cyrilzakka/clinical-trials huggingface dataset:
Clinical Pharmacogenomics of Antidepressant Response

The purpose of this study is to understand how genetic polymorphisms influence the efficacy and side effect profiles of Paroxetine and Escitalopram for major depression treatment.

Despite remarkable progress in recent decades in modern psychopharmacotherapy, patients vary substantially in their response to antidepressants, ranging from total remission to complete treatment failure. Adverse effects, often bothersome and occasionally life-threatening, continue to represent significant challenges to patients and clinicians. Mechanisms responsible for such variability remain poorly understood. In addition, although less appreciated, substantial cross-ethnic variations in psychotropic responses often exist. Recent developments in the field of pharmacogenetics indicate that genetic factors may account for a large part of these differences in response. Specific genetic polymorphisms affecting the function of the serotonin (SERT) system has been postulated to predict the effect of antidepressants. Similarly, genetic mutations have been shown to exert a predominant influence on the expression of a number of drug-metabolizing enzymes, including most of the cytochrome P-450 enzymes that are responsible for the biotransformation of most antidepressants. Polymorphisms of genes controlling these enzymes have been found to be strongly associated with the propensity for various kinds of side effects. Capitalizing on these new developments, the proposed study will examine the predictive value of some of these genetic polymorphisms in 400 patients with DSM-IV major depression prospectively treated with Escitalopram (ECIT) or Paroxetine (PAR). It is postulated that mutations affecting the function of SERT will predict responses to ECIT, polymorphism of CYP2C19 will be associated with the side effect profiles and pharmacokinetics of ECIT.

Eligibility Criteria:
Inclusion Criteria:

* self-identified as of Taiwanese/Chinese ethnic background, and report that both of their parents and all four or three of their grandparents are members of the same ethnic group;
* HAMD-21 \> 17 plus MDE (i.e., current major depressive episode) based on SCID;
* male or female, who, if of child-bearing potential, agrees to use effective contraception including the regular use of contraceptive pills, intra-uterine devises or abstinence;
* age \>= 18;
* capable of giving informed consent;

Exclusion Criteria:

* diagnosis of schizophrenia, schizophreniform disorder, schizoaffective disorder, schizotypal disorder, psychotic depression, bipolar disorders;
* current drug or alcohol abuse or dependence or history of drug or alcohol abuse or dependence within the past 6 months;
* unstable medical or neurological conditions that are likely to interfere with the treatment of depression;
* history of allergy to antidepressants;
* history of seizure disorder;
* pregnancy;
* active suicidal ideation or other safety issues determined by the clinician to not be suitable for inclusion in the study;
Diagnostic Efficiency of Touch Imprints Versus Smears

Cytopathologists work along with radiologist in the diagnosis of lesions. Rapid on site interpretation (ROSE) of fine needle aspiration (FNA) smears of radiologically suspicious lesions is a common clinical practice. In the last years, the investigators have seen trend towards needle core biopsies of radiologically suspicious lesions. The investigators want to analyze the challenges of rapid on site interpretation of touch imprints (TI) of needle core biopsies (NCB) versus fine needle aspiration smears.

This is a retrospective study in which the investigators will analyze the quality of the smears and the touch imprints, the cellularity, the cytomorphologic features of the specimens and the presence of adequate material for ancillary studies. The specimens will be searched through the University of Mississippi Medical Center's Pathology Laboratory information system (Copath), from January 2011 to December 2017. The retrospective cases (January 2011 up to now) will be retrieved using natural language search of fine needle aspiration and touch imprints. The slides of those cases will be reviewed and the cytomorphologic features will be described.

Eligibility Criteria:
Inclusion Criteria:

* 1. Computerized tomography (CT)-Guided Fine needle aspiration (FNA) /Needle core biopsy (NCB) specimens from any site.2. Ultrasound (US) guided FNA/NCB.

