cyrilzakka/clinical-trials huggingface dataset:
Medication Errors and Adverse Drug Events (ADEs) in Ambulatory Pediatrics

The purpose of this study is to determine the rates of medication errors in pediatric outpatients in 6 office practices. Further, we wish to determine the effectiveness of a computerized physician order entry (CPOE) system in reducing errors.

This study has the following 2 goals:

Aim 1: To determine the rates, types, and predictors of medication errors and ADEs.

Aim 2: To perform a trial assessing the effectiveness of an intervention (CPOE) on reducing serious medication errors.

We hypothesize that:

1. Medication errors and ADEs are frequent in ambulatory pediatrics.
2. Presence of the following predictors will be associated with higher error rates: cultural, racial, socioeconomic, educational, and linguistic barriers to communication, understanding, and successful completion of prescribed therapies; complex medical or chronic medical conditions; complex medication regimens; non-physician providers with limited clinical experience; high provider workloads; and complex prescription refill systems.
3. Prevention strategies, including both technology-based and behavioral/ human factors-based interventions, will be effective and cost-effective in reducing rates of serious medication errors (defined as preventable ADEs and non-intercepted potential ADEs).

Eligibility Criteria:
Inclusion Criteria:

* Pediatric providers at the participating office practices during the study period as well as the parents of the patients of these providers.

Exclusion Criteria:

* Pediatric providers or patients at other office practices.
Vestibular Innovation in Pain

The VIP trial will assess the effectiveness, tolerability, and durability of effect of vestibulocortical stimulation (VCS) - a safe \& cost-effective bedside technique - in treating pain, fatigue \& related symptoms using validated patient-reported outcomes. Data from this trial will be used to guide optimized treatment protocols in future randomized controlled trials and help inform the implementation of VCS into standard clinical practice.

VCS is a form of non-invasive neuromodulation whereby cold water is irrigated into the external ear canal.

Eligibility Criteria:
Inclusion Criteria:

* Provision of signed and dated informed consent form
* Age equal to or \>18 years old
* Stated interest in and willingness to receive VCS and to complete the online patient reported outcomes before and after the procedure.
* Owns or has access to a smart phone or computer to complete outcome measures
* Diagnosis of one of the following:

  * Fibromyalgia (FM), with at least a 4/10 average baseline pain on the numeric rating scale at the time of inclusion.
  * Myalgic Encephalomyelitis/Chronic Fatigue Syndrome (ME/CFS)
  * Long-COVID
  * Post Treatment Lyme Disease Syndrome (PTLDS)

Exclusion Criteria:

An individual with any of the following criteria will be excluded from participation in this study:

* History of tympanic membrane injury, rupture, or surgery

  * Including tympanostomy, or "ear tubes," and/or cochlear implant.
* Ear infection within the last 3 months, or current ear pain.
* Current pregnancy
* Bipolar Disorder
* History of seizures (including non-epileptiform seizures)
* History of syncope
* Inability to lay supine for 30 minutes
* Clinically significant medical, psychological, or behavioral conditions that, in the opinion of the investigator, would compromise participation in the study
* Not fluent in English
* History of or current Meniere's Disease
* History of myocardial infarction (MI), stroke or TIA, or coronary artery bypass graft (CABG) in the last three months
* History of hospitalization for severe hypertension
* History of vestibular schwannoma or meningioma resection.
Study Safety and Effectiveness of CURVE Laser Therapy for Circumference Reduction of the Waistline.

The purpose of this study is to assess the safety and effectiveness of the CURVE Low-Level Laser Therapy for circumference reduction of the waistline.

