cyrilzakka/clinical-trials huggingface dataset:
How Reflux Medications Affect the Microbiome of Infants

The changes in the organisms making up the gut microbiota in infants who are taking anti-acid reflux medications (histamine 2 receptor antagonists) as compared to infants who are not taking these medications is not well-studied or understood. Whether these medications change the gut microbiota and microbiome, and what that change may imply for children on these medications, is the focus of this study.

Gut microbiota dysbiosis is associated with diseases ranging from localized gastrointestinal disorders to neurologic, respiratory, metabolic, hepatic, and cardiovascular illnesses. The microbial colonization of the infant gut is known to play a key role in immunologic and metabolic pathways impacting on human health. Disruptions during the complex process of microbial colonization have been shown to increase disease susceptibility during life. A variety of factors are known to influence the gut microbiota, including mode of delivery of neonate, host genetic factors, hose immune response, diet, xenobiotics and other drugs, infections, and environmental microbial exposures.

The diagnosis of gastroesophageal reflux disease in the infant population has increased during the past two decades. Acid suppression medications are used commonly in infants for gastroesophageal reflux disease and other acid-related conditions despite little evidence of their efficacy. Multiple studies have shown adverse effects in pediatric patients using either proton pump inhibitors or H2 receptor antagonists, the two classes of acid suppression medications that are most frequently used in children. Some of these adverse effects may result from alterations in the microbiome caused by these medications. Prior studies have demonstrated significant changes in microbial composition of both gastric and intestinal microbiota with proton pump inhibitor use (5), but to the investigators' knowledge, no prior studies have looked at the effect of H2 receptor antagonists on the microbiome in healthy, full term infants.

Eligibility Criteria:
Inclusion Criteria:

* Full term, at least 2 months of age
* No exposure OR at least 14 days of exposure to H2-receptor antagonist medication
* No exposure to probiotics or antibiotics

Exclusion Criteria:

* Current or recent (within the past 14 days) gastrointestinal infection (viral, bacterial, or fungal)
* Gastrointestinal mucosal disease, or have clinically significant constipation
* Any history of exposure to proton pump inhibitors
* Unvaccinated infants
* Infants with weight-for-length either below the 3rd percentile for age or above the 97th percentile for age
* Infants with rapid weight gain, defined as change in weight-for-length z-score exceeding +0.67 from birth to 4 months of age or birth to 6 months of age
Analysis of Neuromuscular, Circulatory and Biomechanical Responses After Cryotherapy

Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow.

Cryotherapy is a resource applied thermal rehabilitation in order to reduce skin temperature and muscle as well as nerve conduction velocity, and promotes vasoconstriction of arteries and veins resulting in decreased blood flow. Thus, this study aims to evaluate neuromuscular and biomechanical assess hemodynamic and autonomic cardiovascular, and investigate the occurrence of changes in conduction velocity due to the superficial blood cryotherapy by immersion of the forearm. The study will be conducted in 40 volunteers, female, between 18 and 30 years, university, healthy. They will be divided into two groups of 20 volunteers, the group immersion cryotherapy (GI) and control group (CG). For immersion cryotherapy group (GI), individuals will be the right arm to the elbow immersed in a container of water at 6°C ± 2°C for 15 minutes. In the control group (CG), volunteers will remain at rest with the right arm in the same position within a vessel containing water at a temperature indifferent for the same period of 15 minutes. The temperature analysis is performed using a infrared thermographer, muscular strength and synergism will be evaluated by a load cell connected to the electromyograph to examine muscle activation of wrist flexors and extensors, serratus anterior, upper and middle trapezius. The records beat to beat blood pressure and heart rate for cardiovascular autonomic and hemodynamic evaluation will be carried out by means of equipment and Finometer electrocardiogram, respectively, before and after application of cryotherapy. In turn, the data of blood flow velocity will be collected by means of Doppler Ultrasound. The results will be processed and analyzed using descriptive statistics, submitted to a linear regression model with mixed effects (fixed and random effects), with p≤0.05.

