cyrilzakka/clinical-trials huggingface dataset:
Comparison Evaluation of Blood Glucose Meter Systems in a Clinical Setting

The purpose of this study was to test the performance of an investigational Bayer Blood Glucose (BG) meter and five additional Blood Glucose Monitoring Systems (BGMSs). The goal was to obtain glucose samples from subjects with diabetes across the meter operating ranges. A capillary sample was collected from each subject at 3 different times during the visit to obtain natural capillary blood samples with a range of glucose concentrations. Some blood samples were glycolyzed to lower the glucose concentration levels and glucose solution was added to other samples to raise glucose concentration levels. All meter BG results were compared with plasma results obtained with a reference laboratory glucose method (YSI Glucose Analyzer). All lancings and testing were performed by study staff.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 1 or type 2 diabetes mellitus
* 18 years of age or older
* Willing to follow all study procedures

Exclusion Criteria:

* Received an investigational drug or device within the last 30 days
* Current use or recent exposure to any prescription medication within 24 hours prior to screening that in the opinion of the investigator could have an influence on the subject's ability to participate in the study or on the performance on the test device
* Positive pregnancy test obtained at screening (test performed for females only, except if surgically sterile or three years past menopause)
* Hematocrit \<32% or \>55%
* Inadequate veins (in the opinion of the investigator or designated study staff) for venous blood withdrawal or intravenous catheter insertion
* Symptomatic coronary artery disease with a history of angina, or history of a myocardial infarction or coronary intervention (e.g. percutaneous transluminal coronary angioplasty \[PTCA\], stent placement) or coronary artery bypass graft (CABG) within the past 6 months
* Cerebrovascular accident within the past 6 months
* Diagnosis of the following diabetic autonomic neuropathies: symptomatic orthostatic hypotension, heart rate anomalies, gastroparesis
* Being treated for malignancy, except basal cell or squamous cell skin cancers
* Major surgical operation within 30 days prior to screening
* Active alcohol abuse or substance abuse (as judged by the principal investigator)
* Severe mental illness, mental incapacity, unwillingness or language barriers precluding adequate understanding or cooperation (as judged by principal investigator)
* Other medical conditions that would pose safety concerns, interfere with study conduct or seriously compromise study integrity, as judged by principal investigator (reason for exclusion will be clearly documented by investigator or designee)
* Working for a competitive medical device company, or having an immediate family member or someone who is not a family member but is living within the household of someone who works for such a company
The Relationship Between Vascular Adhesion Protein-1 and Diabetic Cardiovascular Autonomic Neuropathy

Exploring the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus

The prevalence of diabetes mellitus is increasing recently, especially in the urban area of developing countries. Subjects with diabetes have higher rate of hospitalization and have higher mortality. Diabetes results in various complications including diabetic retinopathy, nephropathy, neuropathy, and cardiovascular complications. Among these, cardiovascular autonomic neuropathy is one of clinical important complication of diabetes. Diabetic subjects with reduced cardiovascular autonomic function have been shown to strongly associate with an increased risk of silent myocardial ischemia and increased mortality. They also have higher risk of sudden death, intraoperative and perioperative cardiovascular instability. Formation of advanced glycation end product (AGE) and oxidative stress are important causes of diabetic neuropathy. Vascular adhesion protein-1 (VAP-1), an adhesion molecule with an activity of semicarbazide-sensitive amine oxidases (SSAO), which can catalyze endogenous amines to produces corresponding aldehydes, H2O2, and ammonia. We have demonstrated that serum VAP-1 is a source of systemic AGE and oxidative stress, and is associated with nephropathy and atherosclerosis. There are reports demonstrating that subjects with diabetic retinopathy or stroke have higher serum VAP-1. To our best knowledge, there is no report regarding the relationship between serum VAP-1 and neuropathy. In present study, we will measure serum VAP-1 and check cardiovascular autonomic function. We will also explore the relationship between serum VAP-1 and cardiovascular autonomic neuropathy in subjects with type 2 diabetes mellitus.

Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes mellitus

Exclusion Criteria:

* arrythmia
Real World Observational Study of Naloxegol for Patients With Cancer Pain Diagnosed With OIC.

This is a single-arm, open label, multinational, multicentre, prospective, real world observational study of Naloxegol in adult subjects with Opioid Induced Constipation (OIC) in patients receiving Naloxegol in routine clinical practice. Subjects who are receiving Naloxegol (prescribed by their physician according to the SmPC, which recommends that all currently used maintenance laxative therapy should be halted) during the enrolment period may be eligible for enrolment into the study.

The objective of this study is to assess the safety and efficacy of Naloxegol in a real world setting in cancer patients.

The primary safety end point is the incidence of adverse events leading to study discontinuation.

