cyrilzakka/clinical-trials huggingface dataset:
Botulinum Toxin Type A Injection After Topical Anesthesia Versus Petrolatum Ointment

The purpose of this study is to determine whether there is a difference in clinical effect, duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia on one side of the forehead and petrolatum ointment on the other prior to Botulinum Toxin Type A administration for the treatment of forehead rhytides.

This is a prospective, randomized, double-masked, comparative study in patients who present at the Robert Cizik Eye Clinic with horizontal forehead rhytides requiring treatment with botulinum toxin Type A (Botox ®; Allergan, Irvine, CA, USA).

The objective of this study is to determine whether there is a difference in clinical effect (weakness/paralysis of the frontalis muscle), duration of effect, level of discomfort and patient satisfaction in patients receiving topical anesthesia (2.5% lidocaine/2.5 % prilocaine cream, Impax Laboratories, LLC) on one side of the forehead and petrolatum ointment on the other prior to BTX-A administration for the treatment of forehead rhytides.

* Primary outcome variable is change of eyebrow excursion on each side of the forehead from baseline to each follow-up visit.
* Secondary outcome variables

  * Duration of effect, defined as the elapsed time from injection to the end of botulinum, such that return of baseline frontalis function, i.e. within 2 mm of baseline value
  * Perception of pain immediately after injection at each side
  * Patient satisfaction for each side
  * Patient's perception of difference in efficacy

Eligibility Criteria:
Inclusion Criteria:

* 18 to 65 years of age
* Presence of horizontal forehead rhytides
* Good eyebrow excursion (greater than or equal to 5 mm)
* Able to understand and sign an informed consent form that has been approved by the Committee for the Protection of Human Subjects

Exclusion Criteria:

* Previous injection of botulinum toxin in the intended treatment area for the study within the last 4 months
* Known allergy to botulinum toxin
* Known history of sensitivity to local anesthetics of the amide type
* Existing disorder of neuromuscular transmission
* Usage of medication with effect on neuromuscular function
* Women of childbearing potential (who are not postmenopausal for at least 1 year or surgically sterile), who are pregnant or nursing or intend to become pregnant during the time of the study
* Significant brow asymmetry (\> 5mm)
* Unable to follow-up for the duration of the study (16 weeks)
The Effect of Surgical Incision Size on Carpal Tunnel Surgery

This study will investigate the postoperative recovery advantages from having a smaller incision to a larger incision.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing open carpal tunnel release will be included in this study.
* Patients must have clinical evidence of Carpal Tunnel Syndrome
* Patients must have positive EMG results

Patient selection factors include:

1. Ability and willingness to follow instructions
2. Patients who are able and willing to return for follow-up evaluations.
3. Patients of all races and genders.
4. Patients who are able to follow care instructions.

Exclusion Criteria:

* Patients less than 18 years old
* Patients unwillingly or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.
* Patients who qualify for inclusion in the study, but refuse consent to participate in the study.
ST Segment Resolution After Primary Percutaneous Coronary Intervention.

To compare the ST segment resolution after primary percutaneous coronary intervention (PPCI) with and without thrombus aspiration in patients with ST segment elevation myocardial infarction as ST segment resolution is the best indicator for the prediction of the outcome and MACE

The idea of an occluding thrombus and its dissolution had been stated since the 1950s.1 Thrombus is present in the infarct-related artery in 88% of patients undergoing coronary artery angiography within the first 4 h of acute myocardial infarction (AMI).

The finding of ST segment elevation in a patient presenting with chest pain allows rapid identification of those who benefit from emergency reperfusion.

Primary percutaneous coronary intervention (PPCI) is now the preferred strategy for emergency reperfusion in patients presenting with ST elevation myocardial infarction (STEMI).

Thrombus aspiration (TA) might be an effective procedure for reducing distal embolization and improving microvascular perfusion in ST-segment elevation myocardial infarction (STEMI), especially in patients with high thrombus burden.

