cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Implantable Defibrillator Therapy After a Myocardial Infarction

This study will assess whether an implantable defibrillator will increase the likelihood of survival in patients who have had a heart attack, have abnormal test results from a 24 hour heart monitor, and who have low normal heart function.

The REFINE ICD trial will assess whether prophylactic ICD therapy, guided by non-invasive risk assessment tools, reduces mortality in MI survivors with better-preserved LV function.

Eligibility Criteria:
Site investigators are responsible for screening. Subjects must meet all inclusion criteria. Subjects with any exclusion criteria will be excluded.

Initial inclusion criteria (eligibility for Holter screening).

* 18 - 80 years old at time of consent
* History of MI ≥ 2 months prior to screening based on ESC/ACCF/AHA/WHF criteria (both STEMI and NSTEMI subjects are eligible)
* Appropriate post-MI management including revascularization where indicated
* No contra-indication for transvenous ICD placement (e.g., mechanical tricuspid valve, known vascular access problems, active sepsis, etc.)
* LVEF 36% - 50% measured at least 40 days after a confirmed MI ≥ 3 months after coronary angioplasty or coronary bypass surgery and within the following time windows:

  * LVEF ≤ 7 months of screening visit if index MI was ≤ 1 year of enrolment
  * LVEF ≤ 13 months of screening visit if index MI was \> 1 \& \< 3 years of enrolment
  * LVEF ≤ 25 months of screening visit if index MI was ≥ 3 years of enrolment
* Proven, necessary or appropriate medications (e.g. beta-blocker, ACE inhibitor / ARB, statin, and anti-platelet)
* In normal sinus rhythm (ECG documented) ≤ 8 weeks prior to the screening Holter
* Written informed consent
* Able and willing to complete the screening Holter, including the six-minute hall walk

Additional inclusion criterion (eligibility for randomization).

* Abnormal HRT \& TWA (core lab interpretation) on Holter performed at least 2 months after the index MI and the specified time after coronary revascularization
* In normal sinus rhythm (ECG documented) within 8 weeks prior to the screening Holter
* In normal sinus rhythm for ≥ 18 hours of the 24 hr screening Holter as determined by the study Holter Core Lab

Exclusion criteria (randomization or registry).

* Use of antiarrhythmic drugs
* Clinical indication for permanent pacemaker or a cardiac resynchronization device
* Clinical indication for an ICD or cardiac resynchronization ICD
* Prior implantation of a pacemaker, ICD, or Cardiac Resynchronization device
* Any condition, in the investigator's judgment, that would limit life expectancy to \< 12 months
* Chronic renal failure (hemodialysis or peritoneal dialysis)
* Active ischemia that is amenable to revascularization if not previously revascularized
* Participation in another trial that may interfere with the REFINE ICD results.
* Pregnancy
* Inability to comply with the follow-up schedule
Accuracy of 3D Printed Complete Dentures Using Two Impression Techniques: RCT

the aim of this crossover randomized controlled clinical trial is comparing retention of 3D printed maxillary complete dentures produced from thermoplastic impression trays and conventional acrylic impression trays.

The research hypothesis is that there is no difference in patient satisfaction and retention of dentures constructed from definitive impression using the conventional tray and the prefabricated thermoplastic tray


Eligibility Criteria:
Inclusion Criteria:

* Male edentulous patients.
* Cooperative and highly motivated patients.
* Patients with well or moderately developed ridges and healthy attached mucosa of appropriate thickness free from inflammation

Exclusion Criteria:

* Patients with recent extraction less than 3 months ago
* Patients with Parkinson's disease
* Patients with xerostomia.
* Patients with allergy to resins.
* Pathological changes of residual ridges.
* Patient with sever undercuts, or irregular bony exostosis.
* Patients with flabby and flat ridges.
* Patients with medical or psychological conditions that hinder co-operation.
* Patients with class II or III jaw relation.
A Natural History Study of Patients With Dry Eye

This is a multi-center, prospective, controlled, observational study of the natural history of patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Males at least 55 years old or females, at least 40 years old with perimenopausal symptoms
* Baseline OSDI score of ≥ 13
* Patients with mild to moderate dry eye (dry eye disease patients only; not applicable for control group)