This study involves research to obtain information on the CURVE. In recent years Low Level Laser therapy devices have grown in popularity due to increased scientific understanding of their mechanism of action, published research, and patients demand for more non-invasive procedures in body contour and fat reduction. LLL are widely used in health clinics, medical spas and in aesthetic medicine in the treatment of cellulite and for inflammatory conditions such as carpal tunnel syndrome. This study will further evaluate the effectiveness of low-level laser treatments without the extraction of adipose tissue using liposuction or in combination with other treatment modalities.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is an adult ≥ 18 years old and \<65 years of age
2. Subject has maintained a stable weight for the past 6 months (variation no greater than 10 lbs. from "usual weight").
3. Subject is willing to maintain current diet and exercise regimen for the duration of study.
4. Subject is willing and able to provide written informed consent.
5. Subject is willing to return for all scheduled and required visits.
6. Subject is willing to comply with post-laser treatment cardiovascular exercise.
7. Subject is willing to comply with food and fluid requirements pre-treatment and post-treatment.

Exclusion Criteria:

1. Subject is on an active weight control regimen.
2. Subject has a pacemaker.
3. Subject has a history of epilepsy.
4. Subject has a history of any type of cancer, including skin cancer.
5. Subject had a prior surgical intervention for body sculpting/weight loss such as liposuction, abdominoplasty, gastroplasty, lap band surgery, etc.
6. Subject has a medical, physical, or other contraindications for body sculpting/weight loss.
7. Subject has an active infection, wound or other external trauma to the areas to be treated with the laser.
8. Subject is pregnant, breast feeding, or planning pregnancy prior to study end.
9. Subject is participating in any treatment other than the study procedure (existing or new) to promote body contouring and/or weight loss during the course of study participation.
10. Subject is participating in another research study of a device, medication, biologic, or other agent within 30 days or could, in the opinion of the investigator, affect the results of this study.
Adjuvant Treatment of Postoperative Pain Following Endoscopic Carpal Tunnel Surgery by Auriculotherapy

Retrospective study on the effect of auriculotherapy on postoperative pain after carpal tunnel surgery

the project consists of a retrospective analysis of data from the medical records of patients followed by Doctor, between 2016 and 2017, at the Bizet Clinic. This study includes measurements of pain levels and analgesic consumption in patients who received during their care in the clinic a preoperative auriculotherapy session offered by the clinic, during the three days following carpal tunnel surgery. For comparison, this studie also includes a group who underwent the same surgery treated only with analgesics. The objective of study is to analyze the results obtained in the two groups in order to evaluate the effectiveness of auriculotherapy for the management of postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18 to 84 years.
* Patients suffering from carpal tunnel syndrome for whom elective endoscopic surgery is indicated

Exclusion Criteria:

* Have already benefited from an auriculotherapy session.
* Presence of cryoglobulinemia.
* Presence of Raynaud's syndrome.
* Presence of hemoglobinopathy (hemoglobin and capillary abnormalities).
* Allergy to cold.
* Presence of dermatological lesions on the auricle of one of the two ears
Withdrawal Versus Continuation of Amiodarone in Successfully Treated Patients With Persistent Atrial Fibrillation

Amiodarone is considered to be the most effective antiarrhythmic drug in the prevention of persistent atrial fibrillation. It can however cause many adverse events, both cardiac and non-cardiac. Long-term maintenance of sinus rhythm after cardioversion is difficult especially because of high recurrence rates during the first month after cardioversion. Duration of atrial fibrillation, type of underlying disease, left ventricular function, left atrial size and age are associated with maintaining sinus rhythm. Early recurrence of atrial fibrillation may be related to a highly arrhythmogenic period due to recovery from electrical remodelling. Late recurrences may be related to other triggers than recovery from electrical remodelling. In this study the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of late relapses of persistent atrial fibrillation. Furthermore, the investigators want to investigate the effect of amiodarone withdrawal on the occurrence of amiodarone related adverse events as well as adverse events related to atrial fibrillation or underlying heart disease. The investigators also want to investigate which patients characteristics are and potential triggers have a prognostic value in the occurence of late relapses after amiodarone withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* history of persistent atrial fibrillation, necessitating at least one electrical cardioversion
* presence of sinus rhythm during the last 6 months, while on amiodarone treatment without adverse events related to amiodarone
* clinically stable
* age \> 18 years
* written informed consent

Exclusion Criteria:

