cyrilzakka/clinical-trials huggingface dataset:
Inflammation, Autonomic Dysfunction and Airway Disease

To determine whether airway inflammation secondary to inhalation of specific allergens and other environmental agents and functional imbalance of the autonomic nervous system played important roles in asthma and chronic bronchitis.

BACKGROUND:

Asthma and chronic bronchitis are among the most common chronic diseases afflicting middle-aged and elderly adults in the United States, respectively occurring in 4 percent and 5 percent of the population in these age groups. While chronic bronchitis is often caused by cigarette smoking and asthma often occurs in nonsmokers in association with atopy, the two conditions may be difficult to differentiate in many middle-aged and older adults and may share a number of pathophysiologic features including increased airway smooth muscle tone, increased airway responsiveness to bronchoconstricting stimuli, and bronchial mucus hypersecretion. The precise mechanisms which produce the alterations of airway function are not clear. Such functional alterations may be caused by airway inflammation and abnormalities of the autonomic nervous system; however, there are little population data available regarding the importance of airway inflammation and disordered neural regulation in the pathogenesis of airway hyperresponsiveness and mucus hypersecretion. Also, little is known about potential interactions between airway inflammation and disordered neural regulation of airway function in the pathogenesis of chronic airways disease. Information on the relationships may offer insights into the pathophysiologic mechanisms underlying asthma and chronic bronchitis in adults.

DESIGN NARRATIVE:

The study was cross-sectional and used a subgroup of the Normative Aging Study, a longitudinal study of aging in men established by the Veterans Administration in 1963. The study used data normally collected during NAS examinations and included smoking history, socio-economic status, anthropometry, respiratory symptoms and illnesses, and pulmonary function. New data were collected on: indices of inflammation as indicated by histamine, leukotriene, and serotonin in urine; autonomic activity as indicated by urinary catecholamine excretion and heart rate variation induced by deep breathing; autonomic responsiveness as measured by pupillary alpha-adrenergic and cholinergic responses.

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
Acupuncture for Prevention of Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

The purpose is to find out if intraoperative acupuncture performed by needling PC 6 and LI4 point bilaterally, and Yin Tang point will help reduce the incidence postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when added to a prophylactic regimen consisting of ondansetron and dexamethasone. The hypothesis is that the addition of this acupuncture treatment to ondansetron and dexamethasone given for prophylaxis will help reduce the incidence of postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy when compared to patients receiving ondansetron and dexamethasone without acupuncture.


Eligibility Criteria:
Inclusion Criteria:

1. Patient ages 18-64
2. American Society of Anesthesiology Physical Status I, II or III
3. Patients scheduled to undergo laparoscopic cholecystectomy at Harris Health System Ben Taub Hospital

Exclusion Criteria:

1. Scheduled open cholecystectomy - excluded due to increased levels of pain in open procedures
2. Renal dysfunction (Serum Cr \> 1.2) - excluded due to potential altered metabolism of anesthetic and perioperative medications
3. Allergy to any of the standard anesthetic agents
4. Patient inability to properly communicate with investigators (language barrier, dementia, delirium, psychiatric disorder)
5. Patient or surgeon refusal
Preventing Cardiac Complication of COVID-19 Disease With Early Acute Coronary Syndrome Therapy: A Randomised Controlled Trial.

The outbreak of a novel coronavirus (SARS-CoV-2) and associated COVID-19 disease in late December 2019 has led to a global pandemic. At the time of writing, there have been 150 000 confirmed cases and 3500 deaths. Apart from the morbidity and mortality directly related to COVID-19 cases, society has had to also cope with complex political and economic repercussions of this disease.

At present, and despite pressing need for therapeutic intervention, management of patients with COVID-19 is entirely supportive. Despite the majority of patients experiencing a mild respiratory illness a subgroup, and in particular those with pre-existing cardiovascular disease, will experience severe illness that requires invasive cardiorespiratory support in the intensive care unit.

Furthermore, the severity of COVID-19 disease (as well as the likelihood of progressing to severe disease) appears to be in part driven by direct injury to the cardiovascular system. Analysis of data from two recent studies confirms a significantly higher likelihood of acute cardiac injury in patients who have to be admitted to intensive care for the management of COVID-19 disease.

The exact type of acute of cardiac injury that COVID-19 patients suffer remains unclear. There is however mounting evidence that heart attack like events are responsible. Tests ordinarily performed to definitely assess for heart attacks will not be possible in very sick COVID-19 patients. Randomising patients to cardioprotective medicines will help us understand the role of the cardiovascular system in COVID-19 disease. It will also help us determine if there is more we can do to treat these patients.


Eligibility Criteria:
Inclusion Criteria:

1. Confirmed COVID-19 infection
2. Age =/\>40 or diabetes or known coronary disease or hypertension
3. Requires hospital admission for further clinical management.