Exclusion Criteria:

* 1. Specimens obtained through endoscopic fine needle aspirations.2. US-guided specimens from thyroid3. Exfoliative specimens like sputum or urine4. Gynecologic cytology specimens.5. Outside cytology consult cases6. Pathologist performed FNA's
Different Vitamin D Preparations & FGF23 in Humans

Fibroblast growth factor 23 (FGF23) is a new hormone which controls phosphate and vitamin D levels in humans. Excess FGF23 is associated with an increased risk of death in patients with chronic kidney disease. In this study the investigators are investigating the effects of different forms of vitamin D on FGF23 levels in the blood in order to increase our understanding of how this important hormone works.

Fibroblast growth factor 23 (FGF23) is a novel hormone involved in phosphate and vitamin D physiology. X-linked hypophosphatemia (XLH), autosomal dominant hypophosphatemic rickets (ADHR), and tumor induced osteomalacia (TIO) are 3 rare diseases characterized by rickets/osteomalacia, fractures, and hypophosphatemia secondary to renal phosphate wasting and inappropriately low levels of activated vitamin D (calcitriol), which are caused by excess amounts of or mutated FGF23. FGF23 excess also occurs in renal failure, where elevated FGF23 levels predict increased mortality. Thus, abnormal FGF23 appears to be central to both rare and common diseases. While FGF23 appears to be regulated by vitamin D, dietary and serum phosphate, much is still unknown. The effects of different forms of vitamin D on FGF23 stimulation are not well characterized. Similarly, any racial differences in the regulation of FGF23 by vitamin D have not been investigated.

To address these knowledge deficits, we will randomize 52 vitamin D deficient (25OHD \< or = 24 ng/mL by LC/MS) Caucasian and African-American men and women to treatment with either dietary vitamin D or activated vitamin D for 12 weeks. Our primary endpoint will be the change in FGF23 with dietary versus activated vitamin D.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 45 yrs
* Serum 25OHD \< 24 ng/mL by liquid chromatography/mass spectroscopy
* At least 1 menses in the last 3 months (females) and normal serum testosterone (males)
* African-American or Caucasian race

Exclusion Criteria:

* Significant cardiac, hepatic, oncologic, or psychiatric disease
* History of malabsorption, kidney stones, or recent alcohol excess/abuse
* Use of medications known to affect serum phosphate levels including phosphate-binding antacids, sodium etidronate, calcitonin, excessive doses of vitamin D (\> 1000 units per day), excessive doses of vitamin A (\> 20,000 units/day), calcitriol, growth hormone, or anti-convulsants
* Use of thiazide diuretics or cholestyramine
* Serum calcium \< 8 or \> 11 mg/dL, creatinine \> 1.5 mg/dL, or Hgb \< 11 gm/dL
* Serum glucose \>140mg/dL
* Liver function tests \> 2 times the upper limit of normal
* TSH \< 0.1 or \> 7 uU/mL
* WBC \< 2,000 or \> 15,000/cmm
* Platelet count \< 100,000 or \> 500,000/cum
* Hormone replacement therapy (however, oral contraceptives are allowed) or testosterone use
* Urine beta-hCG positive (females)
* Serum phosphate \> 4.6 mg/dL
* Allergy to vitamin D
A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients

The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.

The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.

The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.

The objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).

Eligibility Criteria:
Inclusion Criteria:

* The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing
* The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
* The specimen is a nasopharyngeal swab

Exclusion Criteria:

* The specimen is NOT a nasopharyngeal swab
* The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.
Investigation of Efficacy and Safety of Three Dose Levels of Subcutaneous Semaglutide Once Daily Versus Placebo in Subjects With Non-alcoholic Steatohepatitis.

