linjc16/ctgov huggingface dataset:
Free Iron and Out of Hospital Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Out of hospital cardiac arrest is associated with a poor prognosis. The aim of this study is to provide a better understanding of perturbations of iron metabolism after cardiac arrest and to analyze the impact on clinical centered outcome.

Official Title
-----------------
Iron Metabolism After Out of Hospital Cardiac Arrest

Conditions
-----------------
Arrest Cardio Respiratory

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted to ICU for out of hospital cardiac arrest Therapeutic hypothermia Exclusion Criteria: Absence of consent

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | Mortality | through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurologic outcome | Cerebral Performance Categories scale, ranging from 1 to 5, with a patient considered 1 when he has good cerebral performance and 5 when he has very poor cerebral performance (including brain death) | 6 months post cardiac arrest |
Retrospective Trial on the Efficacy and Safety of Intravitreal Ozurdex in Patients With Diabetic Macular Edema.

Study Overview
=================
Brief Summary
-----------------
To review the safety and efficacy of injections with Ozurdex (700 μg dexamethasone) in clinical practice management of patients with DME.

Official Title
-----------------
A Collaborative Retrospective Trial on the Efficacy and Safety of Intravitreal Dexamethasone Implant (Ozurdex) in Patients With Diabetic Macular Edema (DME). THE EUROPEAN DME REGISTRAR STUDY (ARTES)

Conditions
-----------------
Diabetic Macular Edema

Intervention / Treatment
-----------------
* Drug: Ozurdex


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (≥18 years) with diabetes DME in the study eye (if both eyes have DME both eyes will be included in analysis) BCVA minimum of 20/200 (35 letters) Central Macular Thickness (CMT) ≥300 µm Patients with DME who were treated with Ozurdex at least twice (baseline is before the first Ozurdex injection). Follow up of at least 6 months after the last Ozurdex injection given Complete records including BCVA (OCT and Fluorescein Angiography (FA) if available) throughout the follow up Exclusion Criteria: Patients with ME not secondary to Diabetes Mellitus (DM). Presence of other retinopathies (AMD, RVO) or visually significant ocular morbidity (e.g. advanced glaucoma, corneal opacity) Previous ocular trauma or surgery other than cataract extraction Intravitreal triamcinolone ≤6 months before baseline Intravitreal bevacizumab, ranibizumab, or pegaptanib <1 months before baseline Marked intraocular pressure (IOP) elevation in response to any previous steroid treatment Ocular Hypertension (OHT) in the study eye(s) IOP >23 mm Hg without antiglaucoma medication IOP >21 mm Hg with one antiglaucoma medication Use of 2 or more antiglaucoma medications Glaucoma - Visual Fields (VF) defect > 4 dB

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

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

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

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

Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients. | Percentage of patients with Best Corrected Visual Acuity (BCVA) from baseline to 4 - 6 months after last injection, with comparison between early (<9 month duration of DME) vs late (≥9 month duration of DME), and naïve vs previously treated patients. | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Diabetic Edema, Ozurdex, Retrospective, European, Intra-vitreal injections
Comparison of Catheterized and Clean Catch Urine Specimens for Protein/Creatinine Ratio in Preeclampsia Evaluation

Study Overview
=================
Brief Summary
-----------------
The purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Detailed Description
-----------------
Preeclampsia is the new onset of hypertension and proteinuria after twenty weeks of gestation in pregnant women. The gold standard for evaluation of proteinuria in the diagnosis of preeclampsia is a twenty-four hour urine collection. However, single-specimen protein/creatinine ratios have been used to detect preeclampsia without the delay and inconvenience that a twenty-four hour urine collection would entail. At our institution, women are routinely catheterized for urine collection of protein/creatinine ratios because of concerns that vaginal contaminants would falsely elevate protein measurement in urine. However, no studies have specifically evaluated whether catheterized urine specimens correlate to clean catch urine specimens in protein estimation. Thus, the purpose of this prospective study was to examine whether protein/creatinine ratios in catheterized urine specimens correlate to clean catch specimens in pregnant patients being evaluated for preeclampsia.

