cyrilzakka/clinical-trials huggingface dataset:
Understanding Decision Making in the Intensive Care Unit: a National Study

Given how central Substitute Decision Makers (SDMs) are to the process leading to end of life decisions and sometimes, organ donation, it is striking how poorly understood this decision-making process is. A 2017 scoping review on the topic of soliciting SDM consent to organ donation reported on more than 168 studies covering a broad range of topics, including: SDM characteristics and predictors of consent; the process of soliciting consent; and the effect of the decision on subsequent process of care and on family well-being. An unexplored area, however, is factors - including modifiable factors - that influence SDM decision making at the end of life, which organ donation is part of, such as: responses to stress, support from extended families and friends, and personal beliefs about the ongoing medical conditions. This project seeks to fill this clear and important gap.

In the ICU, at the end of life, SDMs are under incredible emotional distress, have often not eaten or slept properly for days preceding discussions about end of life and organ donation, and are also in the midst of grieving for their loved one. The time pressure poses challenges for SDMs' decision making. Thus, this study will investigate novel, potentially modifiable reasons for end of life decision so that we may better support this personally challenging and important decision, especially if organ donation decision interferes with the decision process.

Primary objective: To investigate beliefs and experiences of SDMs involved in the decision-making process around withdrawal of life sustaining therapies .

Secondary objective: To inform efforts to improve support for SDMs with the aim of improving the decision-making process end-of-life decisions, including when organ donation is involved.

A national multicenter multi-methods study with SDMs will be conducted in two steps. In Step 1, a semi-structured interviews with SDMs will be conducted. The sampling frame will balance interviews with those that were approached or not for organ donation, and consented or not to organ donation. Interviews will be informed by two complementary theoretical frameworks. Building on Step 1 results, in Step 2 a national telephone survey of SDMs will be conducted to test which factors are associated with end-of-life decisions.

Eligibility Criteria:
Inclusion Criteria:

* Substitute decision maker (SDM) and patients with at least 18 years old
* SDM(s) of patients in the ICU with or without brain injury for whom withdrawal of life-sustaining therapies is considered or has been discussed.
* SDM(s) of patients for whom death is expected to occur within approximately 1 hour after withdrawal of life-sustaining therapies
* English or French speakers SDM(s)
* SDM(s) reachable in ICU

Exclusion Criteria:

* SDM is not reachable after pre-consent in ICU (after 5 initial attempts within a 3-week period).
* SDM asks to postpone the interview more than 3 times.
* SDM unable to provide informed verbal consent for any reason.
Randomized Clinical Trial Comparing Transradial Catheterization With or Without Spasmolytic Drugs

Single-center study, randomized, double-blind, placebo controlled, with patients undergoing diagnostic or therapeutic catheterization via the transradial approach. Patients will be randomized into two groups: one group will receive the vasodilator nitroglycerin during the procedure (intervention group), and a second group will receive saline 0.9% in the same volume and time during the procedure (control group).

Will be evaluated: incidence of spasms of the radial artery, ability to perform the procedure without the need to change the access site, pain presented by the patient, time and total radiation of the procedure.


Eligibility Criteria:
Inclusion Criteria:

* Indication for cardiac catheterization
* Suitable candidates for transradial approach

Exclusion Criteria:

* AMI
* Intubated patients
* Complications during procedure (cardiac arrest, pulmonary edema, cardiogenic shock, stroke)
* Prior inclusion in this trial
Efficacy and Safety Study of Azimilide on the Incidence of Cardiovascular Hospitalizations/Emergency Department Visits or Cardiovascular Death in Patients With an Implantable Cardioverter Defibrillator (ICD) (SHIELD-2)

This study will evaluate the efficacy and safety of Azimilide on the incidence of cardiovascular hospitalizations, cardiovascular emergency department visits or cardiovascular death in patients with Implantable Cardioverter Defibrillators (ICDs)


Eligibility Criteria:
Inclusion Criteria:

* Have an ICD implanted and a history of ventricular tachycardia, ventricular fibrillation, or an appropriate ICD therapy.
* Have a left ventricular ejection fraction \<= 0.40

Exclusion Criteria:

* Have New York Heart Association (NYHA) Class IV Congestive Heart Failure (CHF) or have decompensated CHF at the time of randomization;
* Have unstable angina pectoris or a myocardial infarction within 30 days of randomization;
* Have a history of Torsade de Pointes or heart transplantation
* Have chronic atrial fibrillation or atrial fibrillation/flutter, that is not adequately rate controlled in the judgment of the Investigator, at screening;
* Are currently taking systemic Class I or other Class III antiarrhythmic drugs
* Are currently taking systemic drugs that prolong the QT interval
* If female, are currently pregnant or breast feeding, or plan to become pregnant during the course of the study
Application of Digitized Respiratory Sounds for Confirmation of the Position of the Balloon of Endobronchial Blockers

