cyrilzakka/clinical-trials huggingface dataset:
Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients

As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. This study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in in elderly patients presenting to a outpatient cardiology clinics.

Objective:

As the proportion of elderly population increasing over the last years, polypharmacy and drug-drug interactions (DDI) has been a common health care problem. However, very limited epidemiologic data are available describing polypharmacy, potentially DDIs, and potentially inappropriate medications and their consequences in elderly Turkish patients. Therefore, this study will be performed to find out to prevalence of polypharmacy, inappropriate drug use and DDIs in elderly patients presenting to a outpatient cardiology clinics.

Methods:

The EPIC (Epidemiology of Polipharmacy and Potential Drug-Drug Interactions in Elderly Cardiac Outpatients) study will be the first large-scale, observational, real-world multicenter study to evaluate DDIs ve polypharmacy in elderly cardiac outpatients conducted in Turkey. We will enroll all consecutive patients (aged≥ 65 years) admitted to the outpatient cardiology clinics from January 30, 2018, through June 30, 2018, provided written informed consent. Approximately 5000 patients will be enrolled in this non-interventional study. All the data will be collected at one point in time and current clinical practice will be evaluated.

Results:

Patient demographics, disease characteristics, laboratory test results and medications used willl be collected by self reports and medical records. The severity of comorbid diseases will be recorded and scored according to Charlson comorbidity index (CCI) and patients will be divided into three groups: mild, with CCI scores of 1-2; moderate, with CCI scores of 3-4; and severe, with CCI scores ≥5. Polypharmacy will be defined as being on five or more medications at one time, DDIs will be checked with Lexicomp® and and potentially inappropriate medications will be defined with 2015 update of Beers criteria. Severe drug interactions will be defined with category D or X DIs.

Conclusion:

EPIC will be the first study evaluating polypharmacy, potentially inappropriate medications and DDIs in elderly cardiac outpatients in a real world clinical setting.

Eligibility Criteria:
Inclusion Criteria:

* All consecutive patients with aged ≥ 65 years

Exclusion Criteria:

* Patients under 65 years of age
* Patients who do not want to participate in our study
Pocket-sized Ultrasound for Point-of-care Diagnosis of Heart Failure

Assessment of pocket sized ultrasound (Vscan GE Healthcare) for diagnosing heart failure in primary care patients, with a comprehensive cardiac ultrasound examination (Siemens Acusan P10) performed at a specialized the eco.lab, as reference.

Waiting times for cardiac ultrasound is a cause of delay in identification of heart failure, which means delayed treatment, or that treatment recommendations are based on insufficient knowledge. Heart failure is a common condition; about 10% of 80-year-old people are affected and most patients are treated within primary care. A new ultrasound technology with integrated software support for interpretation (pocket-sized ultrasound) promises to improve care for heart patients and lead to earlier treatment with effective drugs. In cooperation with Norwegian researchers and the Region of Jämtland Härjedalen, this project opens opportunities for a significant medical innovation. The new concept, pocket-sized ultrasound for diagnosis of heart failure, has not previously been validated in patients seen in primary care. A new study may provide very important information that is directly applicable in the care of heart failure patients. We aim to recruit 250 study patients from the waiting list of patients referred from GPs, to ultrasound at the dpt. Of Clinical Physiology, Östersund Hospital, due to a suspicion of heart failure. The examinations will be carried out during the same day, with the investigators blinded to each other. The new concept of ultrasound has a potential to provide more cost-effective identification and monitoring of patients with heart failure in primary care.

Eligibility Criteria:
Inclusion Criteria: Study patients fulfil all of the following criteria:

1. Age 20 and over
2. Recruited from primary care clinics, in the Region of Jämtland Härjedalen, Sweden.
3. Referred to comprehensive cardiac ultrasound (reference method) from GPs, due to suspected heart failure.
4. Provide written informed consent before enrolment.

Exclusion Criteria:

1. Non consenting patients.
2. Patients in need of acute medical attention.
Results Comparison of Cervical Cancer Early Detection Using Cerviray With VIA Test

Cervical cancer, primarily caused by Human Papilloma Virus (HPV), is a significant global health concern, ranking as the fourth most common cancer in women worldwide. In Indonesia, it stands as the second most frequent cancer among women. This study investigates the performance of Cerviray® AI and Cerviray® AI Evaluation, an artificial intelligence (AI) technology for diagnosing cervical cancer, aiming to compare its sensitivity, specificity, positive predictive value (PPV), and area under the receiver operating characteristic curve (AUC ROC) with the Visual Inspection with Acetic Acid (VIA) test.