Exclusion Criteria:

* Use of any topical cyclosporine ophthalmic emulsion within 3 months of baseline
* History of herpes keratitis or varicella zoster keratitis
* Any history of allergic conjunctivitis
* Temporary or permanent occlusion or cauterization of the lacrimal puncta for either eye
* Any anterior segment surgery involving a limbal or corneal incision (cataract surgery), keratorefractive procedure (LASIK, LASEK, PRK) within 12 months of baseline, or expectation of such surgery within 2 years
* Patients with known systemic disease
* Any history of corneal transplant
Comparasion of Efficacy of Nebulized With Intravenous Magnesium Sulphate in Children With Asthma

The purpose of study is to assess the effectiveness of nebulized magnesium sulphate in children presenting with acute asthma.Study perfoma consists of demographic variables,exclusion criteria and pediatric asthma score that includes respiratory rate,SPO2 at room air(requirement of oxygen),auscultatory findings in chest,dysnea and retractions.

After getting informed consent from guardian,148 patients of acute moderate ro severe asthma with pediatric asthma score 8-15 will be randomly classified into 2 groups and one group will receive nebulization with magnesium sulphate and other will receive intravenous magnesium sulphate and effectiveness will be compared by 4 point reduction in PAS from baseline in either groups after 6 hours.

Eligibility Criteria:
Inclusion Criteria:

* patients with age 2 to 12 years with acute moderate to severe exacerbation of asthma as per operational definition children who are unrespoinsive to standard treatment of asthma at 60 minutes

Exclusion Criteria:

* those with history of chronic lung disease and abnormal renal function contraindication for MgSO4 due to hepatic or renal disease allergy to MgSo4 children who has other comorbid illness
Long-Term Exercise Maintenance Via Internet Support

Each year, a significant portion of men and women who engage in physical activities such as walking or running reduce their activity and by doing so place themselves at greater risk of obesity, heart disease, and diabetes. Our own prospective epidemiological studies of runners and walkers suggest that during 7.6 years of follow-up over 40% have reduced their mileage by half or more. Research suggests that social support, perceived health benefits, resiliency to interruptions in training, and exercise self-efficacy predict successful maintenance. We have found that runners who successfully maintained or increased their running mileage during this follow-up were more likely to have participated in social events such as marathon, half-marathon, or 10km races.

The purpose of this study is to build upon our current Internet-based survey tools (www.healthsurvey.org) for tracking physical activity and nutrition on full-function activity and diet logs. The existing software allows participants to visualize their accumulated running and walking mileage on a virtual transcontinental route starting in Yorktown, Virginia and ending in Florence, Oregon. To the existing software, we will add the ability to: 1) choose named or anonymous running and walking partners with similar goals and abilities to travel with (or race against) along the transcontinental trail, 2) communicate with partners to provide mutual support, 3) compete as part of virtual running and walking teams created by the user, and 4) be recognized for completing each state on an awards page (optional). Interest in the site will be maintained by providing regular updates on scientific research on running and walking through our proprietary software. The updates will be created from PubMed abstracts that are made more reader friendly by defining all scientific terms in pop-up balloons.

Participants are refered to a specially designed website to encourage participation

Eligibility Criteria:
Inclusion Criteria:

* Currently walking or running for exercise Prior participation in the National Runners' or Walkers' Health Studies

Exclusion Criteria:

* Under 18 years old No internet access
Treating Acute MI Patients With Aggrastat on Their Way to Hospital

Treating an AMI patient with ST elevation with Aggrastat in the ambulance on his or her way to the hospital.


Eligibility Criteria:
Inclusion Criteria:

patients with acute Myocardial infarction with ST elevation , and moving by ambulance to Poriya hospital

Exclusion Criteria:

* women less than 50 years old and 80 years old, bleeding tendency, stroke in the past
Tax Preparation Pilot

The goal of this study to understand what percentage of families in the pediatric clinic at Boston Medical Center (BMC) currently file taxes and use free tax preparation and would accept and use referral to a free tax preparation service. The investigators specifically want to understand which of two methods of connecting to free tax preparation (referral versus navigated connection) is more effective. Also studied will be the feasibility of using surveys on financial wellness and other health indicators to track participants' health.