This observation study is to evaluate the application of the spectral analysis and characteristic parameters of digitized respiratory sounds in the confirmation of the position of the balloon of endobronchial blockers

This is an observational study. We will recruit 30 patients who are scheduled for thoracic surgery under general anesthesia with tracheal intubation and need endobronchial blocker for unilateral lung ventilation during the operation. The standard procedures for confirming the position of the balloon of the endobronchial blocker, including the stethoscopic inspection and the fiberoptic examination, will be performed as routine practice. But in our study, besides the above routine practice, a microphone will be connected to the distal end of the stethoscope (the microphone will not contact directly with the patients) during the checking procedure to record the breathing sound into a digital computer as electronic files. These breathing sound files will be analyzed in a later time with spectral transformation and the characteristics are extracted. These digital signal processing results will be compared with the results of fibroptic exmination and the stethoscopic auscultation in the correct rate of diagnosing the position of the endobronchial balloon. The aim of this study is to examine the usefulness of the spectral parameters of the digitalized breathing sound in confirming the position of the endobronchial blocker balloon.

Eligibility Criteria:
Inclusion Criteria:

* Thoracic disease patients who are scheduled for thoracic surgery and lung isolation requiring endobronchial blocker placement during the surgery
* Adult patients (no younger than 20 years old)

Exclusion Criteria:

* Patients with significant thoracic diseases which result in abnormal respiratory sounds
Electronic Cigarette Use and Quitting in Youth

A mixed method (longitudinal, trajectory and qualitative studies) to provide comprehensive evidence on the impact of e-cigarette use on smoking and quitting among smoking youth in Hong Kong.

Subjects are from a cohort of Youth Quitline callers and smoking youth (N=200) in Hong Kong. The longitudinal study will investigate the effects of baseline e-cigarette use on quitting (including relapse), nicotine addiction and intention to smoke at 12-month telephone follow-up. A qualitative study will be conducted on 10 ex- and 10 current smokers to supplement and facilitate interpretation of the quantitative findings.

Eligibility Criteria:
Inclusion Criteria:

1. Ethnic Chinese
2. Cantonese speakers
3. Smoke at least 1 cigarette in the past 30 days

Exclusion Criteria:

1. Psychologically or physically unable to communicate
2. Undergoing other smoking cessation programme
Creating Naptime: An Overnight, Non-Pharmacologic Intensive Care Unit Sleep Promotion Protocol

Specific Aims:

1. Quantify baseline patient room disruptions in the medical ICU during the proposed nocturnal Naptime .

   1. Obtain baseline light and noise levels in selected medical ICU study rooms.
   2. Obtain baseline activity level levels in selected medical ICU study rooms.
   3. Assess baseline information regarding nursing experience, prior training / beliefs regarding sleep promotion in the medical ICU
2. Assess the feasibility of instituting a 4 hour (Midnight to 4:00 AM) nocturnal Naptime with minimization of patient interaction via tracking of differences in patient room activity, light and noise levels in control versus intervention patients.

   Secondary Aim
3. Examine the associations between Naptime provision and patient sleep quality.

The effects of poor sleep are dauntingly pleiotropic. Inasmuch as sleep deprivation can behaviorally and physiologically mimic delirium in the ICU, there is concern that sleep deprived ICU patients are at risk for the increased mortality, longer hospital stays and worsened physical and mental outcomes of hospitalized patients who experience delirium during their admission. Furthermore, lack of sleep has been associated with decrements in FEV1, FVC and maximal inspiratory pressure in non-ICU COPD patients, increases in respiratory muscle fatigue in healthy volunteers and blunted response to hypercapnea in healthy volunteers. Finally, theoretical concerns exist regarding sleep loss putting patients at risk for prolonged bedrest, adverse cardiovascular events, derangement of metabolism and endocrine function as well as immune suppression; though supported by animal models and brief studies in healthy volunteers, no ICU data exists.

Eligibility Criteria:
Inclusion Criteria:

* All MICU admissions age 18 and older who are admitted no less than 6 hours and no more than 48 hours prior to intended start of the next potential Naptime (midnight start).

