cyrilzakka/clinical-trials huggingface dataset:
Acute Influence of Resveratrol Supplementation and Beet Extract in Recovery After Exercise in Coronary Paths

Introduction: Most cardiovascular diseases (CVD) can be prevented and controlled by adopting lifestyle changes, such as regular physical exercise and nutrition. Resveratrol and beverage extract promote beneficial health effects due to their nutritional properties. Objective: to analyze the effects of resveratrol supplementation and withdrawal extract on post-exercise recovery in coronary heart disease patients. Methods: men diagnosed with ischemic coronary artery disease will undergo four exercise protocols consisting of 30 minutes of aerobic exercise on an ergometric treadmill, with 5 minutes of warm-up, intensity of 30% of the heart rate reserve (HRR), followed by 25 minutes at intensity 60% of FCR and for a final 30 minutes of recovery in the supine position. Before each exercise protocol, all volunteers will consume: 500 mg of placebo (starch), or 500 mg of beetroot, or 500 mg of resveratrol and will also consume resveratrol and drink (500 mg each) 30 minutes before exercise. , the order of each supplementation will be done randomly. Cardiorespiratory parameters and heart rate variability (HRV) will be assessed at different times throughout the experimental procedure. To analyze the moments (rest versus recovery), the Bonferroni post-test will be used for parametric distribution or the Dunn post-test for non-parametric distribution. Statistical significance will be calculated at 5% for all analyses.


Eligibility Criteria:
Inclusion Criteria:

* adult men over 45 years of age
* diagnosed with ischemic coronary artery disease and with preserved left ventricular function (above 50%), confirmed by a previous echocardiogram

Exclusion Criteria:

Volunteers who present at least one of the following characteristics will be excluded:

* smokers
* alcohol drinkers
* those who did not attend a cardiovascular rehabilitation program for at least 3 months prior to data collection
* individuals who have known infections, metabolic and respiratory diseases that could interfere in cardiac autonomic control, unstable angina, uncontrolled hypertension, significant valvular disease, uncontrolled metabolic disease (e.g., uncontrolled diabetes and thyroid disease)
The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in ICU Patients

The Value of Repeated BIOMarker Measurements During an SBT to Predict EXtubation Failure in Mechanically Ventilated ICU Patients

Rationale: In order to prevent extubation failure or unnecessary prolonged ventilation, accurately predicting readiness for extubation is of key importance in ICU care. Currently, clinical criteria and spontaneous breathing trials (SBTs) are used to assess readiness for extubation. Data on the prognostic value of biomarkers in this setting are limited.

Objective: To investigate the association of biomarker measurements (NT-proBNP, hsTroponin-T, CKMB, myoglobin, GDF-15, CRP, IL-6, PCT, Cystatin-C, CA-125, galectin-3, ST-2, albumin) during an SBT with extubation failure in mechanically ventilated ICU patients.

Study design: Multi-centre prospective observational cohort study.

Study population: Adult ICU patients who are mechanically ventilated for more than 48 hours and fulfil readiness-to wean criteria.

Main study parameters/endpoints: Extubation failure (the need for reintubation within 7-days).

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: This study will collect data that is clinically available, but also encompasses repeated biomarker measurements, cardiopulmonary echographic examination and electrocardiography. Because almost all mechanically ventilated ICU patients have an arterial line, blood can be easily sampled without venepuncture and poses negligible risks for the study patients.

Eligibility Criteria:
Inclusion Criteria:

* Aged ≥18 years
* Mechanically ventilated for more than 48 hours
* Fulfilling readiness-to wean criteria
* Written informed consent from the patient or his/her legal representative

Exclusion Criteria:

* Patients with risk factors for laryngeal oedema and a negative cuff leak test (indicating upper airway obstruction with need for steroid treatment)
* Planned replacement of the endotracheal tube for a tracheostomy
* Terminal illness
Direct Comparison of TG and WFO LASIK

To compare the efficacy to different profiles, direct head-to-head studies had been conducted. In one previous review study revealed that TG LASIK provided patient with better uncorrected visual acuity (UCVA) than WFO LASIK and WFG LASIK. In recent previous contralateral eye studies also showed that TG LASIK induced less postoperative higher-order aberration than WFO LASIK. However, these studies included only low-to-moderate myopia patients, for patients with high myopia (spherical equivalent \> 6D), the effect of TG LASIK comparing with WFO LASIK had not been reported before.