* sinus rhythm maintenance is preferable (because of atrial fibrillation related morbidity or any other reason)
* symptomatic heart failure NYHA III or IV
* unstable angina pectoris
* hemodynamically significant valvular disease
* concomitant treatment with other class I or III antiarrhythmic drug
* PCI,CABG, other cardiac surgery or major non-cardiac surgery within the last three months
* recent myocardial infarction (\< 3 months)
* presence of any disease that is likely to shorten life expectancy to \< 1 year
Effect of Pentoxifylline on Cognitive Impairment After Ischemic Stroke

Pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function. The patients with cognitive impairment and non-dementia PSCIND after ischemic stroke were randomly divided into two groups. In addition to the basic drugs of ischemic stroke, the patients were given pentothemine sustained release tablets and blank control respectively to observe the effects of pentothemine on cognitive function and neuronal electrical signals in the patients with ischemic PSCIND. It is expected to explore the possible internal biological mechanism by using transcranial Doppler, oxygen-dependent functional magnetic resonance imaging and craniocerebral magnetic resonance pop analysis. Finally, statistical correlation analysis was used to elucidate the specific mechanism of pentoxifylline in improving cognitive function of non-dementia patients with cognitive impairment after ischemic stroke.

Pentoxifylline can improve cognitive impairment after ischemic stroke, possibly by improving the level of cerebral blood flow, affecting the content of blood oxygen and metabolic substances in the brain, and then playing a protective role in the transmission of nerve electrical signals, and ultimately improving cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Han Chinese, age 40-80 years old, male and female, right-handed;
* The diagnosis is consistent with the Expert Consensus on the Management of Cognitive Impairment after Stroke 2021;
* NIHSS score 1-15 points;
* Daily Living Ability Scale (ADL) ≥75 score;
* The Informed consent signed by the patient or his legal representative

Exclusion Criteria:

* Can not cooperate with the examination (including neuropsychological tests and scale assessment);
* There were memory disorders, dementia with lewy bodies and frontotemporal dementia before the onset of stroke events;
* There were definite infectious diseases 2 weeks before admission; Have a serious mental illness, previous history of cancer, alcohol or drug abuse;
* Use of drugs that may affect cognitive function, including sedatives, anti-anxiety drugs, hypnotics, nootropic drugs, and cholinoid drugs;
* Can not accept brain MRI examination
Anti-Cytokine Therapy for Hemodialysis InflammatION

Anti-Cytokine Therapy for Hemodialysis InflammatION (ACTION) is a phase II multi-center study to evaluate the safety and tolerability of anakinra, an IL-1 receptor antagonist, for patients treated with maintenance hemodialysis.

The ACTION Trial will enroll 80 participants being treated with maintenance hemodialysis for end-stage renal disease. Participants will be randomized to receive Anakinra, 100 mg administered intravenously 3 times per week at the end of the hemodialysis session, or matched placebo. The duration of study drug administration is 24 weeks. There will be an additional 24 weeks of follow-up after study drug administration has been completed.

Eligibility Criteria:
Inclusion Criteria:

1. Maintenance hemodialysis therapy 3 times per week for end-stage renal disease
2. ≥6 months since hemodialysis initiation
3. C-reactive protein measured by high sensitivity assay (hsCRP) ≥2.0 mg/L at screening and within 10 days prior to randomization
4. Most recent single pool Kt/V \> or = 1.2 within 30 days prior to first screening visit
5. Negative tuberculosis interferon gamma release assay (e.g. Quantiferon-TB Gold) for tuberculosis unless documented treatment for a) positive PPD, b) positive interferon gamma release assay, or c) tuberculosis.
6. Negative human immunodeficiency virus (HIV) antibody test, negative hepatitis C Ab test unless viral clearance following direct antiviral therapy is documented, and negative hepatitis B surface antigen positivity.
7. For women of childbearing potential, willingness to use a highly effective method of birth control for up to 4 weeks after the last dose of anakinra.
8. Ability to provide informed consent

Exclusion Criteria:

1. Current or anticipated use of a hemodialysis central venous catheter
2. Acute bacterial infection, including vascular access infection, within 60 days prior to screening unless treated with antibiotics and resolved. Any chronic bacterial infection (e.g., osteomyelitis or bronchiectasis)
3. Hospitalization within 30 days unless for vascular access procedure
4. Cirrhosis
5. Malignancy within the past 5 years with exception of basal or squamous cell carcinoma
6. Use of an immunosuppressive drug within the past 3 months except low doses of oral corticosteroids (total daily dose ≤10 mg/day of prednisone or equivalent)
7. Receipt of live vaccine within the past 3 months. Live vaccines include Varicella zoster, measles, oral polio, rotavirus, yellow fever, and the nasal spray influenza vaccine
8. Absolute neutrophil count (ANC) \<2,500 cells/mm3 (2.5 x 109 cells/L)
9. Platelet count \<100,000/mm3 (100 x 109/L)
10. Known allergy to anakinra
11. Anticipated kidney transplantation, change to peritoneal dialysis, or transfer to another dialysis unit within 9 months
12. Expected survival less than 9 months
13. Pregnancy, anticipated pregnancy, or breastfeeding
14. Incarceration
15. Receipt of an investigational drug within the past 30 days
16. Current or anticipated participation in another intervention study
The PRESSURE CABG Cardiac Surgery Trial

This study will be a pragmatic, prospective, single-centre, unit-based cluster crossover, open-label registry trial. The cardiac surgical intensive care unit (CSICU) will be cluster assigned to alternating MAP targets in 6-month blocks in a sequence. Additional sites across Alberta may be added, as necessary.

Personalized Arm: The target MAP will be defined as +10% of the resting MAP. Resting MAP will be defined in priority order using one of the following MAP measurements:

* Pre-operative anesthesia or surgical consultation;
* Other physician outpatient consultation (e.g. cardiology, family physician, internist) within 30 days of surgery;
* Inpatient measurement the night before surgery;
* Pre-anesthetic MAP

The lower and upper safety limits of personalized MAP targets will be 50mmHg and \<90mmHg, respectively.

Protocolized Arm: The target MAP will be defined as 65 +/- 5mmHg. Pharmacologic and fluid treatment decisions will be at the discretion of the most responsible physician.

In both study arms, the blood pressure control period will extend from anesthetic induction until 12 hours after admission to the CSICU. As an additional safety metric, the anesthesiologist will be encouraged to utilize clinically-driven cerebral saturation monitoring to identify potential hypoperfusion. In cases with low bilateral saturations where the anesthesiologist feels low MAP may be the putative mechanism, the investigators will request that MAPs be raised in 5mmHg increments. Following completion of the study protocol, the MAP and/or systolic blood pressure targets will be at the discretion of the most responsible physician.

Eligibility Criteria:
Inclusion Criteria:

* All patients \> or = to 18 years of age undergoing non-emergent CABG

Exclusion Criteria:

* Pre-induction use of intravenous inotrope, vasopressor, or vasodilator
* Re-operation during the index hospital stay
* Non-CABG valvular or aortic surgery
* \*Patients with end-stage renal disease or pre-operative AKI (defined as in-hospital increase in creatinine by \>50%) will be excluded from the renal outcomes but included in the analysis of secondary outcomes
Electronic Cigarettes (E-cigarettes) as a Harm Reduction Strategy

The purpose of this study is to examine the feasibility of using e-cigarettes as a method for harm reduction and the effects of providing e-cigarettes (or placebo e-cigarettes) on smoking outcomes. Participants will be randomized to receive either e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges, and followed for 3 weeks.

