cyrilzakka/clinical-trials huggingface dataset:
Congestive Heart Failure Outreach Program

Heart failure is a very common condition and is one of the main reasons people are admitted to hospital. There are many things people with heart failure can do to manage their condition at home. Unfortunately many people do not have enough information to do this and need to come back to the hospital because their heart failure got worse. This study will look at different ways to help people learn more about heart failure and how to manage their condition at home.

Background:

Given the clinical and economic importance of heart failure (HF) widely applicable strategies to improve patient outcomes are needed. In Canada,1.4 million hospital days were associated with HF in the fiscal year 2000 and almost one-third of these were readmissions . The majority of acute precipitants of HF relate to poor self-care including excessive sodium and fluid intake, and nonadherence to medications. Data derived from the PaKSAC survey confirm that patients with HF have very poor knowledge of their condition and self-care recommendations.

Disease Management Programs for HF have been shown to improve clinical outcomes by providing intensive education and medical management. Due to the resource intensity of such programs, however, only a limited proportion of the population at risk is served. Clearly more practical educational interventions are needed.

Hypothesis:

An intervention consisting of a video-based educational program for patients with HF, focusing on 3 key steps (salt restriction, daily weights and medication adherence) will improve knowledge of self-care activities, and clinical and economic outcomes at 6 months of follow-up.

Design:

A multicentre randomized control trial comparing a simple, practical educational program for patients with heart failure to usual care. All patients will be assessed using the validated PaKSAC survey (Patient Knowledge of Self-Care Activities in Congestive Heart Failure) at baseline and at 6 months. Those randomized to the intervention will view a 22 minute educational video developed by our group that focuses on 3 key steps to self management. A booklet and series of 3 newsletters will also be provided to the intervention group. The primary outcome is the improvement in clinical outcomes at the end of the 6 month follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* patient in hospital or emergency room with symptomatic CHF confirmed by a physician.
* patient seen in an outpatient clinic with symptomatic CHF confirmed by a physician, AND hospitalized within the previous 6 months for heart failure.
* age greater than 18 years.

Exclusion Criteria:

* asymptomatic CHF
* life expectancy \< 6 months
* receiving chronic hemodialysis or peritoneal dialysis
* unable to communicate (non-English speaking, intubated, etc)
* demented or a mental illness which precludes participation
* receives professional assistance for self-care activities including meals or medications (e.g. nursing home)
* previously enrolled in this study
* participation in another heart failure study, or
* declined to participate
Safety and Efficacy of Dexmedetomidine (DEX) for Sedation of Subjects ≥1 Month to <17 Years Undergoing MRI Scans

This is a randomized, double-blind, dose-ranging study of the efficacy and safety of dexmedetomidine (DEX) when used with propofol as needed, for procedural sedation of pediatric subjects ≥1 month to \<17 years of age undergoing MRI scans in the US and Japan.


Eligibility Criteria:
Key Inclusion Criteria:

1. Male or female subject ≥1 month and \<17 years of age.
2. American Society of Anesthesiologists (ASA) Physical Status I, II or III.
3. Requires non-intubated, spontaneous breathing, moderate to deep sedation (NI MDS) for a magnetic resonance imaging (MRI) study with an intensivist, anesthesiologist or other proceduralist in attendance.
4. Duration of the MRI scan is expected to take at least 20 minutes but no more than 3 hours to complete

Key Exclusion Criteria:

1. Pregnant female subjects (including those with an indeterminate or positive pregnancy test); breastfeeding female subjects.
2. Weight on Day 1 before randomization is less than the 10th percentile of weight for age and sex in the US and Japan or is greater than the 95th percentile of weight for age and sex in the US or greater than the 97th percentile of weight for age and sex in Japan based on sponsor-provided growth charts.
3. Planned medical procedure during the MRI scan or post-MRI recovery period.
4. Requires endotracheal intubation or laryngeal mask airway (LMA).
5. Known allergy to eggs, egg products, soybeans or soybean products.
6. SpO2 \<93 % on room air -
Identification of an Asthma Susceptibility Gene on 3P

To identify susceptibility genes associated with asthma and asthma related phenotypes.

BACKGROUND:

Asthma is an increasingly common disease caused by bronchial inflammation and characterized by bronchial hyperresponsiveness and intermittent airways obstruction. The development of asthma is most likely determined by an interaction between host susceptibility and environmental exposures. Bronchial hyperresponsiveness (BHR) and elevated total serum IgE levels, characteristic findings in asthma, have been shown to have strong genetic components. The identification of the genetic factors that regulate susceptibility to asthma has important public health consequences, and may lead to an improved understanding of the pathogenesis of asthma. This may lead to improved preventive measures and new therapeutic approaches.

The study is in response to a Request for Applications on "Positional Candidate Gene Approaches in Asthma Gene Discovery" issued in October 1999.