The study involved 44 patients from various health centers in West Java Province. Cerviray® AI, Cerviray® AI Evaluation, and VIA tests were administered to high-risk women of childbearing age.

Eligibility Criteria:
Inclusion Criteria:

* high-risk women of childbearing age who would be screened for cervical cancer (by Cerviray AI examination, Cerviray AI evaluation, and VIA test) at 1 clinic and other 4 health centers

Exclusion Criteria:

* incomplete data
* patient refusing to be examined
* patient refusing to participate in the study
A Phase 2a Study of LLX-424 in Patients With a History of Kidney Stones

This is a Phase 2a study of glycolate oxidase inhibitor LLX-424 in patients with a history of kidney stones. Eligible subjects with a history of kidney stones will be randomized to receive study drug (LLX-424 or placebo) for 8 weeks.

This is a Phase 2a, randomized, double-blind, placebo-controlled study designed to assess the safety, tolerability, PK, and PD effects of LLX-424 in patients with a history of kidney stones.

Following completion of screening procedures, on Study Day 1, eligible subjects will be randomized in a 2:1 ratio to receive either LLX-424 or matching placebo, respectively.

An outpatient safety Follow-up Visit will be scheduled on Day 63 or 7 days after the last dose (end of study visit).

Eligibility Criteria:
Inclusion Criteria:

* History of kidney stones documented in medical records
* 24-hour urine oxalate excretion
* Body mass index 18.5 to 38 kg/m2 inclusive
* Estimated glomerular filtration rate ≥ 60 mL/min/1.73m2

Exclusion Criteria:

* History or medical record evidence of kidney stones that are not calcium oxalate
* Unstable kidney function
* Spot urine protein to creatinine ratio ≥ 1 mg/mg at screening
* History of kidney transplantation
* Hemoglobin A1c \> 9.5% at screening
* History of enteric hyperoxaluria, intestinal malabsorption, bariatric surgery, intestinal surgery, inflammatory bowel disease
* History or evidence of cirrhosis
Local and Systemic Oxygen Saturation During 'Death by Squats' Exercise

During the exercise intervention "Death by Squats", which compasses body weight squats until maximum exertion, 25-30 subjects shall be tested for heart rate, the oxygen saturation of the vastus medialis and the triceps, resting and at maximum exertion blood lactate, as well as the rate of perceived exertion on the borg scale. At the end, all should indicate their primary reason for stopping (local fatigue, systemic fatigue, time constraints, motivational deficit).

Subjects in this study will be measured while they are engaged in an exercise protocol until maximum exertion, each in groups of three persons. The overall duration of the study is planned from April 2023 (start of recruitment) until December 2024 (finalization of data acquisition and analysis).

Subjects are executing a CrossFit workout which is planned as follows: Every minute, participants have to perform a given number of Airsquats (bodyweight squat). The first minute starts off with 10 repetitions, the remaining time can be used as a break. In minute two, 12 repetitions have to be done, in minute three 14 repetition, and so on. The subjects stick to this protocol until maximum exertion, in other words, until they are no longer able to execute the given repetitions within the actual minute. During the workout, heart rate is tracked by a 'Polar' chest strap, and the oxygen saturation of the vastus medialis and the triceps are measured using the 'Moxy' muscle oxygen monitor. Further, at rest and at maximum exertion, a blood lactate sample is taken (EKF lactate scout). Subjects rate their perceived exertion on the borg scale after quitting and indicate their primary reason for stopping (local fatigue in legs, systemic fatigue, time constraints).

Eligibility Criteria:
Inclusion Criteria:

* being moderately to severely physically active al least 2 hours/week (all types of sport are eligible)

Exclusion Criteria:

* akute infections, musculoskeletal injuries
* chronic cardiovascular or pulmonary diseases (in case of uncertainty, we recommend appraisal from medical personnel)
The Relationship Between Serum Gasdermin-D Levels and Pyroptosis and Preterm Labor

In this study, the investigators aimed to investigate the relationship between Gasdermin D levels measured from the maternal serum of patients diagnosed with preterm labor and spontaneous preterm labor in pregnant women.

This prospective case- control study was conducted between 15 July 2021 and 15 July 2022 at Bursa Yüksek İhtisas Training and Research Hospital. The study was conducted with pregnant women between the ages of 18-45 who were idiopathic preterm labor. Pregnant women between the ages of 18-45 who were diagnosed with preterm labor between 24-37 weeks of gestational were included. This study was conducted with 160 pregnant women who were diagnosed with idiopathic preterm labor and 167 healthy pregnant women who were in the same gestational week as these pregnant women and were not diagnosed with preterm labor. Group 1 patients diagnosed with preterm labor between 24-37 weeks( study group) (n:160), Group 2 consisted of healthy pregnant women who were not diagnosed with preterm labor between 24-37 weeks ( control group) (n: 167) . In group 1, 80 patients were diagnosed with early preterm (between 24-34 weeks ) and 80 patients with late preterm labor (34-36+6 weeks).