This pilot study will be a two-arm, randomized controlled trial. The investigator will randomize 40 participants into each intervention arm. Participants will be randomized to one of the two arms: e-cigarettes with nicotine cartridges or e-cigarettes with placebo cartridges (0mg). Participants and research assistants will be blind to the allocation of nicotine or placebo e-cigarettes as there are no difference in appearance or odor of the mist emitted from the e-cigarettes with and without nicotine containing cartridges. Participants will be asked to track their nicotine use via text message. All participants will receive a 20-30 minute behavioral counseling consultation with a trained tobacco counselor. Counselors will review each participant's smoking pattern and offer tailored behavioral and environmental change strategies including specific smoking reduction strategy options. Participants will be given a supply of e-cigarettes and followed for 3 weeks

Eligibility Criteria:
Inclusion Criteria:

* 21-35 years old
* daily smokers who smoke at least 10 cigarettes per day (CPD)
* interested in reducing CPDs
* able to provide consent
* Use a cell phone and are willing/able to receive and respond to daily text messages regarding their cigarette use and e-cigarette use on their cell phone
* Willing to use an e-cigarette for 3 weeks

Exclusion Criteria:

* pregnant and/or breast feeding
* currently using smoking cessation medications (including other forms of Nicotine Replacement Therapy (NRT), buproprion, or varenicline)
* enrolled in a smoking cessation program or another cessation trial
* have used an e-cigarette in the past 14 days
* have used any other tobacco products (pipe, cigar, cigarillos, snuff, chewing tobacco, rolling tobacco, or hookah/shisha) in the past 30 days
* score ≥7 (men) or ≥5 (women) on the Alcohol Use Disorders Identification Test (AUDIT-C),
* score ≥ 5 on the Drug Abuse Screening Test-10 (DAST)
* report having a history of asthma, other airways diseases, or heart disease.
PET/MR Imaging In Patients With Cardiac Sarcoidosis

PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac sarcoidosis, a condition which causes scarring and inflammation within the heart muscle, is of particular interest.

The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. This will allow imaging of abnormal areas within the heart in this condition alongside treatment regimens in a way which hasn't been done before. If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.

All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. The scan will be performed twice; once before treatment and once after treatment has been established. A cohort of healthy volunteers will undergo scanning in exactly the same way to enable us to compare the results with hearts of people who don't have cardiac sarcoidosis.


Eligibility Criteria:
Inclusion Criteria:

Cardiac Sarcoidosis Patients:

* Aged over 40 years
* Completion of informed consent
* Established diagnosis of cardiac sarcoidosis
* Established diagnosis as per HRS recommended diagnostic criteria

Healthy Volunteers:

* Aged over 40
* Completion of informed consent

Exclusion Criteria:

* All participants:
* Inability or unwilling to give informed consent
* Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.
* Major intercurrent illness with life-expectancy \<2 years.
* Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
* Adverse reaction or hypersensitivity to 18F-FDG PET tracer
* NYHA Class IV heart failure
* Patients with atrial fibrillation and poor rate control
* Contraindications to MRI scanning
* Previous history of contrast allergy of adverse reactions (Gadolinium-containing agents)
RELIVE Informed Consent Study

An organ transplant is frequently the best option and, in some cases, the only option to save the lives of transplant recipients. Receiving an organ from a living donor eliminates the need to wait for a deceased donor, an option that many transplant recipients do not survive. However, donating an organ presents health concerns to the donor as well. This study will use surveys to evaluate the understanding of risk and psychological pressure that living organ donors felt when making the decision to donate. It will also compare participants' answers across geographic, racial and socio-economic backgrounds.


Eligibility Criteria:
Inclusion Criteria:

* Living donor of a kidney or lung

Exclusion Criteria:

* Unable to give informed consent
The Success of Pediatric Percutaneous Nephrolithotomy

Between June 1997-June 2018, 573 pediatric patients underwent PCNL for renal stone disease by senior surgeons. Data was disunited into 2 groups.

The study showed that PCNL is an operator-dependent procedure, with the improvement of outcomes over time, presumably due to increased operator experience and the involvement of a team member with substantial prior experience During 20 years, by gaining experience and with the development of new tools and optics, fluoroscopy time, operation time, blood loss and complication rates decreased and stone-free rates increased.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patients with kidney stone

Exclusion Criteria:

* Patients with a solitary kidney