DESIGN NARRATIVE:

In an effort to delineate genetic susceptibility to asthma, Dr. Bleecker and colleagues have identified several regions of the genome that contain potential asthma susceptibility genes using a Dutch population of 200 families ascertained through a proband with asthma. The two regions with the strongest evidence for linkage after completing a genome screen were located on chromosomes 3p14-p21 and 5q31. They will identify the asthma susceptibility gene located on chromosome 3p using the Dutch families and determine its contribution to this disease in other populations. There are six specific aims in the study. The first is to develop a high-resolution genetic map of the candidate region on chromosome 3p14-p21. The second aim is to construct a correlated genetic and physical map of the candidate region on chromosome 3p. The third aim is to genotype an additional cohort of Dutch trios (one affected child and both parents) to identify haplotypes and to confirm case-control candidate gene studies. The fourth aim is to analyze known and novel genes from the candidate region using a case-control study design in the same population. The fifth aim is to determine the contribution of the chromosome 3p asthma susceptibility gene in other populations including the U.S. Collaborative Study for the Genetics of Asthma (CSGA) and Dr. Ober's Hutterite population. The sixth aim is to characterize the identified single nucleotide polymorphism (SNP) or haplotype that contributes to asthma susceptibility. There will be interaction with other investigators to determine the impact of each genetic locus and to investigate gene-gene interactions.

Eligibility Criteria:
No eligibility criteria
Corn Glycemic Index

Processing sweet corn may impact digestibility and, therefore, glycemic response following consumption. The primary aim of this study is to assess the glycemic index of various sweet corn products and varieties. An exploratory aim is to assess hunger/satiety scores following sweet corn intake.


Eligibility Criteria:
Inclusion Criteria:

* Able to provide written consent in English
* Willing to consume 50 g of glucose in less than 15 minutes (2 mornings)
* Willing to consume around 250 to 350 g of sweet corn in 10 to 15 minutes (3 mornings)
* Willing to provide 7 capillary blood samples by fingerstick (by fine lancet) during each 2-hour session

Exclusion Criteria:

* Metabolic disease or condition affecting blood glucose, such as diabetes type 1 and 2, metabolic syndrome, or polycystic ovary syndrome
* Baseline fasting blood glucose \> 100 mg/dL
* Currently pregnant
Clinical Characteristics, Outcomes and Risk Factors for Mortality in Pregnant/Puerperal Women With COVID-19 Admitted to ICU in Turkey: a Multicenter, Retrospective Study From a Middle-income Country.

We performed a national, multicenter, retrospective, cohort study. The study was announced on the Turkish Society of Intensive Care Medicine website, which included the study protocol, and the directors of ICUs caring for COVID-19 patients were invited. The study population comprised all SARS-CoV-2-infected pregnant or puerperal women (up to 6 weeks after birth) who were admitted to participating ICUs between 1 March 2020 and 1 January 2022. The exclusion criteria were patients aged \<18 years old, patients with negative COVID-19 PCR test results, patients with active malignant disease, and organ transplant recipients.The following data were collected: patient demographics, gestational age or postpartum day on admission, date of ICU admission, comorbidities, vaccination status, Acute Physiology and Chronic Health Evaluation II (APACHE-2) and Sequential Organ Failure Assessment (SOFA) scores on admission, the worst SOFA score during the ICU stay, the ratio of lung infiltrates if diagnostic imaging was performed, the time interval from the start of symptoms to ICU admission, the duration of ICU stay, laboratory values on admission and the worst laboratory values during the ICU stay, the development of extrapulmonary organ injury,the presence of non-COVID-19 infections, The worst PaO2/FiO2 ratio during the ICU stay, the most invasive respiratory support method applied, and therapies were also recorded. Immunomodulatory therapies such as corticosteroids, IL inhibitors, intravenous immunoglobulin (IVIG) and cytokine hemadsorption, were also recorded. Fetal and neonatal complications were collected. LASSO regression and multiple logistic regression analyses were used to identify risk factors for maternal ICU mortality.


Eligibility Criteria:
Inclusion Criteria:

* The study population comprised all SARS-CoV-2-infected pregnant or puerperal women (up to 6 weeks after birth) who were admitted to participating ICUs between 1 March 2020 and 1 January 2022.

Exclusion Criteria:

* Patients aged \<18 years old, patients with negative COVID-19 PCR test results, patients with active malignant disease, and organ transplant recipients.
A Drug-Drug Interaction Study of the Effect of Rabeprazole, Itraconazole or Fluconazole on the Pharmacokinetics of Vismodegib

This randomized, open-label, 4-arm, multiple-dose study will evaluate the effect of coadministration of a protein pump inhibitor, an inhibitor of P-glycoprotein and CYP3A4, or an inhibitor of CYP2C9 on the pharmacokinetics of vismodegib in healthy female subjects of non-childbearing potential. Subjects will be randomized to receive multiple oral doses of vismodegib, alone or in combination with multiple oral doses of either rabeprazole, itraconazole or fluconazole. Anticipated time on study treatment is up to 11 days.


