cyrilzakka/clinical-trials huggingface dataset:
Fibrostenotic Eosinophilic Esophagitis: Assessment Tools

This protocol addresses a central hypothesis that fibrostenotic Eosinophilic Esophagitis (EoE) is characterized by abnormal esophageal structure and compliance compared to non fibrostenotic EoE and that distinctive cellular and molecular profiles predict the fibrostenotic phenotype. This study aims to define and assess the changes that occur in the structure and dynamics of the esophageal wall in pediatric Eosinophilic Esophagitis along with characterizing the histologic and molecular patterns in fibrostenotic EoE.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled to undergo a clinical upper endoscopy with biopsy

Exclusion Criteria:

* Known connective tissue disorder
* Increased risk of bleeding
* Inflammatory bowel disease, celiac disease, eosinophilic gastroenteritis, or any autoimmune disease
* Other esophageal disease including known achalasia; history of caustic ingestion, esophageal surgery esophageal stricture for other known reason or other esophageal injury.
* Use of oral or intravenous steroids in the preceding 60 days. (Swallowed topical fluticasone, budesonide, etc not included as exclusion criteria.)
Effect of Compressive Therapies on the Healing of Venous Ulcers

The objective of the study is to compare the effect of two treatments on the healing of venous ulcers in follow-up people in two Primary Health Services, in a city in southern Brazil. The two treatments that will be tested are: (1) the high compression elastic bandage and (2) Unna boot. The two treatments are indicated for the treatment of people with venous insufficiency and who have an active ulcer. The treatment will last 26 weeks (6 months). Once a week, during 26 weeks, a nurse will perform the dressing and will apply the therapy high compression elastic bandage or Unna boot according to a drawing and in every two weeks an evaluator will assess the characteristics of the ulcers and the size.

The primary objective is to compare the effect of two compressive therapies, high compression elastic bandage and Unna boot, on time and on the healing characteristics of venous ulcers in Primary Health Care and the secondary objectives are to verify the effects of the therapies in tissue integrity and at the level of pain, to identify quality of life of the participants and to evaluate the cost-effectiveness of the two therapies from the perspective of the Unified Health System. A randomized clinical trial is being carried out in two Primary Health Services in Porto Alegre city, with people with active venous ulcer. 126 venous ulcers, 63 in each group will be followed. The A group receives elastic compressive therapy (high compression elastic bandage) and the B group receives inelastic compressive therapy (Unna boot) by randomization. Once a week, during 26 weeks, a nurse applies the therapy according to the randomization group. And a blind evaluator for therapies will assess the characteristics of the ulcers and the size, on the first day and in every two weeks until 26ª week.

Eligibility Criteria:
Inclusion Criteria:

* people with diagnosis of chronic venous insufficiency recorded in medical records, with active venous ulcer;
* with indication of compressive therapy, who are not using any of the therapies used in the study and who have not used them within 30 days of the initial moment of data collection;
* 18 years old or older;
* with Ankle-Brachial Index (ABI) between 0.8 and 1.2;
* with pulses present on palpation in lower limbs;
* walking people;
* with Body Mass Index (BMI) between ≥ 18.5 kg/m2 and 39.9 kg/m2 (for elderly people: ≥ 22 kg/m2 and 39.9 kg/m2);
* with ankle circumference greater than 18cm.

Exclusion Criteria:

* pregnant women;
* people with mixed, infected or in the epithelialization phase UV (with epithelial tissue in 90% of the UV area);
* uncontrolled diabetics (with Glycated Hemoglobin greater than 7% in the last six months);
* people with medical diagnosis of dermatological, rheumatological and oncological diseases in the member of the active UV or immunosuppressive diseases (for influencing the healing process);
* with allergy to any f the components of the compressive therapies used in the study;
* people using immunosuppressants and/or corticosteroids for more than 21 days (for influencing the healing process).
Response of the Gut Microbiome and Circulating Metabolome to Diet in Children: Ancillary Study to KIDFIT (NCT03405246)

This is an ancillary study to KIDFIT (NCT03405246). KIDFIT tests whether preschool-age children, born to overweight or obese mothers, respond to a healthy DASH diet intervention with better cardiovascular health.

