cyrilzakka/clinical-trials huggingface dataset:
Prevention of Infections in Cardiac Surgery

There is clinical equipoise about the question of whether antibiotic prophylaxis should be given for a short period or an extended period of time as reflected by inconsistencies in major guidelines, current practices at Canadian centers, and as concluded in the three systematic reviews. There also is clinical equipoise on whether the addition of vancomycin to routine cefazolin prophylaxis can further reduce s-SSI rates. A short duration of combined antimicrobial prophylaxis can reduce side effects of exposure to antimicrobials such as infections with C. difficile or emergence of resistance, but may also reduce the incidence of s-SSIs. The objective of the eventual full scale study is to determine whether adding vancomycin to cefazolin can reduce SSIs as well as whether short-term prophylaxis is as effective as long-term prophylaxis. The rationale to conduct the proposed pilot study is to assess the feasibility to conduct this factorial cluster randomized cross-over trial, the adherence to the study protocol at each pilot site, the length of time to fill out the case report forms, and to get reliable estimates of event rates for sample size calculation for the main study


Eligibility Criteria:
Inclusion Criteria:

* All adult patients (≥18 years of age) undergoing open-heart surgery (sternotomy, including minimally-invasive surgical techniques).

Exclusion Criteria:

* Patients on antibiotics at the time of surgery.
* Previous enrollment in this trial.
* Known MRSA carriers. Beta-lactam allergy (IgE-mediated) precluding the use of cefazolin
* Participant in another study that may interfere with this trial.
Randomized DB Controlled Trial of Botulinum Toxin A in Hemiplegic Shoulder Pain and Spasticity

The purpose of this study is to evaluate whether botulinum toxin type A injected into muscles around the shoulder is effective in treating shoulder pain and improving function in patients with shoulder pain and involuntary muscle tightness after a stroke.

Subjects with shoulder pain and spasticity at the shoulder following a stroke resulting in hemiplegia are eligible for participation. Following an initial screening visit involving a history and physical examination, subjects will be entered in to the study if they have significant spasticity of shoulder internal rotation/adduction associated with pain rated at least a 4 on the VAS for pain. Subjects will also be given a cognitive screening in which they will be asked to rate pain in hypothetical situations.

Shoulder pain is a frequent complication following hemiplegic stroke, and may result in further disability. Spasticity is also a complication following stroke . Botulinum toxin is used in the treatment of post-stroke spasticity and may also have pain modulating effects. Participants in this study will be asked to make total of 6 visits over a period of approximately 13 weeks. Eligible subjects will be randomized to 100 to 200 units of botulinum toxin type injected into the pectoralis major at the second visit. If there is significant spasticity for shoulder extension, subjects will also receive injections into the teres major. Subjects will be followed up with assessments of pain, functioning, active and passive range of motion and depression following the initial injection. At the 12 weeks post injection visit, the blinding will be broken and subjects initially injected with placebo will be injected with the active drug. This will be done to give all subjects an opportunity to receive the active drug, as well as to assess the effects of any differences with delayed treatment. All subjects will return 4 weeks later to repeat the same assessments above. Subjects will be called at one year post study enrollment for repeat pain ratings and for information regarding subsequent treatments.

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Eligibility Criteria:
Inclusion Criteria:

* Post stroke greater than 2 months
* Shoulder pain despite PT/OT interventions
* Weight greater than 88 lbs
* Stable medically
* Spasticity

Exclusion Criteria:

* Myasthenia gravis or other medical conditions that preclude use of botulinum toxin
* Pregnancy
* Infection or dermatologic conditions at the injection site
Efficacy of Hypnosis on Pain and Anxiety During Lumbar Puncture for Etiological Diagnosis of Cognitive Impairment

Lumbar puncture is a diagnostic procedure performed as part of the etiological assessment of cognitive disorders. Despite good tolerance and very rare complications, lumbar puncture is still perceived as being painful or anxiety-provoking by patients. Hypnosis could improve pain and anxiety when performing lumbar puncture.