Official Title
-----------------
Prospective Comparison of Catheterized and Clean Catch Urine Specimens for Determination of Protein/Creatinine Ratio in Evaluation of Preeclampsia

Conditions
-----------------
Preeclampsia, Proteinuria, Hypertension, Pregnancy

Intervention / Treatment
-----------------
* Other: urine collection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant hypertensive patients between the ages of 14 - 50 of any gestational age greater than 20 weeks undergoing evaluation for preeclampsia Exclusion Criteria: Ruptured membranes Any vaginal bleeding or spotting Pre-existing urinary tract infections or patients who are found to have a concurrent urinary tract infection upon culture of urine Patients who have previously been enrolled in the study

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 50 Years

Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>women undergoing evaluation for pre-eclampsia | Other: urine collection<br>* clean catch urine collection and catheterized urine collection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between protein/creatinine ratios for clean catch and catheterized urine specimens |  | time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
protein/creatinine ratio, clean catch urine, catheterized urine
Prevalence of Low Back and Pelvic Pain in Pregnant Women

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the prevalence of low back and pelvic pain in Spanish pregnant women. The results should allow for the identification of factors associated with a greater risk of having it during pregnancy. Once risk factors are identified, other studies can assess the effectiveness of measures to reduce this pain.

Detailed Description
-----------------
Validated methods were used to gather data on the prevalence of LBP, LP and PGP, anthropometric and socio-demographic characteristics, history of LBP, obstetrical history, physical activity before and during pregnancy, mattress and sleep characteristics, disability, anxiety, and depression. Separate multiple logistic regression models were developed to identify the variables associated with LBP, LP and PGP.

Official Title
-----------------
Prevalence of Low Back and Pelvic Pain in Pregnant Women and Factors Associated With a Greater Risk of Having it

Conditions
-----------------
Low Back Pain, Pelvic Pain

Intervention / Treatment
-----------------
* Other: Set of questionnaires


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A pregnancy of 28 weeks or more Able to understand, read and write Spanish Seen at participating health centers or hospitals in the study Signs informed consent form Exclusion Criteria: Refusal to participate in the study Being under 18 years of age or legally mentally incapacitated Having a diagnosis of illnesses that can cause back pain

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 48 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 |
| --- | --- |
| Pergnant women<br>Pregnant women, of 28 weeks or more of gestation, who are seen in the Health Centers participating in the study. | Other: Set of questionnaires<br>* A set of questionnaires to determine the existence of low back and pelvic pain during the pregnancy, and to identify possible risk factors.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The prevalence of low back and pelvic pain in pregnant women, measured in the third trimester of pregnancy. |  | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of risk factors, such as anxiety or depression, on low back and pelvic pain in pregnant women. |  | 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
low back pain, pelvic pain, pregnancy
Evaluating Peanut Immunotherapy Dissolving Film in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Open label, cross-over, local pharmacokinetics study of a sublingual film with peanut extract in healthy adults and children

Detailed Description
-----------------
In this study, 15 non-peanut allergic children and adults will be enrolled. At three visits, each at least a day apart, the study product (dissolving film) containing approximately 60 mcg of the major peanut allergen (Ara h 2), equivalent to approximately 1000 mcg of peanut protein, will be placed in one of three areas: the sublingual space, affixed to the buccal mucosa, and in the vestibular space. Concentrations of Ara h2 in saliva collected at several locations over several time points in the mouth will be analyzed by ELISA.

Official Title
-----------------
Evaluating the Placement of a Peanut Immunotherapy Dissolving Film in Healthy Subjects

Conditions
-----------------
Peanut Allergy, Immunotherapy, Pharmacokinetics

Intervention / Treatment
-----------------
* Biological: sublingual film with peanut extract


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 3 years and <30 years. Able to give informed consent. English speaking with no language impairment Regularly consume a meal sized portion (approximately 5 grams) of peanut at least twice per month during the preceding 6 months Exclusion Criteria: History of reaction to peanuts Major active medical problems of the oral cavity or use of medications that might change rates of salivation

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 30 Years

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

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

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

Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Interventional Model Description: Open label, crossover, local pharmacokinetics study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sublingual film with peanut extract<br> | Biological: sublingual film with peanut extract<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of elimination half life (T1/2) of the Ara H2 in sublingual placement |  | 3 days | 
| Measurement of elimination half life (T1/2) of the Ara H2 in buccal placement |  | 3 days | 
| Measurement of elimination half life (T1/2) of the Ara H2 in vestibular placement |  | 3 days |
A Study Of The Safety And Efficacy Of Levetiracetam (Keppra®) (Ucb L059) In Children With Epilepsy

Study Overview
=================
Brief Summary
-----------------
The open-label study to allow pediatric patients who have participated in prior Levetiracetam (Keppra®) studies to continue their treatment with adequate monitoring and standardized follow-up care until Levetiracetam (Keppra®) is approved for use in children or until the completion of the development program for pediatrics.

