cyrilzakka/clinical-trials huggingface dataset:
Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis

Eosinophilic esophagitis (EoE) is characterized by allergy-driven inflammation of the esophagus leading to a variety of gastrointestinal symptoms and increased healthcare utilization. While considered a rare disease, EoE is rapidly increasing in prevalence in the United States. Treatment options are limited and include dietary modifications with the elimination of suspected food triggers or pharmacological options including proton pump inhibitors (PPIs) and swallowed corticosteroids. Compliance to strict elimination diets is difficult thus many patients elect to use swallowed corticosteroids. Because nearly half of all EoE patients are treated with swallowed corticosteroids there is a growing concern regarding the long-term effects of this class of medication.4

It is known that oral corticosteroids can compromise bone mineral density and growth velocity5-7. Furthermore, there have been multiple studies exploring the relationship between inhaled corticosteroids (ICS) and endocrine effects in asthmatics. While the risk of ICS use is less compared to systemic corticosteroids, higher ICS doses do cause deleterious effects on growth and bone health8-11. Currently, there are no published studies examining the effect of swallowed corticosteroids on bone mineral density or growth velocity in patients with EoE. Given the route of administration, there may be more systemic absorption leading to a higher risk of long-term complications.

The proposed work will address the following specific aims:

Specific Aim 1: Assess effects of swallowed corticosteroids on bone mineral density (primary outcome) in children 5-12 years of age with EoE compared to age matched controls.

Specific Aim 2: Evaluation of the effect of swallowed corticosteroids on growth velocity.


Eligibility Criteria:
Inclusion Criteria:

* Intervention:

  1. Age 5-12 years
  2. Diagnosis of EoE based upon a peak eosinophil count of ≥ 15 eosinophils/high powered field (hpf) on at least one esophageal biopsy while on a minimum of 8 weeks of PPI therapy
  3. Patient/Family has elected to start swallowed corticosteroids for the treatment of EoE with a minimum daily dose of at least 0.5 mg budesonide or 440 mcg fluticasone. The decision to start swallowed corticosteroids will be made based upon the judgement of the provider, potential subject, and family during a clinic visit and will not be part of the research procedures.
* Controls:

  1. Age 5-12 years
  2. Followed in the ACH allergy clinic, but not required to have a diagnosis of EoE
  3. Not treated with swallowed corticosteroids

Exclusion Criteria:

* Intervention and controls:

  1. Non-English speaking
  2. Patients actively taking systemic corticosteroids or previous use of systemic corticosteroids within the past 6 months
  3. Patients actively taking inhaled corticosteroids or prior use of inhaled corticosteroids in the 6 months prior to screening
  4. Current or previous treatment with swallowed corticosteroids for EoE at the time of screening
  5. Osteopenia or osteoporosis on baseline dual energy X-ray absorptiometry (DEXA).
Changes of Gas Values in Cord Blood Versus Time and Temperature

The pH levels of a neonatal at his birth are an important factor in establishing the connection between events that occurred during the actual time of birth, to the risk of a significant morbidity development in the future. Gas values in cord blood are measurable and represent the condition of the fetus close to the time of birth. Their level is one of the essential criteria which are used to define acute hypoxic event during birth. As the oxygen supply to the fetus significantly disturbed, deficiency of oxygen in the tissues is growing. Therefore, the tissues begin to accumulate large amounts of acid and thereby developing fetal blood acidosis. Many works connected the presence of cord blood acidosis to development of neonatal cerebral palsy. According to the American Association of Obstetrics and Gynecology, cord blood gas sample is necessary when a prenatal event may be related (rightly or not) with negative neonatal outcome. This approach might be necessary when the case is legally controversial and there is a need to prove that umbilical cord gas values were normal at the prenatal period.

