cyrilzakka/clinical-trials huggingface dataset:
Inflammation, Infection, and Future Cardiovascular Risk

To examine markers of underlying chronic inflammation and infection as potential risk factors for future myocardial infarction (MI), stroke (CVA), and venous thromboembolism (VTE) in plasma samples collected at baseline from healthy participants in the Physicians' Health Study (PHS).

BACKGROUND:

The PHS is a cohort which included 14,916 men initially free of cardiovascular disease and cancer who provided plasma samples at study entry in 1982. These men were randomly assigned in a factorial design to aspirin or beta-carotene therapy, and have been followed prospectively for the occurrence of vascular disease.

DESIGN NARRATIVE:

Employing a nested case-control design, baseline plasma samples are assayed for four markers of inflammation (interleukin-6, TNF-alpha, soluble ICAM, soluble VCAM) and four markers of chronic infection (antibody titers directed against Chlamydia pneumoniae, Helicobacter pylori, Herpes simplex virus, and cytomegalovirus). Case subjects are those study participants who have subsequently developed MI (N=550), CVA (N=400), or VTE (N=200). Control subjects are selected from those study participants who remained healthy during follow-up and are matched to the cases by age, smoking status, and follow-up time. Data on usual cardiovascular risk factors, lipid parameters, and hemostatic markers of risk are already available in the PHS and will be used to evaluate the results for potential confounding and effect modification. Since the PHS was a randomized trial of low-dose aspirin for its initial 5 years, this cohort also provides the unique opportunity to investigate whether the use of an agent with anti-inflammatory properties modifies the risk of subsequent thrombosis among those with underlying inflammation. Indeed, this intriguing hypothesis has recently been raised regarding data relating another marker of inflammation, C-reactive protein, to future risks of myocardial infarction and stroke.

These analyses will take advantage of an existing blood bank from a well-characterized large cohort with many years of follow-up and high quality end-point verification. Thus, this study could provide an efficient and cost-effective mechanism to evaluate the posited, but unproven roles of inflammation and infection as risk factors for future cardiovascular disease.

The study completion date listed in this record was obtained from the "End Date" entered in the Protocol Registration and Results System (PRS) record.

Eligibility Criteria:
No eligibility criteria
The Effect of Bundle Approach on Foot Care Behaviors and Diabetic Wound Healing in Patients

This study was planned to standardize foot care behaviors with a patient-participated care package approach, to ensure healing of existing wounds, and to evaluate the effect on foot care behaviors to prevent the development of new diabetic foot ulcers. The sample of the study consisted of a total of 97 patients, 49 patients in the care package group and 48 patients in the control group.

Hypotheses of the Study H1. The foot care behaviors of patients who receive a patient-participatory care package approach to diabetic foot ulcer prevention will be higher than those of patients who do not receive a care package.

H2. Patient-involved care package approach prevents the development of new diabetic foot ulcers.

H3. Patient-involved care package approach provides healing of existing diabetic ulcers.

The research was planned as a randomized controlled experimental study to standardize foot care behaviors with a care package approach consisting of evidence-based practices for patients with diabetic ulcers who applied to Başakşehir Çam and Sakura City Hospital diabetic wound outpatient clinic in Istanbul, to ensure healing of existing wounds, to prevent new diabetic foot ulcers, and to evaluate the effect on foot care behaviors. The average number of patients with diabetic foot ulcers 1-2 and 3 according to the Wagner classification is 300 people. According to the Power analysis (G\*Power 3.1.9.7), it was aimed to reach at least 95 people in total with an effect size of 0.458, 5% margin of error and 95% power.Data were collected by the researcher through face-to-face interviews with the patient. "Patient Identification Form", "Nottingham Functional Foot Care Diagnosis Form (NAFF)", "Diabetic Foot Evaluation and Follow-up Form" were used. The patient identification form consists of 17 questions as a result of literature review. The Nottingham Assessment of Functional Footcare (NAFF) was developed by Lincon et al. in 2007 and focuses on foot care behaviors. "Diabetic foot assessment and follow-up form" was created by the researcher and the depth, length and width of the wound were measured to observe whether new wounds were formed and the healing status of the wound. Spearman Correlation Test was used to analyze the measured data with each other. P-values below 0.05 were considered as statistically significant results.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years of age,
* No reading and comprehension problems,
* No psychiatric disorders,
* Wounds with Wagner 1-2 and 3 according to the Wagner classification (
* Individuals who agreed to participate in the study.

