cyrilzakka/clinical-trials huggingface dataset:
Targeting Access and Knowledge of Earned Income Tax Credit (EITC) Utilization and Policies

The earned income tax credit (EITC) is the largest United States poverty alleviation program, providing up to $6,600 for working families as a tax refund. Prior studies have shown the EITC's benefits for social outcomes and health. Effects are even more significant for single mothers and Black women. Despite these known benefits, 20%-33% of eligible individuals do not receive benefits, leaving $7 billion unclaimed annually. The Targeting Access and Knowledge of EITC Utilization and Policies (TAKE-UP) Study is a pilot randomized controlled trial that will develop and test the feasibility of several culturally tailored, scalable interventions to increase the take-up of the EITC among participants in the Special Supplemental Food Program for Women, Infants, and Children (WIC).


Eligibility Criteria:
Inclusion Criteria:

* Enrolled in Special Supplemental Nutrition Program for Woman, Infants, and Children (WIC)
* Eligible for but did not receive the Earned Income Tax Credit (EITC) in the prior tax year
* At least one dependent under 18 years
* Having earned income (including income of spouse, if applicable) for the current tax year within EITC eligibility thresholds based on marital status and number of dependents
* English or Spanish-speaking
* Living in California and not planning to move within the next year
* Immigration status compatible with EITC eligibility
* Access to a phone that receives text messages
* Willing to share relevant fields from tax forms if filing taxes (e.g., adjusted gross income)
* Willing to be randomized.
Bimodal Analgesia as Form of Pain Control Post Long Bone Fracture

The purpose of this prospective randomized study is to evaluate the risks and benefits of using bimodal analgesia, (i.e. Narcotics and NSAIDS) vs Narcotics alone post long bone fracture.

This will be a prospective, randomized, control trial looking at the benefit of bimodal analgesia in the treatment of long bone fractures. The traditional pain control regimen following fracture fixation typically involves a course of narcotics on an as-needed basis for pain relief. Recent data has shown that adding NSAIDS to the pain regimen as part of a bimodal approach to pain control, improves the efficacy of pain management and reduces narcotic use. Laboratory research on NSAIDs as it pertains to bone healing, however, has shown in animal models that there may be a positive association between NSAIDS and non-union rates. In other words, NSAIDS may prevent or delay bone healing. These results, however, have not been tested prospectively in humans.

The purpose of this study is to look at the combination of NSAIDS and narcotics post long bone fracture and monitor the effects on narcotic use and healing rates to ultimately and conclusively establish the risk or benefit of NSAIDS after long bone fracture.

Eligibility Criteria:
Inclusion Criteria:

* skeletally mature patients over the age of 18 years
* Fracture of Tibia, femur, or Humerus.

Exclusion Criteria:

* Open fractures grade III
* Open fractures with suspected compartment syndrome
* history of prior fracture in particular limb.
* Concurrent usage of Steroid drugs, and immunosuppressants.
* Prior or current history of GI bleeding.
Retrospective Case Study Examining Patient Outcomes Compared to the ChemoFx Assay in Endometrial Cancer Patients

The purpose of this study is to assess the relationship of assay sensitive patients versus assay resistant patients with progression free survival.

This is a multicenter, retrospective chart review study of de-identified drug response marker results and a limited data set of clinical outcome data. Data from approximately 70 cases will be collected from approximately 10 study sites and correlated to the ChemoFx drug response marker results. The outcome of progression free survival will be defined as the period of time between the first dose of chemotherapy following the report of the marker result until clinical progression or death. Objective response will be measured from the first dose of chemotherapy following the report of the marker result until progression or change in therapy. Overall Survival will be measured from the start of chemotherapy to the actual date of death.

Eligibility Criteria:
Inclusion Criteria:

* Case has an original pathology report showing stage III, IIIa, IIIb, IIIc, IV, IVa, IVb, or recurrent endometrial cancer.
* Case includes a pathology or cytology report from initial diagnosis showing disease of one or more of the following histologic epithelial cell types: serous adenocarcinoma, endometrioid adenocarcinoma, mucinous adenocarcinoma, undifferentiated carcinoma, transitional cell carcinoma, clear cell carcinoma, or adenocarcinoma, not otherwise specified (N.O.S.).
* Case has been identified for pattern of response evaluation.
* Case must have a commercial ChemoFx drug response marker final report.

Exclusion Criteria:

* Cases of patients who were deceased prior to 1 cycle of chemotherapy.
Risk Factors of Epistaxis Recurrence in Adults

We study all patients admitted to the Emergency Department in the Institution between 01/2022 and 07/2023. The information about the recurrence of nose bleeding was searched on their medical file and by calling the patient to confirm ou get the information. Thus, several potentiel risk factors were studied.

