-----------------
The study is aimed at assessing the clinical follow-up and the outcomes of pregnancies exposed to ella, whether due to failure of the emergency contraception or inadvertent exposure during pregnancy.

Official Title
-----------------
Prospective Multicenter Observational Study to Assess Clinical Follow-up and Outcomes of Pregnancies Exposed to Ella

Conditions
-----------------
Emergency Contraception

Intervention / Treatment
-----------------
* Drug: ella


Participation Criteria
=================
Eligibility Criteria
-----------------
Pregnant women, exposed to ella during the menstrual cycle in which the pregnancy started (treatment failure) or at any time during pregnancy (inadvertent exposure during pregnancy) Adolescents and/or adults in the USA, depending on the respective State law

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

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 |
| --- | --- |
| ella<br> | Drug: ella<br>* ella, single intake, tablet 30mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Experienced Assessed Pregnancy Outcomes | Live birth outcomes: Healthy baby; Congenital anomaly: a baby born with a congenital anomaly; Neonatal death: a newborn who died during the first 28 days of life; Preterm birth: a baby born at less than 37 weeks of gestational age; Pregnancy loss outcomes: Ectopic pregnancy: implantation of the fertilized egg and pregnancy development in a location outside the uterus and attempt to develop in this location; Spontaneous abortion: early fetal death (i.e. less than 20 completed weeks of gestation); Fetal death: Intermediate fetal death (between greater than 20 and less than 28 completed weeks of gestation); Late fetal death (greater or equal to 28 completed weeks of gestation); Induced abortions can be either: An induced abortion for non-medical reason; An induced abortion for medical reasons (termination of pregnancy for fetal anomaly, or for other pregnancy or maternal health complications) | up to 9 months after pregnancy diagnosis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ella, ulipristal acetate, pregnancy, emergency contraception
Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate which cognitive-linguistic symptoms are most commonly experienced following brain tumor treatment. Cognitive surveys will be administered after treatment of primary brain tumor cancer.

Official Title
-----------------
Evaluation of Cognitive-Communication Deficits Following Treatment of Primary Brain Tumor Patients

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

Intervention / Treatment
-----------------
* Other: Cognitive Surveys


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: be between18 to 89 years old; have undergone at least one cycle of a cancer treatment regimen (e.g., chemotherapy, radiotherapy, surgery) have completed at least one cycle of a cancer treatment regimen within five years of enrollment in the study; be native speakers of American English; have obtained a minimum of a high school education; self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; and must demonstrate capacity to sign informed consent based on Informed Consent for Research: A Guide to Assessing a Participant's Understanding tool. Exclusion Criteria: are younger than 18 years old or older than 89 years old; have not undergone at least one cycle of a cancer treatment regimen following diagnosis (e.g., chemotherapy, radiotherapy, surgery) have not undergone at least one cycle of a cancer treatment regimen in the five year period prior to enrollment; are not native speakers of American English; have not obtained a minimum of a high school education; do not self-report at least one cognitive-linguistic or social-emotional deficit as assessed by the FACT-BR; or do not demonstrate the capacity to sign informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Cognitive Surveys|Complete the Cognitive Communication Survey, standardized cognitive and language assessments, and the Follow-up Cognitive Communication Survey after treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive Communication Survey | Survey is completed at time of consent | 1 day at time of consent | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive-linguistic Standardized Testing | Standardized testing will be completed | within 3 months of cognitive communication survey | 
| Follow-up Survey | Survey will be completed | within 6 months after completion of standardized testing |
Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogenic Hematopoietic Cell Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
To depict the incidence, outcomes and standards of care (SoC) of adenovirus (AdV) infections and associated practice patterns in allogeneic hematopoietic cell transplant recipients. It is expected that participating centers will be in the United Kingdom, France, Spain, Germany, and Italy.