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who were diagnosed with idiopathic preterm labor and gave birth in our hospital
* Pregnant women without vaginal infection
* Healthy pregnant women between 24-37 weeks without a diagnosis of preterm labor

Exclusion Criteria:

* Multiple pregnancies
* Pregnant women with a prediagnosis of chromosomal and congenital anomalies in the fetus
* Women with a known infective or autoimmune disease before pregnancy
PyloPlus Urea Breath Test System Pediatric Safety and Efficacy Study

This is a multi-center, non-randomized, open label study. Subjects will be enrolled on a walk-in basis. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. All children will be exposed to non-radioactive 13C-Urea with citric acid, and shall submit a stool sample.

Centers will house a PyloPlus UBT Analyzer to document results. PyloPlus Analyzer results shall remain blinded to the investigator and treating physician. No patient management decisions should be made based on the investigational PyloPlus® UBT System.

Treating physician will prescribe a H. Pylori Stool Antigen Test to Stool test at either LabCorp or Quest Diagnostic, for the patient, which will be used for diagnostic purposes by the ordering physician.

Total duration of study is anticipated to be approximately 6 months.


Eligibility Criteria:
Inclusion Criteria:

* Male or female age 3-17 at the time of visit
* Subject/Legal guardian (and subject when relevant) is willing to sing the Informed Consent/Assent Form
* Naive to H. pylori treatment in the past 4 weeks

Exclusion Criteria:

* Pregnant and/or lactating women
* Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient of the quality of data
* Participation in other interventional trials
* Allergy to test substrates
* Antibiotics taken within 4 weeks of the testing
* Study subjects shall not consume the following items at least 1 hour prior to the PPUBT test: Mouthwash, Chewing Gum, Carbonated Beverages, Cigarette Smoke, Acetone (to simulate the effect of ketone production that may result from some diets), Alcohol, Food
* Children 12 years and older - to be excluded after a written notification from the sponsor is received at the site that the limit of (approx.) 1/3 of the sample size was achieved for this group
The Clinical and Economic Impacts of e-Heath on Diabetes

This project addresses the following Null Hypotheses:

1. There will be no difference will be found in the use of the search engine and the information accessed among the three education modes.
2. There will be no difference in education mode's effect on metabolic control, self-care management practices, and medical resource utilization.
3. There will be no difference in the economic impact on the health care system based on differing education modes.

In addition to the face-to-face education process currently used at the CHR, this project will develop two modes of eHealth education. Education mode 1 (control) is comprised of participants educated using CHR's current traditional face-to-face delivery method, with printed materials and written log journals. These participants will be trained to use the University's web portal if they elect to access internet-based diabetes information. This allows for the tracking of the type and amounts of diabetes information accessed by participants. Education mode 2 (static interface) participants will be educated using digitized forms of the traditional materials provided by CHR as well as an electronic log journal (e-journal) where participants will record their diabetes-related outcomes and behavioural information. Education mode 2 will be assessed and approved by CHR. Education mode 3 (dynamic interface) participants will be educated using the digitized traditional materials from education mode 2 as well as an enhanced dynamic e-journal (visualization of blood glucose and alerts). In addition, this mode will provide informative disease-related internet sites and diabetes news and articles vetted by the medical team. Participants and health professionals will then be able to electronically discuss the content and quality of this information (discussion board). New sites and articles will be added on an ongoing basis. Participants will also have access to a chat room that will encourage information sharing with other education mode 3 participants and health professionals at CHR. Education mode 3 will be assessed and approved by CHR.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 or older
* Literate
* Not participating in other clinical trials
* Diabetes diagnosed within the last three months
* Type 2 diabetes
* No medical conditions that could compromise metabolic control
* No linguistic, cognitive or psychosocial barriers that would hinder study completion
* Computer and internet literate
* Access to high-speed internet

Exclusion Criteria:

* Under the age of 18
* Not literate
* Participating in other clinical trials
* Diabetes diagnosed greater than three months ago
* Type 1 diabetes
* Gestational diabetes
* Additional medical conditions that could compromise metabolic control
* Linguistic, cognitive or psychosocial barriers that would hinder study completion
* Not computer and internet literate
* No access to high-speed internet
Staffing Patterns of Comprehensive Primary Care Practices

Examines staff size and composition of the 496 advanced primary care practices participating in CMS's comprehensive primary care initiative, in 7 regions (states or local areas) that were selected for the demonstration.