The relation between recurrence and those factors were studied at first individually and then all the significant ones were analyzed with a multivarious statistical test.

We study all patients admitted to the Emergency Department in the Institution between 01/2022 and 07/2023. The information about the recurrence of nose bleeding was searched on their medical file and by calling the patient to confirm ou get the information. Thus, several potentiel risk factors were studied : oral anticoagulants, sex, INR, anti-platelets drugs, diabetes, obesity, arterial hypertension, heart failure, hemoglobin at the admission, history of chronic rhinosinusitis, appointment with an ENT during the acute bleeding, sleep apnea, age, anatomic abnormality, recent surgery within 2 months, previous admission within 30 days in the emergency department, nasal trauma.

The relation between recurrence and those factors were studied at first individually and then all the significant ones were analyzed with a multivarious statistical test.

This study aim to provide a pronostic score of recurrence that can happen after the 3 fisrt weeks after the event. When a recurrence happens before 3 weeks, this was considered to be a non control of the bleeding episode.

This score will be then tested on our cohort to evaluate specificity and sensibility.

Eligibility Criteria:
Inclusion Criteria:

* Patient who is admitted at the emergency department between 01/2022 and 07/2023 for nose bleeding.
* Age over 18 yo

Exclusion Criteria:

* Opposition to be included
* Patient who has not his willness to provide opposition to participate.opposition
Clinical Utility and Outcome Prediction of Cardiovascular Computed Tomography (PREDICT-CT)

In this study the investigators retrospectively and prospectively collect information from enrolled subjects undergoing CCTA and evaluate the association of cardiac and non-cardiac imaging with laboratory markers and clinical data including outcome.

In this study the investigators retrospectively and prospectively collect information from enrolled subjects through a period of a total of 10 years to evaluate multidimensional associations between phenotypic manifestations of cardiovascular disease via CCTA and cardiac and non-cardiac imaging, serum biomarkers, demographic and clinical information, clinical presentation (cross-sectional), therapy changes (time-varying) and their ability to predict mortality and MACE (major adverse cardiac event ) (longitudinal) in patients clinically indicated for CCTA.

The aim is to establish a comprehensive cross-sectional, time-varying and longitudinal data collection for individuals undergoing clinically-indicated CCTA to date in order to apply novel multiparametric approaches to determine cardiovascular significance to clinically-important patient-centered events. For data collection this registry will follow a standard CRF (case report form) structure, so to enable the merging of this data-set with other international registries, which might contribute in overcoming some gaps of knowledge from previous CCTA studies.

Eligibility Criteria:
Inclusion Criteria:

* Adult individual \>18 years
* Undergoing clinically indicated CCTA
* Signed informed consent or waiver

Exclusion Criteria:

* None
Metabolomic Alterations in the Vascular Compartment in Patients With Sepsis

This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock

This study will investigate the metabolic alterations of vascular cells caused by sepsis and septic shock in 60 patients

Eligibility Criteria:
Inclusion Criteria:

* 18 year or older
* Sepsis or Septic shock

Exclusion Criteria:

* Pregnant or breastfeeding
* Hemoglobin ≤ 5.0 mmol/L
* Platelets ≤ 5.0 mia/L
* Consent not obtainable
* Do not resuscitate order
Association Between Functional Changes in the Brain and the Perception of Pain in Patients With Inflammatory Bowel Diseases (IBD) - Measured With Functional Magnetic Resonance Imaging.

In the study the investigators aim to test whether transcranial direct current stimulation (tDCS)-induced pain reduction is in association with functional changes in the brain measured with functional magnetic resonance imaging (fMRI) in patients with chronic inflammatory bowel diseases (IBD).

Hypothesis: Transcranial direct current stimulation can reduce the perception of pain in patients with chronic inflammatory bowel diseases, which is in association with changes in the brain measured via fMRI.


Eligibility Criteria:
Inclusion Criteria:

* Inflammatory bowel disease
* Chronic pain (more than 3 months)
* Pain (VAS \> 3/10)

Exclusion Criteria:

* Contraindication to transcranial direct current stimulation
* Contraindications to functional magnetic resonance imaging (fMRI)
* Pregnancy
* Sever internal or psychiatric condition
Effect of Amino Acids and Sugar Alcohols on Satiation Peptides and Activation of Specific Brain Regions

With this study the investigators investigate the effects of amino acids (tryptophan, leucin) and sugar alcohols (xylitol, erythritol) on satiety mechanisms and brain activation.


