cyrilzakka/clinical-trials huggingface dataset:
Quantitative Evaluation of Aerosols Produced in the Dental Office

Background: Maintaining biosafety in dental practice requires an efficient elimination of aerosols produced during dental treatment. The objective of this research was to assess the quantity of aerosols and aerobic bacteria present in the air during the treatment of caries. Methods: This study was divided into two groups based on the caries treatment method involving 60 patients with 60 m olar teeth (n=60) in the mandible. Group 1 (n=30) received a conventional dental turbine W\&H Synea TA-98LC (W\&H, Bürmoos, Austria), while Group 2 (n=30) received an Er:YAG laser (LightWalker, Fotona, Slovenia). Measurements of aerosol particles between 0.3 - 10.0 μm near the operator's mouth were taken using the PC200 laser particle counter (Trotec GmbH, Schwerin, Germany). The number of aerobic bacteria in the air was determined using 60 micro-biological plates with a microbiological medium (Columbia Agar with 5% Sheep Blood) and the sedimentation method. A control group G3 was established to measure the initial aero-sol level and the initial total number of bacteria CFUs (colony-forming units) before each treatment.


Eligibility Criteria:
Inclusion Criteria:

- The subjects were chosen for the study under the subsequent inclusion criteria: occurrence of medium or profound caries on Black class I, ICDAS 3,4

Exclusion Criteria:

* Patients with systematic diseases that can influence the treatment of periodontitis
* Patients under or took antibiotics 2 months.
* Patients under or took immunosuppressors the last 6 months.
* Pregnant or lactating woman.
Investigating Dynamic Interactions in Distributed Cognitive Control Networks

The purpose of this study is to investigate the brain activity associated with cognitive tasks (thinking, reasoning, remembering) in order to understand how the brain works during certain tasks and to improve treatment for diseases like dementia and attention deficit disorders. Cognitive (thinking) impairment may include poor memory function, poor attention span, or psychiatric disorders (ex: ADD, depression). The investigators are interested in the brain activity related to these issues, and want to investigate changes in brain activity while we record activity from specific areas of the brain. These recordings are in addition to clinical (routine or standard of care) recordings being performed to monitor for seizures and do not impact the clinical care.

Routine intracranial monitoring (ICM) surgery involves placement of several (10-20) electrodes into the brain through a small opening to a target structure. Participants have been deemed a surgical candidate for this procedure, and detailed discussion of the procedure will occur as part of the surgical consent. The Investigators may place sensors (stickers) to monitor participant's arm/hand movements and brain activity. Sensors may be placed on participant's scalp and/or arms and legs. The Investigators may place a device on participant's wrist or finger to measure position (accelerometer). The Investigators may perform voice recordings, eye movement tracking, and motion capture recordings to obtain measures of how stimulation affects speech and other movements. These are performed without any attachment of devices.

Cognitive tasks: Multiple cognitive tasks may be used and will be decided upon based on the clinical symptoms, exam, or comorbidities. These may include Go/No-go, Simon/Stroop task, Stop-signal task, language tasks, Tower of London, gambling task, maze navigation, choice-reaction time, delay tasks, and attention tasks.

Cortico-cortical evoked potentials and Patterned Stimulation: Stimulus pulses at precise time intervals and or various patterns will be delivered across adjacent electrode contacts at a series of electrode sites while simultaneously recording neural activity at other electrodes. This does not require any activity from participant.

Tasks will be administered via computer monitor positioned in front of the you. This will be connected to a recording computer. Participant will respond via keyboard, mouse, or response button.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for surgery based on multi-disciplinary consensus review
* Have a diagnosis of medically-refractory epilepsy
* A minimum of 18 years of age
* Willingness to participate in the paradigms described in the protocol

Exclusion Criteria:

* Inability to provide full and informed consent
* Age younger than 18
* Are not physically able to participate in study-related activities
* Major medical or surgical complication
Cediranib (AZD2171, RECENTIN™) in Addition to Chemotherapy in Patients With Untreated Metastatic Colorectal Cancer

The purpose of this study is to determine if Cediranib when added to chemotherapy is more effective than chemotherapy alone in prolonging life expectancy and slowing disease progression in patients with previously untreated metastatic colorectal cancer.