Eligibility Criteria:
Inclusion Criteria:

* healthy individuals, age range: 18 - 30 years old

Exclusion Criteria:

* not present: previous circulatory, nervous or metabolic diseases, metal implants in areas to be studied; fracture on upper limb studied; history of pain or injury in the joints studied
* are not in menstrual period or a week before it
* not be making use of antipyretic drugs
Is a Smartphone Application Effective as an Oral Medication Adherence Aid

This research will act as a pilot study that will be conducted to determine the effectiveness of a smartphone medication adherence application on adherence to oral hypertensive, diabetic, and dyslipidemic medications using a prospective randomized design. Subjects will be recruited from the University of Arkansas for Medical Sciences (UAMS) Internal Medicine Clinic North, and the study data will be collected using only subject self-reports and subject pharmacy records.


Eligibility Criteria:
Inclusion Criteria:

* Males and females at least 18 years of age
* Provide informed consent
* Prescribed an oral medication indicated for hypertension, diabetes, or dyslipidemia during 12 weeks pre-enrollment
* Own a smartphone (Android or iOS) with unlimited text messaging, email access, and app store access
* Oral confirmation that the subject has not previously used a medication adherence app
* Able to consult with a pharmacy or medical student during the recruitment process for purposes of consent, data collection, and/or medication reconciliation, and/or MyMedSchedule registration

Exclusion Criteria:

* Severely impaired vision
* Reside in a nursing home
* Non-ambulatory/bedridden
* Not fluent in English
A Trial to Test an Acceptance-based Therapy Program Among Adolescent Girls With Overweight/Obesity

The purpose of this study is to investigate the effects of an acceptance-based therapy weight loss intervention compared with enhanced care for adolescents.

Participants will complete baseline assessments and adolescents will be randomized to either an ABT weight loss intervention or enhanced care.

The intervention will include 15 sessions over 6 months. Enhanced care will include 15 healthy lifestyle handouts over 6 months.

Post-treatment assessments will occur.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent between ages 14-19 with overweight or obesity at or above the 85th percentile for sex and age as determined by CDC growth charts

Exclusion Criteria:

* Known pregnancy or plans to become pregnant in the next 2 years
* Plans to move out of the area in the next year
* Autism, any intellectual disability (e.g., down syndrome)
* Any condition prohibiting physical activity
* A diagnosis of cardiovascular disease or diabetes
* Have active cancer or cancer requiring treatment in the past 2 years
* Have active or chronic infections (e.g., HIV or TB)
* Have active kidney disease or lung disease
* An eating disorder or substance abuse disorder
* Having recently begun a course of or changed the dosage of any medications known to affect appetite or body composition
* Weight loss greater than or equal to 5% in the previous 6 months
* If they do not follow the study plan
Bone Augmentation Techniques in Extraction Sockets

The study will compare the density and strength of regenerated bone in extraction sockets after being grafted with two different materials: Bone Allograft and Bone Allograft with Amnion.

The investigators hypothesize that sockets grafted with the Amnion graft will exhibit enhanced healing patterns and will accelerate the formation of regenerated bone in the grafted areas.

The amniotic allograft is a cryopreserved allograft tissue matrix derived from human placental tissues recovered from live healthy donors. Amniotic tissue is an abundant source of collagen which provides an extracellular matrix to act as a natural scaffold for cellular attachment in the body; collagen provides a structural tissue matrix that facilitates cellular migration and proliferation in-vivo. The product is developed using proprietory techniques by BioDlogics, LLC. The amniotic allograft growth factors are thought to enhance formation of a supportive scaffold for regeneration, to facilitate interactions between cell types, and to influence anti-inflammatory, anti-microbial and immuno-privilege activities.

Atraumatic extractions and socket grafts will be performed. Dental implants will be inserted into the grafted areas 8 weeks post-graft. The implants will be restored and followed for 24 months post-insertion.