Eligibility Criteria:
Inclusion Criteria:

* Healthy normal weight subjects with a body-mass index of 19.0-24.9
* Healthy obese subjects with a body-mass index of \> 30
* Normal eating habits (no diets; no dietary changes; no special dietary habits such as vegetarian/vegan)
* Age 18-40 years
* Stable body weight for at least three months

Exclusion Criteria:

* Smoking
* Substance abuse
* Regular intake of medications (except for oral contraceptives)
* Medical or psychiatric illness
* History of gastrointestinal disorders
* Food allergies
* Pregnancy, breast feeding
* Body piercings that cannot be removed
* History of claustrophobia
* Left-hander
Study of the Safety and Efficacy of MLN1202 in Patients in Multiple Sclerosis

This was a phase 2a study of MLN1202 to determine safety, tolerability and initial efficacy in patients with relapsing-remitting multiple sclerosis (RRMS). It was conducted in 2 dose cohorts enrolling a total of 50 patients. Efficacy was assessed by comparing the numbers of new gadolinium-enhancing brain lesions during the screening and treatment periods.


Eligibility Criteria:
Inclusion Criteria:

Each patient was to have met all of the following inclusion criteria to be enrolled in the study:

* 18 years of age or older
* Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
* An Expanded Disability Status Score (EDCC) of 0 to 5.5, inclusive
* Be willing and able to comply with the protocol for the duration of the study period
* Be willing to use adequate "double-barrier" contraceptive methods for the duration of the study period
* If female, must be neither pregnant or breast-feeding
* Written informed consent
* To be enrolled in the treatment phase of the study each patient must have a total of at least 2 new gadolinium-diethylenetriamine pentaacetic acid (Gd)-enhancing lesions seen over the series of 3 pretreatment magnetic resonance imaging (MRI)s.

Exclusion Criteria:

Patients meeting any of the following exclusion criteria were not to be enrolled in the study:

* Diagnosis of primary progressive multiple sclerosis (PPMS) or secondary progressive multiple sclerosis (SPMS)
* Received any investigational drug or experimental procedure within 3 months prior to study day 0
* If the patient has received disease-modifying treatments they must be discontinued prior to study day 0 as follows:

  1. Cyclophosphamide or mitoxantrone- 6 months prior
  2. Interferons, glatiramer acetate and azathioprine- 12 weeks prior
  3. Methotrexate, IV immunoglobulin, cyclosporin, plasma exchange or corticosteroids- 8 weeks prior
* Never have been exposed to Tysabri® (natalizumab)or any other VLA-4 (α4β1)antagonist
* Have an active infection or be considered to be at high risk for developing an infection
* Have a history of hepatitis B, C or human immunodeficiency virus (HIV)
* Have a chest X-ray within 6 months of study day 0 with clinically significant findings or abnormalities
* Have inadequate renal or hepatic function
* Have a known history of cancer, except for distant history (\>10 years) of carcinoma in situ of the cervix or adequately treated basal cell carcinoma of the skin
* Received any live, attenuated vaccinations within 30 days prior to study day 0
* Have a history of illicit drug or alcohol abuse within 5 years of study day 0
* Have a history of hypersensitivity to prior monoclonal antibody (mAb) treatment
* Have a history of allergy or sensitivity to Gd
* Have a history that would preclude serial MRI scans
Ventilation in Cardiac Surgery

The purpose of this study is to evaluate prospectively ventilatory practices in the perioperative cardiac surgery period.

This is a International Multicentre Observational Trial on all adult cardiac surgery patients with cardiopulmonary bypass (CPB).

Eligibility Criteria:
Inclusion Criteria:

* All consecutive cardiac surgery patients with CPB during one predefined period,
* Elective or urgent surgery as defined by EuroSCORE2.

Exclusion Criteria:

* Refusal of consent,
* Pregnant women,
* Age \< 18 years,
* Heart transplant, ECLS, ventricular assist
* Emergency or salvage surgery as defined by EuroSCORE2
CASTRO-B - Study on CRP Apheresis in STROke Patients in Berlin

This study explores the use of CRP level reduction in patients after suffering from acute ischemic stroke. Using selective CRP-apheresis, the investigators aim to reduce the secondary inflammatory tissue damage in the course of infarction maturation using infarction growth in MRI as the primary outcome as a surrogate.