This ancillary study to KIDFIT investigates how the children's gut microbiomes (bacteria in the intestines) and blood metabolomes (small molecules in the blood) are affected by the DASH diet intervention, and how the microbiome and metabolome relate to the children's cardiovascular health over time. The investigators hypothesize that (1) the DASH diet will modify the gut microbiome and blood metabolome, (2) the gut microbiome and blood metabolome will be related to each other, and (3) the microbiome and metabolome will be associated with the children's cardiovascular health profiles (things like weight, body fat, blood pressure, and cholesterol).

The majority of deaths from cardiovascular disease (CVD) in US adults ages 25-54 years are associated with suboptimal diet. While diet is an important target of CVD prevention efforts in adults, intervention on the childhood diet may be more effective. Animal data suggest that early-life diet has the unique potential to modulate biological systems and durably program a child's biology for long-term health or disease. The objective of this study is to define the molecular effects of a dietary pattern intervention on the gut microbiome and circulating metabolome in young children. This objective will be attained through an ancillary study to KIDFIT, a clinical trial that tests the effects of a 12-month Dietary Approaches to Stop Hypertension (DASH) diet intervention on adiposity and other cardiovascular health (CVH) metrics (e.g., blood pressure, lipids) in 3- to 5-year old children. Using additional participant samples, deep phenotyping and advanced bioinformatics, the ancillary study will address three specific aims. First, it will test the effect of the DASH diet intervention on the gut microbiome, including abundances of microbial taxa, communities, and metabolism-related genes and transcripts. Second, it will define the associations of diet and the gut microbiome with the circulating metabolome. Using targeted and nontargeted metabolomics approaches, blood metabolites, metabolite networks, and metabolic pathways will be evaluated. Finally, in an exploratory fashion, it will probe pathways linking the diet intervention with subsequent adiposity and CVH metrics, through the gut microbiome and serum metabolome. The expected outcome is a preliminary model of how the DASH diet alters the gut microbiome and circulating metabolome in young children, and how these alterations relate to short-term CVH outcomes.

Eligibility Criteria:
Inclusion Criteria:

- participating in KIDFIT (NCT03405246)

Exclusion Criteria:

- none
Dexmedetomidine for Sedation Undergoing Bronchoscopy

Several sedatives or analgesics can be used to achieve appropriate levels of sedation for endoscopic procedures. Dexmedetomide is notable for providing sedation without respiratory depression. We hypothesized dexmedetomide is more suitable for sedation of bronchoscopy than other sedative drugs.

A retrospective chart review was conducted. All patients undergoing flexible bronchoscopy with moderate sedation were enrolled.The primary analysis outcome was safety profile during procedure included incidence of procedure interruption, incidence of snoring and observed apnea, transient hypoxemia and hypotension. The secondary outcome was measured by recovery profile (awake and ambulation time).

Eligibility Criteria:
Inclusion Criteria:

* sedation undergoing flexible bronchoscopy

Exclusion Criteria:

* without sedation undergoing flexible bronchoscopy
Optimizing Fall-risk Prediction in Older Adults With Cancer

To establish the optimal strategy of fall-risk assessment to predict falls in older adults receiving cancer therapy.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥65
* Receiving systemic cancer therapy, including conventional chemotherapy, novel/targeted agents or hormonal agents (e.g. anti-estrogen or anti-androgen) OR will begin systemic therapy within the next 4 weeks.
* Estimated life expectancy \>1 year
* Anticipated to receive ongoing care at Siteman Cancer Center and its satellite sites
* Able to understand and willing to sign an IRB-approved written informed consent document

Exclusion Criteria:

* Unable to read and understand English
Immune Function in Offsprings of Females With Inflammatory Bowel Disease

1. To evaluate the immune response to vaccines in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of IBD mother not treated with anti-TNF medications.
2. To evaluate the immune function of B and T cells at 3 months and one year of age in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of non anti-TNF treated mothers.

The secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated with anti-TNF medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of IBD patients not treated with anti-TNF medications during pregnancy.

Significance -The results of this study have the potential to change clinical practice of anti TNF treatment during pregnancy and the follow-up of infants born to these patients

1. We aim to evaluate the immune response to vaccines in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of IBD mother not treated with anti-TNF medications.

2 WE aim to evaluate the immune function of B and T cells at 3 months and one year of age in infants of IBD patients treated with anti-TNF medications during pregnancy compared to infants of non anti-TNF treated mothers.

Our secondary aims are to follow anti TNF drug levels in infants born to IBD patients treated with anti-TNF medications during pregnancy and to evaluate the risk of infections during the first year of life in this population, compared to children of IBD patients not treated with anti-TNF medications during pregnancy.

The results of this study have the potential to change clinical practice of anti TNF treatment during pregnancy and the follow-up of infants born to these patients

Eligibility Criteria:
Inclusion Criteria:

1. Children born to mothers with IBD who were treated with ant-TNF medications, other medications or not medically treated for IBD during pregnancy .
2. Regular vaccination for hepatitis B at birth, 1 and 6 months of age and other scheduled non-live vaccines at 2,4, and 6 months of age.
3. Inform consent signed by the parents.

Exclusion Criteria:

1. Children with intrauterine or perinatal infections, congenital diseases or malformations.
2. Absence of immunization records.
3. Known immune deficiency of mother and/or child. 4. Mothers with hepatitis B
Anorectal Manometery in Pediatric Chronic Refractory Constipation

Anorectal manometry and high-resolution anorectal manometry (HRAM) are becoming the investigation of choice for understanding the pathophysiology of chronic constipation with or without fecal incontenance in children in many institutions. In high resolution anorectal manometery we are able to gain information whether the symptoms are related to sphincter dysfunction, impaired sensation, or pelvic floor dyssynergia

Primary objective: To assess different patterns of anorectal manometry in children with chronic refractory constipation with or without fecal incontinence.

Secondary objective: To determine the effectiveness of different modalities of treatment of chronic refractory constipation based on the anorectal findings. To assess the safety ,tolerability and effectiveness of lubiprostone in pediatric age group with chronic refractory constipation. To assess the effect of elimination of cow milk products in patient with chronic refractory constipation.

Eligibility Criteria:
Inclusion Criteria:

1. Children and adolescents aged from 4 to 16 years.
2. Participants fulfilling Rome IV criteria for the diagnosis of functional constipation.

   At least 2 of the following present at least once per week for at least 1 month:
   * 2 or fewer defecations in the toilet per week
   * At least 1 episode of fecal incontinence per week
   * History of retentive posturing or excessive volitional stool retention
   * History of painful or hard bowel movements
   * Presence of a large fecal mass in the rectum
   * History of large-diameter stools that may obstruct the toilet The symptoms cannot be fully explained by another medical condition (Hyams et al., 2016).
3. Participants who have chronic refractory constipation. Chronic refractory constipation (CRC) is defined as children who are unable to pass stools in spite of being on maximum laxative therapy and require daily rectal stimulation in the form of enemas or suppositories to pass stools 4-Is willing and able to keep a diary on his/her own and willing and able to complete a questionnaire.

5-The participant or, when applicable, the participant's legally acceptable representative signs and dates a written, informed consent form and any required privacy authorization prior to the initiation of any study procedures.