Despite the class III recommendation for routine Thrombus Aspiration use before balloon angioplasty or stenting. manual Thrombus Aspiration might still remain a useful strategy for the interventional cardiologist when treating selected patients with significant thrombus burden during PPCI.

Thrombus grading is classified as:

Grade 0: No angiographic characteristics of thrombus are present. Grade 1: Possible thrombus is present with a such characteristics as: Reduced contrast density, haziness, irregular lesion contour Or smooth convex meniscus at the site of total occlusion Suggestive but not diagnostic of the thrombus.

Grade 2: There is a definite thrombus with greatest dimension \<1/2 the vessel diameter.

Grade 3: There is a definite thrombus but with greatest linear dimension\>1/2 but \<2 vessel dimension.

Grade 4: There is a definite thrombus but with greatest linear dimension \>2 vessel dimension.

Grade 5: There is a total occlusion (unable to assess thrombus burden due to total vessel occlusion.

The analysis of ST-segment resolution on the electrocardiogram (ECG) consists of a simple tool, of easy use and low cost, able to document success of the epicardial reperfusion and tissue reperfusion after primary PCI.

The persistence of ST-segment elevation on the ECG, despite the restoration of a normal epicardial flow, signifies a poor prognosis; such persistence is known to be associated with larger infarct size and higher combined rate of severe cardiovascular adverse events.

Eligibility Criteria:
Inclusion Criteria:

. patients with STEMI within 24 hours of chest pain.patients killip class 1 is included in this study

xclusion Criteria:

* killip II-IV
* Previous myocardial infarction
* Patients with left bundle branch block
* Patients with advanced cancer disease
* Patients qith contraindications to anti-coagulation
* Patients with sensitivity to clopidogrel
Evaluation of the H1-coil Deep TMS in the Treatment of Negative Symptoms and Cognitive Deficit in Schizophrenia

The study evaluates the feasibility of using a 4 week stimulation protocol with the deep TMS H-coils for the treatment of negative symptoms and cognitive deficit in schizophrenia patients


Eligibility Criteria:
Inclusion Criteria:

* DSM IV Diagnosis of Schizophrenia
* PANNS Negative \> 21

Exclusion Criteria:

* risk factors for convulsions
* PANNS positive \> 24
Comparison Study of ISV-303 to Durasite Vehicle in Cataract Surgery Subjects

The purpose of this study is to evaluate the ocular safety, tolerability and efficacy of topical administration of ISV-303 compared with Durasite Vehicle.


Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects age 18 or older scheduled for unilateral cataract surgery with posterior chamber intraocular lens implantation
* If a female is of childbearing potential, the subject must agree to and submit a negative pregnancy test before any protocol-specific procedures are conducted. The subject must use effective contraception for the duration of the study. Post menopausal is defined as having no menses for at least 12 consecutive months
* Signature of the subject on the Informed Consent Form
* Willing to avoid disallowed medications for the duration of the study
* Willing and able to follow all instructions and attend all study visits
* Able to self-administer the IMP (or have a caregiver available to instill all doses of study drugs )
* Additional inclusion criteria also apply

Exclusion Criteria:

* Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the IMP or any of the procedural medications
* Currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive pregnancy test
* Currently suffer from alcohol and/or drug abuse
* Prior (within 30 days of beginning study treatment) or anticipated concurrent use of an investigational drug or device
* A condition or a situation, which in the investigator's opinion may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation
* Additional inclusion criteria also apply
Comparison of Immuno, Reacto and Safety of Recombinant Hepatitis B Vaccine With or Without MPL in Healthy Older Adults

In the present study the immunogenicity, reactogenicity and safety of recombinant hepatitis B vaccines with and without MPL will be evaluated in older healthy subjects

At the time of conduct of this study, the sponsor GlaxoSmithKline was known by its former name SmithKline Beecham

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects between 50 and 70 years old.
* Written informed consent will have been obtained from the subjects.
* Good physical condition as established by physical examination and history taking at the time of entry