The aim of our study is to analyze and compare the visual performance of TG LASIK and WFO LASIK in high myopia and low-to-moderate myopia patients, , particularly UCVA, corrected distance visual acuity (CDVA), contrast sensitivity (CS), and wavefront aberration.


Eligibility Criteria:
Inclusion Criteria:

* age between 20 and 50 years old
* CDVA of both eyes could reach 0.1 logarithm of the minimum angle of resolution (logMAR)
* stable refractive errors of myopia and astigmatism

Exclusion Criteria:

* cataract
* corneal opacities or irregularities
* dry eye (Schirmer's test I ≤ 5mm)
* amblyopia
* coexisting ocular pathologies
* glaucoma
* non-dilating pupil
* history of intraocular surgery, laser therapy, or retinopathy
* optic nerve or macular diseases
* estimated postoperative cornea residual stromal thickness less than 250 μm
* pregnancy or under lactation
* uncontrolled diabetic mellitus or systemic immune disease
* refusal or unable to maintain follow-up
TIVA Versus Inhalational Anesthesia and Tissue Oxygenation in Cardiac Surgery

The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. The primary objective of this study was to compare the effects of midazolam-based TIVA and sevoflurane-based (SEVO) inhalation anesthesia maintenance on intraoperative central and regional tissue oxygenation parameters.

A pressing issue in anesthesiology involves developing an understanding of the non-anesthetic effects of the medications typically used in intravenous and inhalation anesthesia methods. Few studies describe the effects of both intravenous and inhalational anesthetics on regional tissue perfusion is described under stable anesthetic conditions. There is the issue of whether inhalational anesthetics compromise regional tissue perfusion even though systemic parameters are within normal ranges. It is still debated how these effects may be different under pathophysiological conditions, such as cardiac surgery.

Maintaining tissue perfusion and oxygenation is the cornerstone of therapy for patients with cardiac disease. An imbalance in oxygen delivery and tissue oxygen consumption leads to anaerobic metabolism, cellular injury, and organ dysfunction, and is associated with poor outcomes. Consequently, monitoring tissue oxygen delivery and consumption status is of paramount importance in cardiac surgery patients. Routinely used monitors in intraoperative settings such as pulse oximetry, blood pressures, hemoglobin saturation levels, lactate, acid-base status, and central venous oxygen saturation levels all reflect tissue metabolism. Near-infrared spectroscopy (NIRS) is a non-invasive optical technique that can be used to continuously monitor tissue oxygen delivery and oxygen consumption status. Cerebral autoregulation can blunt the effect of impaired systemic oxygen delivery. Thus, cerebral NIRS may be a good predictor of neurological outcomes, but skeletal muscle NIRS serves as a follow-up indicator of many other postoperative complications due to impaired perfusion and oxygenation. Therefore, both cerebral and somatic monitoring may contribute to a more complete evaluation of hemodynamic competence. Obtaining the cerebral and somatic oxygenation levels are valuable to help in clinical management during cardiopulmonary bypass (CPB) and cardiac surgery as a whole.

The aim of this study was to evaluate the effect of total intravenous anesthesia (TIVA) and inhalational anesthesia techniques on tissue oxygenation in cardiac surgery. For this purpose, the effects of midazolam-based TIVA or sevoflurane-based inhalation anesthesia maintenance on intraoperative central and somatic tissue oxygenation parameters were compared in patients undergoing cardiac surgery.

Eligibility Criteria:
Inclusion Criteria:

- coronary surgeries with CPB

Exclusion Criteria:

* emergency surgeries,
* operations
* ejection fraction under 40%
* coronary surgeries in conjunction with other procedures
* cerebrovascular accident
* neurological disorders
* hematologic disorder
* chronic alcohol use
Assessment of Psychological Strain and Perioperative Fear in Intravitreal Injections

1. Intravitreal injection can induce perioperative stress for the patients.
2. Different factors can modulate the pre-operative fear and physiologic reaction.

