cyrilzakka/clinical-trials huggingface dataset:
A Randomized, Multiple Dose, Double Blind, 5-way Crossover Study of the Electrocardiographic (ECG) Effects of Bilastine

The purpose of this study is to evaluate the effect of two doses of bilastine (20 and 100 mg) compared to bilastine 20 mg administered with ketoconazole 400 mg, moxifloxacin 400 mg, and placebo. Subjects will receive each of the five study treatments in a crossover fashion administered once daily for 4 days.

This is a single center, Phase 1 study that utilizes a randomized, multiple-dose, double-blind, 5-way crossover design with a placebo control and two active controls. A minimum seven day washout period following four days of dosing for each of the five treatments.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects with no clinically significant findings note on screening assessments including medical history, physical examination and laboratory results

Exclusion Criteria:

* Clinically significant medical condition
* Clinically significant history of ECG abnormalities or family history of QTc interval syndrome
* Use of tobacco and/or nicotine products \>3 months prior to screening
* Use of any prescription medications within 14 days prior to screening
* Use of over the counter medications (including herbal products) within 7 days prior to screening
Detachable String Magnetically Controlled Capsule Endoscopy for Patients with AUGIB

Use CE for pre-examination of patients with AUGIB symptoms in emergency centers may reduce the need for emergency electronic gastroscopy and have certain advantages in clinical work. Patients with low-risk lesions can be discharged without the need for EGD and hospitalization, greatly improving the utilization of medical resources.

The investigators plan to conduct exploratory research by sequentially performing DS-MCE and EGD examinations on AUGIB patients with stable hemodynamics, using EGD as the gold standard to evaluate the sensitivity of DS-MCE in diagnosing upper gastrointestinal bleeding lesions and active bleeding.

Eligibility Criteria:
Inclusion Criteria:

* No gender limit, age ≥ 18 years
* Presenting to the emergency department with melena or hematemesis
* Hemodynamically stable at presentation
* No endoscopic examination has been performed due to this bleeding
* Agree to participate in this clinical trial and sign an informed consent form

Exclusion Criteria:

* Patients with acute active massive bleeding or hemodynamic instability (blood pressure \< 90 mmHg and heart rate \> 120 beats per minute)
* Patients with Hematochezia
* Hemodynamics remained unstable after fluid resuscitation
* Known or suspected intestinal obstruction, stenosis, or fistula
* Severe motor disorders such as asthma, swallowing disorders, or gastric paralysis
* History of abdominal surgery that affects the normal structure of the digestive tract in the past
* When capsule retention occurs, the problem cannot be solved through surgery due to subjective or objective reasons
* Implantable medical devices such as pacemakers, electronic cochlear implants, drug infusion pumps, and neural stimulators are installed inside the body, except for MRI compatible products
* Pregnant women
* Those who require MRI examination before capsule endoscopy discharge
* Suffering from severe cardiovascular and pulmonary diseases (such as severe myocardial infarction, arrhythmia, heart failure, and respiratory failure)
* Refuse MCE or gastroscopy examination
* The researchers believe that the subjects have any other factors that are not suitable for participation in the study
Individualized vs Low PEEP in One Lung Ventilation

The aim of the prospective crossover study is to investigate the effect of individualized positive end-expiratory pressure (PEEP) on measures of tissue oxygenation, compared with low PEEP.

During surgery on the lung, ventilation of one lung at a time is often necessary. During thoracic surgery requiring one-lung ventilation (OLV), hypoxemia (reduced oxygen tension in blood) can present a clinical challenge. Due to multiple factors, the likelihood of hypoxemia during OLV in obese patients is increased. Atelectasis (collapse of the lung airspaces) contributes to hypoxemia and can be mitigated by application of recruitment maneuvers and positive end-expiratory pressure (PEEP). A recruitment maneuver is a breath given in a mechanically ventilated patient that helps to open up collapsed air spaces, and PEEP is application of a continuous amount of positive pressure that helps keep the air spaces open at the end of an exhaled breath. Adjusting the level of PEEP to each individual patient's optimal lung compliance (individualized PEEP) improves blood oxygen levels compared to application of standard low PEEP (5 cmH2O); however, higher levels of PEEP required to achieve optimal lung compliance could increase intrathoracic pressures to a level that impedes normal circulation. This could negatively affect blood flow (cardiac output) and delivery of oxgyen to vital organs.