Exclusion Criteria:

1. Clear evidence of an acute coronary syndrome or myo-pericarditis that requires specific treatment that precludes randomization.
2. Evidence of active bleeding
3. Pregnancy.
4. Age \<18 years
Prospective Radiomics Study for Breast Cancer

The goal of this prospective study is to develop MRI-based models representing tumor microenvironment in participants with invasive breast cancer.

The main purpose of this study is to analyze the association of diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images of 3T MRI before treatment with the immunohistochemical reactivity of tumor microenvironment including the extracellular matrix and immune cells of core-needle biopsy specimens For this purpose, investigators extract 16145 radiomic features from the intratumoral and peritumoral regions on MRI of participants with invasive breast cancer before treatment.

The written informed consents for the participation into this prospective study is done in participants who are diagnosed with invasive breast cancer before surgery with curative intent. After enrollment, breast MRI is done for particpants and diffusion-, T2-, and dynamic contrast-enhanced T1-weighted images are extracted from the results of MRI of participants. The tumor tissue samples are archived from participants before surgery through core-needle biopsy and the immunohistochemistry is done to assess the components of tumor microenvironment including intraturmoal and peritumoral components through volume histochemical assessment. Radiomic feature selection and prediction model building are performed using the least absolute shrinkage and selection operator and linear regression analysis, respectively. The investigators apply fivefold cross-validation to prevent overfitting, and the performance is evaluated using the area under the receiver operating characteristic curve (AUC) and the DeLong test.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with invaseiv breast cancer

Exclusion Criteria:

* Diagnosed with other cancers
Biomarkers Research in Anxiety for Validation and Efficacy

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

A within-subjects design will be used for this preliminary investigation of four biomarkers across two contexts of use: prediction of treatment response (i.e., stratification) and quantification of response (i.e., change).

The main questions the study aims to answer are:

* To evaluate the stability of each potential biomarker over a 3-4-week retest period. The biomarkers are hypothesized to have adequate stability (ICC: \> .5) in the absence of intervention.
* To determine which baseline biomarker scores predict response to a manualized cognitive behavioral therapy (CBT) program for treating anxiety, Being Brave.
* To determine which biomarkers are sensitive to treatment response.

Eligibility Criteria:
Inclusion Criteria:

* Age between 3;0 and 6;11 years old
* A diagnosis of autism spectrum disorder using DSM-5 diagnostic criteria
* A diagnosis of anxiety disorder using DSM-5 diagnostic criteria
* Use of fluent 2-3 word phrases or fluent speech (i.e., Module 2 or 3 for ADOS-2)
* Cognitive ability (either verbal or non-verbal IQ) \> 80 using the DAS-2
* A parent/guardian who is willing/able to participate and respond to interviews/surveys in English and willing/able to participate in Being Brave parent training in English and support homework activities.

Exclusion Criteria:

* Presence of seizures
* Premature birth (\<36 weeks) or low birth weight (\<2500 gms)
* Known genetic or medical disorders (e.g., Fragile X), or injuries (e.g., stroke) with implications for the nervous system or that require regular psychoactive medication that alter EEG/RSA/EDR signal (e.g., anti-convulsants)
* Significant sensory or motor impairment (e.g., blindness)
* Major physical abnormalities
* Exposure to environmental factors that could contribute to neurocognitive delays (significant alcohol exposure in utero, extreme environmental deprivation)
* Previous CBT for anxiety
* Presence of conduct or oppositional defiant disorder or ADHD so severe as to interfere with the child's ability to take part in treatment
* Presence of a primary presenting problem for which the intervention would be inappropriate (e.g., obsessive-compulsive disorder, severe mood disorder, suicidality)
* Psychotic symptoms in the child or parents
* Parent/caregiver who is not fluent in English or English is spoken in the home less than half of the time.
Vagal Nerve Stimulation for Gastroparesis

This study is investigating a new form of treatment for a digestive disorder called gastroparesis. Gastroparesis is thought to be caused by a mix of inflammation and neural dysfunction. The vagal nerve is a large nerve originating from the brain that regulates digestive function. Patients with gastroparesis have what is a called a low vagal tone which results in gastrointestinal motility problems and inflammation; therefore, investigators hypothesize that increasing vagal tone through a hand-held vagal nerve simulator will reduce inflammation and gastrointestinal motility problems in gastroparesis patients. Investigators will evaluate this hypothesis through the use of upper endoscopy testing, breath testing, and blood, stool, urine, heart rate variability, and saliva testing before and after 4 weeks of vagal nerve stimulation (VNS) treatment.