Official Title
-----------------
Incidence and Outcomes Associated With the Management of Adenovirus Infections in Allogeneic Hematopoietic Cell Transplant Recipients: AdVance

Conditions
-----------------
Adenovirus Infections, Human

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: At least one AdV positive test, regardless of specimen within 6 months following the first allo-HCT Subjects first allo-HCT must have been performed between 1 January 2013 and 30 September 2015 Exclusion Criteria: AdV negative

Ages Eligible for Study
-----------------
Minimum Age: 0 Months
Maximum Age: 90 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 |
| --- | --- | --- |
| Number of participants with non-relapse related mortality 3 and 6 months after first AdV Virema in paediatric allo-HCT recipients | To assess non-relapse related mortality 3 to 6 months after first adenovirus viremia. | 3 and 6 months after first adenovirus viremia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who were hospitalized To assess the number of hospitalizations | To assess the number of hospitalizations, length of stay, and ICU stay. | 3 to 6 months | 
| The rate of adenovirus infection progression | To assess the rate of progression to disseminated adenovirus disease within the first year following allo-HCT | 3 to 6 months |
A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients

Study Overview
=================
Brief Summary
-----------------
The study is designed to compare the performance of the Ambu AuraGain Laryngeal Mask Airway and LMA Supreme in normal airway patients.

Detailed Description
-----------------
Ambu AuraGain Laryngeal Mask Airway is a newly designed supraglottic device. We design this study to test its clinical performance in normal airway patients, in comparison with LMA Supreme.

Official Title
-----------------
A Comparison of the Ambu®AuraGain™ and the Laryngeal Mask Airway Supreme™ in Normal Airway Patients

Conditions
-----------------
Supraglottic Airway

Intervention / Treatment
-----------------
* Device: Ambu AuraGain
* Device: LMA Supreme


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists Ⅰ-Ⅲ classification Patients evaluated as eligible for a LMA Body Mass Index ≤35kg/m2 Exclusion Criteria: Patients with known or predicted difficult airway Active respiratory infection Risk of aspiration Head and neck surgery Emergent surgery

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parellel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ambu AuraGain<br>Subjects will receive the Ambu AuraGain size 3 to size 5 based on manufacturer guidelines | Device: Ambu AuraGain<br> <br> |
| Active Comparator: LMA Supreme<br>Subjects will receive the LMA Supreme size 3 to size 5 based on manufacturer guidelines | Device: LMA Supreme<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oropharyngeal leak pressure | The airway pressure at which an airway leak is observed after successful placement of the device | Up to 1 minute after the time of confirmed device placement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time | Time needed to insert the device | Up to 1 minute on each insertion attempt | 
| Ease of insertion | Number of attempts to place the device | Up to 1 minute on each insertion attempt | 
| Fiberoptic Grade of Laryngeal View | Fiberoptic Grade of Laryngeal View through each device will be graded using a previously grading system | Up to 1 minute after placement of device | 
| Postoperative Complications | Patient will be evaluated for sore throat, dysphonia, stridor, dysphagia, blood stain on device | 2 hours after removal of the device |
Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to test over time immunity to SARS-CoV-2, a recently identified coronavirus responsible for the 2019 world-wide pneumonia outbreak known as COVID-19. Adults and children diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

Official Title
-----------------
Understanding Immunity to SARS-CoV-2, the Coronavirus Causing COVID-19

Conditions
-----------------
Coronavirus

Intervention / Treatment
-----------------
* Other: There is no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (18 years and older) and children with confirmed COVID-19 (RT-PCR diagnosis). Adults (18 years and older) and children without COVID-19 for controls (who test negative for COVID-19 but may have viral symptoms) Exclusion Criteria: Patients with special risks attendant to venipuncture will be excluded.

Ages Eligible for Study
-----------------
Minimum Age: 2 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 |
| --- | --- |
| COVID-19<br>Participants diagnosed with COVID-19 | Other: There is no intervention<br>* There is no intervention<br>|
| Controls<br>Participants not diagnosed with COVID-19 | Other: There is no intervention<br>* There is no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing Immunity to SARS-CoV-2 over time |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing the virus over time |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunity
Mobile Phone Radiation and Brain Rhythm in Epileptic Patients

Study Overview
=================
Brief Summary
-----------------
This work is intended to assess the effect of -30 minutes- exposure to mobile-phone on the functions of the central nervous system (CNS) in epileptic patients.

Detailed Description
-----------------
This work shows the effect of the 30 minutes mobile waves' radiation over the normal person brain activity (EEG) and cognition (P300) together with the effect over the unstable brain of the epileptic patients. Exposure to mobile-phone radiation has been reported to increase the spectral power of electroencephalograms (EEGs), particularly in the alpha band, during both the waking and sleeping states. The tendency toward electrical instability of the neural networks of epileptic patients suggests that these individuals may be especially sensitive to electromagnetic fields espcially mobile-phone radiation (MPR). The short-term effects of exposure to electromagnetic (EM) fields on a number of cognitive variables such as memory, attention and speed of decision-making could be assedsed by P 300 latency and amplitude.