Evidence addressing OLV in obese patients is lacking. The purpose of this study is to compare brain oxygen levels (cerebral oxygen saturation) and measures of blood flow and gas exchange during OLV with individualized PEEP vs low standard PEEP in obese patients undergoing thoracic surgery. To our knowledge, there is no previous study that compares oxygen delivery to vital organs (such as the brain) during OLV using individualized PEEP versus standard low PEEP, in an obese patient population.

In this study, subjects undergoing OLV during surgery to remove a portion of the lung (lobectomy) will undergo a process to determine their individualized PEEP and then two 20-minute experimental periods-- one period with OLV with low PEEP and one period with OLV with individualized PEEP. Measurements of cerebral oxygen saturation, blood oxygen levels, cardiac output, and blood pressure medication dose will be measuring before and after these experimental periods during surgery.

Eligibility Criteria:
Inclusion Criteria:

1. Subject undergoing elective pulmonary lobectomy requiring one-lung ventilation
2. Body-mass index ≥ 30 kg/m2
3. Age ≥ 18 years and ≤ 80 years

Exclusion Criteria:

1. Age ≤ 18 year or ≥ 80 years
2. Moderate or severe cardiac valvular disease
3. Left ventricular ejection fraction \< 30%
4. Moderate or severe right ventricular systolic dysfunction
5. Severe pulmonary hypertension
6. Presence of pulmonary bullae or blebs on preoperative chest imaging studies (e.g., radiograph, computed tomograph)
7. Emergency surgery
8. Previous history of lung surgery on the non-operative lung
9. Pregnancy
10. Incarceration
11. Mental incapacitation
12. Patient refusal
13. Non-English speaking
Safety of MenACWY-CRM Vaccination in Adolescents

The purpose of this US FDA post-marketing commitment study is to evaluate the safety of MenACWY-CRM among 50.000 vaccinated adolescents within a large US Healthcare Maintenance Organization who received MenACWY-CRM vaccination as part of their routine clinical care. The pre-specified 26 events of interest are events commonly evaluated in vaccine safety studies and include certain neurological, immunological, vascular, musculoskeletal and hematologic disorders. All events are collected retrospectively.

This is an observational study, vaccines administration and data that is collected is only as part of routine clinical care. Vaccinated subjects are not actively recruited.

Events of interest: Seizure, Aseptic meningitis, Bell's Palsy, Multiple Sclerosis, Guillain-Barre Syndrome, Acute disseminated encephalomyelitis, Cerebellar ataxia, Transverse myelitis, Brachial Neuritis, Hashimoto's disease, Systemic Lupus Erythematosis, Henoch Schonlein Purpura, New Onset Juvenile Diabetes Mellitus, Rheumatoid arthritis, Idiopathic Thrombocytopenic Purpura, Iridocyclitis, Acute glomerulonephritis, Nephrotic syndrome, Grave's disease, Autoimmune hemolytic anemia, Myasthenia Gravis, New onset asthma, Allergic urticaria, Anaphylaxis, Meningococcal Disease, Suicide attempt.

Eligibility Criteria:
Inclusion Criteria:

1. Enrolled in the HMO for at least 6 months prior to vaccination
2. Between the ages of 11 and 21 years (inclusive - i.e. has not reached their 22nd birthday) at the time of the vaccination.
3. Received the vaccine during the study period

Exclusion Criteria:
Echo Systemic Sclerosis

Systemic sclerosis is an autoimmune connective tissue disease with undefined etiology and characterized by progressive fibrosis of the skin and major organs. Dry eyes and / or buccal syndrome is commonly reported in patients with systemic sclerosis. Goujerot-Sjogren syndrome is a chronic autoimmune disorder that is characterized by dryness of the eyes (xerophthalmia) and / or mouth (xerostomia). It may be primary or secondary to another connective tissue disease (such as lupus, rheumatoid arthritis or other). Several criteria have been validated to classify the SS but require a labial salivary gland biopsy, invasive act which complications can sometimes be reported (hematoma, lip sensory defect).

Several scores based on the evaluation of the ultrasound homogeneity of the salivary glands were developed but no studies have evaluated ultrasound abnormalities of salivary glands in patients with systemic sclerosis.

Descriptive explorative study of three population showing sicca symptoms (Systemic sclerosis, Gougerot-Sjogren syndrome, Sicca-Asthenia-Polyalgia syndrome).

Patient will be enrolled in the rheumatology department of University hospital of Clermont-Ferrand (France).

Salivary glands ultrasonography will be performed on all patients enrolled by the same expert and blinded to the diagnosis of the patient. Echostructure of the two salivary glands will be graded 0 to 4 and the size calculated.

