cyrilzakka/clinical-trials huggingface dataset:
Behavioral Economics Intervention to Increase Treatment Seeking in the National Guard

The study is a randomized controlled trial of a single-session behavioral economics (research combining the areas of economics, social psychology, and cognitive psychology) intervention (i.e., BEAST) is a"warrior-culture" consistent (i.e., focusing on positive soldier traits, solving practical problems), highly scalable, and extremely brief (10-minute) intervention to encourage treatment seeking among MS National Guard problems for various life stressors. Participants will be 112 National Guard members. It is hypothesized that BEAST will lead to more self-reported motivation to seek treatment and more actual treatment seeking behavior.


Eligibility Criteria:
Inclusion Criteria:

* National Guard active
* \> 17 ACSS-FAD

Exclusion Criteria:

* those determined by military or study personnel to be actively psychotic, manic, or who are imminently suicidal and in need of emergency services.
The Addition of Oral Analgesics to LET During Laceration Repair

Background Approximately 30 million children are treated in emergency departments each year in the United States, of which two to three million are children presenting with lacerations. Topical numbing medication is the standard of care in children with regard to pain control during laceration repair. While topical numbing medications are effective, children often require further pain control during laceration repair in the form of an injected numbing medication, which in itself is painful. No evidence currently exists regarding the concurrent use of oral pain medications to combat laceration procedural pain.

Research Question Does the addition of ibuprofen or oxycodone to lidocaine, epinephrine, and tetracaine (LET) topical anesthetic provide more effective pain control than LET alone during laceration repair?

Design This is a double-blinded, randomized-controlled study.

Methods Subjects in all three groups will receive topical anesthetic. In addition to topical anesthetic, two groups of children will receive either of two oral analgesics, ibuprofen or oxycodone, while the third group will receive a placebo.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking patients
* Patients 4 years of age up to 10 years of age
* Patients seen in the ED needing simple facial laceration repair
* Patients with no chronic medical problems

Exclusion Criteria:

* Any patient who's parent or primary caretaker refuses consent
* Any patient who's parent or primary caretaker needs an interpreter
* Any child with complex laceration(s) or bites
* Any child who has received pain medication at home in response to the facial laceration.
* Children needing procedural sedation
* Children with a known allergy to lidocaine, epinephrine, tetracaine, ibuprofen, or oxycodone
* Patients with known or pre-existing medical conditions where the study protocol cannot be used
* This includes any patient with a medical condition that prevents appropriate use of the pain scale
* It also includes patients with medical conditions that warrant the use of chronic medications
Laryngeal and Esophageal EGF-r Expression in Patients With Reflux Laryngitis

* Saliva plays an important role in the homeostasis of the digestive tract mucosa.
* Salivary organic components, such as the Epidermal Growth Factor(EGF) have been found in defficient concentrations in patients with gastroesophageal reflux disease (GERD) and reflux related laryngitis (LPR).
* The epidermal growth factor receptor (EGFR) signaling pathway is one of the most important pathways that regulate growth, survival, proliferation, and differentiation in mammalian cells
* Eperdermal growth factor receptor (EGFR) overexpression has been linked to hyperproliferative diseases.
* It is unknown if the inflammatory process in GERD is realated to difficiencies in EGFR expression.
* The objective of the current study was to try to establish a correlation between the expression of EGFR in the laryngeal and esophageal mucosa and the severity of laryngitis in adults with GERD and LPR

Objectives: The expression of the Epidermal Growth Factor receptor (EGFR) has been studied in a number of neoplastic and chronic diseases, but there are no reports in literature regarding its expression in chronic laryngitis associated to Gastroesophageal Reflux isease (GERD), also known as Laryngopharyngeal Reflux (LPR). The current study compared the expression of EGFR in the esophageal and laryngeal mucosa of adults with GERD and LPR. Study Design: Prospective based on imunohistochemical analysis of parafine embedded biopsy specimens and clinical data. Methods: From August, 2004 to February 2007 a total of 24 adults with confirmed diagnosis of LPR and no other clinical conditions or habits known to cause chronic laryngitis were studied at a University Hospital. Biopsies of the distal esophagus and the retrocrycoid laryngeal mucosa were obtained during upper digestive endoscopy. Data were analyzed statistically comparing samples in each individual and between individuals using the severity of histological signs of inflammation on hematoxacillin and eosinophillin (HE) stains to immunohistochemical analysis of the expression of EGFR. Other independent variables were severity of symptoms and signs, gender and age. Fishers´s exact test and multivariance ANOVA tests were used with significance level established at 95%.