Eligibility Criteria:
Inclusion Criteria:

* Females of non-childbearing potential
* Body mass index (BMI) 18 to 32 kg/m2, inclusive
* In good health, determined by no clinically significant findings from medical history, physical examination. 12-lead ECG, and vital signs
* Clinical laboratory evaluations, complete blood count and urinalysis within the normal range for the test laboratory, unless not deemed clinically significant by the investigator
* Negative test for drugs of abuse at screening and check-in (including alcohol)
* Negative for hepatitis B, hepatitis C and HIV infection
* Non-childbearing potential is defined as: non-pregnant, non-lactating, and either postmenopausal for at least 1 year or surgically sterile (e.g. bilateral oophorectomy and/or hysterectomy)

Exclusion Criteria:

* Significant history or clinical evidence of any metabolic (including type 1 or 2 diabetes). allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, endocrine, GI (including gastric or duodenal ulcers), Zollinger-Ellison syndrome, Barrett's esophagus, urological, neurological, or psychiatric disorder
* History of inflammatory arthritis
* History of symptomatic hypotension
* History of seizure disorders
* History of bipolar or major depressive disorder
* History of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (appendectomy, hernia repair, and/or cholecystectomy will be allowed)
* History of alcoholism or drug addiction within 1 year prior to check-in
* Use of any tobacco- or nicotine-containing products within 6 months prior to check-in
* Participation in any other investigational study drug or biological agent trial in which receipt of investigational study drug occurred within 5 half-lives or 30 days, whichever is longer, prior to check-in
* Use of PPIs, H2-receptor antagonists, or antacids within 1 month prior to check-in
* History of chronic PPI use (\> 30 days of continuous daily dosing) within 6 months of check-in
Effects of Immersive Virtual Reality Traning on an Eye-hand Coordination and Time Reaction

Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. In most educational communities VR has been used as an opportunity to support many students. VR allows the user to observe the world generated for their own needs as the real world and experience impressions that are not available in real life. It was decided to examine how immersive VR-game will affect the eye-hand coordination on music school students. The experimental group received a five-day training sessions using immersive VR game "Beat Saber", while control group was inactive comparator.

Eye-hand coordination can be defined as the ability to perform activities that require the simultaneous use of eyes and hands. Eye-hand coordination supports our daily activities, interactions with objects and people, and is critical to understanding how the brain creates internal models of the space and generates movement within it (2). The eye-hand coordination represents the integration of visual information, perceptual stimuli and motor decisions in order to perform a specific task. Along with the development of technology, opportunities for stimulation of eye-hand coordination with the use of technical novelties have appeared. Virtual reality (VR) is a three-dimensional image, which is created by means of computer programs. It has become one of the technologies that offer many possibilities of application and use of its various aspects that can bring great benefits in the real world. In most educational communities VR has been used as an opportunity to support many students. VR allows the user to observe the world generated for their own needs as the real world and experience impressions that are not available in real life. It can be assumed that VR can help trainers or teachers, especially music teachers, by interacting through movement, realization and graphic images, to develop and shape skills such as eye to hand coordination. The use of virtual reality gives a wide range of possibilities for training, so it was decided to examine how it will affect the coordination of the eye-hand response in music school students.

The aim of the research was to evaluate the eye-hand coordination of music school students undergoing training sessions in the musical game "Beat Saber" conducted in immersive virtual reality.

Eligibility Criteria:
Inclusion Criteria:

* acceptance to participate in the research,
* age 14-24

Exclusion Criteria:

* diagnosed neurological diseases,
* fear of restricted vision or putting on goggles,
* diagnosed musculoskeletal diseases,
* injuries to the musculoskeletal system,
* regular sports activities during the week.
Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children

The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.


Eligibility Criteria:
Inclusion Criteria:

* surgery under general anesthesia
* require central venous catheterization

Exclusion Criteria:

* central vein anomaly
* hematoma in central vein
* catheterization site infection
Prevail Global Study

The purpose of the study is to evaluate the clinical safety and efficacy of the Prevail DCB.

The Prevail Global study is a prospective, premarket, interventional, multi-center, global, dual cohort clinical study enrolling subjects undergoing percutaneous coronary intervention for in-stent restenosis (ISR Cohort) in a randomized controlled study of the Prevail Drug-Coated Balloon, and subjects undergoing percutaneous coronary intervention of the Prevail Drug-Coated Balloon for de novo lesions in small vessel disease (DNSV Cohort) in a single arm prospectively enrolled study.