C-reactive protein (CRP) is an acute-phase protein binding to phosphocholine, thereby marking damaged tissue. This in turn activates the complement system and the cellular immune system engaging the unspecific immune system in an inflammatory tissue-degrading reaction. Such a pattern is observed in ischemic stroke, and elevated CRP levels can be measured in stroke survivors' sera. Several observational studies reproduced higher CRP levels with negative outcome in stroke. In another vascular model disease, myocardial infarction, selective CRP apheresis reduced infarct size in humans. The investigators therefore designed this pilot study to explore the effects of selective CRP reduction in ischemic stroke patients.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 - 85 years
* Informed consent signed by patient
* Patients with acute ischemic stroke in the Arteria cerebri media (MCA) territory within 36 hours of event
* Acute MRI with evidence of infarction
* NIHSS ≥ 4
* CRP \> 5 mg/l

Exclusion Criteria:

* Withdrawal of consent
* Systolic blood pressure \<100 mmHg before the apheresis
* Blood pressure relevant extra- and intracranial stenoses (NASCET 70)
* Apheresis contraindication
* Participation in other interventional studies
MK-0941 Multiple Dose Study in Japanese Patients With Type 2 Diabetes (MK-0941-011).

The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Japanese Male or Female between 20 to 65 years of age
* Diagnosis of Type 2 Diabetes
* Patient being treated by diet and exercise alone

Exclusion Criteria:

* Patient has a history of Type 1 Diabetes
* Patient is being treated with glaucoma medications
* Patient has donated blood or participated in another clinical study in the past 12 weeks
* Patient is a regular user of any illicit drugs or has a history of drug, including alcohol, abuse
High Dose Risankizumab for Psoriasis

This is a pilot study that explores whether higher initial doses of risankizumab (300 mg and 600 mg, 2 times and 4 times the standard initial doses for plaque psoriasis) can more effectively target resident memory T cells, a type of immune cell within psoriatic lesions, and whether this results in higher levels of completely clear skin and for longer periods of time following withdrawal of drug. It is believed that resident memory T cells in psoriatic skin contribute to the persistence of psoriasis. It is believed that if the study drug can more effectively eliminate these cells, better clearance of psoriasis may be achieved (when compared to standard initial doses of study drug).


Eligibility Criteria:
Inclusion Criteria:

* Subject has provided written consent
* Subject has the ability to comply with all study visits and procedures
* Subject is at least 18 years of age
* Subject has chronic stable plaque psoriasis for at least 6 months and with a severity of BSA greater than or equal to 10 and PASI greater than or equal to 12
* Female subjects of child-bearing potential must have a negative urine test at screening and baseline. Female subjects must be either postmenopausal, or permanently surgically sterile, or for women of child-bearing potential practicing at least one form of birth control

Exclusion Criteria:

* Breastfeeding or pregnant women, or women who plan to become pregnant during study period
* Participation in any other clinical trial
* Active infection with HIV, hepatitis B virus, or hepatitis C virus
* Active infection with tuberculosis or untreated latent tuberculosis
* History of known active cancer, other than non-melanoma skin cancer or cervical carcinoma in situ, in the past 3 years
* History of drug or alcohol abuse in the past 6 months, as per investigator's assessment
* History of suicidal ideation or attempts in the past 6 months
* Presence of any concurrent illness, which in the opinion of the investigator, would place the patient at unnecessary safety risk during the trial or interfere with completion of the trial
* Treatment with topical medications for psoriasis in the past 2 weeks
* Treatment with oral medications for psoriasis in the past 4 weeks
* Phototherapy for psoriasis in the past 4 weeks
* Any prior treatment with Risankizumab
* Treatment with biologic medications for psoriasis (other than Risankizumab) in the past 4 months
The Impact of Starbright World on Children Being Treated at the NIH

This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. Our outcome evaluation of SBW will include assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and willingness to return to the NIH for treatment of children who are being treated at NIH. They will be assessed while engaging in "normal" recreational activities (in one of two available playrooms) and while using Starbright World. In addition, we will conduct a process evaluation of the implementation of Starbright World.

This study seeks to evaluate the impact of Starbright World (SBW) on hospitalized children. SBW is a virtual environment designed to link seriously ill children into an interactive online community where they can play games, learn about their condition, or talk with other ill children who are connected to the network. Our outcome evaluation of SBW will include assessments of pain, mood (anxious, depressed and energetic), anger, loneliness, and willingness to return to the NIH for treatment of children who are being treated at the NIH. They will be assessed while engaging in "normal" recreational activities (in one of two available playrooms) and while using Starbright World. In addition, we will conduct a process evaluation of the implementation of Starbright World.

Eligibility Criteria:
Children between the ages of 8 and 21.

Currently on active protocol at NIH.

Access to playrooms on the 9th, 11th, 13th, and 14th floors.

Ability to read and understand English.

No presence of mental illness.

Ability to understand and/or perform tasks involved in using Starbright World.