The primary efficacy end point is the response rate assessed in the 4 week observation period. Response is defined as three or more bowel movements (without the use of rescue laxative treatment in the previous 24 hours) per week and an increase of one or more bowel movements over baseline.

Eligibility Criteria:
Inclusion Criteria:

* Patient ≥ 18 years old
* Patient who is receiving treatment with opioids for at least 4 weeks, and is expected to remain on opioids for duration of study
* Patient with opioid-induced constipation
* Patient in whom the clinician plans treatment with Naloxegol according to routine clinical practice (Naloxegol SmPC recommends that all currently used maintenance laxative therapy should be halted)
* Signing of the informed consent

Exclusion Criteria:

- Patients with colorectal cancer
Reducing Disabilities in Alzheimer's Disease (RDAD) Translation in Area Agencies on Aging (AAAs)

The University of Washington's Northwest Research Group on Aging is partnering with Area Agencies on Aging (AAA) in Washington and Oregon to complete this translational investigation of RDAD (Reducing Disabilities in Alzheimer's Disease). RDAD is an evidence-based program with demonstrated efficacy in helping older adults with dementia maintain physical function and remain physically and mentally healthy. This study asks two questions: 1) Can AAA partners successfully translate and implement RDAD, and 2) Is AAA implementation of RDAD effective in producing desired outcomes among agencies, providers, and older adults with dementia and their family members. This study is being conducted in Washington and Oregon states.


Eligibility Criteria:
Inclusion Criteria:

Care Recipients must

* Have a diagnosis of dementia
* Be 65 years of age or older
* Currently exercise no more than 150 minutes a week and not regularly participate in a formal exercise program.

Caregivers must

* Live in the community
* Provide care to the care recipient with dementia

Exclusion Criteria:

Either Care-recipient or Caregiver must not

* Plan to move to a long-term residential care setting within 6 months of enrollment.
* Plan to move from the study geographic area within 4 months of enrollment.
* Have a known terminal illness (with death anticipated within the next 12 months)
* Have had a hospitalization for a psychiatric disorder in the 12 months prior to baseline
* Be actively suicidal, hallucinating, or delusional
* Be blind, deaf, or not ambulatory
Bioequivalence Study of Fluoxetine in Healthy Adult Subjects Under Fasting Condition

To evaluate and compare the relative plasma bioavailability and therefore the bioequivalence of two different immediate release products each Fluoxetine 10 mg, after administering a single oral dose, to healthy adult subjects under fasting conditions.

Enrolled subjects were randomized in a two-phase, two-sequence, cross-over design to receive a single dose of the test product (T) or the reference product (R) at each phase, under fasting conditions, with a wash-out period of 21 days.

Fluoxetine plasma concentrations were determined using a validated LC-MS-MS method, followed by Pharmacokinetics, and statistical analysis using Phoenix WinNonlin® software to determine the average bioequivalence.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent is obtained for the study.
* Age 18 - 55 years
* Body mass index between 18.5 and 30 kg/m2
* Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on physical examination.
* Vital signs without significant deviations.
* All laboratory screening results are within the normal range or clinically non-significant

Exclusion Criteria:

* History or presence of any disorder or condition that would render the subject unsuitable for the study, place the subject at undue risk, or interfere with the ability of the subject to complete the study in the investigator's opinion.
* History of any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, allergic, dermatologic, hematologic, neurologic, or psychiatric disease, or cancer.
* Any confirmed significant allergic reactions against any drug or multiple allergies.
* Clinically significant illness 28 days before study phase I.
* Alcohol or any solvent intake.
* Regular use of medication.
* Positive urine screening of drugs of abuse.
* Use of any systemic medications (prescription medications, OTC products, supplements, or herbal preparations) for 14 days prior to dosing and during the study.
* History or presence of significant smoking (more than one pack per day of cigarettes) or refusal to abstain from smoking for 48 hours before dosing until checkout.
* Blood donation within the past 60 days.
* Participation in another bioequivalence study within 60 days prior to the start of phase I of the study.
Simulation-Based Caregiving Skills Training for Family Members of High Grade Glioma Patients

Family caregivers of patients with a primary brain tumor experience a high caregiving load including assistance with activities of daily living without any formal training. It is not surprising that this vulnerable caregiver population reports high levels of distress along with numerous caregiving-related concerns, which may compromise their ability to provide quality care. This project will examine the feasibility and initial evidence for efficacy of a caregiving skills intervention aiming to improve caregiver and patient psychological health; caregiving efficacy and role adjustment; and reduce patient cancer-related symptoms and healthcare utilization.

Trial 1 (single-arm study)

• Aim 1: Examine the usability of the intervention content and trial assessments in 10 caregiver-patient dyads to refine study procedures as needed.