Exclusion Criteria:

* participants who have anorectal malformation
* participants who have neurological disease affecting lower limbs
* Has a history of hypersensitivity or allergies to lubiprostone
Promoting Adherence to Anti-Hypertensive Medications and Lifestyle Guidelines Through Mindfulness Practice

Adherence is a major problem for the approximately one-third of Americans over the age of 20 who suffer from Hypertension (HTN). Hypertension can be controlled through medication adherence and lifestyle modifications (diet and exercise). However, nearly 50% of those with HTN report poor adherence to their antihypertensive medications, lifestyle changes, or both as primary reasons for failing to control their blood pressure. Currently, behavioral interventions are limited to providing education or reminding individuals to take better care of themselves by starting and adhering to proper diet and exercise program. Given the lack of adherence reported, education and reminders alone may not be sufficient to promote health behavior change. Interventions that appeal to individual's internal drive may be more effective, given that behavior adoption and maintenance are usually associated with intrinsic motivation and volition. Mindfulness practice is an intervention that shows promise in changing lifestyle behaviors. The purpose of this study is to investigate the use of UCLA's Mindful Awareness Program (UCLAMAP) on promoting self-management behaviors, specifically adherence to medication, diet, and exercise for those individuals with HTN. We will randomize 52 individuals with HTN who have difficulty with adherence to antihypertensive medications and lifestyle changes to the intervention group or the attention-control group. The intervention includes six sessions of the mindfulness training through UCLA's Mindful Awareness Research Center (MARC).


Eligibility Criteria:
Inclusion Criteria:

* over 21 years of age
* able to understand and speak English
* self-report of having difficulty with a healthy diet and engaging in regular physical activity.

Exclusion Criteria:

* On chemotherapy for cancer treatment
* Current substance abuse disorder (i.e., drugs, alcohol).
* Current diagnoses of Post-traumatic stress disorders, severe anxiety, or severe depression.
* On hemodialysis.
* Pregnant. (Pregnant women may develop Preeclampsia, which is a pregnancy complication characterized by high blood pressure)
Experiences With a Genetic Test for Personalized Nutrition Test for Personalized Nutrition

The investigators will use a web-based survey to collect data on individual attitudes and self-reported health behaviour changes following genetic testing for personalized nutrition. Participants (n=80) are employees of a large multi-national food company's R\&D division located in Australia, Switzerland, USA and the UK. They underwent a genetic test for personalized nutrition in March 2015 that was offered at no cost through the company wellness program. A registered dietitian completed a pre-test consultation and disclosed the test results with DNA-based dietary advice. The test provided information on 7 components of diet and additional information on individual risk for gluten intolerance.


Eligibility Criteria:
Inclusion Criteria:

* Completed a genetic test for personalized nutrition through company wellness program.

Exclusion Criteria:

* None.
Effect of Pediatric Intensive Care Unit Diaries on PICS-p

When children become very sick and need to stay in a Pediatric Intensive Care Unit (PICU), it can have a big impact on their recovery and their family's well-being. Sometimes kids and their families feel worried or sad even after they leave the hospital. This can have an impact on the quality of their life after hospital discharge.

To help understand and improve these experiences, the investigators want to study the "PICU diaries." These are journals that families and hospital staff can write in during the child's time in the hospital. Parents, other visitors and healthcare professionals can share thoughts, experiences, and even drawings or photos related to the child's admission. The content is a narrative account of what happens during the child's hospital stay, for the family to take home at PICU discharge.

The investigators believe that writing in these diaries might help children and their families feel better after leaving the hospital. It might help kids feel less worried or sad, and it might also help their parents or caregivers feel better too.

The study will include children who have been in the PICU and their families. Some families will receive these special diaries to use during their time in the hospital, while others won't. We'll then see how everyone feels after they leave the hospital and compare the two groups to see if the diaries make a difference.

The investigators hope that by understanding how these diaries can help, healthcare professionals can make hospital experiences better for everyone involved.