In the ISR Cohort this will be accomplished by randomizing subjects to either a Prevail DCB arm or an Agent DCB arm to compare results of the treatment of ISR with coronary lesions previously treated with DES or BMS in native coronary arteries. In the DNSV Cohort this will be accomplished through collection of data to compare results of the Prevail DCB to a DES historical control in subjects undergoing PCI for de novo lesions in small vessel disease.

Subjects will be enrolled at approximately 65 study sites; the same study sites will be used for enrollment of both cohorts. The enrollment period is anticipated to be approximately 12 months. Subjects will remain in the study with follow-up clinical assessments through 5 years, study exit, or death, whichever comes first.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Negative pregnancy test
* Stable or unstable angina, positive functional test, or stable NSTEMI
* Life expectancy \>1 year
* Willing and able to cooperate with study procedures and required follow up evaluations

Exclusion Criteria:

* Known hypersensitivity or contraindication to antiplatelet medications or a sensitivity to contrast media which cannot be adequately pre-medicated
* History of an allergic reaction or significant sensitivity to paclitaxel or any other analogue or derivative
* Platelet count \< 100,000 cells/mm³ or \> 700,000 cells/mm³, or a white blood cell (WBC) count \< 3,000 cells/mm³
* Renal insufficiency (or failure)
* Acute MI
* Previous PCI of the target vessel within 6 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of the target vessel within 12 months post-procedure
* History of a stroke or transient ischemic attack (TIA)
* Active peptic ulcer or upper gastrointestinal (GI) bleeding
* History of bleeding diathesis or coagulopathy or will refuse blood transfusions
* Documented left ventricular ejection fraction (LVEF) \<30%
* Planned surgery that would cause interruption in recommended DAPT duration per current guidelines
* Currently participating in an investigational drug or another device study that has not completed the primary endpoint or that clinically interferes with the current study endpoints; or requires additional coronary angiography, IVUS or other coronary artery imaging procedures
Thermal QST for Interscale Block Evaluation

Thermal quantitative sensory testing (QST) is a method to evaluate peripheral nerve blocks in a quantitative way. It assesses the neurosensory effects of local anesthetics, like nerve block intensity, duration, recovery, neurotoxicity, the effect of spread of local anesthetic solutions and the effect and the eventual neurotoxicity of adjuvants. We aimed at investigating, in a quantitative way, the block characteristics of 3 different commonly used local anesthetics on peripheral nerves through the application of thermal QST by measuring changes in sensory detection thresholds. Furthermore, we wanted to evaluate if QST could be of value for measuring gradual changes in block characteristics on the adjacent nerves at distance of the injection site in an US-ISB.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients scheduled for diagnostic and therapeutic shoulder arthroscopy, with or without decompression technique were eligible

Exclusion Criteria:

* contraindications for ISB
* diabetes mellitus
* peripheral neuropathy
* patients receiving chronic analgesic therapy
* contraindications for NSAID
* patients with an initial QST with abnormal values
Evaluation of the Perception of Quality of Care of Patients Admitted to a Medical-Surgical ICU

The objective of this prospective observational cohort study is to describe the perception of quality of care of patients or reference companions admitted to a medical-surgical ICU.

Background: Quality assessment in health systems is essential for the improvement and development of services. Assessments using the structure, process and outcomes model are the most widespread, however understanding the health system as a business model makes assessment essential. how much the service is able to meet the expectations of the patient and the market.

The Institute for Healthcare Improvement (IHI) highlights three domains (Triple aim) in which health systems must develop. Among them is "Improving the patient experience". One of the 6 domains of quality of care is patient-centeredness. Several funding institutions and scientific authorities have, in recent years, encouraged patient-centered clinical research with the use of outcomes that are also patient-centered.

The perception of the quality of the service provided to the critically ill patient or even is an uncommon outcome in the literature, especially evaluated with an objective and effective tool.

The SERVQUAL tool proposed by Parasuraman et al. It aims to compare the expectations and perceptions of the patient/companion regarding the quality of care provided.

In the literature, data on patient-centered perspectives and demands are scarce.

Purpose: To identify the difference between expectation and perception of care quality during the stay in the general ICU of a tertiary hospital. Objectives: To evaluate the perception of quality of care of patients admitted to a general ICU through the SERVQUAL tool translated and culturally adapted to the portuguese idiom.

Methods: A prospective, observational cohort study involving adult patients admitted to the general ICU (53 beds) of a tertiary hospital from July 1 to September 30, 2023. The SERVQUAL tool questionnaire of expectations will be applied in the first 24 hours after admission to the ICU and the perception questionnaire applied in the first 24 hours after discharge from the unit.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥ 18 years old
* consent form signed by the patient or a family member.

Exclusion Criteria:

* Patients unable to respond and who do not have reference companions
* Patients readmitted to the ICU during the study period.