Trial 2 (RCT)

Aim 1 (primary aim): Determine the feasibility of implementing a caregiving intervention using a randomized controlled design in 50 caregiver-HGG patient dyads.

Aim 2: Evaluate the initial evidence for intervention efficacy relative to a WLC group regarding patient and caregiver psychological symptoms (primary outcome), caregiver caregiving efficacy and role adjustment, and patient cancer-related symptoms and healthcare utilization (secondary outcomes).

Aim 3: Understand caregivers' experiences using qualitative methods regarding participation in this study and explore emerging themes as possible intervention mediators/moderators to be examined in future research.

Eligibility Criteria:
Inclusion Criteria:

* FCGs (e.g., spouse/partner, parent, adult child) of patients diagnosed with HGG receiving any form of cancer treatment (including palliative intent) at MDACC.
* Patients must have a Karnofsky Performance Status (KPS) of 100 to 50. If the patient's Karnofsky Performance Status drops below 50 both patient and caregiver will be removed from the study.
* Both FCGs and patients must be willing to participate and (1) ≥18 years old and able to (2) read and speak English and (3) provide informed consent.

Exclusion Criteria:

* FCGs who regularly participate in psychotherapy with a licensed professional (self-reported).
* Patients with cognitive impairment that would impede ability to complete self-report surveys as documented in the medical record.
* Children under the age of 18 will not be included in this trial. First and foremost, it is unlikely that a person under the age 18 is diagnosed with an HGG.
* Childhood brain tumors tend to be diagnosed in infancy and the caregiving and symptom management needs are vastly different than in the adult patient population. Additionally, the assessment tools are not validated for minors.
* While pregnant caregivers (self-reported) are study eligible, we will also exclude pregnant patients (medical notes). It is unlikely that patients diagnosed with an HGG will be pregnant. Moreover, the current caregiver intervention is not designed to address the care needs of pregnant cancer patients.
The Development of a Domestic Violence Perpetrator Collusion Measurement Tool

We propose an experimental design to empirically establish the potential link between the media portrayal of DV and changes in an individual's DV descriptive and injunctive social norms. Specifically, this study will measure the degree to which people implicitly collude with DV perpetration.

Aim 1: To determine the impact of media "frames," "labeling," and "information inclusion" on "implicit collusion" with a DV perpetrator.

Hypotheses: Consumers exposed to media reports using "thematic frames" will be less likely to implicitly collude with perpetrators than those exposed to "episodic frames." Consumers exposed to DVH news stories labeled as "domestic violence" will be less likely to implicitly collude with perpetrators than consumers exposed to news stories labeled as "assault." Implicit collusion will correlate positively with the addition of non-relevant perpetrator "humanizing" characteristics. Consumers given negative information about the victim of DVH will be more likely to implicitly collude with the perpetrator than consumers given negative information about the perpetrator.

Aim 2: To determine how media portrayals of domestic violence impact descriptive and injunctive norms about domestic violence and, ultimately, drive implicit collusion with perpetrators.

Hypotheses: Controlling for individual pre-existing attitudes and social norms, consumers exposed to thematic frames or the label of DV will be less likely to shift their norms in a way that supports DV than those exposed to episodic frames or the label of assault. Consumers provided negative victim information or non-relevant characteristics that humanize the perpetrator will be more likely to shift their norms to accept DV.

Exploratory Aim: To identify racial/ethnic, gender, age, and regional differences in DV social norms.

Hypothesis: The media will differentially impact subpopulation DV attitudes, social norms and implicit collusion.

Eligibility Criteria:
Inclusion Criteria:

* Members of the public who are 18 years or older, who identify as White or African American or Hispanic.

Exclusion Criteria:

* Members of the public will be excluded if they are unable to read or understand English.
Topical Diclofenac on Macular Thickness After Phacoemulsification

Eyes of 108 diabetic patients have underwent phacoemulsification and intraocular lens implantation surgery have enrolled. Fifty four eyes have received the conventional postoperative care with steroid drop, whereas the other group (54 eyes) have given a preoperative diclofenac drop four times daily in addition to steroid drop and continued six weeks after surgery. All patients have evaluated by Optical coherence tomography (OCT) preoperatively and days 1, 30, and 90.The outcome measures including best corrected visual acuity (BCVA) and OCT findings were compared in and between both groups.


Eligibility Criteria:
Inclusion Criteria:

* Diabetic patients with non-proliferative diabetic retinopathy that were candidate for phacoemulsification and intraocular lens implantation

Exclusion Criteria:

* Eyes with clinically significant macular edema based on the ETDRS(Early Treatment Diabetic Retinopathy Study) study and/or central macular thickness \>260µ were not included. Neither did we include the eyes with other accompanying diseases affecting the macula or eyes with history of previous retinal laser photocoagulation or intraocular surgery.
* Eyes with severe cataract that preclude performing an acceptable quality optical coherence tomography (OCT) were not enrolled either.
Efficacy of Amplification With Hearing Aids for Tinnitus Relief

This study evaluates the treatment efficacy of tinnitus in people with mild hearing loss. One-third of participants will use hearing aid, one-third of participants will use customized music, while the other one-third participants will receive no treatment (waiting list control).