Eligibility Criteria:
Inclusion Criteria:

* Adults with reflux laryngitis diagnosed by clinical symptoms (Reflux Symptom -Index \>13) and videolaryngoscopic signs (Reflux Finding Score \>7)
* A positive 24-hour doube probe esophageal ph monitoring test

Exclusion Criteria:

* Other known causes of chronic laryngitis or inflammatory conditions of the pharynx, larynx and upper digestive tract.
* Current or past history of Head and Neck or digestive tract tumors.
Piloting a Biofeedback Intervention for Adolescents With Overweight and a History of Adverse Childhood Experiences

Adverse childhood experiences (ACEs), referring to traumatic experiences occurring before 18 years of age (e.g., abuse/neglect), are associated with a 30-70% increased risk of developing adolescent and adult obesity and obesity-related cardiometabolic comorbidities, which may be due to dysregulation in stress-related physiology and engagement in stress-related behaviors. While adolescents with ACEs have a 2.25 times increased risk of obesity, standard-of-care lifestyle (e.g., nutrition/physical activity) interventions do not typically incorporate trauma-informed care, including assessment and therapeutic attention to effects of ACEs. Heart rate variability (HRV) biofeedback is an evidence-based, relatively brief, mind-body intervention targeting the stress physiology that can be dysregulated in adolescents with ACEs. The objective of this proposal is to adapt and test a 4-session HRV biofeedback protocol for 12-17-year-olds with BMI\>85th percentile and ACEs. First (Phase 1), we will iteratively adapt a 4-session HRV biofeedback facilitator protocol with n=3-5 adolescents with overweight/obesity and ACEs, using adolescent quantitative and qualitative feedback to hone and optimize HRV biofeedback for this population (Aim 1). Next (Phase 2), we will conduct a randomized waitlist-controlled pilot study of n=30 adolescents with overweight/obesity and ACEs to assess acceptability and feasibility (Aim 2) and to describe changes in theorized targets of biofeedback (Aim 3).


Eligibility Criteria:
Inclusion Criteria:

* Four or more ACEs
* BMI at or above the 85th percentile;

Exclusion Criteria:

* Major renal, hepatic, endocrinologic, rheumatologic, cardiac, or pulmonary medical problem likely to affect mood or weight
* Medications affecting mood or weight (e.g. anti-anxiety/depressants/psychotics, stimulants, mood stabilizers, insulin sensitizers, weight loss)
Clinical Evaluation of Nano Hydroxyapatite Reinforced Glass Ionomer in Treatment of Root Caries in Geriatric Patients

In geriatric patients, will the clinical performance of nano hydroxyapatite reinforced glass ionomer be better than conventional glass ionomer cement in treatment of root caries lesions over one year follow up?

Glass carbomers are commercialized under the name of GCP Glass Fill, this material may be an interesting subject of research, certainly its bioactive properties as the manufacturer claims this material to have remineralizing properties. If this is the case, GCP Glass Fill could be an interesting reference material for further bioactivity studies

Eligibility Criteria:
Inclusion Criteria:

* • ≥ 50 years old

  * Males or females.
  * Community-dwelling
  * Have five or more of their own teeth
  * With ≥ 1 root caries lesion

Exclusion Criteria:

* • Patients younger than 50 years old

  * Disabilities.
  * Systemic diseases or severe medically compromised.
Future Innovations in Novel Detection of Heart Failure FIND-HF