Eligibility Criteria:
Inclusion Criteria:

* Written Informed Consent
* Carcinoma of the colon or rectum
* One or more measurable lesions

Exclusion Criteria:

* Adjuvant/neoadjuvant therapy within 6-12 months of study entry
* Untreated unstable brain or meningeal metastases
* Specific laboratory ranges
* Specific cardiovascular problems
* Participation in other trials within 30 days
Divalproex vs. Lamotrigine for Bipolar Disorder

This study is a retrospective chart review of patients treated for bipolar disorder at the TVAMC in the past four years cross-referenced with the electronic pharmacy file for having received a prescription of divalproex or lamotrigine.

The primary objective of the study is to assess the long-term outcome in bipolar patients treated with divalproex versus lamotrigine in a retrospective chart review of veterans as measured by time to relapse into any significant mood episode (i.e. mania or depression). The primary hypothesis is that bipolar patients will demonstrate significantly greater time to relapse in those treated with divalproex compared to those treated with lamotrigine. The secondary objective of the study is to assess the safety and relative tolerability of divalproex and lamotrigine in this population based on discontinuation due to side or adverse effect.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Bipolar I or Bipolar II disorder
* Prescription of divalproex (any formulation except for Depakene/valproic acid) or lamotrigine in the electronic pharmacy profile.
* Age 19 or older
* Demonstrated stability for at least 4 weeks on an adequate dose of each medication (at least 50mg/d lamotrigine or 15mg/kg/day divalproex).
* Treatment at the TVAMC for at least 6 months following the prescription of divalproex or lamotrigine.

Exclusion Criteria:

* Primary diagnosis of schizoaffective or schizophrenia during the evaluation period.
* Prescription of divalproex and lamotrigine given concurrently during the observation period.
* History of Dementia or cognitive disorders
Comparison of a Patient Warming System Using a Forced-air, Non-compressible Under-body Mattress Versus a Regular Forced-air Underbody Mattress System During Pediatric Cardiac Catheterization

The study is a comparison of a patient warming system using a forced-air, non-compressible under-body mattress (Möck \& Möck, Hamburg, Germany) versus a regular forced-air underbody mattress system during pediatric cardiac catheterization in 40 patients.

The hypothesis is, that the non-compressible mattress provides better warming with less incidence of perioperative hypothermia (Core temperature \< 36 °C) and faster warming slope (°C / time). The study is prospective, randomized, controlled and single-blinded.

Inclusion criteria will be pediatric patients \< 1 year of age without fever or a treatment of therapeutic hypothermia.


Eligibility Criteria:
Inclusion Criteria:

* Pediatric patient scheduled for cardiac catheterization (diagnostic and/or interventional)\< 1 year old

Exclusion Criteria:

* fever or therapeutic hypothermia
A Phase 3 Study of NBI-98854 for the Treatment of Tardive Dyskinesia

The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854 administered once daily for the treatment of Tardive Dyskinesia (TD) symptoms.

This is a Phase 3, randomized, double-blind, placebo-controlled, parallel, fixed-dose study to evaluate the efficacy, safety, and tolerability of two doses of NBI-98854 (40 mg and 80 mg) compared to placebo, administered once daily. The study design includes a double-blind, placebo-controlled treatment period for 6 weeks and a double-blind NBI-98854 treatment period for an additional 42 weeks, for a total of 48 weeks of treatment. Final follow-up assessments will be conducted 4 weeks after the last dose of the study drug.

Eligibility Criteria:
Inclusion Criteria:

1. Subjects of childbearing potential must agree to use hormonal or two forms of nonhormonal contraception (dual contraception) consistently during the screening, treatment and follow-up periods of the study.
2. Female subjects must not be pregnant.
3. Have one of the following clinical diagnoses for at least 3 months prior to screening: Schizophrenia or Schizoaffective Disorder, or Mood Disorder.
4. Have a clinical diagnosis of neuroleptic-induced TD for at least 3 months prior to screening.
5. Have moderate or severe TD.
6. If using maintenance medication(s) for schizophrenia or schizoaffective disorder, or mood disorder, be on stable doses.
7. Be in good general health.
8. Have adequate hearing, vision, and language skills to perform the procedures specified in the protocol.
9. Have a negative drug screen for amphetamines,barbiturates, benzodiazepines, phencyclidine, cocaine, opiates, or cannabinoids