Exclusion Criteria:

* Positive titres for anti hepatitis antibodies
* Any vaccination against hepatitis B in the past.
* Any previous administration of MPL
* Elevated serum liver enzymes at two subsequent determinations 14 days apart.
* History of significant and persisting hematologic, hepatic, renal, cardiac or respiratory disease.
* Axillary temperature \> 37.5°C at the time of injection.
* Any acute disease at the moment of entry.
* Chronic alcohol consumption.
* Any treatment with immunosuppressive or immunostimulant therapy.
* Any chronic drug treatment, which in the investigator's opinion, precludes inclusion into the study.
* History of allergic disease likely to be stimulated by any component of the vaccine.
* Administration of any other vaccine(s) or any immunoglobulin during the study period.
* Simultaneous participation in any other clinical trial.
Brain Retraction Monitoring Sensor Study

The purpose of this study is to utilize a sensor incorporated into a brain retractor blade to monitor electrical activity and pressure applied to the brain during retraction required for the selected skull base operations. The overall goal of the study is to develop a protocol and guidelines to prevent the development of brain retraction injury during neurosurgical procedures requiring significant retraction.

During neurosurgical operations for aneurysms, tumors, or other lesions located in the skull base, the surgeon must employ retracting devices in order to displace one or more lobes of the brain enough to gain adequate surgical exposure. These retractors are adjusted by hand to optimize exposure. It is often difficult for the surgeon to gauge the amount of pressure actually applied to the brain during such placement of the retractor. Moreover, it is also possible to position the blade of the retractor inadvertently such that a focal pressure point occurs at the tip of the retractor blade against the brain. Thus, injury to the brain can occur as a result of brain retraction when either the force applied is excessive or when the pressure is not adequately distributed to a large enough area of brain. This injury is thought to be the result of ischemia (inadequate blood flow) caused by the retraction, local trauma, or a combination of both. It has been estimated that this type of brain retraction injury occurs in approximately 10% of major cranial base tumor procedures or 5% of intracranial aneurysm surgeries. The specific aim of this research is to identify changes in electrical activity of brain tissue subjected to necessary retraction during neurosurgical procedures that may give forewarning of imminent brain retraction injury. It is anticipated that this information will permit development of guidelines that will enable the neurosurgeon to take steps to minimize such injury, i.e., by temporarily releasing or otherwise modifying the brain retraction. Cerebral electrical activity, together with the amount of retraction pressure being applied, will be recorded directly from the tissue at risk by means of a silastic electrode grid containing a pressure monitor placed on the surface of the cerebral cortex underneath the retractor blade.

Eligibility Criteria:
Inclusion Criteria:

* A patient must be scheduled to undergo skull base surgery requiring significant brain retraction
* Informed Consent

Exclusion Criteria:

* None, other than patients in whom major surgical complications are encountered that are unrelated to brain retraction may be excluded from subsequent data analysis
The Effect of Ear Plug and Eye Mask on Sleeping Quality in Critically Ill Patients

Sleep is a complex physiologic and behavioral process essential for rest, repair, well-being, and survival. Sleep is defined as a periodic, reversible state of cognitive and sensory disengagement from the external environment. Critically ill patients experience poor sleep quality. Surveys of ICU survivors have shown that sleep disruption, pain and intubation for mechanical ventilation are the major sources of anxiety and stress during the ICU stay. Many physiological, psychological and environmental factors contribute to the incidence of sleep disruption for the ICU patients. The primary physiologic factors documented in the literature are pain, medications and illness.The primary psychological factors documented in the literature are stress and worry. Environmental factors include noise, patient care activities and therapeutic modalities as mechanical ventilation. Our research aim will be the impact of effective interventions like use of ear plugs and eye mask on decreasing light exposure and promoting sleep in ICU patients.

50 patients in the age range 18- 60 years admitted to ICU of Assiut university hospitals will be randomly allocated into into two groups (control group and intervention group).