Exclusion Criteria:

* Under 18,
* Wounds other than diabetic ulcers,
* Wounds with Wagner 4 and Wagner 5 according to the Wagner classification (this wound class includes ischemic wounds),
* Below/above knee amputation in the limb other than the at-risk/injured foot,
* Psychiatric problems,
* Refuses to work or wants to leave during the work,
* Individuals with reading and comprehension problems.
A Pilot Study of Curcumin and Ginkgo for Treating Alzheimer's Disease

The purpose of this study is to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression.

A double-blind, randomized, clinical trial of 30 subjects will be carried out to develop procedures for testing the effectiveness of curcumin on slowing Alzheimer's disease (AD) progression. Curcumin is a polyphenolic molecule extracted from turmeric and is widely and safely used as a yellow food coloring. Because of its strong anti-inflammatory activity, curcumin was tested in animal models of AD, where it significantly reduced levels of brain amyloid, oxidized proteins, and isoprostanes, and prevented cognitive deficits. AD patients will receive placebo, 1 g, or 4 g of curcumin daily for six months. All patients will also receive 120 mg ginkgo leaf extract daily. At 0, 1, 3, and 6 months of the study, a cognitive test will be performed, and blood samples will be analyzed for levels of isoprostane, amyloid beta protein, metals, and cholesterol. Curcumin and its metabolites will be measured in blood at 1 month. The primary objective for this first human study of curcumin in AD is to examine safety and procedures for a possible larger trial testing curcumin against AD. The secondary objective is to determine whether curcumin affects biochemical measures, and, if so, which dose is most effective. The tertiary objective is to determine whether curcumin slows cognitive decline in AD. This study may lead to inexpensive treatment that delays progression of AD.

Eligibility Criteria:
Inclusion Criteria:

* Ethnic Chinese living in Hong Kong
* Progressive decline in memory and cognitive function for at least 6 months
* NINCDS-ADRDA diagnosis of possible or probable AD
* Mild to severe dementia with Cantonese version of MMSE scores between 0 and 28
* Informed consent from patient and/or caregiver
* Both elderly home residents and outpatients are eligible
* Patients may take any medication

Exclusion Criteria:

* Anticoagulant or antiplatelet treatment or bleeding risk factors
* Currently smoking
* Other severe, end-stage illness
Enteroadsorbent Polymethylsiloxane vs Probiotic Lactobacillus Reuteri in the Treatment of Rotaviral Gastroenteritis

This study evaluates a new drug, new enteroadsorbent polymethylsiloxane (Enterosgel) in the treatment of rotavirus gastroenteritis in children. Half of the participants received a new drug, polymethylsiloxane and half of the participants received standard treatment - probiotic L. reuteri (BioGaia).

Polymethylsiloxane and probiotic L. reuteri both hasten symptoms of the rotavirus gastroenteritis but they do so by a different mode of action.

Polymethylsiloxane is an enteroadsorbent and it possibly acts by adsorption of viruses and doing so it prevents binding rotaviruses for enterocytes. Another mode of action can be forming a thin layer over the mucosal surfaces thus protects them from various damaging factors.

Probiotics help the healing of the intestinal mucosa presumably in few ways - by normalization of gut flora, by competition with pathogen bacteria for binding sites and nutrients and by stimulation of intestinal immune system.

Eligibility Criteria:
Inclusion Criteria:

1. age 6-36 months
2. proven rotavirus gastroenteritis
3. symptom duration less than 48 hours
4. informed consent of the parents/caregivers

Exclusion Criteria:

1. rotavirus vaccination
2. rotavirus infection in a patient's history
3. severe acute or chronic illness with possible influence on rotavirus gastroenteritis outcome
Evaluate ALLN-177 in Patients With Enteric Hyperoxaluria

The purpose of this study is to determine the efficacy and safety of ALLN-177 in patients with enteric hyperoxaluria.