Heart failure (HF) is increasingly common and associated with excess morbidity, mortality and healthcare costs. New medications are now available which can alter the disease trajectory and reduce clinical events. However, many cases of HF remain undetected until presentation with more advanced symptoms, often requiring hospitalisation. Earlier identification and treatment of HF could reduce downstream healthcare impact, but predicting HF incidence is challenging due to the complexity and varying course of HF. The investigators will use routinely collected hospital-linked primary care data and focus on the use of artificial intelligence methods to develop and validate a prediction model for incident HF. Using clinical factors readily accessible in primary care, the investigators will provide a method for the identification of individuals in the community who are at risk of HF, as well as when incident HF will occur in those at risk, thus accelerating research assessing technologies for the improvement of risk prediction, and the targeting of high-risk individuals for preventive measures and screening.


Eligibility Criteria:
Inclusion Criteria:

1. Aged 16 years and older
2. No history of heart failure
3. A minimum of one year follow up

Exclusion Criteria:

-
Maternal and Neonatal Benefits of Prophylactic Administration of Vitamin K Before Elective Cesarean Section

Vitamin K deficiency can cause serious risks to pregnant women and their babies that may lead to hemorrhage, especially in newborns. We aim to evaluate the efficacy of vitamin k in decreasing blood loss during and after elective cesarean section (CS), and to assess the neonatal beneficial effects of prophylactic maternal vitamin k administration.


Eligibility Criteria:
Inclusion Criteria:

1. Age from 20-40 years.
2. Gestational age between 36-39 weeks.
3. Patients who will undergo an elective cesarean section.
4. Full-term alive baby.
5. Non-scarred uterus.
6. No obstetric or medical complications.
7. No bleeding tendency.

Exclusion Criteria:

1. Patients at less than 36 gestational weeks.
2. Patient refusal.
3. Patients who have thrombo-embolic complications.
4. Patients with obstetric and medical complications.
5. Patients with anomalous fetuses.
6. Patients on anti-coagulant drugs, long-term antibiotics, and anti-epileptic drugs.
7. Patients with obstetric cholestasis.
8. Patients with a previous history of preterm labor.
9. Patients with multiple pregnancies.
10. Gestational hypertension or preeclampsia.
11. Blood clotting disorders.
12. Placental abnormalities such as, Placenta accreta, Placenta increta, and Placenta percreta.
13. Placental abruption and Placenta previa.
Retrospective Study of Viral Reactivation Across All Bone Marrow Transplant Protocols Since 2010

Background:

Some blood and immune disorders can be helped with HSCT. This is allogeneic hematopoietic stem cell transplantation. The person who gets the stem cells has their immune system suppressed. This is done to help prevent their body from rejecting the transplant. During this time, the person is at a high risk to get viral infections. Researchers want to study the records of people who had transplants a few years ago. They want to look at how often certain viral complications happened.

Objective:

To study how often certain viral complications occurred after HSCT and what risks factors were involved.

Eligibility:

Records will be reviewed. No participants will be contacted.

Design:

Researchers will review medical records from the NIH Clinical Center.

The records will be from people who had HSCT between 2010 and 2015 when they were between 4 and 85 years old. They already gave consent for their data to be studied.

Data collected will include:

Vital statistics like age and sex

Viral status of the recipient and donor

Reason for transplant

Transplant details

How the immune system recovered after transplant

If the recipient got graft versus host disease

Any infections

Overall survival

This protocol is a retrospective chart review of patients who have underwent hematopoietic stem cell transplantation (HSCT) at the NIH Clinical Center. If this proposal is approved, BTRIS will identify and populate the patients in these protocols, and BTRIS identified reports will be used going forward.

BTRIS identified reports will be used to review patient progress notes, all aspects of the transplant platform, as well as viral titers over the course of each patient s follow-up, supplemented by review of paper or CRIS electronic medical records as needed.