There are 6 research visits

Visit 1 and visit 2 may take up to 8 weeks (screening/baseline) Visit 3 and visit 4 will take 4 weeks (VNS treatment) visit 5 and 6 will take approximately 4 weeks (VNS followup/washout)

Consequently, it is possible that if a patient were to be at the farthest ends of visit windows, they could potentially be in the study for approx 16 weeks. Visit 1 and 2 may be less than 8 weeks which would shorten the patient's overall involvement in the study.

The treatment phase of the study will always be 4 weeks with an additional 4 week washout phase.

Use of the VNS device takes 4 weeks. Endoscopy and blood work are taken before and after the treatment period.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female.
2. Age 21-65 years old.
3. Established diagnosis of functional dyspepsia, idiopathic or diabetic gastroparesis as per AGA (American Gastroenterology Association) guidelines.
4. Patient is capable of giving informed consent and undergo upper endoscopy.
5. Patient is on stable doses of other medications for gastroparesis for preceding 4 weeks prior to enrollment (baseline measures).

Exclusion Criteria

1. Surgical-related gastroparesis
2. Extrinsic myopathy or neuropathy causing gastroparesis.
3. Use of narcotic pain medications in the preceding 2 weeks of study enrollment.
4. Patients with enteric feeding tubes or requiring parenteral nutrition (Patients with g-tubes who are stable for 3 months and not using the g-tube for venting may be eligible. patient with J-tubes are not eligible.
5. Patients with severe flare requiring hospitalization.
6. Untreated significant depression or suicidal thoughts.
7. Pregnant or breast-feeding women.
8. History of gastric pacemaker implantation.
9. Patients with prior gastric surgery, including fundoplication, partial/total gastrectomy, or gastric bypass.
10. Patients with malabsorption of enteric, pancreatic, or hepatibiliary etiology.
11. Patients with primary pulmonary disorders that affect the spirulina breath test.
12. Patients with implantable electronic devices.
13. Patients with carotid artery atherosclerosis.
Hernia-Prophylaxis in Acute Care Surgery H-PACS

Incisional hernia is a common complication in visceral surgery and varies between 11 and 26% in the general surgical population. Patients requiring emergency laparotomy are at high risk for the development of incisional hernia and fascial dehiscence. Among this population the incidence of incisional hernia in patients undergoing emergency surgery varies between 33-54%. Incisional hernias are associated with a high morbidity rate, such as intestinal incarceration, chronic discomfort, pain, and reoperation and typically require implantation of a synthetic mesh in a later second operation. Fascial dehiscence represents an acute form of dehiscence and has been observed in up to 24.1% and is associated with a mortality rate up to 44%.

The gold standard for abdominal wall closure during elective and emergency operations is a running slowly absorbable suture. In the elective situation it has been shown that prophylactic mesh implantation in high risk patients reduced the incidence of incisional hernia significantly.

The investigators and others have shown that mesh implantation in patients undergoing emergency laparotomy or in contaminated abdominal cavities are safe .

With a randomized controlled trial the investigators now aim to compare the incidence of incisional hernia after prophylactic mesh implantation versus standard of care in patients requiring emergency laparotomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing emergency midline laparatomy
* Emergency laparoscopy with expected conversion to midline laparatomy
* Written informed consent

Exclusion Criteria:

* ASA ≥5
* Septic shock
* Pregnant women
* Prior mesh Implantation
* Known sensitivity for porcine material or Polysorbate 20
Hopelessness and Self-care Power in Hemodialysis Patients

The purpose of this study is to investigate the correlation between hopelessness level and self-care agency in patient receiving hemodialysis treatment.

While the symptoms and signs that occur as a result of renal failure can be controlled with hemodialysis treatment, the reasons such as the nature of the disease, disease-related symptoms, treatment period and patients' dependency on the hemodialysis machine due to this treatment lead to many physical and psychological problems in the patients. Patients undergoing hemodialysis face physical problems such as becoming dependent, impairment of the socio-economic status, inability to fulfill their role in the society, and changes in work life and various psychological problems such as anxiety, depression, isolation, rejection of the disease, delusions, and hallucinations. it is hoped that this study aiming to determine whether or not there is a correlation between hopelessness level and self-care agency of hemodialysis patients would make a great contribution to the limited available literature.