This is a phase 3, multicenter, randomized, double-blind, placebo-controlled study. This study is designed to determine whether treatment with ALLN-177 for 28 days can reduce urinary oxalate excretion in patients with enteric hyperoxaluria and to evaluate the safety of ALLN-177 in this patient population compared to placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Provided informed consent
2. Age 18 or older
3. History of hyperoxaluria secondary to a known underlying enteric disorder associated with malabsorption (e.g., bariatric surgery, Crohn's disease, short bowel syndrome, or other malabsorption syndrome)
4. Urinary Oxalate ≥ 50mg/24h

Exclusion Criteria:

1. Acute renal failure or estimated glomerular filtration rate (eGFR) \< 30mL/min/1.73 m2
2. Unable or unwilling to discontinue Vitamin C supplementation
Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa

Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa

Tranexamic Acid Use in Elective Cesarean Section for Women With Placenta Previa to detect efficacy of Tranexamic acid in decreasing blood loss

Eligibility Criteria:
Inclusion Criteria:

* Term pregnancy (more than 37 weeks of gestation)
* Diagnosis of placenta previa was confirmed by ultrasound
* The patient hemoglobin percentage is more than 10 mg/dl

Exclusion Criteria:

* Invading placenta previa diagnosis was confirmed by Doppler ultrasound studies
* Emergency lower segment cesarean section
* Associated medical comorbidities
Recanalization of Congenital Nasolacrimal Duct Obstruction by Endodiathermy Probe and Intubation Versus Intubation Only

The purpose of the current work is to assess the efficiency and success rate of endodiathermy probe followed by intubation in children more than 2 years compared to the success rate of intubation (as a standard method) which varies from 75% to 85% in several studies

The study will be conducted on children above 2 year and will be divided randomly into two groups:

Group (I): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with metal probe and then intubation with bicanlicular silicon tube.

Group (II): 80 eyes of children suffer from congenital nasolacrimal duct obstruction will have probing with endodiathermy probe and then intubation with bicanlicular silicon tube

Eligibility Criteria:
Inclusion Criteria:

1. Children in the age group above 2 years old
2. No history of previous probing.
3. No history of previous intubation.
4. Children with no any other association or congenital anomalies cause watery eye.
5. children suffer from congenital nasolacrimal duct obstruction.

Exclusion Criteria:

1. children less than 2 years old.
2. previous probing.
3. previous intubation.
4. children with any other congenital anomalies as congenital ectropion , congenital entropion
5. children suffer from any upper lacrimal anomalies as obstruction or stenosis.
Nova Cold Hands Raynaud's Disorder, a Disease Which Results in Decreased Blood Flow to the Hands and Feet.

Patients presenting to UIC rheumatology clinic with Raynaud's disorder and scleroderma will be asked to participate. 10 hands of patients with both Raynaud's disorder and scleroderma will be studied. This research study is being done to better understand Raynaud's disease and to assess the role of blood flow measurement in diagnosing the disorder, specifically, through data collected by an MRI procedure called NOVA FLOW. NOVA is a blood flow measurement software system owned by the study's sponsor, VasSol, Inc.

The investigators propose to obtain volumetric flow data on 10 hands of patients with Raynaud's disorder and scleroderma at UIC rheumatology clinic and compare these results with previously established volumetric flow data for non-Raynaud's patients. Through this analysis, the invstigators will be able to better understand and correlate subjective and objective measures of both disease presentation and progression. Collection of cross sectional data will allow us to better address the following questions Is it possible to more precisely diagnose patients with Raynaud's disorder based on NOVA analysis as well as clinical findings

Is it possible to stratify patients with Raynaud's disorder into categories which may allow:

i. Prediction of disease course and prognosis ii. Prediction of response to specific treatment modalities (vasodilators vs anti-coagulation vs surgical or chemical denervation) The investigators propose to collect measurements of disease severity as well as functional assessment of patients Raynaud's and scleroderma in order to address the following questions c. Does NOVA flow and volume data correlate with measures of Raynaud's and scleroderma disease severity index d. Does NOVA flow and volume data correlate with OT assessment of hand functionality.