The PH levels of a neonatal in his birth are an important factor in establishing the connection between events that occurred during the actual time of birth, to the risk of a significant morbidity development in the future. Gas values in cord blood are measurable and represent the condition of the fetus close to the time of birth. Their level is one of the essential criteria which are used to define acute hypoxic event during birth. As the oxygen supply to the fetus significantly disturbed, deficiency of oxygen in the tissues is growing. Therefore, the tissues begin to accumulate large amounts of acid and thereby developing fetal blood acidosis. Many works connected the presence of cord blood acidosis to development of neonatal cerebral palsy. According to the American Association of Obstetrics and Gynecology, cord blood gas sample is necessary when a prenatal event may be related (rightly or not) with negative neonatal outcome. This approach might be necessary when the case is legally controversial and there is a need to prove that umbilical cord gas values were normal at the pre-natal period.

Aim of study Our aim is to find the effect of the cord blood sample storage way, and the effect of the sample taking time from the delivery.

Eligibility Criteria:
Inclusion Criteria:

Gestational age 37 weeks and above. Vaginal or cesarean births.

Exclusion Criteria:

Women who had medical indication to cord blood sample taking for gas measurement (Apgar\<7 in the 5th minute, premature labor (under 37 weeks), multiple pregnancy, vacuum birth, urgent cesarean
Study to Assess the Effect of StemAlive® Supplement on the Levels of Stem Cells in Human Volunteers

Combination of various herbs is known to promote mobilization of hematopoietic stem cells. Hence the current study has been intended to study the effect of Stem Alive® on mobilization of stem cells. Stem Alive® include ingredients like green tea, ashwagandha, etc which are known to be used as traditional medicine. They are also tested qualitatively in academic and nutritional science research centers throughout the world and which substantially according to those studies stimulate the augmented availability of circulating hematopoietic cells. This study is projected to investigate the mobilization of stem cells on healthy human volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Male and Female Volunteers
* Willing to sign Informed Consent Form

Exclusion Criteria:

* Anemia
* SGOT and Serum Creatinine values twice the upper limit of normal
* Volunteers who smoke / consume alcohol / take recreational drugs
* Fever or Flu in the last one week of screening
* History of Gastric or Duodenal Ulcer
* Volunteers on vitamins, nutritional or herbal products since last one month
* Pregnant, Breast feeding and Lactating women
* Volunteers taking antibiotic, NSAIDS, anti-inflammatory within last 7 days
* Allergic to ingredients of test product
* Any co morbid or systemic condition or immunocompromised state making volunteer unfit for participation.
* Volunteers deemed unfit for the study by the Investigator
The Effect of Platform Switching on Single Implants in the Esthetic Zone, Following Flapless Surgery and Early-Loading Protocols

The impact of platform switching with flapless surgery on early-loaded single-tooth implants on esthetic outcomes.

Evaluation of clinical, radiographic and microbial outcomes of single implants with platform switching, compared to those with conventional platform.

Eligibility Criteria:
Inclusion Criteria:

* Patients should be at least 18 years old and not currently pregnant
* Systemically healthy with no medical contraindications to implant surgery
* Having intact opposite tooth to proposed implant sites
* The edentulous ridge with minimal ridge deformities.

Exclusion Criteria:

* unstable medical status or conditions which may compromise wound healing
* osseous metabolic disorders (e.g., osteoporosis, Paget's disease etc.)
* uncontrolled dental or periodontal diseases
* edentulous ridges with the presence of fibrous dysplasia, severe tissue undercut, residual root, as well as insufficient dimensions or volume
Irinotecan in Treating Aging Patients With Solid Tumors

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Aging may affect the way these drugs work.

PURPOSE: Phase I trial to determine the relationship between aging and the effectiveness of irinotecan in treating patients who have solid tumors.

OBJECTIVES:

* Determine whether there is a relationship between the pharmacokinetic characteristics of irinotecan and aging in patients with non-hematologic malignancies.
* Determine whether there is a relationship between the toxic effects of this drug and aging in these patients.
* Determine whether the relationship between genotype (UGT1A1, CYP3A, and other relevant genes) and phenotype (pharmacokinetics, toxicity) is affected by aging in these patients treated with this drug.
* Analyze data collected on the co-morbid conditions and concurrent medications in these patients treated with this drug.

OUTLINE: This is a multicenter study. Patients are stratified according to age (18 to 55 vs 70 and over).