Eligibility Criteria:
Inclusion Criteria:

* Systemic sclerosis diagnosis established by a rheumatologist and met ACR 2012 criteria
* Or primary Gougerot-Sjogren patient who met American-European Consensus Group (AECG) classification criteria.
* Or patient presenting a sicca syndrome but not met Gougerot-Sjogren criteria

Exclusion Criteria:

* History of radiotherapy on face and neck
* Infection such as VIH or Hepatitis C
* Sarcoidosis
* Amylosis
* Wearing contact lenses
* Hyper IgG4 syndrome
A Study of Erlotinib (Tarceva) in Participants With Non-Small Cell Lung Cancer (NSCLC)

This study will assess potentially predictive markers of efficacy in participants with NSCLC receiving oral erlotinib (Tarceva) therapy. The anticipated time on study treatment is until disease progression, unacceptable toxicity or death.


Eligibility Criteria:
Inclusion Criteria:

* Advanced NSCLC
* Tumor accessible for biopsy by bronchoscopy
* Disease progression following course of standard chemotherapy, or participants unwilling/unable to undergo chemotherapy

Exclusion Criteria:

* Unstable systemic disease
* Any other malignancies in the last 5 years
* Brain metastases
* Previous treatment with therapy acting on the epidermal growth factor receptor (EGFR) axis
Continuous Hemoglobin Evaluation

Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective surgery.

Exclusion Criteria:

* 0
Additional Hyperbaric Oxygen After Lower Extremity Amputation

This study evaluates the effect of additional hyperbaric oxygen therapy after lower extremity amputation. The patients will be randomized after amputation to either a treatment group receiving hyperbaric oxygen therapy, or control group.

Hyperbaric oxygen therapy has been used to treat hard to heal wounds for decades. Amputation, especially distal lower extremity amputations have the same problem with healing and patients often need to be re-amputated more proximally. In these patients oxygen levels are often the decisive factor. Providing additional oxygen under hyperbaric conditions will increase tissue oxygen concentration sufficient for the amputation stump to heal. This will give the patients a more distal amputation with better condition for ambulation.

Eligibility Criteria:
Inclusion Criteria:

* Lower extremity amputation because of chronic wound, osteomyelitis, ischemia, necrosis.
* Fit to receive hyperbaric oxygen therapy determined by an anesthesiologist/Hyperbaric Medicine Physician.
* Able to cooperate and follow up appointments
* Included within 7 days after final surgery

Exclusion Criteria:

* Not fulfilling inclusion criteria
* Pregnancy
* Dementia
Multicenter Blood Culture Quality Improvement

False positive blood culture results due to specimen contamination with bacteria inhabiting patients' skin is a common problem in emergency departments (EDs) in the United States. Contaminated blood cultures lead to patient harm through unnecessary hospitalizations and ED visits, delays in surgery, unneeded antibiotics, and unnecessary procedures. The investigators have developed a multifaceted quality improvement improvement bundle (The Blood Culture QI Program) designed to minimize blood culture contamination in the ED. In this study, the investigators will implement the quality improvement bundle in six community hospital EDs and evaluate its effectiveness at reducing contamination.

The Blood Culture QI Program has four components: (1) education: content knowledge and standardized experiential training on sterile technique designed for ED nurses; (2) process redesign: change in patient safety attitude and conversion of blood culture collection from a clean to a sterile technique; (3) checklist use: reinforcement of optimal blood culture collection technique at the point of care; (4) feedback: systematic charting and reporting of contamination rates to the ED nurses who collect cultures. In order to convert blood culture collection into a fully sterile procedure, the investigators developed the Sterile Blood Culture Collection Kit, a novel materials kit that contains the equipment needed to collect a culture using sterile technique, including: (1) a 3ml solution of 2% chlorhexidine gluconate - 70% isopropyl alcohol (Chloraprep, CareFusion) skin prep device; (2) a sterile drape; (3) a sterile needle; and (4) gauze.

The investigators will evaluate the effectiveness of the Blood Culture QI Program after implementing it in six community hospital EDs. Our study will compromise six replications of an interrupted time series study wherein each replication will be powered for internal validity to test the hypothesis of decreasing the contamination rate by 50% at each site. A stepped wedge (also called multiple baseline) design will be used to implement the program across hospitals to evaluate the generalizability (external validity) of program effectiveness. The primary analysis will be an interrupted time series analysis at each site comparing the proportion of ED blood cultures contaminated during a post-implementation intervention period with a pre-intervention baseline period.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have a blood culture ordered for clinical purposes in one of the participating centers during the study period.