Eligibility Criteria:
Inclusion Criteria:

* Inclusionary criteria for this study will be patients with a diagnosis of Raynaud's disease and scleroderma (per ACR criteria for the diagnosis for systemic sclerosis) and age between 18-85.

Exclusion Criteria:

* Exclusion criteria for Raynaud's patients will include history of botox injection to the hands within 6 months, non-English speaking patients and those unable to understand informed consent, and the presence of confounding medical conditions preventing the patient from full participation.
SPHERE Hypertension Baseline Data Study

We are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an EMT.

We are collecting baseline data on patients who have high blood pressure readings (160/100 or higher) at a 9-1-1 response by an EMT. We want to understand what these patients currently remember occurring during the 9-1-1 response around their high blood pressure measure; if the patients seek a second reading; if the patients seek follow-up care as a result of the high blood pressure measure. We are also interested if patients trust EMTs as a provider of preventive health care. This baseline data will also allow us to more accurately measure the success of a future intervention study aimed at motivating subjects to receive a follow-up hypertension assessment from a physician after receiving a high blood pressure reading from an EMT.

Eligibility Criteria:
Inclusion Criteria:

* Systolic blood pressure greater than or equal to 160 and/or diastolic blood pressure greater than or equal to 100
* Patient is at least 18 years old
* Patient was not transported by paramedics
* Patient was not admitted to a hospital
* Patient is not a nursing home/adult family home resident
* Patient's phone number is listed in the MIRF database

Exclusion Criteria:

* not meeting inclusion criteria
CCCR Lupus Patient Navigator Program

To address the health disparities in SLE outcomes for minorities, targeted intervention will be used to address the common barriers to care among patients; a comprehensive patient navigator approach will be utilized based on evidence from prior studies is the purpose of this research. The navigator services most commonly provided include facilitation and coordination of care, practical support, including scheduling transportation and referrals to financial assistance programs, appointment scheduling and reminders, education and psycho-social support. The most effective patient navigators address both health system and patient barriers.


Eligibility Criteria:
Inclusion Criteria:

1. Self-identified Minority.
2. Patients ≥ 18 years of age as documented in the electronic medical record.
3. Meeting either American College of Rheumatology or SLICC Classification Criteria for SLE as documented in the electronic medical record.
4. Ability to speak and understand English by self-report.
5. In the past six months having ≥ 1 missed clinic or diagnostic study/laboratory visit as documented in the electronic medical record, or self-reported failure to adhere with prescribed medical therapy for SLE.
6. In the past six months having been prescribed at least one immunosuppressive medication for SLE activity as documented in the electronic medical record regardless of whether taking the medication.
7. Currently enrolled into the Core Center for Clinical Research (CCCR; Pro 00021985) with properly executed Informed Consent Document and HIPAA Authorization.
8. Have telephone access.

Exclusion Criteria:

1. Unwilling or unable to give informed consent.
2. Being a prisoner or institutionalized individual.
3. Without telephone access.
4. Do not meet all of the inclusion criteria listed above.
Book Sharing for Toddlers with Clefts

Children with clefts exhibit difficulty with language and literacy compared to children without clefts. However, little is known about interventions to address these difficulties in the cleft population. This study will test the efficacy of a parent-focused dialogic book-sharing intervention for toddlers with isolated cleft palate. The study will use a randomized controlled trial (RCT) design and Intention to Treat (ITT) analyses. Child outcomes include expressive and receptive language. Parent outcomes of interest include the frequency and quality of shared reading interactions. To assess mechanisms of action, the study will test whether changes in child outcomes are mediated by changes in parents' behavior. Analyses will also explore heterogeneity in outcomes to determine whether the intervention is more effective in certain clinical or demographic sub-groups.