Investigation of efficacy and safety of three dose levels of subcutaneous semaglutide once daily versus placebo in subjects with non-alcoholic steatohepatitis


Eligibility Criteria:
Inclusion Criteria: - Informed consent obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial except for protocol described pre-screening activities which require a separate informed consent. - Male or female, aged 18-75 years (both inclusive) (for Japan: male or female aged 20-75 years (both inclusive)) at the time of signing informed consent - Local histological diagnosis of NASH followed by histological confirmation of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening - Histologic evidence of NASH based on central pathologist evaluation of a liver biopsy obtained up to 21 weeks before screening. - NASH fibrosis stage 1, 2 or 3 according to the NASH CRN fibrosis staging system based on central pathologist evaluation Exclusion Criteria: - Known or suspected abuse of alcohol (above 20 g/day for women or above 30 g/day for men), alcohol dependence\* or narcotics. (\* = assessed by the Alcohol Use Disorders Identification Test (AUDIT questionnaire)) - Diagnosis of type 1 diabetes according to medical records - HbA1c above 10% at screening - History or presence of pancreatitis (acute or chronic) - Calcitonin equal or above 50 ng/L at screening - Family or personal history of multiple endocrine neoplasia type 2 or medullary thyroid carcinoma. Family is defined as a first degree relative - Body Mass Index (BMI) ≤ 25.0 kg/sqm at the screening visit (visit 1) - Female who is pregnant, breast-feeding or intends to become pregnant or is of childbearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice)
Text Messaging in Healthcare Utilization

The overall goal is to assess the feasibility and effectiveness of using text messages as an educational tool in order to improve health care utilization among the parents and caregivers of newborns; in particular, the investigators seek to understand how educational text messages counteract the effects of low health literacy as it relates to non-urgent visits to the emergency department.

Health care utilization is a issue germane to health care providers, insurers, and patients alike. Reducing non-urgent visits to the emergency department (ED) and primary care providers can improve both the quality and cost of care. There are barriers, however, to educating patients about more appropriate health care utilization. Low health literacy is one such barrier, particularly for caregivers of pediatric patients. Research reveals that up to half of caregivers seeking treatment at the ED have low levels of health literacy; levels that can make it more difficult to not only make sound decisions, but also provide effective follow-up care. Moreover, low levels of literacy perpetuate a cycle of seeking care for non-urgent conditions. Education initiatives designed to counteract the effects of low health literacy on health care utilization have been shown to reduce non-urgent ED visits by as much as 80%. These education interventions, while effective, are complex, costly, or time-intensive. For example, home visits by a nurse, parenting classes, and video tools are all shown to reduce non-urgent ED use, but each poses a unique problem for implementation in high volume, urban, pediatric primary care clinic. To date, no study has examined the effectiveness of text messaging as a possible avenue for educating caregivers about issues related to health care utilization. Text messaging has been shown to support behavioral change, and represents a fast and cost-effective alternative to more labor-intensive and expensive alternatives.

Danis Pediatrics, the pediatric practice of Saint Louis University physicians within SSM Cardinal Glennon Children's Medical Center (CGCMC), serves as a medical home to primarily urban, low-income patients. In the first half of 2014 alone, there were 5259 visits to the ED by caregivers of patients \< 13 months of age. Of those, 520 Danis Pediatrics patients accounted for 919 of those visits. In short, just under 1 in 5 visits to the CGCMC ED is a Danis patient, and Danis patients visit the ED approximately 2 times in the first year. Previous studies of patients at Danis Pediatrics suggest that this population has access to text messaging and is interested in receiving healthcare-related information from their pediatric provider.

Eligibility Criteria:
Inclusion Criteria:

* English-speaking parents and/or guardians of newborns (aged 0 to 2 months)
* Receive primary care at Danis Pediatrics
* Must have reliable mobile phone service and be able to receive text messages

Exclusion Criteria:

* Non-English speaking caregivers
* No reliable text messaging service
Wii Balance Board in Dizziness

Patients with dizziness presently undergo physical therapy rehabilitation. Our study will study whether Wii Balance Board made by Nintendo Inc. will be helpful in patients with dizziness. They will undergo dizziness evaluation to quantify their dizziness.