The aim of the study is to assess the influence of perioperative factors on objective outcome measures, which indicate the physiologic stress reaction.

Eligibility Criteria:
Inclusion Criteria:

* First intravitreal injection received ever

Exclusion Criteria:

* No known affective or mental disorder
* Condition does not allow standardized survey
Effectiveness of Dance on Patients With Fibromyalgia

The aim of the present study is to assess the effectiveness of belly dance as a treatment for pain and improving the quality of life of patients with fibromyalgia.

Eighty female patients with fibromyalgia between 18 to 65 years were randomly allocated to a dance group (n=40) and control group (n=40). Patients in the dance group underwent 16 weeks of belly dance twice a week, while the patients in the control group remained on a waiting list. Patients were evaluated with regard to pain (Visual Analogue Scale), function (6 minute walk test), quality of life (Fibromyalgia Impact Questionnaire and SF-36), depression (Beck Inventory), anxiety (State-Trait Anxiety Inventory) and self-image (Body Dysmorphic Disorder Examination) questionnaire. Evaluations were carried out at baseline, after 16 weeks and after 32 weeks.


Eligibility Criteria:
Inclusion Criteria:

* classification of fibromyalgia based on the criteria of the American College of Rheumatology
* female gender
* aged between 18 and 65 years

Exclusion Criteria:

* not having altered treatment in previous three years
* having signed a term of informed consent
* patients with other rheumatic diseases, painful osteoarticular conditions, uncontrolled cardiopulmonary disease, diseases of the lower limbs or uncontrolled diabetes were excluded
Glycemic Response Testing

The purpose of this study is to assess whether added food ingredient(s) affect glycemic responses to a liquid meal tolerance test (LMTT).


Eligibility Criteria:
Inclusion Criteria:

* Male or female (not less than 40% males or females
* Non-smoker
* Aged 18 to 55 years
* Have a body mass index between 18.5 to 29.99 kg/m2
* Healthy, non-diabetic, no gastric bypass surgery
* Not allergic to mustard, dairy or soy
* Having a fasting plasma glucose (finger stick) \<100 mg/dl (\<5.5 mmol/L)
* Willing and able to provide written informed consent
Does Numerical And Pictorial Information On Risk And Benefit Affects The Uptake Of Colorectal Cancer Screening?

To establish whether provision of numerical data, framed as event rates and illustrated by pictograms, and including figures for all-cause mortality, affects subjects' attitudes to colorectal cancer (CRC) screening.

Design and Intervention. Randomised questionnaire and telephone study comparing the responses of a control group given the standard National Health Service (NHS) CRC screening information with the responses of an intervention group given the same information but enhanced with additional numerical and pictorial information.

Setting


Eligibility Criteria:
Inclusion Criteria:

Age 60 - 70

-

Exclusion Criteria:

* No previous cancer or previous colonoscopy Not able to give informed consent
A Study to Evaluating the Pharmacokinetics, Safety, and Efficacy of ATG 016 Monotherapy in IPSS-R Intermediate Risk and Above Myelodysplastic Syndrome (MDS)

This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy.

This is a Phase Ⅰ/II, Open-label Study to Investigate the Pharmacokinetics, Safety, and Efficacyof ATG 016 Monotherapy in IPSS-R Intermediate Risk and above Myelodysplastic Syndrome (MDS) Patients after Failure of Hypomethylating Agent (HMA)-based Therapy. In Phase I: approximately 15 to 21 subjects and Phase II: approximately 44 subjects; approximately 59 to 65 subjects will be enrolled totally in this study.

Eligibility Criteria:
Inclusion Criteria:

1. Understand and voluntarily sign an informed consent document prior to any study related assessments/procedures are conducted.
2. ≥18 years of age, males or females.
3. Eastern Cooperative Oncology Group (ECOG) performance status of ≤2.
4. A life expectancy longer than 3 months in the opinion of the investigator at the screening.
5. Male subjects (Including those who have received vasectomy) must agree to use condoms during sex with a woman of childbearing age and have no plans to impregnate the woman throughout the study and for 3 months following the last dose after the date of signing the ICF.