These pilot findings will be used to design a larger study that aims to assess whether integrating free tax preparation services into a pediatric clinic can increase tax filing rates and, as a result, the amount of money families receive in tax refunds. Additionally, the investigators hope to understand whether receiving this service impacts parental stress as well as how parents and babies are using the healthcare system.


Eligibility Criteria:
Inclusion Criteria:

* Guardian of a child 0-5 years
* English, Spanish, or Haitian-Creole -speaking
* Child is a Boston Medical Center pediatric primary care patient

Exclusion Criteria:

* Guardian not present at time of clinic visit
* Have no taxable income for the calendar year
* Not using BMC for pediatric primary care
* Have already filed their taxes for 2020
A Comparison of Sustained and Extended Release Bupropion Following Bariatric Surgery

This study is being conducted to evaluate how the body absorbs and processes the sustained release (SR) and extended release (XL) medication bupropion (Wellbutrin®). Subject who are 1-3 years post gastric bypass surgery will be invited to participate. Non-surgical controls will also be enrolled based on a matching criteria to post gastric bypass subjects. Participants will be asked to complete two 12-hour study days approximately 11 days apart.


Eligibility Criteria:
Inclusion Criteria:

1. Male or Female
2. Age 18-65 (inclusive, at time of informed consent)
3. No tobacco use in the past three months.
4. Underwent Roux-en-Y Gastric Bypass weight loss surgery 12-36 months prior to study OR has not had a weight loss surgery but matches the gastric bypass patients on age, gender, and BMI.
5. Ability to read, write and understand English

Exclusion Criteria:

1. Taking a medication that has a clinically significant interaction with bupropion or an interaction that may alter the study data.
2. Hypersensitivity to bupropion or any excipient contained within the dosage forms.
3. Inability to tolerate repeated blood draws.
4. Any history of bipoloar disorder or a psychotic disorder.
5. Current major depressive disorder or current suicidality.
6. Alcohol or substance dependence in the past year.
7. Currently pregnant or lactating or unwillingness to use medically accepted contraception during study
8. Taking a medication which significantly alters gastrointesinal transit time or significantly reduces acid secretion (e.g. routine use of proton pump inhibitors, H2 antagonists, sucralfate).
9. Medical conditon which may increase participant risk with bupropion (e.g., history of significant head injury, seizure disorder, etc.)
10. Self reported history of viral hepatits or HIV.
11. Positive urine drug screen unless documented prescription of a non-interacting medication.
12. History of seizures or epilepsy or other conditions which may increase seizure risk with bupropion as described in the package insert (e.g. history of significant head injury, alcoholism, etc).
13. History of eating disorder such as anorexia nervosa or bulimia.
14. Renal impairment as evidenced by an estimated glomerular filtration rate of less than 60 ml/min/1.73 m2 as reported by the laboratory, or any other abnormality on a renal panel that the medical provider feels puts the participant at risk or may compromise the study data
15. Hepatic insufficiency as defined by any hepatic enzyme greater than 3x the upper limit of normal or other hepatic laboratory abnormalities at the discretion of the medical provider.
16. Any significant electrolyte abnormality on a basic metabolic panel that the medical provider feels may put the subject at risk of a seizure from bupropion.
A Study of the Effects of Pirtobrutinib (LOXO-305) on Repaglinide (CYP2C8 Substrate) in Healthy Participants

The main purpose of this study is to evaluate the effect of pirtobrutinib (LOXO-305) on single oral dose of repaglinide (CYP2C8 substrate) when administered as multiple doses by conducting the blood tests to measure how much pirtobrutinib (LOXO-305) is in the bloodstream and how the body handles and eliminates pirtobrutinib (LOXO-305) in adult healthy participants. The study will also evaluate the safety and tolerability of pirtobrutinib (LOXO-305). The study is conducted in two periods. Participants will stay in this study for up to 54 days.