Eligibility Criteria:
Inclusion Criteria:

* Abnormal posturography exam

Exclusion Criteria:

* Pregnant Women and children
Tomosynthesis in Screening Mammography

Tomosynthesis is a new digital mammographic tool which can be performed at the same time as routine screening mammography. It creates CT-like slices through the breast, minimizing the tissue overlap. Tomosynthesis has the potential to improve screening mammography outcomes by increasing cancer detection rates, decreasing false negative rates and false positive rates. This trial will help determine if tomosynthesis is useful in a screening setting.

We will evaluate the effect of tomosynthesis mammography outcomes in a screening setting. We will collect data on interpretation time, recall rates, cancer detection rates, and interval cancer rates in dense breasts(≥ 50% glandular density). If the interpretation time is less than 4X a routine read, and the recall rates have dropped \< 30% of initial values, we will then conduct a study with larger numbers to better evaluate cancer detection rates and interval cancer rates.

Eligibility Criteria:
Inclusion Criteria:

* Females 40-69 years of age attending Screen Test Kingsway referred for a screening mammogram as defined by Canadian Cancer Society guidelines.
* Prior mammogram report indicating ≥ 25% breast density.

Exclusion Criteria:

* Prior mammogram report indicating \<25% breast density.
* Breast implants
* Pregnancy
ET-01 in Subjects With Lateral Canthal Lines

This study tests an investigational drug formulation called ET-01, botulinum toxin, Type A, topical, in lateral canthal lines (LCL).

This product is being tested for its ability to reduce lateral canthal lines, also known as Crow's Feet.

Eligibility Criteria:
Inclusion Criteria:

* 25 - 65 years of age
* minimal to moderate Crow's Feet wrinkles at rest
* moderate to severe Crow's Feet wrinkles on contraction
* willingness to refrain from any product affecting skin remodeling
* female subjects must be not pregnant and non-lactating-

Exclusion Criteria:

* history of adverse reactions to any prior botulinum toxin treatments
* history of vaccination or non-response to any prior botulinum toxin treatments
* botulinum toxin treatment in the prior 6 months
* present or history of neuromuscular disease, eyelid ptosis, muscle weakness, paralysis, or "dry eye"
* history of peri-ocular surgery, brow lift or related procedures
* procedures affecting the lateral canthal region in the prior 12 months
* application of topical prescription medication to the treatment area
* female subjects who are pregnant or are nursing a child
Enhancing PAP Adherence Among Spanish-speaking Hispanic Adults With OSA

This study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility of a linguistically and culturally adapted tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with OSA.

This feasibility study seeks to enhance long-term positive airway pressure (PAP) adherence among Spanish-speaking Hispanics, a group with known PAP outcomes disparities. This study will assess the feasibility, usability and 6-month effectiveness of a linguistically and culturally adapted efficacious tele-management intervention (Automated Management, AM) for Spanish-speaking Hispanic adults with obstructive sleep apnea (OSA) (N=50). A prospective, randomized, parallel group, unblinded, feasibility trial is proposed. AM is a tele-management strategy that includes evidence-based components for improving shorter-term PAP adherence consisting of education, support and troubleshooting, and brief targeted motivational enhancement delivered by tele-messaging. The automated two-way, interactive communication is algorithmic based on PAP use and behavioral profiles defined at baseline. The innovative, technology-based interventions are designed to ensure access to sustained care that overcomes barriers such as distance/geography, transportation limitations or lost work/productivity time. As such, AM can provide equitable access to quality long-term PAP management that may mitigate known PAP adherence disparities for minority adults with OSA. If effective for long-term PAP adherence, these strategies may alter OSA care paradigms, improve outcomes and associated healthcare costs, and reduce disparities.