Exclusion Criteria:

* Patients who are "boarding" from other intensive care units at Yale New Haven Hospital; these patients are not cared for by our providers and would not be subject to our protocols.
* Patients without an identifiable surrogate who cannot consent for themselves.
* Comfort care only patients
* Patients undergoing the hypothermia protocol.
* Patients enrolled in the MIND\*USA delirium study.
* Non-English speaking patients
Reducing Blood Culture Contamination:

Bloodstream infections cause significant morbidity and mortality and their prompt identification is an essential part of modern medicine. False positive results in blood cultures are primarily due to contaminants. It has been estimated that up to 50% of positive blood cultures represent contamination. These false positive cultures, at the microbiological laboratory level, require significant additional resources for workup. Additionally, they result in unnecessary antibiotic treatment and hospitalization days, causing needless harm to patients. Various methods have been implemented in order to reduce blood culture contaminants, including modifying the solution used for sterilizing the skin and feedback on contamination rates. However, it has been shown that the bacteria which colonize the human skin are not only on the surface but in fact colonize deeper surfaces as well. The SteriPath device diverts the initial 1-2 ml blood so as to remove any potential skin plug with contaminants. Thus, the principle object of this study is the determination of the rate of contamination of blood culture taken prior to initiating intervention versus the rate of contamination using three interventions: Monthly feedback via departmental report card, a chlorhexidine plus alcohol wipe and the SteriPath device. Secondary objectives will include ease of use of the wipes and the SteriPath device and an estimate of the sensitivity of SteriPath device use to true bacteremia. If the various interventions will be shown to reduce contamination, researchers will also attempt to estimate the financial effects of those reductions, comparing intervention cost to estimated savings related to reduced contamination.


Eligibility Criteria:
Inclusion Criteria:

* adult patients hospitalized in our institution in whom blood cultures are taken

Exclusion Criteria:

* none
Exploratory Clinical Study to Evaluate Sodium Oxybate (Xyrem) on Potential Endocrine Changes

To monitor for endocrine changes in response to treatment of cataplexy with Xyrem, to focus on the hypothalamic pituitary axis and to confirm the safety of Xyrem on potential endocrine changes.


Eligibility Criteria:
Inclusion Criteria:

Inclusion Criteria:

* Narcoleptic patients with cataplexy

Exclusion Criteria:

* Subjects not diagnosed with narcolepsy with cataplexy

Exclusion Criteria:
A Single Group Study to Evaluate the Effects of a pH Balanced Cleanser on Women's Intimate Health.

This virtual single-group study will last 8 weeks, involving the daily use of a pH Balanced Cleanser by 40 female participants. The study aims to evaluate the effect of the cleanser on signs of vulvar and vaginal health and its tolerability.

Participants will use the Love Wellness pH Balanced Cleanser daily during showers. Questionnaires will be completed at Baseline, first use, Week 2, Week 4, Week 6, and Week 8. Vaginal pH testing will be conducted weekly using Vaginox vaginal pH testing strips. The primary objective is to assess parameters of vulvar and vaginal health, while the secondary objective is to evaluate product tolerability.

Eligibility Criteria:
Inclusion Criteria:

* Female participants aged 18+
* Self-reported issues with vaginal odor, itching, or intimate skin discomfort
* Previous use of vaginal cleansers without severe adverse reactions
* Generally healthy without uncontrolled chronic diseases
* Willing to avoid intra-vaginal products during the study
* Consistent use of any vaginal health-targeted supplements for at least 3 months prior

Exclusion Criteria:

* Pre-existing chronic conditions preventing protocol adherence
* Planned reproductive health procedures
* Recent changes in medications or supplements targeting vaginal health
* Known severe allergic reactions
* Pregnancy, breastfeeding, or attempting to conceive
* Unwillingness to follow study protocol
* History of vaginal, cervical, vulvar, uterine, or ovarian cancer
* Recent changes or discontinuation of hormonal birth control
* Recent surgeries or invasive treatments
RCT- Comparing Testimonial Versus Documentary Organ Donation Video Education

Investigators will evaluate organ donation educational videos with a 2x3 single blinded Randomized Control Trial (RCT) in partnership with our 26 Latino Owned Barbershops (LOBs). The testimonial video about Uncontrolled Donation after Circulatory Determination of Death (uDCDD) with an uplifting ending will serve as control. Experimental videos may include live uDCDD footage, differing endings, or combinations. Video production will be informed by the entertainment education model and produced with experts including an Academy Award winning filmmaker. The primary outcome is whether participants immediately enroll in the NY State Organ Donor Registry (either online or by our RA mailing in the official form with prepaid postage). Investigators hypothesize that each video will induce differences in registration compared to the control and that there is an interaction effect with video genre and story outcome.


Eligibility Criteria:
Inclusion Criteria:

* Dominican and Puerto Rican Latinos.
* Participants who pefer to speak Spanish.
* Participants who reside locally in NYC, New Jersey, or Connecticut, (tri-state area) for at least four weeks (28 days) in a year.
* Participants able to understand the verbal consent process.