Eligibility Criteria:
Inclusion Criteria:

* Being 18 years or older,
* To be receiving hemodialysis treatment for at least three months,
* Not having mental confusion or having any psychiatric problems,
* Hearing-sight (except for those who use glasses)-speech problem
* Volunteering to participate in the research

Exclusion Criteria:

* Being 18 years or younger,
* have cognitive impairments,
* not being able to complete the questionnaires,
* not wanting to participate in the study,
* having decided to leave the job
RAndomized Comparison of Efficacy and Safety of Lipid-lowerING With Statin Monotherapy Versus Statin/Ezetimibe Combination for High-risk Cardiovascular Diseases (RACING Trial)

The clinical efficacy of LDL-lowering therapy have been proven with strong evidences and more emphasized. However, there are also growing concerns that high-intensity statin would be related to increased risk of adverse effects. In addition, there was an inconsistency of efficacy of statin according to ethnic population. Asian population showed more profound LDL reduction not only from high potent statin but from moderate to low potent statin. Conventional strategies for lowering LDL-cholesterol was focused on statins, therefore doubling of previously described dose of statin would be common way in patients with inadequate lowering LDL-cholesterol level. Additive ezetimibe will also an alternative strategy not only to lower LDL-cholesterol level and also to reduce the need of dosage of high-intensity statin to fulfill sufficient LDL-cholesterol lowering effect. We will evaluate whether additive ezetimibe with rosuvastatin will have comparable clinical efficacy in terms of clinical outcomes and goal attainment of LDL-C compared to rosuvastatin monotherapy.


Eligibility Criteria:
Inclusion Criteria:

* Age 19-80 years
* Documented CVD (cardiovascular disease), previous MI(Myocardial Infarction), ACS (Acute Coronary Syndrome), coronary revascularization and other arterial revascularization procedures, ischemic stroke, or PAD (peripheral artery disease)

Exclusion Criteria:

* Active liver disease or persistent unexplained serum AST or ALT elevation more than 2 times the upper limit of normal range
* Allergy or hypersensitivity to any statin or ezetimibe
* Solid organ transplantation recipient
* History of any adverse drug reaction requiring discontinuation of statin
* Pregnant women, women with potential childbearing, or lactating women
* Life expectancy less than 3 years
* Inability to follow the patient over the period of 1 year after enrollment, as assessed by the investigator
* Inability to understand or read the informed content
Oral Nutritional Supplement Effect on HDL Function

Evaluate the effects of a proprietary supplement on total HDL, HDL functionality, HDL particle size and HDL particle number (HDL-P)


Eligibility Criteria:
Inclusion Criteria:

* Male and non-pregnant female patients or female patients of childbearing age on contraception age 18-80years.
* Total HDL level 38mg/dL or lower in men and HDL 45 mg/dL or lower in women and a low HDL-P defined as less than 7000 by Spectracell LPP Plus.
* CHL HDL Fx score equal to or greater than 0.9.
* Patients will remain on their present diet, exercise program, medications (except for those who alter serum lipids) sleeping habits, alcohol intake, caffeine intake, smoking amount and emotional status as best as possible related to stress and anxiety and maintain body weight at baseline visit as best as possible to avoid confounding variables.
* No other lipid lowering supplement can be taken during the study.
* All lipid lowering supplements must have been discontinued at least 30 days prior t o study entry.

Exclusion Criteria:

* Pregnant females
* Females of childbearing age not on an accepted contraception control method
* Previous myocardial infarction within 5 years
* Unstable angina
* Previous stroke or TIA within 5 years
* Uncompensated congestive heart failure
* Previous PCTA or stent within 5 years
* Previous CABG within 5 years
* Patients on statins, fibrates, or other lipid lowering medications or any supplement known to affect serum lipids.
* Known or previous cancer within 5 years
* Type 1 diabetes mellitus
* Kidney disease as defined by serum creatinine over 2.5 mg/dL
Assessment of Renal Function by Multiparametric MRI

Metabolic syndrome is a collection of conditions that affect at least three of the following five criteria: abdominal obesity, high blood pressure, high fasting glucose levels, high triglyceride levels, and low levels of high-density lipoprotein (HDL) cholesterol. Chronic kidney disease (CKD) is a common complication of metabolic syndrome, with an estimated prevalence of 13-40%. Early diagnosis of progressive conditions before the onset of reduced glomerular filtration rate (GFR) or albuminuria may be of clinical benefit but is not possible at present. Furthermore, the diagnosis and quantification of CKD in the context of metabolic syndrome is challenging due to the lack of reliable diagnostic biomarkers, and the current methods may not accurately reflect kidney function in patients with metabolic syndrome. Magnetic resonance imaging (MRI) has been sparsely explored as a potential tool to assess renal perfusion, oxygenation, and fibrosis. Multiparametric MRI (mpMRI) combines several different imaging techniques to provide a more comprehensive evaluation of tissue structure and function. These techniques hold promise for non-invasive assessment of kidney function, but their clinical utility is still largely experimental. Therefore, we aim to conduct an exploratory study to investigate the reliability, reproducibility as well as the validity of parameters for kidney function of multiparametric MRI as well as compare these parameters in between healthy patients and patients with metabolic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed metabolic syndrome

Exclusion Criteria:

* MRI exclusion criteria