Exclusion Criteria:

1. History of central nervous system (CNS) involvement.
2. Toxicity from prior antitumor therapy did not return to Grade 1 or baseline (Except for alopecia, neutropenia, anemia, and thrombocytopenia. For neutrophils, hemoglobin, and platelets, please follow Exclusion Criteria No. 5).
3. History of human immunodeficiency virus (HIV) infection.
4. History of severe bleeding disorder, such as hemophilia A, hemophilia B, and vascular hemophilia.
5. History of allogeneic stem-cell transplantation.
6. Serious psychiatric or medical conditions that, in the opinion of the investigator, could interfere with treatment, compliance, or the ability to give consent.
7. Pregnant or lactating women.
Food Security and Perceptions and Barriers to Healthy Eating in Individuals With Spinal Cord Injuries

Food security is one's ability to get food. Individuals with a Spinal Cord Injury (SCI) have many risk factors for low rates of food security. Some of these risk factors include lower levels of income and employment. Our long-term goal is to identify if food security is more prevalent in the SCI population, and to develop ways to improve food security in the SCI population. The purpose of this study is to determine the rates of food insecurity in a sample of people living with a SCI and to identify some perceptions of barriers to healthy eating in the SCI population.

Food security is one's ability to get food. Individuals with a SCI have many risk factors for low rates of food security. Some of these risk factors include lower levels of income and employment. This study consists of a one-time survey using the US Adult Food Security Survey and another previously validated survey about perceptions of barriers to healthy eating.

Our long-term goal is to develop a large SCI food security and perceived barriers to healthy eating multicenter study in order to determine if these factors are significant issues in the SCI population. We also aim to determine the causes of these issues in order to develop interventions to improve the health of all people living with a SCI and potentially reduce their health care costs. The purpose of this study is to determine the rates of food insecurity in a sample of people living with a SCI and to identify some perceptions of barriers to healthy eating in the SCI population. This will also develop preliminary data to support a NIH R level grant application for a large, multicenter study to further explore SCI food security at the national level. Our central hypothesis is that there will be an increased rate of food insecurity in the SCI population compared to other groups in the literature, and that this will be associated with income and environmental barriers.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years old
* Male or female, any ethnicity, with the history of a spinal cord injury at least one year prior (without a diagnosis of Multiple Sclerosis or malignant cancer)
* Community wheelchair user
* Voluntary, informed consent of participant and interest in participating in further research studies
* Lives in the community, not a skilled nursing facility

Exclusion Criteria:

* age \<18 years old
* Chronic, nontobacco substance-abuse
* Community ambulator
Helping Young Children Improve Eating

This study will evaluate the impact of different types of educational materials on parent and child feeding behaviors. Specifically, the investigators will test the feasibility, acceptability, and effectiveness of an investigator-developed series of parent training videos designed to teach behavioral strategies to promote feeding in young children with feeding difficulties.


Eligibility Criteria:
Inclusion Criteria:

* Parents of patients ages 18 months through 6 years currently on the waitlist (for an estimated time of at least 4-6 weeks) for outpatient feeding therapy, or with feeding concerns identified in a primary care visit; English-speaking parents; parent has the technology to access the videos and REDCap survey.

Exclusion Criteria:

* Parents of patients not currently eating by mouth; parents of patients currently being treated by a psychologist, occupational therapist, or speech therapist to address feeding, eating, or swallowing skills; parents of patients who have aspirated on their most recent videofluoroscopic swallow study or who currently have a tracheostomy.
Clinical Prognosis of Patients With Atrial Fibrillation During Radiofrequency Ablation

This study is an ancillary study to Isochrone-AF. The investigators hypothesize that patients eligible but non-included in the primary study (patients classified as non-reducible or non-inducible) will have different prognosis and electro-physiclogical characteristics to the patients included and randomized into the Isochrone AF study.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 18 years old
* The patient is available for 18 month follow-up
* The patient has paroxysmal or persistent atrial fibrillation

Exclusion Criteria:

* The subject is participating in a category 1 interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is pregnant or breastfeeding Early Study Exit Criteria: Patient does not have paroxysmal or persistent AF at the time of inclusion
Work, Weight, and Wellness Program: The 3W Program

The purpose of this study is to increase physical activity, improve diet, and reduce obesity of hotel employees.