Eligibility Criteria:
Inclusion Criteria:

1. Be a registered University of Alabama at Birmingham (UAB) dental school patient
2. Existence of one or more non-adjacent teeth in the aesthetic zone that are scheduled for extraction
3. Healthy enough to undergo the proposed therapy
4. Demonstrated willingness to comply with study directions and time-line
5. Able to consent for themselves
6. Able to read and understand the informed consent form -

Exclusion Criteria:

1. Pregnant or lactating at the time of enrollment
2. Previous Malignant neoplasm
3. Known hypersensitivity to bone grafting materials
4. Know hypersensitivity to titanium
5. Any medical of medication that in the opinion of the investigators may adversely affect bone healing
6. Any indication of an inability to make autonomous decisions -
Effects of Vitamin D on Renin Expression in Hypertensive Patients

The cardiovascular effects of vitamin D therapy (in humans) have been documented only in patients with known vitamin D deficiency or hyperparathyroidism (a surrogate marker of inadequate vitamin D activity). It is unknown whether the cardiovascular benefits of vitamin D therapy extend beyond these patients to the general hypertensive population. We propose to directly measure the effect of vitamin D therapy on plasma renin activity (PRA), plasma renin concentration (PRC), renin transcription (in mononuclear leukocytes), and blood pressure in hypertensive (but otherwise healthy) patients in a randomized, controlled, experimental trial. This will be the first study to assess vitamin D receptor (VDR) biological (PRA, PRC, renin mRNA, and polymorphisms) and hypertensive activity in patients without vitamin D deficiency. We hypothesize that vitamin D inhibition of renin transcription will produce significant reductions in PRA, PRC, renin transcription, inflammatory cytokines, SBP, and DBP, with potential variation by VDR genotype. Such a result may prove to be significant in the treatment of hypertension, as even modest blood pressure reductions (5 mmHg) are associated with a 14% reduction in mortality due to stroke, a 9% reduction in mortality due to CHD, and a 7% overall reduction in all-cause mortality.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients age \> 55 years.
2. Female patients must be postmenopausal, as determined by surgical hysterectomy or 12 month history since last active menstruation
3. Stage I hypertension (JNC VII Criteria): mean systolic blood pressure (mSBP) 140-159 mmHg and mean diastolic blood pressure 90 - 99 mmHg (mDBP)2
4. Provide informed consent

Exclusion Criteria:

1. Serum vitamin D \<55 pmol/L
2. Serum calcium \>10.5 mg/dL
3. Serum phosphate (inorganic) \>5.5 mg/dL
4. Serum parathyroid hormone (PTH) \>1.3 pmol/L
5. Vitamin D supplements, calcium supplements, estrogen replacement therapy, corticosteroids (inhaled/oral), or hydroxymethyl glutarate CoA reductase inhibitors (statins) within 30 days prior to randomization
6. Stage II hypertension (JNC VII criteria): mSSBP \>160 mmHg or mSDBP \>100 mmHg
7. Use of alpha2-agonists, beta-blockers, or more than 2 anti-hypertensive medications at screening
8. Estimated creatinine clearance \<30 mL/min by Crockroft-Gault Formula
9. History of heart failure (HF), acute myocardial infarction (AMI), acute coronary syndrome (ACS), transient ischemic attack (TIA), cerebrovascular accident (CVA), peripheral vascular disease (PVD), or known clotting disorder
10. Insulin dependent diabetes mellitus (patients stabilized on oral regimens may be enrolled)
11. History of hypersensitivity reaction to 1α, 25-(OH)2 vitamin D3 (calcitriol)
Implications of Covid-19 on the Lifestyle Changes

Northern Italy has been profoundly touched by the Covid-19 pandemic. To limit the outbreaks of contagion, the Italian government imposed 2.months of complete lock-down, which imposed the social isolation for the whole population and, for those positive to the Covid-19, the complete confinement at home. Despite the recommendations for conserving healthy lifestyle of the Italian Government, during the lock-down the likelihood to fall into unhealthy behaviours might have increased.

This study aims to describe the impact of Covid-19 on the lifestyles of a population of Italian adults living in an area of high spread of Sars-CoV-2.

The aims of this study were to detect the changes in lifestyles occurred during the imposed lock-down phase and the support services used the most by participants.

This study consists in the administration of an on-line survey addressed to adult individuals living in the province of Reggio Emilia (Italy). The survey was posted on-line on the website of the Azienda USL- IRCCS di Reggio Emilia and it was spread to the community through apps and social networks.