The study will involve review of patient records and will not use specimens or participant contact. The participants whose records will be reviewed in this protocol were enrolled in NIH protocols between 2010 and December 1, 2020. BTRIS policy requires approval from Principal Investigators on certain protocols. These Principal Investigators have been contacted via email for permission to conduct this study and have verified that none of the original protocols or informed consent documents precludes such a review of clinical data.

Eligibility Criteria:
* ELIGIBILITY CRITERIA:

Subjects will not be recruited for this study.
Studying Genes in Samples From Younger Patients With Desmoplastic Small Round Cell Tumor Registered on COG-D9902 or COG-ABTR01B1

RATIONALE: Studying samples of blood and tumor 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 genes in samples from younger patients with desmoplastic small round cell tumor registered on COG-D9902 or COG-ABTR01B1.

OBJECTIVES:

* To perform whole-exome sequencing on desmoplastic small round cell tumor (DSRCT) samples and their available matched normal samples to identify novel mutations, single nucleotide polymorphisms, or copy number changes associated with these tumors.
* To identify regions of interest that may be involved in the pathogenesis (including the region of EWSR1-WT1 translocation) from the whole-exome sequencing and perform detailed resequencing and transcriptone sequencing to further define the molecular aberrations at the RNA level.

OUTLINE: This is a multicenter study.

Archived tumor tissue samples are analyzed for DNA sequencing, effects of RNA on gene expression levels, novel RNA isoforms, splice variants, and translocations.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Tumor and blood samples from patients registered on COG-D9902 or COG-ABTR01B1 obtained from the Cooperative Human Tissue Network (CHTN) and the Children's Oncology Group (COG) tumor banks
* Matched normal samples

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Genetic Factors Affecting the Severity of Beta Thalassemia

Patients with genetic diseases can have widely differing severities. We are looking for genetic factors which influence the severity of beta thalassemia.

The understanding of the phenotypic variability of genetically homogeneous disorders represents a major challenge. In beta thalassemia, the beta globin gene is affected by a variety of mutations. The group of patients to be analyzed here is homozygous for a splice site mutation that is common in the Middle East. In contrast to this genetic homogeneity, the spectrum of the clinical phenotype ranges from mild anemia to most severe, transfusion dependent anemia. We will use a genetic linkage approach to identify modifying factors and by analyzing the efficiency of an mRNA surveillance mechanism that is referred to as nonsense-mediated decay and represents a candidate genetic modifier of beta thalassemia and other genetic disorders.

Eligibility Criteria:
Inclusion Criteria:

* Identification of homozygous IVS1 nt 6 beta thalassemia mutation
Single Rising Peroral Doses of BI 1744 CL in Healthy Volunteers

Study to investigate safety, tolerability, and pharmacokinetics of single rising peroral doses of BI 1744 CL.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males according to the following criteria: Based upon a complete medical history, including the physical examination, vital signs (BP, PR), 12-lead ECG, clinical laboratory tests
* Age ≥21 and ≤45 years
* BMI ≥18.5 and \<30 kg/m2 (Body Mass Index)
* Signed and dated written informed consent prior to admission to the study in accordance with Good Clinical Practice (GCP) and the local legislation

Exclusion Criteria:

* Any finding of the medical examination (including BP, PR, and ECG measurements) deviating from normal and of clinical relevance
* Evidence of a clinically relevant concomitant disease
* Gastrointestinal, hepatic, renal, respiratory, cardiovascular, metabolic, immunological or hormonal disorders
* Diseases of the central nervous system (such as epilepsy) or psychiatric disorders or neurological disorders
* History of relevant orthostatic hypotension, fainting spells or blackouts
* Chronic or relevant acute infections
* History of relevant allergy/hypersensitivity (including allergy to the drug or its excipients) as judged clinically relevant by the investigator
* Intake of drugs with a long half-life (\>24 hours) within at least 1 month or less than 10 half-lives of the respective drug prior to randomisation
* Use of drugs which might reasonably influence the results of the trial based on the knowledge at the time of protocol preparation within 10 days prior to enrolment in the study or during the study
* Participation in another trial with an investigational drug within 30 days prior to randomisation
* Smoker (\>10 cigarettes or \>3 cigars or \>3 pipes/day)
* Inability to refrain from smoking on trial days as judged by the investigator
* Alcohol abuse (regularly more than 40 g alcohol per day)
* Drug abuse
* Blood donation (more than 100 mL blood within 4 weeks prior to randomisation or during the trial)
* Excessive physical activities within 1 week prior to randomisation or during the trial
* Any laboratory value outside the reference range that is of clinical relevance
* Inability to comply with dietary regimen of the study centre