Lumbar puncture is an invasive procedure potentially inducing pain and anxiety indicated in elderly patients for cognitive assessment. Indeed, the measure of amyloid biomarkers and tau in the cerebrospinal fluid is useful in the etiological diagnosis of cognitive disorders. With the ageing of the population and the increase incidence of cognitive disorders, this diagnostic procedure will be more and more frequent. Many studies have shown the efficiency of hypnosis during invasive procedure, especially in young children. The absence of side-effect is a major asset in elderly patients at high iatrogenic risk. It represents an interesting alternative to anxiolytic or sedative treatments. Nevertheless, its effectiveness in the elderly during lumbar puncture remains to be demonstrated. Investigators hypothesized that hypnosis may decrease pain and anxiety during lumbar puncture associated to setting comfort situation (relational care, music, transcutaneous anesthesia).

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 70 years old
* Indication for a lumbar puncture for etiological diagnosis of cognitive impairment
* Understanding French Language
* Written and informed consent for this study signed by the patient
* Affiliated to Health Insurance

Exclusion Criteria:

* MMS\< 17 or cognitive impairment not allowing informed consent
* Contraindication to lumbar puncture
* Refusal to sign the written and informed consent
* Patient deprived of freedom by court or administrative order
Phototherapy Combination With Topicals in Vitiligo

Patients will be included in a randomized controlled clinical trial, will enroll only adult vitiligo patients with surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NBUVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo.

Patients to be included in this randomized controlled study are adults with generalized vitiligo of surface area of at least 10% who are being followed in the outpatient dermatology clinics of King Abdullah University Hospital (KAUH) and are planned to start on phototherapy Narrow Band Ultraviolet light B (NB-UVB), regardless if they have previous treatment for their disease, one month wash off period will be given for patients who are already on phototherapy or other treatments for vitiligo. In our going study, adult patients will be enrolled into 2 groups ( around 20 patients per each) in which NBUVB will be given 2-3 sessions per week in combination with one of the following randomly; one group will start on Tacrolimus 0.1% ointment twice daily, a second group will start on calcipotriol \& betamethasone containing cream once daily, photos will be taken and the exact sites involved will be detected, efficacy of treatment will be assessed according to repigmentation percentages of vitiligo areas from baseline at 3 and 6 months. The improvement at 6 months compared to baseline will be classified into 5 groups according to the percentage of repigmentation as follow; excellent (76%-100%); moderate (51%-75%); mild (26%-50%); minimal (1%-25%); or no response.

Eligibility Criteria:
Inclusion criteria:

* Adult patients ( ≥ 18 years).
* Diagnosed with vitiligo clinically and by using wood's light
* Generalized type vitiligo and BSA ≥ 10%
* Planned by his physician to start on phototherapy
* Wash off period for patients on treatment of one month duration.

Exclusion criteria:

* Children less than 18 year old
* Localized type vitiligo or BSA less than 10%
* Unable to do phototherapy
* Pregnant women with vitiligo
* Previously failed to response to phototherapy
The First Twenty (TF20) for Volunteer Firefighters in a Clinic Based Setting

The First Twenty® (TF20) was recently developed as a not-for-profit, web-mobile program for firefighters (FFs) specifically focused on improving fitness and nutrition knowledge and practices. The program was designed by FFs with backgrounds in tactical fitness, marketing and program development professionals, and nutrition and exercise scientists. Preliminary data suggests the program is well-received by FFs and results in significant improvement in body composition and physical fitness. One innovative approach for the eventual dissemination of TF20 to VFFs is through their fitness-for duty medical exams. The synergy created by linking the TF20 intervention components, feedback to the VFFs from their medical exam, and health messages from their physician is predicted to maximize the impact of this much-needed intervention. The goal of the proposed project is to tailor TF20 for use in a clinic based setting (CB-TF20) for VFFs and to pilot test it in comparison to the American Heart Association's Life's Simple 7 (LS7), a web-based diet and physical activity knowledge/behavior and lifestyle program. The specific aims are to: 1) Conduct formative research with key stakeholders in the VFF community (e.g., physicians, department leadership, VFFs) to determine best practices for implementing a clinic-based, web-mobile health and wellness program with VFFs and medical providers; 2) Develop a clinic-based version of TF20 (CB-TF20) and beta-test it with VFFs; and, 3) Conduct a 6 month, 2-arm, pilot cluster (i.e., department) randomized clinical trial (PCRCT) to determine the comparative effectiveness of the revised CB-TF20 to LS7 on body composition, Framingham Risk Scores, and diet/physical activity knowledge and behaviors among VFF with BMI \>25.0kg/m2; and conduct an evaluation of the CB-TF20 materials and technology. This innovative R34 study is a critical step in providing a much needed intervention for VFFs and those providing their annual examinations.