The on-line survey is free to access, self-administered and it consists of 50 questions. The questions investigates the changes occurred in employment status, physical exercise, diet, tobacco and alcohol consumption, sleep quality and leisure activities during the pandemic lock-down phase as well as the available local support services used and perceived as useful.

Eligibility Criteria:
Inclusion Criteria:

* adult individuals living in the province of Reggio Emilia (Italy)

Exclusion Criteria:

-
Patients Derived Organoids in Ovarian Cancer

Among cancer models, patients derived organoids (PDOs) best reproduce tumor's tissue architecture, intratumor heterogeneity and are able to mimic in vivo patients' drugs response.

For these reasons, it has been designed a study to assess the feasibility of PDOs immune cells co-culture in OC patients and the concordance between ex vivo sensitivity and in vivo treatment response. If proven effective and reliable, PDOs could be introduced into clinical practice as empirical predictor of patients' response to antineoplastic drugs.


Eligibility Criteria:
Inclusion Criteria:

1. Preoperative clinical, serological and radiologic suspicion of International Federation of Gynecology and Obstetrics (FIGO) stage IIIC or greater ovarian, fallopian tube, or primary peritoneal cancer;
2. Histologic diagnoses of epithelial ovarian cancer at frozen section
3. Age \>18 and years;
4. Estimated life expectancy of at least 4 weeks;
5. Performance status (PS) according to Eastern Cooperative Oncology Group (ECOG) \< 2

Exclusion Criteria:

1. Non-serous histology at frozen section;
2. Patients with a diagnosis of immunodeficiency or is receiving chronic systemic steroid therapy (\> 10 mg equivalent prednisone/daily) or any other form of immunosuppressive therapy within 7 days prior to the enrollment.
Physical Excercise Program in Children With Drug-resistant Epilepsy

Pediatric epilepsy has been described as an age related-condition, and it has a strong impact on childhood quality of life. Psychological symptoms and self-esteem impairment are common facts. Although there are some studies studying the benefits of physical exercise in order to improve seizure control in adults with epilepsy, we have not found studies that support it in pediatric population. Few studieshave reported in childhood some benefits in terms of quality of life, self-esteem and improvement of neuropsychological symptoms. Therefore, it is necessary to use a validated and applicable scale of quality of life in children with epilepsy. Otherwise, findings may be difficult to reproduce


Eligibility Criteria:
Inclusion Criteria:

1. Age 5-14 years
2. Diagnosis of epilepsy (must meet at least one of the following criteria):

   1. At least 2 unprovoked seizures in a period of more than 24 hours
   2. A seizure and probability of future seizures similar to the general risk of recurrence (60% or more) than if the patient had had 2 crises.
   3. Diagnosis of epileptic syndrome.
3. Adequate communication skills with your family.
4. Absence of significant motor limitation.
5. Parents or legal guardians must have given consent to participate in the study.

Exclusion Criteria:

b) Exclusion criteria:

1. Failure to meet any of the aforementioned requirements.
2. Failure to complete completely and/or legibly any of the instruments of evaluation. c) Abandonment criteria

1. Failure to deliver the submitted questionnaires in a timely manner. 2. Failure to attend the scheduled appointment to complete the questionnaires control. 3. Not responding to phone calls, e-mails or requests made to make a new appointment.
Dipyridamole Assessment for Flare Reduction in Systemic Lupus Erythematosus (SLE)

Dipyridamole, a medication extensively used in combination with aspirin for stroke prevention, is a promising new treatment for lupus. Dipyridamole has been shown to inhibit certain lymphocyte populations that are over-reactive in lupus and to delay the emergence of lupus-related pathology in mice with lupus. The investigators are interested in investigating the efficacy of dipyridamole in preventing flares in patients with lupus and its impact on biomarkers of disease activity.