Exclusion Criteria:

1. Have an active, clinically significant unstable medical condition within 1 month prior to screening.
2. Have a known history of substance dependence, or substance (drug) or alcohol abuse
3. Have a significant risk of suicidal or violent behavior.
4. Have a known history of neuroleptic malignant syndrome.
5. Have a known history of long QT syndrome or cardiac tachy-arrhythmia.
6. Have a cancer diagnosis within 3 years of screening (some exceptions allowed)
7. Have received an investigational drug within 30 days prior to screening or plan to use an investigational drug (other than NBI-98854) during the study.
8. Have a blood loss ≥550 mL or donated blood within 30 days prior to Baseline.
9. Have an allergy, hypersensitivity, or intolerance to tetrabenazine.
10. Have had previous exposure with NBI-98854 or had previously participated in an NBI-98854 clinical study.
11. Are currently pregnant or breastfeeding.
Anxiety Level Assessment of Anesthesia Providers During COVID-19 Pandemic

Healthcare providers caring for acutely ill or critical patients are exposed to constant stressful situations that can lead to psychiatric manifestations. Depression and anxiety derived from stressful work environments can negatively impact the ability to perform at full capacity directly affecting the quality of care the patients receive.

The Severe Acute Respiratory Syndrome Coronavirus 2 infection created a sudden and deep crisis involving every sector worldwide not only affecting sick patients and the healthcare system but also the economy, politics, food, and drugs and social interactions.

Hospital workers have experienced the crisis first-hand and have witnessed constant death, a decrease in personal protective equipment supplies, exposure to contracting the virus, risk of contagion to others, and overburdened hospital capacity.

The aim of this study is to evaluate how the coronavirus disease 2019 (COVID-19) pandemic has affected healthcare workers. Specifically, to evaluate levels of anxiety and identify factors contributing to anxiety on faculty, residents, and nurse anesthetists in our institution.

The coronavirus disease 2019 (COVID-19) pandemic has affected multiple aspects of everyday life worldwide. Pandemics unleash a societal sense of fear and anxiety. Hence, the COVID-19 pandemic have had a profound impact on mental health. This has led to substantial research on this topic; however, literature evaluating the mental health effects of the pandemic on small groups of people is scarce. Healthcare workers have undergone significant psychological pressure and stress during viral surges of this pandemic. Furthermore, the levels of anxiety vary as the number of cases varies between regions and across time.

After approval by the Institutional Review Board (Protocol # 160167), a cross-sectional study was conducted to identify anxiety levels during the COVID-19 pandemic among anesthesia providers at our institution. The participants included Faculty anesthesiologists, anesthesiology residents, Certified Registered Nurse Anesthetists, and Nurse Anesthetists students. Data were collected from August 26 to September 15, 2020. A questionnaire containing the General Anxiety Disorder-7 (GAD-7) scale, followed by a set of questions with binary answers to evaluate the presence or absence of anxiety-related factors during the COVID-19 pandemic, was administered through direct approach and voluntary participation of the subjects.

Eligibility Criteria:
Inclusion Criteria:

* Anesthesiology providers at Augusta University Medical Center (AU) (Active resident enrolled in the Anesthesiology residency program of Augusta University, Anesthesiologist and Certified Registered Nurse Anesthetist)
* Willingness to participate in the study

Exclusion Criteria:

* Refuses to participate
Multi-component Workplace Energy Balance Intervention

The purpose of the WorkACTIVE-P study is to assess the outcome of an innovative multi-component intervention focused on increasing energy expenditure and re-balancing the disrupted energy balance equation of sedentary workplaces with an ultimate target of reducing workers' abdominal obesity.

The energy expenditure intervention includes replacing workplace sedentary time with access to a dedicated pedal desk and increasing steps/day with wearable monitors. Both components are incorporated into an electronically-delivered behavior monitoring and support infrastructure, thus enabling continuous management. The investigators will utilize pedaldesks manufactured and owned by Pennington Biomedical Research Center to conduct this study at Blue Cross Blue Shield of Louisiana offices in Baton Rouge, La. 40 individuals will be recruited and randomized to either a control arm or combined Walk More Pedal Desk (WMPD) intervention. Primary (MRI-determined visceral adipose tissue) and secondary (changes in body weight, total adipose tissue, subcutaneous adipose tissue, blood pressure, blood lipids, fasting glucose and insulin, HbA1-c, free-living accelerometer-determined walking, time spent in sedentary behavior, exercise, and dietary intake) outcomes will be assessed at baseline and month 3.