Official Title
-----------------
A Multi-Center, Open-Label, Long-Term, Follow-Up Study Of The Safety And Efficacy Of Levetiracetam (Ucb L059) In Children With Epilepsy

Conditions
-----------------
Epilepsy, Partial

Intervention / Treatment
-----------------
* Drug: Levetiracetam (Keppra)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed Study N151, or any other applicable pediatric trials of Levetiracetam (Keppra®) Be a patient for whom the treatment of Levetiracetam (Keppra®) would be of potential benefit such that the patient/parent(s)/legal guardian and the Investigator agree to continue treatment. Exclusion Criteria: Not be on a ketogenic diet (during the course of this study). Not have seizures too close together to accurately count (i.e., the patient's seizures must be countable).

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam (Keppra)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To allow pediatric patients who have participated in a previous trials the opportunity to receive open-label levetiracetam (Keppra) treatment. |  |  | 
| Efficacy measured by weekly seizure frequency. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To obtain standardized descriptive safety and efficacy data in pediatric epileptic patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Epilepsy, Pediatric , partial onset epilepsy,, Levetiracetam (Keppra®)
Classification and Characterization of Patients Treated With Efalizumab for Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
The main objectives of the project are: To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI) To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.

Detailed Description
-----------------
This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc. We will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.

Official Title
-----------------
Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab

Conditions
-----------------
Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: efalizumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: moderate to severe plaque psoriasis for more than six months eligible for efalizumab treatment according to current Norwegian guidelines Exclusion Criteria: Pregnant or breast-feeding patients Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection. Patients suffering from HIV, Hepatitis B or C, active tuberculosis, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year. Patients with history of cancer in the preceding 5 years, including lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled. Patients with impaired renal or hepatic function.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: efalizumab|efalizumab|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response PASI 75 |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dermatology Life Quality index (DLQI) |  | 2 years | 
| Psoriasis disability Index (PDI) |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
drug therapy, efalizumab
Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to gather information to help doctors understand how Covid-19 affects the lungs in children.

Official Title
-----------------
Transpulmonary Pressure Measurements in Intubated Children With Covid-19 Respiratory Failure

Conditions
-----------------
COVID 19

Intervention / Treatment
-----------------
* Diagnostic Test: Transpulmonary pressure measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 0-17 years of age, 10 kg or greater, with suspected or confirmed Covid-19 respiratory failure requiring endotracheal intubation and mechanical ventilation admitted to Mayo Clinic Hospital, St. Mary's Campus Pediatric Intensive Care Unit. Exclusion Criteria: Patients <10 kg Patients with pre-existing chronic mechanical ventilation (chronic respiratory failure) Patients with known esophageal disease (strictures, known esophageal anatomic abnormalities) Patients with severe coagulopathy (for which placement of esophageal balloon or other gastric tube via nose or mouth is contraindicated) Patients who are pregnant (as determined by standard pregnancy testing criteria for Pediatric ICU admission).

Ages Eligible for Study
-----------------
Maximum Age: 17 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: Intubated pediatric patients with COVID-19 respiratory failure<br> | Diagnostic Test: Transpulmonary pressure measurements<br>* Transpulmonary pressure measurements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transpulmonary pressure | Numerical data | Through study complication, usually 2 weeks |
Dose-escalation Study of Safety of PBCAR19B in Participants With CD19-expressing Malignancies

Study Overview
=================
Brief Summary
-----------------
This is a Phase 1, nonrandomized, open-label, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR19B in adult study participants with CD-19 expressing malignancies.

Official Title
-----------------
A Phase 1 Study of PBCAR19B in Participants With CD19-expressing Malignancies

Conditions
-----------------
CD19 Expressing Malignancies, Hematologic Malignancy

Intervention / Treatment
-----------------
* Genetic: PBCAR19B


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsed or refractory CD19+ expressing malignancies At least 2 prior regimens per Standard of Care Exclusion Criteria: No history of active CNS involvement

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: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dose Level 1<br>In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion. | Genetic: PBCAR19B<br>* Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused<br>* Other names: Allogeneic Anti-CD19 CAR T cells;|
| Experimental: Dose Level 2<br>In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion. | Genetic: PBCAR19B<br>* Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused<br>* Other names: Allogeneic Anti-CD19 CAR T cells;|
| Experimental: Dose Level 3<br>In this study, PBCAR19B, allogeneic anti-CD19 CAR T Cells, is used to treat participants with relapsed or refractory (r/r) Non-Hodgkin Lymphoma (NHL). Route of Administration: Intravenous injection/infusion. | Genetic: PBCAR19B<br>* Single dose of Allogeneic Anti-CD19 CAR T cells will be injected/infused<br>* Other names: Allogeneic Anti-CD19 CAR T cells;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum Tolerated Dose (MTD) | To determine the maximum tolerated dose (MTD) | Day 1 - Day 28 | 
| Number of participants with Dose Limiting Toxicity(ies) | To assess adverse events as dose limiting toxicities as defined by the protocol and CTCAE v5.0. | 1 year |