T cells in systemic lupus erythematosus (SLE) express an abnormal phenotype characterized by increased effector functions and deficient regulatory responses. Dipyridamole, a phosphodiesterase inhibitor extensively used in combination with low dose aspirin in secondary stroke prevention, has been proposed as a specific T cell directed treatment for SLE. Dipyridamole inhibits the calcium/calcineurin/NF-AT pathway in SLE T cells in vitro and abrogates expression of cytokines and costimulatory molecules, eventually also affecting B cell responses. Dipyridamole delays the emergence of lupus related pathology in lupus prone mice, but has not yet been studied in humans with SLE. The investigators aim to investigate the efficacy of dipyridamole in the prevention of flares in SLE patients after withdrawal of background immunosuppressive medications. The investigators will additionally evaluate the safety and tolerability of dipyridamole and its impact on quality of life measures in this population. Furthermore, the effect of dipyridamole on T and B cell biomarkers will be examined.

Eligibility Criteria:
Inclusion Criteria:

* Patients with SLE meeting the 1997 ACR Classification Criteria
* Evidence of positive ANA or anti-dsDNA within one year of screening
* SLEDAI ≥4 or ≥1 BILAG A or B at screening, despite standard of care

Exclusion Criteria:

* Leukopenia (WBC \<2.000/mm3) or lymphopenia (lymphocytes \< 300/mm3)
* AST or ALT \>3 times above normal cut off values
* Acute lupus nephritis defined as class II, IV or V nephritis diagnosed within 6 months or prot/creat \> 1.5 gm/gm due to active lupus or in process of receiving induction therapy for nephritis
* Active CNS lupus affecting mental status
* Pregnancy or breast feeding
* Current requirement for anticoagulation
* Contraindication to aspirin or dipyridamole, including history of recent or severe GI bleeding, hemoglobin \<9 mg/dL, platelet count of \<30,000 /mm3 or unstable platelet count
* Any other medical condition, whether or not related to lupus which, in the opinion of the investigator would render the patient inappropriate or too unstable to complete the study protocol
* Inability or unwillingness to understand and/or sign informed consent
Prevention Trial to Achieve Cardiovascular Targets

The objective of IMPACT (Investigation of Motivational Interviewing and Prevention Consults to Achieve Cardiovascular Targets) is to determine the best management strategy for patients undergoing cardiovascular intervention. IMPACT is a prospective randomized trial that will enroll 400 patients post-cardiovascular intervention. The study will compare different cardiovascular prevention strategies: (1) usual care, (2) cardiovascular prevention consult, and (3) cardiovascular prevention consult with a behavioral intervention program over a 6-month period. The trial hypothesis is that for patients undergoing a cardiovascular intervention, a prevention consult and behavioral intervention is superior to usual care in reducing cardiovascular risk. The primary endpoint will be non-HDL cholesterol. Secondary endpoints include other lipid values, metabolic risk, smoking cessation, physical activity, nutritional status, medication adherence and quality of life. IMPACT is scheduled to begin enrollment in the June of 2012.

SPECIFIC AIMS

Primary aim:

The primary aim is that a targeted Cardiovascular Prevention consult will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.

Secondary aim:

The secondary aim is that a targeted Cardiovascular Prevention consult plus a behavioral intervention will reduce non-HDL cholesterol compared to usual care at 6 months post-intervention.

Eligibility Criteria:
Inclusion Criteria:

* at least 21 years of age or older
* Subjects scheduled to undergo a percutaneous coronary or peripheral vascular intervention
* Patients must have the ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Life expectancy less than 1-year
* Inability to walk
Assessment of Serum Levels of Vitamin D, Vitamin B12 and Folic Acid Among Patients With Lifelong Premature Ejaculation and Non-responding to Dapoxetine Treatment.

Therefore, this study will aim to assess serum levels of vitamin D, vitamin B12 and folic acid among patients with lifelong PE and non-responding to dapoxetine treatment.

We will consider the patients with LPE non-responding to dapoxetine treatment when they used the optimum dose (30 and 60mg) dapoxetine for 4 separate times with no response.

Serum vitamin D, vitamin B12, and folic acid levels will be assessed in all subjects included in the study. Venous blood samples will be drawn and kept into EDTA bottles in the morning between 8 and 10 a.m. after an overnight fast of about 10-14 hr.

Eligibility Criteria:
Inclusion Criteria:

* premature ejaculation
* non-responding to dapoxetine treatment.

Exclusion Criteria:

* diabetes mellitus,
* chronic prostatitis,
* Advanced renal or hepatic diseases
* neurological diseases and
* C.N.S. medications