Participating practices all have electronic health records, submitted applications to participate in this demonstration program designed to improve primary care practices, and were selected as the most advanced of the applicants in terms of use of health information technology and certification as a medical home or possessing features similar to those of a medical home. Participating practices will receive monthly payments from Centers for Medicare \& Medicaid (CMS) for Medicare patients attributed to the practice, and from other payers in the market taht are participating in the initiative. The demonstration began in October 2012 and will continue for 4 years. This early paper focuses on describing these practices at the outset of the demonstration.

Eligibility Criteria:
Inclusion Criteria:

* All Medicare fee-for-service patients who receive the majority of their Evaluation and Management visits from one of the study practices.

Exclusion Criteria:

* none.
Canadian Humira Post Marketing Observational Epidemiological Study: Assessing Effectiveness in Ankylosing Spondylitis

The current study will assess the real - life effectiveness of adalimumab in the management of Ankylosing Spondylitis (AS) with emphasis on the prevention and management of extra-articular manifestations.


Eligibility Criteria:
Inclusion Criteria:

* Adult \>= 18 years old
* Has provided written informed consent allowing the use of their data for the study and providing permission for contact by the study personnel
* Active Ankylosing Spondylitis as per the judgment of the treating physician
* Inadequate response or non tolerant to current NSAID (Nonsteroidal Anti-Inflammatory Drug) or DMARD (Disease-Modifying Anti Rheumatic Drug) based treatment for AS

Exclusion Criteria:

* Currently participating in another prospective study including controlled clinical trials and observational studies
* Patient cannot or will not sign informed consent
* Stable disease with adequate tolerance and response to current treatment and no change in treatment is indicated
* Previous treatment with anti-TNF (Tumor Necrosis Factor) or other biologic agent
* Presence of other condition that, in the opinion of the treating physician, prohibits the patient from participating in the study or obscures the assessment of the treatment of AS
Study of OPA-15406 Ointment in Patients With Atopic Dermatitis

The purpose of this study is to assess the efficacy and safety of OPA-15406 ointment in patients with atopic dermatitis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of atopic dermatitis based on the criteria of Hanifin and Rajka

Exclusion Criteria:

* Subjects who have an atopic dermatitis or contact dermatitis flare-up defined as a sudden intensification of atopic dermatitis.
* Subjects who have an active viral skin infection.
* Subjects with a current or history of malignancy.
Real-Time Functional Magnetic Resonance Imaging Neurofeedback for Regulation of Psychophysiological Functions

The purpose of this study is to determine the potential efficacy of real-time functional magnetic resonance imaging neurofeedback (RT- functional magnetic resonance imaging (fMRI) -NF) in regulating brain activity and psychophysiological functions.

The overall goal of the outlined study is to establish a real-time functional magnetic resonance imaging neurofeedback (RT-fMRI-NF) protocol aiming at modulating brain activity and psychophysiological functions. About two weeks after the initial training session it will be estimated how stable training effects have been. The two weeks in between, subjects will receive ambulatory training of the strategies via a smartphone-based application.

Eligibility Criteria:
Inclusion Criteria:

* Sufficient spoken and written knowledge of English
* Right-handedness
* Access to smartphone
* Availability to participate in the study

Exclusion Criteria:

* Color blindness
* Presence of cardiovascular disease
* Medication intake affecting cardiovascular function
* Medical MRI contraindication
Digoxin Versus Ivabradine in Heart Failure With Reduced Ejection Fraction

Study hypothesis: Comparing the effect of digoxin and ivabradine in chronic heart failure patients with a left ventricular ejection of 35% or lower and sinus rhythm with heart rate 70 beats per minute or higher, and who are taking maximal dose of a beta blocker if tolerated.

Selected patients have chronic heart failure with left ventricular systolic dysfunction and sinus rhythm. They take optimal medical therapy.

Eligibility Criteria:
1. Inclusion Criteria:

   * Left ventricular ejection fraction of 35% or lower (Ischaemic or non-ischaemic etiology)
   * Sinus rhythm with heart rate of 70 beats per minute or higher
   * Symptomatic heart failure with functional capacity of New York Heart Association class II, III, IV
2. Exclusion Criteria:

   * Chronic renal failure with glomerular filtration rate \<30 ml/min
   * Atrial fibrillation
   * Pace maker rhythm
   * Advanced stage chronic obstructive lung disease
   * Comorbidity with expected survival below 1 year