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old.
* Mechanically ventilated patient.
* Conscious patient.
* No hearing problems.
* No eye disease.
* Not receiving narcotic drugs five to six hours before sleep time at night.
* No underlying disease that is affecting sleep such as rheumatoid arthritis and migraine.

Exclusion Criteria

* Head injury.
* Psychiatric disease.
* Shocked patients
A Study to Assess Intraocular Pressure and Ocular Safety of the Beta-3 Agonist Mirabegron in Research Subjects

The purpose of this study is to assess the affect of mirabegron on intraocular pressure (IOP) in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* Female subject must be either post-menopausal (defined as at least 2 years without menses) or surgically sterile (at least 1 month) or of childbearing potential with contraception. All women of childbearing potential will be required to use contraception consisting of two forms of birth control (one of which must be a barrier method), must not be lactating, and must not be breastfeeding during the study period and for 30 days after final study drug administration. All women of childbearing potential must have a negative urine pregnancy test
* Male subject with female spouses/partners who are of childbearing potential must use contraception consisting of two forms of birth control (one of which must be a barrier method) during the study period
* Subject may either be otherwise healthy or have symptoms of overactive bladder by self-report

Exclusion Criteria:

* History of glaucoma or ocular hypertension
* Abnormal visual field in either eye
* Ophthalmic condition that would interfere with reliable Goldmann tonometry (e.g., corneal edema, uveitis, severe keratoconjunctivitis sicca)
* History of major ocular infection, inflammation, or herpes simplex keratitis; evidence of current clinically significant blepharitis or conjunctivitis
* Any history of ocular surgery including refractive surgery such as laser-assisted in situ keratomileusis (LASIK) or photorefractive keratectomy (PRK) in any eye
* Ocular trauma within the past six months
* Severe myopia
* Diabetes, Type I or Type 2, with or without medical management
* Cardiovascular disease requiring pharmacotherapy
* History of any type of dysrhythmia
* Systemic hypertension requiring pharmacotherapy
* Past diagnosis of any connective tissue or autoimmune disease including rheumatoid arthritis and spondyloarthropathies
* History of psychiatric illness requiring hospitalization
* Recent history (within past 24 months) of alcohol or other substance abuse (with the exception of nicotine)
* Used tobacco-containing products or nicotine-containing products within past 3 months
* Has been part of any clinical study past within 30 days or currently taking part in a clinical study other than the present study, or has participated in any previous study with mirabegron at any time
* Ocular medication of any kind within past 30 days
Sleep for Inpatients: Empowering Staff to Act

Getting better sleep in the hospital is especially important due to a variety of adverse health effects that can potentially worsen patient recovery.

To address these concerns and improve sleep in US hospitals, we aim to develop the SIESTA (Sleep for Inpatients: Empowering Staff to Act) program as an educational intervention designed to prepare hospital staff to assist patients in obtaining better sleep in hospitals and recognize the importance of screening for sleep disorders. The major educational goals of this proposal is to develop and pilot test an online educational program (SIESTA) which aims to train and motivate medical professionals to provide better sleep for hospitalized patients.

We will utilize data from an ongoing sleep study, performed by the research team at the University of Chicago that looks at how adult patients are able to sleep while they are in the hospital, as a means of education for the participating medical staff.


Eligibility Criteria:
Inclusion Criteria:

* To be eligible to participate in this study, the subjects must be University of Chicago hospital employees over the age of 18 years old.

Exclusion Criteria:

* We will exclude any hospital staff under the age of 18 years old from this study as well as hospital patients and non-hospital staff.
Comparison of the Right and Left Internal Jugular Vein Using Ultrasound

The purpose of this study is to determine whether there is a difference between the diameter, and the cross-sectional area of the right internal in left internal jugular vein in preoperative, mechanically ventilated patients.

Secondary the relationship between the internal jugular vein to the common carotid artery will be examined.