Acoustic stimulation could induce plastic changes in the auditory cortex, and tinnitus mechanisms have been viewed as a negative consequence of neural plasticity in the central nervous system after peripheral aggression. Cortical changes (neural activity in the deafferented cortical area was reduced but the adjacent frequencies of the hearing loss region activated more extensive cortical areas) occur after sensorineural hearing loss, while exposure to an acoustically enriched environment or using hearing aids may minimize or reverse the plastic tonotopic map changes in the auditory cortex. The use of hearing aids in tinnitus management for people with significant hearing loss will always be associated with an improvement in hearing handicap and quality of life, and that complicates the interpretation of how much hearing aids specifically affect tinnitus. Thus studies on tinnitus patients with mild hearing loss could be illuminating, and this population will be targeted in the present study.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or above
* can provide written informed consent
* have a diagnosis of subjective tinnitus, i.e., the tinnitus can only be heard by the patient and there is no acoustic source
* a tinnitus duration of more than one year
* have pure-tone average between 20 and 40 dB HL
* have bilateral symmetrical hearing loss (i.e. difference less than 15 dB)
* have at least a medium level of distress caused by tinnitus as indicated with total scores above 30 on the TQ-CH
* are committed to complete the 12-month follow-up

Exclusion Criteria:

* objective tinnitus, i.e. tinnitus produced by an internal acoustic source activating the cochlea and can be heard by another person
* received other forms of tinnitus treatments within three months before the baseline assessment session
* any history suggestive of psychiatric illness
* psychological distress or depression as indicated with total scores at or above 15 on the Cantonese HADS
* current hearing aid users
* inability to complete the study as revealed by the medical reports
Ablation of Complex Fractionated Electrograms With or Without Additional Linear Lesions for Persistent Atrial Fibrillation

While there is a consensus to perform pulmonary vein isolation (PVI) as a cornerstone for paroxysmal and persistent atrial fibrillation (AF), different additional ablation approaches are used for substrate modification: linear lesions, ablation of complex fractionated atrial electrograms (CFAE) or a combination of both. The aim of this study is to determine whether there is a difference in terms of freedom from arrhythmia recurrence between PVI with CFAE ablation in combination or not with linear lesions in patients with persistent AF.


Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic persistent AF
* After PVI +CFAE ablation, no termination into sinusrhythm or atrial tachycardia

Exclusion Criteria:

* Left atrial thrombus
Follow-Up Study of Patients Previously Treated With Pimecrolimus Tablets for Chronic Plaque-Type Psoriasis

This extension study is being conducted to collect post-treatment safety information on patients who previously participated in the core clinical trial.


Eligibility Criteria:
Inclusion Criteria:

* Consenting patients who participated in the core clinical trial
POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

This study aims to evaluate the use of POCUS to assess diaphragmatic function and its association with clinical outcomes in patients with respiratory failure who are admitted to the emergency department.

Respiratory failure is a common condition that requires prompt diagnosis and treatment in the emergency department. Diaphragmatic dysfunction (DD) is a potential contributor to respiratory failure, but it is often underdiagnosed and undertreated. Point-of-care ultrasound (POCUS) is a non-invasive and feasible tool that can measure diaphragmatic function using parameters such as diaphragm excursion and diaphragm shortening fraction (DSF). However, the prognostic value of POCUS for DD in patients with respiratory failure is unclear.

This study is a prospective observational cohort study that will enroll consecutive patients with respiratory failure who are admitted to the emergency department of a tertiary hospital. All patients will undergo POCUS examination of the diaphragm within 6 hours of admission by trained emergency physicians. The primary outcome will be the composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission. The secondary outcomes will include length of hospital stay, intensive care unit admission, and ventilator-free days. The association between POCUS parameters of diaphragmatic function and clinical outcomes will be analyzed using multivariate logistic regression and Cox proportional hazards models.

Eligibility Criteria:
Inclusion Criteria:

* Respiratory failure defined as one or more of the following: respiratory rate \>24 breaths/min, oxygen saturation \<90% on room air, PaO2/FiO2 ratio \<300 mmHg, or need for supplemental oxygen
* Ability to provide informed consent or availability of a legal representative

Exclusion Criteria:

* Pregnancy
* History of thoracic surgery or trauma
* Known neuromuscular disease affecting the diaphragm
* Contraindications for POCUS examination such as chest wall deformity, subcutaneous emphysema, or skin infection