BACKGROUND:

In Hawaii, as in many other states, tourism is a large industry. Most hotel jobs require little education or training, and hotels employ large numbers of persons and immigrants with low socioeconomic status. Hawaii, with the world's most ethnically diverse population, has high rates of obesity and diabetes, particularly among those of Polynesian ancestry (about 20-22% of the population). This study will include a comprehensive lifestyle change program delivered through worksites in partnership with a large health care system.

DESIGN NARRATIVE:

Thirty-one hotels employing 11,000 persons on the island of Oahu are pair-matched. One member of each pair is assigned to a high intensity intervention and the other to a low intensity intervention. Both interventions are intended to reduce BMI through an emphasis on a healthy diet and increased physical activity. All employees are assessed annually for three consecutive years. The assessment includes a survey on lifestyle habits, stage of change, and attitudes toward weight, as well as measurement of BMI. The high intensity intervention hotels receive the following: 1) environmental changes to support lifestyle change and obesity control; 2) worksite based groups that offer state-of-the-art behavioral interventions; and 3) after-hours "Re-Invent Yourself" groups designed for persons who want to lose at least 25 pounds and are highly committed to doing it. These interventions incorporate all the elements that produce sustained weight loss and an innovative decision tutorial based on decision theory. The primary outcome is the mean difference between hotels in the high intensity and low intensity interventions in change in BMI from baseline to 12 and 24 months. Secondary outcomes address effects of the intervention on ethnic and occupational subgroups stage of change, absentee days, and worker compensation claims.

Eligibility Criteria:
Inclusion Criteria:

* Employed at the hotel

Exclusion Criteria:

* Unable to read English, Korean, or Chinese
Study Of Pregabalin (Lyrica) In Patients With Painful Diabetic Peripheral Neuropathy

Patients will be switched from their current medication for painful diabetic peripheral neuropathy to evaluate the safety and efficacy of pregabalin as compared to placebo. All patients will receive pregabalin, and half of patients will receive placebo at some point during the study.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have painful diabetic peripheral neuropathy and be receiving treatment for this condition.

Exclusion Criteria:

* Patients with other pain conditions cannot participate.
Web-Based Coping and Communication Skills Intervention in Improving Psychological Adaptation in Patients With Gynecological Cancer

This pilot clinical trial studies how well web-based coping and communication skills intervention works in improving psychological adaptation in patients with gynecological cancer. Web-based intervention, such as coping and communication skills intervention, may help doctors to get a better understanding of ways to help gynecological cancer patients cope with their cancer experience.

PRIMARY OBJECTIVES:

I. To examine the feasibility and acceptability of an online coping and communication skills intervention (CCI).

II. To collect pilot data on the impact of online CCI on global and cancer-specific distress.

OUTLINE:

Patients complete 3 modules of online CCI intervention.

After completion of study, patients are followed up at 2 months.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed with any stage of primary ovarian cancer, primary peritoneal cancer, or primary fallopian tube cancer in the past 6 months
* Newly diagnosed with high grade stage 2, any grade stage 3 or higher endometrial cancer in the past 6 months
* Newly diagnosed with stage 2 or higher cervical cancer within the past 6 months
* Newly diagnosed with any stage uterine cancer (both sarcoma and carcinosarcoma) in the past 6 months
* At the time of recruitment the patient is on active treatment defined as either currently receiving chemotherapy or radiation or less than 6 months post-cancer surgery
* At the time of recruitment, a Karnofsky performance status of 80 or above or an Eastern Cooperative Oncology Group (ECOG) (80) score of 0 or 1
* English speaking
* Has internet access
* Must give informed consent within 6 months of diagnosis