Eligibility Criteria:
Inclusion Criteria:

* Must have Body mass index (BMI) within the range of 18.0 to 32.0 kilograms per square meter (kg/m²), inclusive
* Male and female participants in good health, determined by no clinically significant findings from medical history, 12-lead Electrocardiogram (ECG), vital sign measurements, or clinical laboratory evaluations as assessed by the investigator
* Female participants of non-childbearing potential and male participants who follow standard contraceptive methods
* Must have comply with all study procedures, including the 16-night stay at the Clinical Research Unit (CRU) and follow-up phone call

Exclusion Criteria:

* History or presence of any diseases or conditions of clinical significance by the Investigator (or designee) and/or Sponsor
* Known ongoing alcohol and/or drug abuse within 2 years prior to Screening
* History of significant hypersensitivity, intolerance, or allergy to any drug compound, food, or other substance, unless approved by the Investigator (or designee)
A Comparative Study of Ultrasound Versus CT Measurement of Tongue and Oral Cavity Size

Difficulty in managing the airway is the single most important cause of major anesthesia-related morbidity and mortality. The currently used clinical method of predicting airway difficulty used by anesthetists is limited and not very highly sensitive or specific. Any additional bedside method that increases its specificity and sensitivity would be valuable. This project is designed to study and measure the tongue thickness and oral cavity height by using an ultrasound scan and comparing them with the same measurements obtained by CT scan. These will also be compared to a more complicated measurements used in previous studies to investigate any correlation with the currently used clinical methods. This information will help us decide if ultrasound may help Anesthesiologists assess difficulties in airway management in a more accurate, precise and reliable simpler method.


Eligibility Criteria:
Inclusion Criteria:

* Age between 18 to 80 Years
* Gender: Both males and females are eligible for the study
* ASA I-III
* Scheduled for CT-scan of the head and neck as part of medical investigation (for test validation part)

Exclusion Criteria:

* Volunteer/ patient refusal
* Language Barrier
* Known oropharyngeal, laryngeal or head and neck disease or cancers
* Multiple amalgam fillings of the teeth
* Past history of oral or head and neck surgical procedures
* Past history of burns or radiotherapy of the head and neck region
* Presence of any scars, sinuses, infection, swelling, cysts in the head and neck region
Caudal Blockade and Electrocardiographic Changes

Caudal epidural blockade is frequently used as an adjunct to general anesthesia in children for perioperative analgesia. Intravascular injection of local anesthetic is a known complication that can adversely affect the neurological and cardiovascular systems. This study will look at the delayed effects of a caudal epidural block on the electrical activity of the patient's myocardium by trying to characterize the incidence of ECG changes within 60 minutes after the caudal dose is given.


Eligibility Criteria:
Inclusion Criteria:

* ASA grade 1 or 2
* Receiving general anesthesia with a caudal block

Exclusion Criteria:

* Preexisting cardiac comorbidities
Assaults Against Health Care Professionals in a Tertiary Intensive Care Unit

This study aims to investigate the occurrence of workplace violence, both physical, verbal, and sexual assaults, from patients and their relatives towards intensive care unit staff members.

Workplace violence, as defined by the International Labor Organization, includes any action, incident, or behavior that assaults, threatens, harms, or injures a person during their work. Healthcare workers face the highest risk of workplace violence among all professions. Violence can take many forms, including verbal abuse, physical offenses to sexual harassment. While most research focuses on psychiatric and emergency departments, workplace violence in intensive care units (ICUs) is understudied and often underreported.

As a result, little is known about its prevalence and risk factors, leading to a lack of awareness and effective prevention strategies. The aim of this retrospective single-center cohort study is to investigate the occurrence of workplace violence, both physical, verbal, and sexual assaults, from patients and their relatives towards ICU staff members. The study will assess the frequency, characteristics, and circumstances of these events in an intensive care setting. Additionally, the consequences of such incidents and the measures taken afterward will be examined. This analysis aims to identify potential risk factors and possible targets for intervention, ultimately contributing to the development and implementation of protocols that enhance the safety of both healthcare professionals and patients.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age
* Reported incident of physical, verbal or sexual violence in the intensive care unit at the University Hospital Basel

Exclusion Criteria:

None defined.
UVB-Induced MVP Release in Human Skin

This study is designed to assess if ultraviolet B radiation (UVB) found in sunlight causes the release of microvesicle particles in human skin, and if antioxidant vitamins can block their production.