Eligibility Criteria:
Inclusion Criteria:

* children/adolescents admitted to the PICU
* Mechanical ventilation for \> 48 hours
* Patient's age \<19 years old

Exclusion Criteria:

* parents who are unable to communicate in Italian language
* parents who have not signed and informed consent
* patients with a poor prognosis
Effect of Small Daily Doses of B-carotene on Breast Milk Retinol

The purpose of this pilot study is to determine whether breast milk retinol concentration increases in response to daily supplementation with small amounts of vitamin A (\~600 ug RAE/d), as either a b-carotene or retinyl palmitate, 6 d/week for 3 weeks. A secondary purpose is to evaluate sampling methods for collecting breast milk samples in a community setting. The results of this pilot study will allow us to determine whether milk retinol is a useful indicator for evaluating the impact of food-based interventions on the vitamin A status of lactating women.


Eligibility Criteria:
Inclusion Criteria:

* lactating women breastfeeding a single infant 4-12 months of age

Exclusion Criteria:

* chronic disease
* breastfeeding more than one infant
* severe anemia
* signs or symptoms of vitamin A deficiency
A Study to Assess the Bioequivalence of Different Formulations of Risedronate in Healthy Male and Female Subjects

Randomized, double-blind, 2-treatment, 2-period, 2-sequence, crossover study, The study will consist of a screening visit, study center admission (preceding Treatment Periods 1 and 2), 2 treatment periods (4 days each), 1 washout period (14 to 17 days separating periods 1 and 2), and exit procedures.


Eligibility Criteria:
Inclusion Criteria:

* male or female, 18 to 65 years of age
* if female, non-lactating and either surgically sterile or postmenopausal
* body mass index less than or equal to 32 kg/m2 at screening

Exclusion Criteria:

* no use of a bisphosphonate within 1 month
* no history of GI disease
* no use of any medications within 7-14 days prior to scheduled dosing day
Behavioral AI to Predict and Increase Peritoneal Dialysis Uptake

Scaled Insights Behavioral AI will be used to improve clinicians ability to detect and understand: The likelihood of patients with kidney failure opting for peritoneal dialysis and to select the right personalized nudge to get CKD patients to choose peritoneal dialysis

Scaled Insights' can utilize the data from this study to develop individualized nudges for healthcare professionals that can be broadly deployed within a digital platform so that clinics across the English speaking world can use it as a means of supporting patients with CKD in selecting peritoneal dialysis treatment.

Using Scaled Insights novel Behavioral Artificial Intelligence solution, the proposed project has two aims:

1. to identify personality attributes of patients with Chronic Kidney Disease and correlating their personality attributes with their subsequent choice of dialysis. Once correlated into personality based clusters, the AI Model will then be able will determine which personality cluster each net new patient will fall into and therefore predict their specific likelihood of opting for peritoneal dialysis or hemodialysis
2. once prediction is possible, customized nudges towards the selection of PD will be developed and tested to improve the likelihood that patients will opt for peritoneal dialysis

Hypotheses:

1. Scaled Insights Behavioral AI will identify the personality characteristics of patients with Chronic Kidney Disease who are likely to opt for both peritoneal dialysis and hemodialysis (Phase 1)
2. Scaled Insights Behavioral AI will identify the nudges that are most effective in encouraging or supporting patients with Chronic Kidney Disease in choosing peritoneal dialysis over hemodialysis (Phase 2)


Eligibility Criteria:
Inclusion Criteria:

* Phase 1: US and UK adult patients aged 18+ years, with Chronic Kidney Disease stage 4-5.
* Phase 2: US and UK adult patients aged 18+ years, with Chronic Kidney Disease stage 4-5.

Exclusion Criteria:

* Phase 1: Young people aged \&lt;18 years. People who do not have Chronic Kidney Disease. People who reside outside of the USA and UK.
* Phases 2: Young people aged \&lt;18 years. People who do not have Chronic Kidney Disease stage 4-5. People who reside outside of the USA and UK.
Trial of NovoSeven® in Haemophilia - Joint Bleeds

This trial is conducted in the United States of America (USA). This study compares the effectiveness and safety of NovoSeven® to FEIBA (FEIBA VH) in haemophilia patients with inhibitors being treated for joint bleeds.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of hemophilia A or B with inhibitors to factor VIII or IX, respectively