Eligibility Criteria:
Inclusion Criteria:

* BMI: \> or equal to 25.0 kg/m2 and \< or equal to 40 kg/m2
* Waist Circumference: \>102 cm (men) or \> 88 cm (women)
* Any one of the other four defining risk factors defining metabolic syndrome (Triglycerides \> or equal to 150 mg/dL , HDL Cholesterol \< 40 mg/dL (men) or \< 50 mg/dL (women), Resting blood pressure \> or equal to 130 mm Hg systolic / 85 mm Hg diastolic, Fasting glucose \> or equal to 110 mg/dL)

Exclusion Criteria:

* Systolic blood pressure \> 179 mmHg and/or diastolic blood pressure \> 99 mmHg
* Self-reported Type 1 or Type 2 diabetes, or use of diabetes-related medications
* Significant CVD or disorders
* Other significant medical conditions including but not limited to implants that may interfere with MRI, chronic respiratory, gastrointestinal, neuromuscular, or psychiatric conditions, malignancies in the past 5 years, with the exception of skin cancer therapeutically controlled, endocrine (including diabetes), any other medical conditions or disease (including arthritis) that is life threatening or that can interfere with or be aggravated by exercise.
* Poor compliance to activity monitors
Low Protein Diet in Patients With Collagen VI Related Myopathies

* This is a 2 stage exploratory study with a 3-month observational phase on the natural course, followed by a 12-month, open-label, non-comparative, single-arm, phase II pilot study on the efficacy, safety and tolerability of a low-protein diet (LPD) in 8 adult patients with Bethlem myopathy (BM) and Ullrich congenital muscular dystrophy (UCMD).
* Objective of this trial is to test the effect of a normocaloric LPD to reactivate autophagy in BM/UCMD patients. The primary end point of the study will be the change in muscle biopsy of Beclin 1, a marker of autophagy, at 1 year of LPD treatment when compared to baseline.
* The rationale rests on our discoveries that (i) mitochondrial dysfunction mediated by inappropriate opening of the PTP plays a key role in collagen VI myopathies; (ii) defective autophagy with impaired removal of defective mitochondria amplifies the defect; and (iii) reactivation of autophagy with a low-protein diet or treatment with cyclosporine A, the mitochondrial PTP inhibitor, cured Co6a1-/- mice, hinting at a common target among all beneficial treatments - namely autophagy.
* Specific aims of this project are to (i) study the modifications of clinical, nutritional and laboratory parameters in a cohort of patients with BM/UCMD during a 3-month observational period before starting the LPD treatment; (ii) assess the effect of a normocaloric LPD in correcting defective autophagy in muscle of patients; (iii) test if new non-invasive biomarkers of activation of autophagy examined in the blood are mirroring the effect of LPD in the muscle biopsy; (iv) assess the clinical efficacy and safety of the LPD with an innovative combination of complementary measures of the nutritional status in patients.
* The anticipated output is defining and validating a therapeutic nutritional approach in autophagy upregulation for BM/UCMD.


Eligibility Criteria:
Inclusion Criteria:

* Males or females aged ≥18 years.
* Women of childbearing age must have a negative pregnancy test and must use adequate contraception during the study.
* Clinical and molecular diagnosis of Bethlem myopathy or Ullrich congenital muscular dystrophy.
* No previous treatment with CsA within 6 months prior to the start of the study.
* Willing and able to adhere to the study visit schedule and other protocol requirements.
* Written informed consent signed.

Exclusion Criteria:

* Current or history of liver or renal disease.
* Pregnant or breast-feeding women.
* Any serious internal medicine condition interfering with the study.
30g vs 33g Needle for Intravitreal Injections

We are comparing the patient experience between the standard 30 g needle to the smaller 33 g needle for intravitreal injections of ranabizumab or aflibercept for age related macular degeneration, diabetic macular edema, or retina vein occlusions.