Patients receive irinotecan IV over 90 minutes once weekly for 4 weeks. Treatment continues in the absence of disease progression or unacceptable toxicity.

Patients are followed for survival.

PROJECTED ACCRUAL: A total of 140 patients (70 per stratum) will be accrued for this study within 3.5 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically confirmed non-hematologic malignancy
* Brain metastases or primary brain tumors are eligible provided patient is not receiving steroids or antiepileptic medications

PATIENT CHARACTERISTICS:

Age:

* 18 to 55 or 70 and over

Performance status:

* CTC 0-2

Life expectancy:

* Not specified

Hematopoietic:

* Granulocyte count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3

Hepatic:

* Bilirubin no greater than upper limit of normal (ULN)
* SGOT no greater than ULN

Renal:

* Creatinine no greater than ULN

Other:

* Not pregnant or nursing
* Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least 4 weeks since prior chemotherapy (6 weeks for nitrosourea)
* No more than 1 prior chemotherapy regimen for metastatic disease (no limit if administered in the adjuvant setting)
* No prior camptothecin

Endocrine therapy:

* See Disease Characteristics

Radiotherapy:

* At least 4 weeks since prior radiotherapy
* No concurrent radiotherapy, including for palliation

Surgery:

* At least 4 weeks since prior major surgery
Promoting Altruism to Enhance Vaccine Acceptance

Subjects enrolled in this study are eligible for the seasonal influenza vaccine. The purpose of this research study is to figure out if increasing individuals' awareness of the benefits of herd immunity, specifically to the local pediatric oncology community, can improve vaccination uptake rates.

The purpose of this study is to identify associations with influenza vaccine hesitancy, including parental demographics and altruism score, in families with healthy children attending two pediatric practices.

Also, in the cohort of families with baseline vaccine hesitancy, to assess the effectiveness of a pilot educational intervention focusing on the development of herd immunity for pediatric oncology patients by measuring:

1. The change in vaccine hesitancy scores pre- and post-intervention.
2. The rate of influenza vaccine uptake compared to historic controls from previous influenza seasons.

Another aim is to explore the relationship between baseline influenza vaccine hesitancy rates and baseline altruism scores. Effectiveness of this intervention is dependent on parental altruism levels; therefore, the study team also seeks to determine if there is an association between parental altruism and vaccine hesitancy for their children.

This is a single-arm prospective cohort study. The study will enroll legal guardians of children who are influenza vaccine-eligible to measure their vaccine hesitancy scores, altruism scores, and the impact of an educational intervention focused on herd immunity on the guardians' vaccine hesitancy score.

Eligibility Criteria:
Inclusion Criteria:

* All legal guardians of children aged 6 months and up who are influenza vaccine-eligible and present to the pediatric clinic.

Exclusion Criteria:

* Legal guardians of children who are not influenza vaccine-eligible including children less than 6 months of age, children on immunosuppressive medications, and children with underlying medical conditions resulting in an immunocompromised state.
Chemokine Expression in Nummular Dermatitis and Atopic Dermatitis

The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and their expression levels in epidermis in AD and ND patients.

Atopic dermatitis(AD) is a common cutaneous inflammatory disease. The pathogenesis of atopic dermatitis involves a complex interaction between atopy and environmental protein allergens which produces Th2 immune responses with IgE formation, Th2 cells dominate in lesions of atopic dermatitis, whereas Th1 and Th2 cells co-dominate in late eczematus lesions.

Nummular dermatitis(ND) is another common cutaneous inflammatory disease. The nummular patches and papules disseminated over four extremities and less over trunk . The serum levels of Th2 chemokines(CCL17, CCL22, CCL27) are elevated in AD patients. The expression levels of these chemokines in lesional epidermis are also increased. CCL18 which is derived from APC is also increased in the serum as well as lesional skin of AD patients. In contrast, there are very few reports regarding the chemokine expression profiles in ND patients. Because erosis is a remarkable exacerbating factor for ND. The investigators hypothesize that ND is a specialized contact dermatitis induced by environmental substances. It has been known, CCL17 and CXCL10 were highly expressed in lesion of allergic contant dermatitis, whereas almost no expression of these chemokines could be detected in lesions of irritant contact dermatitis.