Placement of a central venous catheter (CVC) for surgery is used for hemodynamic monitoring and venous access. Most often the right internal jugular vein (RIJV) is used. The RIJV is preferred over the left-sided internal jugular vein (LIJV) because cannulation of the LIJV is more difficult and associated with a higher complication rate(1). A possible explanation for the higher complication rate can be explained by the difference in diameter between the RIJV and the LIJV. It has been demonstrated that large vessels are easier to catheterize than small ones.

Data suggest that the internal jugular veins are most often asymmetric but data are limited. Until now, there is one small prospective study in which 80 ICU patients where examined (30 patients were mechanically ventilated) which showed an asymmetry in 62,5% and a dominant RIJV in 68% and a smaller study performed by Lobato and colleagues in which 50 healthy patients were examined. They measured the cross-sectional areas of the internal jugular veins. They showed that in 80% the RIJV was greater than the LIJV. Two CT studies has been done so far. In 2009 Tartière and colleagues carried out an observational study in 190 patients. All patients were in the supine position, neutral head position an spontaneous breathing. During the CT patients were asked to hold there breath. The study showed that the diameter and cross-sectional area of the RIJV were significantly greater than those of the LIJV. A smaller retrospective CT-study (88 patients) performed by Lim et al in 2006 showed a larger RIJV in 79,5% compared to the LIJV.

Until now, there are no data known about the difference between the RIJV and LIJV in preoperative mechanical ventilated patients when ultrasound is used.

Eligibility Criteria:
Inclusion Criteria:

* all patients who will need a central venous access preoperative are included (e.g. for medication, nutrition, antibiotics)and are mechanically ventilated

Exclusion Criteria:

* \< 18 years of age
* neck or head surgery in the past
* radiation therapy of the neck
* known thyroid pathology
* skeletal deformities.
A Study to Evaluate the Effect of Vagus Nerve Stimulation in Patients Undergoing VT Ablation

Vagus nerve stimulation (VNS) has been shown to be beneficial in multiple studies including heart failure. The goal of this clinical investigation is to gain additional information about how vagus nerve stimulation relates to abnormal heart rhythms. The outcomes of this study will help researchers design new therapies for patients that have complex and life-threatening ventricular arrhythmias.

This study is a non-randomized, prospective study in 6 patients with scar mediated ventricular arrhythmias who are scheduled to undergo a catheter ablation procedure. The study will last up to 30 minutes in the cardiac electrophysiology lab. Cervical VNS is performed percutaneously through the internal jugular vein during the patient's routine ventricular tachycardia (VT) ablation procedure.

Eligibility Criteria:
Inclusion Criteria:

* Presence of structural heart disease as defined as EF ≤ 50% or presence of ventricular scar as detected by imaging modalities or electroanatomic mapping, hypertrophic cardiomyopathy, cardiac sarcoidosis, or arrhythmogenic right ventricular cardiomyopathy.
* Age \> 18 years old
* Underlying sinus rhythm with heart rate \> 50 bpm.
* Provision of signed/dated informed consent and stated willingness to comply with all study procedures

Exclusion Criteria:

* Active ongoing cardiac ischemia as assessed by: ECG, cardiac enzymes, symptoms, coronary angiography with evidence of significant epicardial coronary stenosis (\>70%), or stress testing. (Note: positive troponin assay due to Internal Cardiac Defibrillator (ICD) shocks is not an exclusion criterion).
* Status post orthotopic heart transplantation
* Women who are pregnant (as evidenced by pregnancy test if pre-menopausal).
* Unable or unwilling to comply with protocol requirements.
* Known channelopathy such as long QT syndrome, Brugada syndrome, and catecholaminergic polymorphic VT.
* Known peripheral neuropathy or history of autonomic dysfunction due to non-cardiac causes.
* New York Heart Association Class IV heart failure or use of current vasopressor medications
* Incessant VT
* Persistent atrial fibrillation
* Frequent premature atrial or ventricular contractions
* Inability to give informed consent.