Eligibility Criteria:
Inclusion Criteria:

* Male subjects
* Ages 21 to 45
* Skin type: Fitzpatrick Type I or II

Exclusion Criteria:

* Have underlying diseases that could affect wound healing
* On medications that are known photosensitizers (e.g., doxycycline) or anti-inflammatories (e.g., NSAIDS \[except for low-dose aspirin\] or steroids)
* History of abnormal scarring (e.g., keloids)
* Should not be on Vitamin C or E supplements for past month
* Unable to understand/complete informed consent
* Large volar arm tattoos that would inhibit the ability to conduct/evaluate the skin testing
* Renal compromise/kidney stones or allergy to Vitamin C/Vitamin E or lidocaine anaesthetic
* Use of tanning bends or recent UVB exposure to the areas in the past 3 months
* Recent (within 1 week) use to sunscreen to volar forearms
Prontosan Versus Saline in the Cleansing of Chronic Leg Ulcers in Diabetic Patients

This is a randomized controlled double blinded study involving two (2) investigational sites in the United States. All subjects (n=40) will receive either Prontosan Wound Irrigation Solution and Gel treatment or standard of care treatment (0.9% saline) and placebo gel. This is a 12-week study.


Eligibility Criteria:
Inclusion Criteria:

* Male or female diabetic (type I or II) patients ≥ 18 years of age.
* Diabetic ulcer(s) present for ≥ 4 weeks located below the knee.
* A total surface area of ≥ 3 cm2 and ≤ 16 cm2.
* Willingness to wear an off-loading device if medically indicated (e.g., DH shoe or Walker).

Exclusion Criteria:

* Pregnant women and nursing mothers.
* Uncontrolled diabetes as defined by glucose levels \>225 mg/dl.
* HbA1c ≥ 12%.
* Subjects with a wound infection.
* Subjects receiving antibiotic therapy within 14 days of enrollment.
* Subject with history of or clinical evidence of: Cardiac insufficiency (NYHA functional classification IV), angina pectoris (CCS functional classification IV), unstable pulmonary, renal, hepatic, endocrine or hematologic disease as determined by the Investigator (serum creatinine of \> 3.0; transaminase or alkaline phosphatase levels equal to or greater than 5 times the upper limit) malnutrition (albumin \< 2.5 g/dL).
* Peripheral arterial occlusive disease with a non-palpable pulse on both dorsal pedial and the posterior tibial artery.
* Presence of gangrene.
* Active rheumatic or collagen vascular disease (including rheumatoid arthritis, scleroderma, and systemic lupus erythematosus)
* Subjects that have been diagnosed with HBV, HVC, AIDS or are HIV positive.
* Osteomyelitis diagnosed by x-ray, bone biopsy, or other radiological procedure within 90 days prior to Screening Period.
* Active radiation therapy below the hip.
* Subject currently receiving, or has received oral or parenteral corticosteroids, immunosuppressive or cytotoxic agents within 30 days prior to Baseline Visit (Visit 1, Week 0) or is anticipated to require such agents during the course of the study.
* Current participation or participation in another investigational drug or medical device study within the last 30 days.
* Subjects who test positive for alcohol and or illicit drug use.
* Subjects who are unable to comprehend or comply with study requirements or ability to sign an informed consent.
* Subjects, who in the opinion of the Investigator would not be a suitable candidate for this study (reason for exclusion needs to be documented).
Resistance Exercise Effects on Fear Avoidance and Physical Function in Obese Older Adults With Low Back Pain

The purpose of this study is to determine if a 4 month resistance exercise program reduces the severity of low back pain, pain-related fear avoidance and improves mobility compared to standard care.


Eligibility Criteria:
Inclusion Criteria:

* chronic low back pain for \>6 months
* \>3 pain episodes per week
* waist circumferences ≥102 cm for men
* waist circumferences ≥ 88 cm for women
* willing and able to participate in regular exercise for 14 weeks
* using pain medications to control low back pain
* free of abnormal cardiovascular responses during a screening graded maximal walk test

Exclusion Criteria:

* unable to walk
* participating in regular resistance exercise training (\>3X week) in the past 6 months
* pain symptoms are too severe and prevent strength testing or walking
* acute back injury
* spinal stenosis that precludes walking one block due to neurogenic claudication
* back surgery within the past 2 years
* current use of weight loss interventions (drugs; exercise interventions)