The aim of this study is to measure the serum levels of CCL17, CCL18, CCL22 and CXCL10 and their expression levels in epidermis in AD and ND patients. The investigators hope that the results of this study will provide useful information for clinical differential diagnosis for AD and ND as well as understanding the pathogenesis of ND.

Eligibility Criteria:
Inclusion Criteria:

* age:20\~40, atopic dermatitis, BSA\>10%, no asthma
* age:20\~40, nummular patches\>10, no atopy

Exclusion Criteria:

* systemic immunosuppresive agents within 4 weeks
* high dose topical immunosuppresive agents within 4 weeks
PFA 100 Evaluation and Reference Interval HOACNY

The purpose of this research is to evaluate instrument functionality and develop a reference range of normal data by healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to consent to study

Exclusion Criteria from entire study

* Primary hemostasis diagnosis

  * Von Willebrand Disease
  * Bernard-Soulier syndrome
  * Glanzmann thrombasthenia
  * Idiopathic thrombocytopenic purpura
  * Drug-induced thrombocytopenia
  * Heparin-induced thrombocytopenia
  * Thrombotic thrombocytopenic purpura
  * Hemolytic uremic syndrome
* Participant is on anticoagulant therapy

  * Specifically thienopyrdines \[Ticlopidine, Clopidogrel\] and GPIIb/IIIa inhibitors \[ReoPro, Aggrastat, Integrilin\]
* Participant is on medication that contains ASA or aspirin (see list below in Study Procedure)
* Participant is on nonsteroidal anti-inflammatory agents that are known to induce temporary platelet dysfunction (see list below in Study Procedure)
* Participant is on non-prescription medications containing aspirin (see list below in Study Procedure)
* PFA-100 result falls outside of reference interval listed in the package insert (suggested criteria in the PFA-100 Evaluation Protocol as described in the PFA-100 System: Getting Started Guide)
* If hematocrit is less than 35%
* If platelets are less than 150 x10\^3/uL

Exclusion Criteria from Cohort B but not Cohort A

* Potential for adverse reactions between current medication and aspirin as dictated by staff pharmacist
* Allergy to ASA or aspirin
* Previous allergic reaction to ASA or aspirin
* Participant is pregnant
* Asthma, or history of, with nasal polyps and rhinitis
* Stomach ulcers or bleeding
* Severe kidney disease
* Severe liver disease
* Hemophilia
* Pregnant or breast feeding
Executive Function and Symptom Reduction in Youth Receiving Home-based Treatment With Collaborative Problem Solving

In this project, the investigators will extend prior results of parent-reported executive function growth and symptom reduction in children receiving home-based treatment with the Collaborative Problem Solving treatment approach (CPS), with a particular focus on examining children who have attention deficit hyperactivity disorder (ADHD). The investigators will examine executive functioning (EF) of children who are receiving CPS, measuring EF with parent-report and objective computer-based tasks, at two timepoints: at the start of treatment and approximately four months later, and will collect symptoms at these plus three additional timepoints: at discharge, 6-months after discharge, and 12-months after discharge.


Eligibility Criteria:
Inclusion Criteria:

* Clients of participating non-profit organization that are receiving home-based youth mental health care
* Speaking and writing English at level necessary to complete study requirements

Exclusion Criteria:

* Youth is in full state custody and consent cannot be obtained by a guardian
* Youth and/or guardians do not speak English well enough to complete standardized measures
* Youth has a confirmed or suspected Full Scale IQ below 70, or carries a prior diagnosis of Autism Spectrum Disorder at the moderate or severe level
Montefiore Medical Center Healthy Marriage and Relationship Education Program

The proposed program will flexibly provide an array of relationship promotion activities incorporating case management and job placement/career advancement activities: marriage and relationship education; pre-marital education and marriage skills; marriage enhancement and marriage skills for married couples; and divorce reduction and relationship skills. In addition, our proposed local evaluation will examine factors that might account for the observed impacts of attending relationship education programs (i.e., higher levels of relationship satisfaction), including dosage of workshops, relationship commitment and longevity, and skill learning.