The US fire service serves as the front line of defense against any domestic emergency and volunteer firefighters comprise the majority of firefighters, often with negative consequences for the health of personnel. While rates of overweight and obesity remain high among firefighters and cardiovascular disease remains the leading cause of line of duty deaths, few resources tailored to the unique culture and needs of firefighters are available to help occupational medicine physicians who provide their fitness for duty examinations. By engaging firefighters and occupational medicine clinicians in tailoring an internet/mobile intervention and pilot testing the program with a sample of volunteer firefighters, the investigators will be poised to implement a full-scale clinical trial with the developed program.

Eligibility Criteria:
Inclusion Criteria:

* Willing to complete all assessments
* Internet accessibility via computer, tablet or smartphone and ability to use devices appropriately
* Medically cleared to participate in the program through clinicians
* ≥18 years

Exclusion Criteria:

* Not meeting inclusion criteria
Geography of ED Use and Population Health

The goal of this study is to create predictive models of emergency care and metrics for population health that can be used to analyze how events like hospital closures or disasters like Hurricane Sandy affect health care utilization by patients in specific populations or geographic regions. Additionally, it will allow the development of metrics for population health that can act as surveillance mechanisms to measure disease prevalence and identify patterns in emergency department use that can be used to identify specific geographic regions where health care is either optimized to promote health or needs to be improve so that population health can be improved.

The purpose of this study is to analyze the geographic patterns of emergency department utilization. This study will look at the relationship that geographic proximity and local population factors have on patient use of emergency departments. Geographic proximity of alternative hospitals and elicit other patient and hospital specific factors, such as demographic, insurance type, diagnosis, and socioeconomic factors that lead patients to choose specific hospitals for emergency care or generally lead to patients accessing emergency care will be compared.

Patterns of emergency department utilization by patients will be identified in specific geographies such as Census tracts to determine clusters of high and low emergency department use. We also analyze the patterns of emergency care use based on specific disease conditions.Investigators will analyze the rate of emergency department use for patients with diabetes to determine population prevalence of diseases using emergency department data. Studying the pattern of use by specific geographies or disease conditions will also allow us to understand how emergency department use varies among populations by geographies and the socioeconomic and health care factors local to those regions.

Eligibility Criteria:
Inclusion Criteria:

* Patients visiting an emergency department in New York State

Exclusion Criteria:

* Depending on the population analyzed, may exclude some subpopulations such as children (in order study adults), prisoners or patients transferred from other healthcare facilities (in order to study non-institutionalized individuals).
Genomic Determinants of Outcome in Cardiogenic Shock

The aim of this project is to understand the heterogeneity of both the immune consequences and treatment responses in CS. We will explore this heterogeneity through identification of transcriptomic sub-phenotypes and their association with outcomes, including therapeutic responses.

This is a prospective observational cohort study in 8-10 cardiac centres across Europe. We will recruit patients presenting with acute myocardial infarction (AMI) and CS who are supported medically (n=100); with extracorporeal membrane oxygenation (n=50); and with the Impella Device (n=50). We will also enrol patients who present with either AMI and no evidence of CS (n=50) or CS due to non-ischaemic pathologies (e.g. myocarditis: n=50) as comparators. The recruitment target is 300 patients.