Official Title
-----------------
Mobile Phone Radiation and Brain Rhythm in Epileptic Patients

Conditions
-----------------
Epilepsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Both sexes Above 18 years Epileptic patients (regardless of whether symptomatic, idiopathic, focal or generalized) Exclusion Criteria: Age less than 18 years Chronic medical condition Epileptic fit in the last 48 hours

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Epilepsy Patients<br>males and females whose age more than 18 years, diagnosed with epilepsy, regardless of whether symptomatic,idiopathic ,focal or generalized | |
| Healthy Control<br>males and females whose age more than 18 years | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Digital Electroencephalography (EEG) examination |  | one day | 
| P300 test | The P300 Test: Neurophysiological Test. P300 wave was defined as the most positive point of the average waveform to the target tones after 250 msec and before 600 msec. For each subject P300 latency and P300 amplitude were obtained to detect any significant abnormality | one day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Mobile phone
Inhaled Corticosteroid Replacement Study - Efficacy and Safety of Ro 27-2441 (Test Drug) in Moderate Persistent Asthma

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to evaluate the anti-inflammatory action and safety of Ro 27-2441 (study drug) in asthmatic patients currently taking inhaled corticosteroids. The research is being conducted at up to 40 clinical research sites in the US. Study participants will have a number of visits to a research site over a 4-month period.

Conditions
-----------------
Asthma

Intervention / Treatment
-----------------
* Drug: Dual Integrin Antagonist


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persistent asthma for more than 1 year Currently receiving treatment with a stable dose of inhaled corticosteroids for more than 3 months In good health as demonstrated by medical history and physical exam Negative urine pregnancy test Commitment to use two forms of effective contraception simultaneously throughout the study duration and for 1 month after discontinuing therapy Exclusion Criteria: Hospitalization for treatment of asthma and/or treatment with oral/injectable corticosteroids within 3 months before the start of the study Undergoing allergy shots unless on a stable maintenance dose for 3 months before the start of the study History of chronic pulmonary diseases other than asthma Treatment of conditions other than asthma with oral corticosteroids within 1 month of the start of the study Current tobacco usage Smoking history of greater than 10 pack-year history of cigarette smoking (number of packs smoked per day times the number of years smoked) History or evidence of drug or alcohol abuse Diagnosis or evidence of an infectious illness within one month of Visit 1 Clinically significant diseases as assessed by the study doctor Participation in another clinical study with an experimental drug within one month of start of the study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dual Integrin Antagonist|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

Study Overview
=================
Brief Summary
-----------------
To evaluate the current medical practice and its influence on health-related quality of life, in patients who are treated with injectable bone antiresorptive drugs (biphosphonates or denosumab) for at least one year.

Detailed Description
-----------------
This protocol will evaluate the pursuit of injectable bone antiresorptive treatments or their switch to oral biphosphonates, or treatment stop, in the contexte of medical practice. The primary end-point is the health-related quality of life (QoL). Secondary endpoints are safety, overall survial, the impact of toxicities of the treatment on QoL, and the description of supportive care.

Official Title
-----------------
Evaluation of Medical Practice in the Management of Bone Metastases After Injectable Bone Antiresorptive Treatment, and Its Influence on Quality of Life

Conditions
-----------------
Tumor With Bone Metastasis

Intervention / Treatment
-----------------
* Other: quality of life questionaries
* Drug: intravenous or oral bone antiresorptive treatments


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with histologically proven tumor with bone metastasis, single or multiple (with or without metastasis extra-osseous) Patients treated with injectable bone antiresorptive therapy for 12 months or more Signed written informed consent Exclusion Criteria: patient with any medical or psychiatric condition or disease which would make the patient inappropriate to complete quality of life questionaries patient under guardianship, curator or under the protection of justice, pregnant or breast-feeding women

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: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: quality of life questionaries<br>Patients should complete 3 quality of life questionaries (EORTC-QLQ C30 ; EORTC QLQ-BM22 and Euroqol EQ-5D) at many time points : at inclusion, every 3 months and at the end of study visit (2 years after inclusion) | Other: quality of life questionaries<br> <br> Drug: intravenous or oral bone antiresorptive treatments<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluation of 4 targeted dimensions of the EORTC-QLQ-BM22 quality of life questionarie | evaluation of 4 parameters: painful sites characteristics of pain, functional impairment, psychosocial aspect | to 6 months |