This is a prospective, randomized, interventional pilot study, which seeks to compare the patient experience using 30-gauge versus 33-gauge needle for bilateral same-day intravitreal injections of ranibizumab or aflibercept for the treatment of wet age-related macular degeneration (AMD), diabetic macular edema (DME), or macular edema associated with retinal vein occlusion (RVO). The null hypothesis is that there is no difference in patient discomfort or pain with the 30-gauge needle compared to the 33-gauge needle.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing bilateral, same-day, intravitreal injections of either ranibizumab oraflibercept for the diagnosis of wet AMD, DME, or RVO-associated macular edema

Exclusion Criteria:

* 1) Patients who do not receive Betadine ophthalmic solution prior to intravitreal injection due to documented allergy 2) Patients who are receiving intravitreal bevacizumab (this medication iscompounded into pre-filled 1-mL tuberculin syringes).
The Use of Chlorhexidine and a Probiotic Lozenge in the Nonsurgical Therapy of Periodontitis

The aim of this study is determining the additional effect of a 2-week home usage of chlorhexidine in periodontitis patients undergoing scaling and root planing supplemented with a dual-strain probiotic lozenge.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with generalized (\>30% of teeth affected) periodontitisstage III and IV periodontitis, grade B or C (C only with smoker modifier) = generalized chronic periodontitis including smokers
* A minimum of three natural teeth in each quadrant, excluding third molars
* Willing and able to give informed consent
* Not more than 50% of the patients in each group will be smokers.
* Smokers should smoke between 10 to 40 cigarettes a day

Exclusion Criteria:

* Patients with localized periodontitis or periodontitis stage I or II or grade A or grade C or grade C with diabetes modifier
* Patients with orthodontic appliances (removable or fixed)
* Pregnant or lactating woman
* Patients with a history of systemic diseases that may correlate with periodontal health, such as diabetesrheumatic fever, liver or kidney disease, and neurological deficiencies
* Patients taking medication which may affect the periodontium (bisphosphonates, phenytoin, cyclosporin, nifidepine, chronic use of non-steroidal anti-inflammatory drugs)
* Patient who had taken systemic antibiotics up to 3 months prior to treatment or medical conditions requiring prophylactic antibiotic coverage
* Participation in any other clinical study
* Tobacco chewing or sniffing
Interval Versus Continuous Training in Heart Failure

BACKGROUND: The physiopathology of the heart failure involves compensatory mechanisms as exacerbated neurohormonal activity, endothelial dysfunction and consequently the muscle disability and exercise intolerance. The interval exercise training has been proposed as one efficient method to heart failure patients. It seems that the main mechanism involved in the benefit of the interval exercise training is "shear stress". AIM: To study the interval exercise training versus the continuous exercise training in the sympathetic activity and in the peripheral muscle perfusion in heart failure patients. Moreover, we will evaluate the muscle apoptosis, microRNA in plasma and muscle biopsy, biomarkers levels of inflammation, quality of life and exercise capacity. METODOLOGY: Will be selected 40 patients (male and female) with age between 30 and 60 years, left ventricular ejection fraction less than 40% and functional class I, II and III. These patients will be randomized into three groups: Interval (AIT), continuous (MCT) and control (CG). All patients will be evaluated with microneurography, peripheral muscle perfusion, muscle biopsy, blood samples, accelerometer, cardiopulmonary exercise test and quality of life before and after end of the period of 03 (three) months.


Eligibility Criteria:
Inclusion Criteria:

* stable chronic heart failure without changing in treatment for at least 6 weeks
* ejection fraction less then 40%, as measured by transthoracic echocardiography
* optimal clinical treatment for chronic heart failure according to current guidelines.

Exclusion Criteria:

* asthma or chronic obstructive pulmonary disease using inhaled corticosteroids
* functional class IV (New York Heart Association - NYHA)
* atrial fibrillation
* complex ventricular arrhythmia
* pacemaker or implantable cardioversor/defibrillators
* chronic renal insufficiency, defined as serum creatinine above 2,5 mg/dL
* intermittent claudication
* morbid obesity
* cirrhosis
* alcoholism
* using illicit drugs
* performing regular physical activity
* participating in another study
* invasive procedure planned
* persistent nonadherence to therapeutic regimen
* peak respiratory exchange ratio (RER) lower than 1.00