Eligibility Criteria:
Inclusion Criteria:

* All of the following are required for inclusion following screening:

  * Willing to provide informed consent or appropriate consent from a nominated consultee or personal consultee
  * Presentation within 24 hours of onset of ACS symptoms.
  * CS can only be secondary to ACS (Type 1 MI STEMI or N-STEMI) or myocarditis
  * Planned or completed revascularisation of culprit coronary artery

CS will be defined by:

* Systolic blood pressure \<90 mmHg for at least 30 minutes
* A requirement for a continuous infusion of vasopressor or inotropic therapy to maintain systolic blood pressure \> 90 mmHg.
* Clinical signs of pulmonary congestion, plus signs of impaired organ perfusion with at least one of the following manifestations:

  * altered mental status.
  * cold and clammy skin and limbs.
  * oliguria with a urine output of less than 30 ml per hour.
  * elevated arterial lactate level of \>2.0 mmol per litre.

Exclusion Criteria:

* Any of the inclusion criteria not met and:

  1. Unwilling to provide informed consent.
  2. Echocardiographic evidence (recorded within 90 mins of end of PCI procedure) of mechanical cause for CS: eg ventricular septal defect, LV-free wall rupture, ischaemic mitral regurgitation.
  3. Age \<18 and ≥80 years.
  4. Shock from another cause (sepsis, haemorrhagic/hypovolaemic shock, anaphylaxis, etc).
  5. Significant systemic illness
  6. Known dementia of any severity
  7. Comorbidity with life expectancy \<12 months.
  8. Out-of-hospital cardiac arrest (OHCA) and any of the following:

     1. No return of spontaneous circulation (ongoing resuscitation effort)
     2. pH \<7
     3. Without bystander CPR within 10 minutes of collapse
  9. Arterial lactate level of \<2.0 mmol per litre.
Pharmacokinetics of IDX719 in Participants With Normal and Impaired Hepatic Function (MK-1894-008)

The purpose of this study is to evaluate the pharmacokinetics (PK) and safety and tolerability of single-dose administration of IDX719 in participants with normal hepatic function and participants with varying degrees of hepatic impairment.


Eligibility Criteria:
Inclusion Criteria:

* Read and sign the written informed consent form (ICF) after the nature of the study has been fully explained.
* All subjects of childbearing potential must have agreed to use a double method of birth control (one of which must be a barrier) from Screening through at least 90 days after the last dose of the study drug.
* Male subjects have agreed not to donate sperm from Day -1 through 90 days after the last dose of study drug.

Exclusion Criteria:

* Pregnant or breastfeeding.
* Other clinically significant medical conditions or laboratory abnormalities
Oxytocin on Approach Bias and Craving

This will be a laboratory-based investigation of the behavioral and neural effects of intranasal oxytocin on craving for alcohol and approach bias in moderate to heavy alcohol using subjects. This study uses a within-subject, randomized, placebo-controlled, counterbalanced, crossover design to compare the effects oxytocin and placebo. In this way, all subjects will be scanned twice; once following oxytocin administration and once following placebo administration, and will complete a series of behavioral tasks (both in and out of the scanner) at both visits.


Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers who are 21-40 years of age
* If female, 10 or more alcoholic drinks must be consumed weekly.
* If male, 14 or more alcoholic drinks must be consumed weekly.
* Meets DSM-V criteria for Alcohol Use Disorder (AUD).
* Score 8 or greater on the Alcohol Use Disorders Identification Test (AUDIT)
* If female, must be non-lactating, not pregnant, and using a reliable contraception method (i.e. abstinence, intrauterine device \[IUD\], hormonal birth control, or barrier method).
* Native English speaker
* Right handed
* High school graduate or equivalent.
* Able and willing to provide an informed consent.
* Able to understand and follow the instructions of the investigator

Exclusion Criteria:

* Positive urine drug screen (except marijuana).
* Using cocaine, stimulants (other than nicotine and caffeine), amphetamines, hallucinogens, ecstasy, opiates, sedatives, pain pills, sleeping pills, or other psychoactive drugs within 2 weeks of the start of the study (except marijuana).
* Marijuana use more than 3 times/week.
* Current enrollment in an alcohol, or other drug treatment program or current legal problems relating to alcohol, or other drug use.
* Currently trying to quit alcohol use.
* History of major alcohol related complications within the preceding 2 years (liver failure/cirrhosis, pancreatitis, esophageal varices, etc.).
* Has a history of atrophic rhinitis, recurrent nose bleeds, cranial surgical procedures, hypophysectomy, chronic congestion, or sinus problems.
* Has a history of cardiac arrhythmia.
* Clinically significant medical or psychiatric illness requiring treatment as determined by screening blood tests, medical history, and/or physical exam performed or reviewed by the study physician.
* Severely low blood (\< 90/50) pressure or uncontrolled high blood pressure (\>160/100).
* SGPT/ALT or SGOT/AST values greater than 2x upper limit of normal.
* BAC level \> 0.00% at the beginning of screening visit (within margin of error of detection).
* Has a neurological dysfunction or psychiatric disorder (confirm with study physician).
* Has a history of brain trauma (confirm with study physician).
* Has an allergy or intolerance to oxytocin.
* Has received an investigational drug within 30 days of Screening Visit.
* Has any MRI scanning contraindications.
* Has a history of claustrophobia.
Single-dose AME Study With [14C]AR882 in Healthy Male Subjects

This is an open-label, single-dose, absorption, metabolism, excretion, and mass balance study following a single dose of \[14C\]AR882 in healthy adult male subjects. Whole blood, plasma, urine, and fecal samples will be analyzed for at least 144 hours following the single dose of AR882 to measure total radioactivity and plasma drug concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Body weight no less than 50 kg and body mass index (BMI) within the range of ≥ 18 and ≤ 33 kg/m2
* Must have a minimum of 1 bowel movement every 2 days
* Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, vital signs or ECGs

Exclusion Criteria:

* Inadequate venous access or unsuitable veins for repeated venipuncture
* Positive serology to HIV (HIV1 and HIV2) and/or Hepatitis C antibodies, and/or Hepatitis B
Acoustic Stimulation for Seizure Suppression

The objective of this study is to test the feasibility and physiological effect of low-frequency (1 Hz) acoustic stimulation delivered during nocturnal NREM sleep in epilepsy patients. The long-term goal is to develop this protocol for daily, long-term use in a home setting, for nocturnal seizure and IED suppression

1. To test the feasibility of wearing an earphone system delivering acoustic stimulation during a night of sleep in adult epilepsy patients monitored in an inpatient unit.
2. To determine the acute physiological effects of low-frequency acoustic stimulation on interictal epileptiform discharge (IED) frequency during NREM sleep in adult patients with epilepsy in an ambulatory setting.
3. To determine the feasibility of applying low-frequency acoustic stimulation in a long-term home setting in adult epilepsy patients with frequent nocturnal seizures.

Eligibility Criteria:
Inclusion Criteria:

* 18-60 years old
* Able to provide informed consent
* MOCA ≥26
* Fluent in English
* Frequent nocturnal IEDs (≥ 10% of the sleep record)
* Monitored on the adult epilepsy monitoring unit (EMU, for Aim 1 only) Additional inclusion criteria for Aim 3
* Frequent nocturnal seizures (≥1 per week)

Exclusion Criteria:

* Hearing impairment
* Diagnosis of a sleep disorder (sleep apnea, periodic limb movements of sleep, or other medical conditions with frequent arousals)
* Psychoactive medication use (other than AEDs, for example SSRIs, antipsychotics, BDZ, or stimulants)
* Seizures ≤ 24 hours prior to study.
* Alcohol or recreational drug use in the 24 hours prior to the study
* BMI ≥ 30
* MOCA \<26
* History of recent travel across time zones within the 1 month prior to study activities
* Shift work for 1 month prior to study activities Additional Exclusion Criteria for Aim 3
* No medication changes at least 1 month before study, and during 3 months of study activities