Exclusion Criteria:

* Persons who are visually impaired and are unable to watch the videos.
* Persons who are hearing impaired and are unable to hear the audio on the videos.
* Persons who are cognitively impaired and thus are unable to provide consent to register for organ donation by signing the New York State Organ Donor Registry application.
* Persons who self-report to be registered in the New York State Organ Donor Registry.
* Persons who previously are enrolled in this randomized controlled trial.
* Persons psychologically unfit or who refuse.
Effect of Depression, Anxiety and Stress Scores on Embryo Transfer Success

Psychological status of couples attending to IVF programmes is important due to possible effect on final result. Observers aim to investigate the depression, anxiety and stress scores of couples before and after the procedure.

Studying effect of psychology on IVF is not a new idea. "Before and after" scores of women attending to IVF programmes had been studied numerous times. However, there is not sufficient data about the contbibution of male compartment upon the process. Investigators aimed to study both male and female participants. Final scores will not be evaluated unless at least good quality blastocsyt is transferred.

Eligibility Criteria:
Inclusion Criteria:

* 20 to 40 year old women attending to IVF programme

Exclusion Criteria:

* Azospermia and severe male factor for whom sperm freezing will be required
* History of RIF
* Known genetik abnormality of couples
Comparison Between Two Tacrolimus-based Immunosuppressant Regimens and Induction With Thymoglobulin in Kidney Transplants From Deceased Donors With Expanded Criteria

The disparity between supply and demand for organs has stimulated the development of strategies to increase the availability of kidney grafts. Such strategy involves the use of kidneys with expanded donor criteria (EDC). This is a study initiated by the investigator, open, prospective, randomized, single center designed to compare the safety and efficacy of two immunosuppressive regimens based on thymoglobulin, tacrolimus and everolimus versus thymoglobulin, tacrolimus and mycophenolate sodium in renal transplant recipients with donor criteria expanded.


Eligibility Criteria:
Inclusion Criteria:

* Adults (\> 18 years) candidates to renal transplant with expanded criteria deceased donors;
* Low risk of acute rejection, defined as first kidney transplant recipients and Panel Reactive Antibody (PRA) \<50%.
* Signature of the informed consent form (ICF)

Exclusion Criteria:

* Patients receiving immunosuppressive therapy before transplantation;
* Patients who have received an investigational drug within last 30 days;
* Patients with a known contraindication to the administration of an anti-thymocyte globulin;
* Patients with a positive test for human immunodeficiency virus (HIV);
* Patients who had cancer (except non-melanoma skin cancer) within last two years;
* Pregnant women, breastfeeding women, and women of childbearing potential unwilling to use condoms or oral contraceptives will be excluded;
* Patients with any Panel Reactive Antibody (PRA) equal to or higher than 50%, class I or class II, will also be excluded;
* Patients with positive test for parasites (protozoa and helminths).
Egg Diet to Improve Metabolic Health and Function

The purpose of this study is to determine the effects of change in diet quality (carbohydrate restriction versus fat restriction) on body composition, fat distribution, cardiometabolic risk factors, physical function, and quality of life in aging adults with obesity.

The purpose of this study is to determine the effects of change in diet quality (carbohydrate restriction versus fat restriction) on body composition, fat distribution, cardiometabolic risk factors, physical function, and quality of life in aging adults with obesity. Data from previous studies support the hypothesis that consumption of lower-CHO, higher-fat food sources rich in high-quality proteins and essential fatty acids, such as whole eggs, has beneficial effects on metabolic health. The study will test the hypothesis that a reduced CHO higher- fat, egg-rich diet induces selective depletion of total and abdominal adiposity, preserves lean mass, and reduces inflammation and oxidative stress. In turn, these favorable changes in body composition, fat distribution, and metabolic health will confer improvements in physical function in obese, aging adults.

Results from this study will form an empirical basis for developing an easily implemented, non-pharmacologic treatment (i.e. change diet quality by incorporating more low carbohydrate, whole foods such as eggs) to prevent or reverse sarcopenia and other age-related diseases of metabolic origins.

Eligibility Criteria:
Inclusion Criteria:

1. between 60-75 years of age,
2. have a BMI ranging from 30-40 kg/m2,
3. sedentary (\<2h/wk of intentional exercise, and agree to maintain their level of activity throughout the study).

Exclusion Criteria:

1. those with uncontrolled diabetes,
2. unwilling to eat the prescribed diets,
3. recent weight change (+/- 10 lbs. in previous year),
4. history of eating disorder,
5. difficulty chewing and swallowing solid food,
6. digestive diseases,
7. cognitive impairment,
8. uncontrolled blood pressure (systolic blood pressure \> 159 or diastolic blood pressure \>95 mm Hg),
9. history of non-skin cancer in the last 5 years,
10. cardiovascular disease event; severe pulmonary disease; renal failure; major liver dysfunction,
11. current/recent smoker,
12. use of estrogen or testosterone replacement therapy,
13. current use of oral corticosteroids (\>5 d/mth),
14. using medications for treatment of psychosis or manic-depressive illness, and
15. dependence on others for food procurement or preparation.