Eligibility Criteria:
Inclusion Criteria:

* A child's parent or primary caregiver provides a signed and dated informed consent form and permission for their child to participate.
* A child's parent is willing to comply with all study procedures and be available for the duration of the study.
* Child is between the ages of 24 to 32 months at the time of enrollment.
* Child has been diagnosed with isolated cleft palate, with or without cleft lip.
* Child has received palate repair surgery.
* The family's preferred language is English or Spanish.
* The family has access to a smartphone or similar device (e.g., tablets) capable of recording and sending videos.

Exclusion Criteria:

* Diagnosed genetic condition associated with developmental delay (e.g., 22q11 deletion).
* The child has a diagnosis of autism spectrum disorder
* The child has a tracheostomy tube
* Child delivered \< 32 weeks' gestation.
* Child in state custody or foster care.
* Child with significant sensory impairment (blindness, sensorineural hearing loss).
* The caregiver speaks a language other than English or Spanish
* The caregiver does not own a smartphone or similar device capable of recording/sending video
Metabolic Factors of Outcomes From Gastric Bypass Surgery

The objective of this study is to determine whether the metabolic, endocrine and energetic response to short term caloric restriction are factors in weight loss in subjects having gastric bypass (GB) surgery.


Eligibility Criteria:
Inclusion Criteria:

Subjects satisfying the following criteria will be considered the screening population and will be eligible for enrollment in this study:

1. Subject is willing to give consent and comply with evaluation and treatment schedule
2. 18 to 65 years of age (inclusive) on date of signing the ICD
3. Subject is scheduled to have non-revisional GB surgery between 2 weeks to 4 months after signing the ICD
4. Able to read, understand, and follow study procedures as outlined in the ICD.

Exclusion Criteria:

Subjects meeting the following criteria will not be eligible for enrollment:

1. Unable or unwilling to attend follow-up visits and examinations
2. Women who are pregnant, nursing at the time of screening, or planning to become pregnant within one year of the GB surgery
3. Clinically active cardiac, renal, hepatic or GI disorders
4. Screening laboratory tests with any of the following:

   * alanine aminotransferase \[ALT\] and/or aspartate aminotransferase \[AST\] ≥ 4 times upper limit of normal (ULN) according to VAMC normal ranges
   * AST:ALT \> 2:1 according to VAMC normal ranges
   * Serum Creatinine ≥ 1.5 times ULN according to VAMC normal ranges
   * Blood Urea Nitrogen (BUN) ≥ 1.5 times ULN according to VAMC normal ranges
   * Positive test results for Hepatitis A, B or C
5. Clinically active thyroid or lipid disorders:

   * Thyroid-stimulating hormone (TSH) flagged as critical value (per VAMC lab normal ranges)
   * Triglycerides \> 400 mg/dL
6. Anemia:

   * Mean corpuscular volume (MCV), mean corpuscular hemoglobin (MCH), and mean corpuscular hemoglobin concentration (MCHC) outside normal VAMC range; or
   * Hematocrit \< 36%
7. Uncontrolled hypertension which required a medication regimen adjustment during the 3 months prior to screening
8. Currently prescribed or taking atypical antipsychotic medication
9. Currently prescribed or taking chronic, long-term, oral corticosteroid medication
10. Diabetes requiring a drug regimen which includes insulin treatment at the time of screening
11. Unwilling or unable to refrain from having a procedure or surgery which involves the removal of skin tissue which could result in weight loss
12. Any medical condition or finding for which the PI used medical discretion to determine the subject should be excluded; or
13. Participation in any other investigational device or drug study (non survey based trial) during the course of the trial.
Comparison of Soft Toothbrush and Brushless Cleaner in Their Ability to Remove Plaque From Teeth

The aim of this study is to observe whether a brushless cleaning device can be equally as effective in removing plaque from the teeth as a soft toothbrush. The goal is to give people an alternative to bristle brush cleaning if they find they are brushing too hard. The hypothesis is that it is possible to maintain healthy teeth and gingiva by using brushless methods in conjunction with flossing.


Eligibility Criteria:
Inclusion Criteria:

* 18 yrs of age
* healthy gingiva

Exclusion Criteria:

* less than 18 yrs old
* patients with braces
* decisionally impaired