Eligibility Criteria:
Inclusion Criteria:

* Spanish-speaking and reading
* Self-identified Hispanic
* Adults ≥ 18 years-old
* Males and females
* Moderate-severe OSA defined as AHI ≥15 events/hour using a hypopnea criterion of a 4% oxygen desaturation (AHI4%)
* Expected availability for the duration of the study (6 months from date of randomization)
* Ownership of smartphone with unlimited text messaging capability
* Referred to PAP treatment and able and willing to be treated with PAP

Exclusion Criteria:

* Other sleep apnea or nocturnal respiratory insufficiency or failure diagnosis other than OSA established by polysomnogram (PSG) or home sleep apnea test (HSAT)
* Requirement of supplemental oxygen or other non-invasive ventilation modality
* Women referred to PAP because of new-onset OSA with pregnancy as PAP treatment may be time-limited (enrolled women who become pregnant during the trial and are already on PAP treatment will not be excluded)
* Anticipated or scheduled bariatric surgery and/or referred to sleep evaluation by bariatric surgery
Magnetic Resonance Study of Liver in Chemotherapy

The purpose of this study is to see whether magnetic resonance (MR) techniques can detect changes caused by chemotherapy in the livers of patients who have been treated for colorectal cancer. Some patients who undergo chemotherapy for colorectal cancer may experience side-effects in their livers. These side effects may influence further treatment options. If this study finds that MR techniques detect changes in the liver due to chemotherapy, then MR methods may eventually be used to help patients and physicians plan further treatment.

Each patient will have 4 MR exams: prior to or within one week of the start of the chemotherapy regimen, one after 6 weeks of chemotherapy, a third after completion of chemotherapy (between 12 and 24 weeks post-initiation of chemotherapy) and a long term followup study at least 4 months after the completion of chemotherapy. Normal volunteers will be recruited and studied by MR for comparison to patient data.

Eligibility Criteria:
Inclusion Criteria:

* Provide written informed consent.
* 21 years of age or older.
* Histologically confirmed diagnosis of colorectal carcinoma (patients only).
* Resected primary colorectal cancer and no metastatic disease or primary colorectal cancer with no metastatic disease and planned resection after neo-adjuvant chemotherapy or metastatic colorectal carcinoma considered by the attending physician to have resectable or potentially resectable hepatic metastases (patients only). Each patient will be staged by his/her attending physician in the Department of Medicine or Surgery. Hepatic metastases are considered resectable if they are expected to be completely removable with negative margins by a procedure that leaves behind sufficient liver parenchyma with arterial/portal blood supply, venous drainage and biliary drainage for subsequent regeneration and survival. Potentially resectable indicates that a reduction in tumor size due to chemotherapy could render the tumors resectable.

Exclusion Criteria:

* Inability to cooperate for an MR exam.
* Contraindication to MR:

  * Pacemaker
  * Aneurysmal clips
  * Any ferrous metallic implants which could be deflected by the magnet
  * Metal implants in field of view which could distort the images and spectroscopy data
  * Pregnant women
  * Age and mental status wherein he/she is unable to cooperate for MR study
* Patients who are considered to have unresectable hepatic metastases will be excluded. Hepatic metastases are considered unresectable if their removal would leave behind insufficient liver parenchyma for subsequent regeneration and survival. In addition, hepatic metastases are considered unresectable if their removal would be expected to leave behind residual disease (positive margins). Also, patients are considered unresectable if they have any comorbid conditions which would jeopardize successful recovery from hepatic resection.
Effects of High-intensity Interval Training and Moderate-intensity Continuous Training on Functioning of Attentional Networks and Heart Rate Variability in Healthy Adults

This study investigated the effects of HIIT and MICT on functioning of attentional networks and explored the relationship between heart rate variability (HRV) and these networks in healthy adults.


Eligibility Criteria:
Inclusion Criteria:

* normal or corrected-to-normal vision
* normal auditory function without any reading disorders
* right-handed

Exclusion Criteria:

* color blindness
* color weakness
* dyslexia
* history of smoking
* cardiovascular diseases
* personal or family history of mental illness