The objective of the proposed evaluation is to delineate those factors and sub-groups that account for the observed impact of HMRE services on the quality of relationships. Specifically, we are interested in investigating the following factors:

1. Commitment: Are couples that are more committed to each other (measured in terms of marital status, duration of relationship, or relationship commitment scale scores) more motivated to attend a greater number of HMRE workshops? Do they actually learn more relationship skills, and report improvements in their relationship quality?
2. Hopefulness: How does hopefulness about the relationship impact outcomes?
3. Dosage: Is attendance at a greater number of workshops related to improvements in relationship satisfaction and relationship quality?
4. Couple characteristics: How are various demographic factors related to observed outcomes?
5. Skill acquisition: How much did couples actually learn during the course of the relationship workshop?

In order to explore these research questions, we will be conducting an evaluation that utilizes pre-and post-survey data and qualitative interview information from participants. This will be a descriptive study and not a random assignment design. Data collection will begin when couples who expressed interest in the program attend a preliminary interview with one of Montefiore's clinical staff on site. The program and study will be explained to the couple and they will be asked to consent to participate. Once consent is gathered, on-site staff will administer measures required by our funders through an online system called nForm, or Information, Family Outcomes, Reporting, and Management. This online system was developed by Mathematica Policy Research, an agency contracted by the Department of Health and Human Services to conduct a Cross-Site evaluation of all grantees who received funding to provide relationship education services. Preliminary demographic information will be collected through surveys completed by participants online through secure web browsing at a Montefiore facility.

Eligibility Criteria:
Inclusion Criteria:

* In a committed relationship
* 18 years or older
* expecting a child or are caring for a child in the home at least 50% of the time (biological, foster, adopted, kinship care, etc.)

Exclusion Criteria:

* Active intimate partner violence and increased risk of intimate partner violence
Heart Rate Variability (HRV)-Guided Transcranial Direct Current Stimulation (tDCS)

This technology development project will be informed and guided by initial data collection of human subject data. For this purpose, the investigators will recruit n=100 people with mild to moderate depression in a double-blinded, parallel-arm, sham-controlled data collection period administered at home and using the investigator's remotely supervised (RS) tDCS protocol. Enrolled participants will complete 10 days of 30-minute tDCS (2.0, DLPFC left anodal) using the RS-tDCS protocol. During each daily session, standard HR and impedance-based HR (i-HR), obtained from the tDCS headset, will be collected to identify a possible marker of response to tDCS in depression. Participants will be randomized 2:1 to active vs. sham tDCS.


Eligibility Criteria:
Inclusion Criteria:

* Mild to moderate depression (Beck Depression Inventory(BDI)-II 14-28)
* Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-V-TR) Depressive episode
* Wide Range Achievement Test (WRAT)-4th Reading Recognition subtest standard score \>85

Exclusion Criteria:

* Primary neurologic, psychiatric (e.g., multiple sclerosis, stroke, Parkinson's disease, spinal cord injury, intracranial mass, traumatic brain injury (TBI), epilepsy, mild cognitive impairment (MCI), or dementia), or major medical disorder (e.g., history of myocardial infarction, diabetes, thyroid disease, arrhythmia, atrial fibrillation) (medical history review)
* DSM-V-TR bipolar depression, psychotic disorder, or alcohol or substance use disorder (M.I.N.I.)
* Active or high suicidality risk (Columbia-Suicide Severity Rating Scale, C-SSRS), or otherwise judged as inappropriate by the study clinicians
* History of a heart transplant, presence of permanent pacemaker implant or Left Ventricular Assist Device
* Use of certain medications that can affect heart rate variability, such as beta-blockers, calcium channel blockers, or cardiac glycosides
* Use of antidepressant, antipsychotic, anxiolytic, or stimulant medications
* Pregnant or planning pregnancy during the study period
* Seizure disorder or recent (\<5 years) seizure history
* Presence of metal objects in the head/neck
* Any skin disorder or skin sensitive area near stimulation locations