The following exclusion criteria are specific for this study due to the known class side effect profile of β2 mimetic drugs:

* Asthma or history of pulmonary hyperreactivity
* Hyperthyrosis
* Allergic rhinitis in need of treatment
* Clinically relevant cardiac arrhythmia
* Paroxysmal tachycardia (\>100 beats per minute)
Mic-Key Versus Mini One Family Preference Comparison

The objective of this study is to compare two low profile balloon gastrostomy button enteral feeding devices, both currently used as standard of medical care. The investigators aim to compare family preference and rate of complications between the two devices in a prospective cohort of children. This is the first step in comparing initial and long-term outcomes along with the need for seeking medical advice for gastrostomy site-related complications.

The secondary aim of this study is to follow this population long term (4 years) to document the prevalence of: granulation tissue, infection, skin breakdown, and how long the gastrostomy tube balloon remains functional (does not lose water).

This is a single center prospective, randomized study with a crossover design, comparing two low profile balloon gastrostomy buttons (Figure 1), MIC-Key™ and MINI One™ that are routinely used at CMH. Each subject will be randomly assigned to one button type at the time of initial placement. After placement, standard practice is to perform the first gastrostomy change in the clinic at 2 months where the primary caregivers replace the button under supervision. Therefore, the initial device after randomization will remain in place for 2 months. At the first scheduled device change, the other type of button will replace the original gastrostomy button device. This will remain in place for another 2 months. At the routine visit at 4 months the parents will be asked to choose which button they prefer to keep. This will meet the primary outcome endpoint of the study. The investigators will continue to follow as many subjects as possible to 4 years in order to identify any potential differences in secondary end points.

A caregiver satisfaction survey is routinely used in the clinics. Parent responses to this survey will be also be used in the study analysis.

Eligibility Criteria:
Inclusion Criteria:

* Children ages 0-5 years of age requiring 0.8 cm or 1.0 cm gastrostomy feeding devices for enteral nutrition seen in the Surgery, GI or Special Care clinics
* Gastrostomy placement after IRB approval (enrollment will continue until 170 evaluable subjects have completed the 4 month visit. Expected attrition for the 4 year follow-up is 40%.
* English-speaking families

Exclusion Criteria:

* Children with dermatologic conditions influencing gastrostomy site healing and tract epithelialization
* Children with immunosuppression
* Children with active malignancy requiring treatment
* Inability to commit to 4 months follow up
A Pilot Trial of the Non-invasive H.G.R Glucometer

A pilot study evaluating the accuracy of a non-invasive glucose monitor (GWave) with venous glucose measured by core laboratory during a glucose tolerance test (GTT) in patients with type 2 diabetes.

The study is conducted on 5 subjects undergoing a 75gr GTT, with blood glucose measured at baseline and at 8 time points up to 180 minutes post glucose ingestion both by GWave non-invasive glucometer and by core lab glucose measurement.


Eligibility Criteria:
Inclusion Criteria:

1. Informed consent obtained before any study-related activities. Study-related activities are any procedures that are carried out as part of the study, including activities to determine suitability for the study.
2. Male or female.
3. Age above or equal to 18 years at the time of signing informed consent.
4. Diagnosed with type 2 diabetes mellitus ≥ 180 days before screening.
5. HbA1c of 6.0-8.0% .

Exclusion Criteria:

1. Participants under the age of 18 years
2. pregnant women or patients with normal blood glucose.