Exclusion Criteria:

* Age \< 18 years old
Treatment Rates and Compliance to Treatment in Patients With Familial Hypercholesterolemia

Familial hypercholesterolemia is a genetic disease characterized by increased levels of low density lipoprotein cholesterol (LDL-C). It is underdiagnosed and undertreated despite relatively high prevalence and significant association with increased mortality.

Patients older than 18 years old and have a serum low density LDL-C≥250 mg/dL were identified from the hospital database. A questionnaire was completed via phone. Patients were classified as definite, probable and possible familial hypercholesterolemia according to Dutch Lipid Clinical Network Criteria

Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old and have a serum LDL-C≥250 mg/dL

Exclusion Criteria:

* Patients who refuse dto interview
* Serum TSH≥10 mIU/mL
* Glomerulonephritis or nephrotic syndrome
* ALT or AST higher than 3 times of normal limits
* Serum triglyceride \>400 mg/dL
Maintenance Bee-Venom Immunotherapy Administered at 6-Month Intervals Does Not Protect Against re-Stings

Maintenance venom immunotherapy administered at 6-month intervals to bee-venom allergic patients failed to provide protection from systemic reactions after sting challenges. These patients should continue their immunotherapy at 1-3 month intervals.

Background: The intervals at which maintenance venom immunotherapy (MVIT) is administered have been progressively extended over the years.

Objective: To examine whether the administration of bee venom (BV) maintenance dose (MD) at 6-month interval is safe and efficacious.

Methods: The usual 3-month interval at which venom allergic patients were receiving their MVIT was gradually extended to 6 months. Systemic reactions (SRs) to immunotherapy injections or to field stings were regularly recorded. BV allergic patients were deliberately sting-challenged after reaching the 6-month interval.

Eligibility Criteria:
Inclusion Criteria:

* Venom allergy

Exclusion Criteria:

* none
Virtual and Physical Health Assessments and Treatment Plans

The aim of the current study is to compare virtual clinic visits (i.e., real-time, face-to-face visits conducted over the internet with tablet devices) to actual physical clinic visits. After both types of visits (virtual versus physical) physicians will be asked to classify patients into low, moderate or high risk for a vascular intervention. It is hypothesized that there will be good agreement between classifications made after the virtual visits as compared to those made after physical visits. That is, virtual visit classifications will be as good as those made after physical visits.

Patient dissatisfaction can increase because of the complexities associated with navigating modern health care systems. It is easy to speculate that some of this dissatisfaction is associated with travel, wait times and other issues that arise during routine clinic visits. The authors of recent studies have demonstrated that it is possible and feasible to conduct many routine visits remotely. It is our belief that virtual health assessments and treatment plans (VHAT) conducted remotely can be as effective, perhaps be more efficient and increase patient satisfaction when compared to regular physical health assessments and treatment plans (PHAT). Physicians want to provide optimal health care; however, in geographically isolated areas such as some locations in West Virginia that can be a challenge. It seems reasonable to believe that monitoring patients with telehealth technology, collecting on-going real time data and conducting VHAT can provide high quality health care for patients. It can also help to classify health risk, increase patient and medical staff satisfaction, decrease staff time for visits, while at the same time increase the efficiency of the follow-up process. The investigators plan to compare the physician assessments and future treatment plans made using VHAT to those made after PHAT. It is believed that VHAT assessments will be in agreement with those made with PHAT.

Eligibility Criteria:
Inclusion Criteria:

-Patients referred to and scheduled for an initial visit at our Vascular Center of Excellence (VCOE).

Exclusion Criteria:

* Patients that are deemed urgent cases by the VCOE, and scheduled within two weeks for the initial clinic visit.
* Patients who are scheduled to have the placement of an arteriovenous (AV) fistula at the time of the initial clinic visit.
Transfusion Requirements in Cardiac Surgery

This is a multi-centre randomized controlled pilot trial of two transfusion strategies in high risk patients having cardiac surgery. This study will be conducted in 7 Canadian centers and 1 American centre. Patients allocated to a "restrictive" transfusion strategy will receive a red cell transfusion if their hemoglobin is 75 g/L or less intraoperatively and postoperatively. Patients allocated to a "liberal" transfusion strategy will receive red cell transfusion if their hemoglobin concentration is 95 g/L or less intraoperatively and postoperatively in the intensive care unit, and less than 85 g/L on the ward.

The primary objectives of this study are to determine 1) enrollment rates (patients enrolled/patients eligible), 2) consent rates (consent obtained/patients approached); and 3) protocol adherence (incidence and reasons for non adherence, lack of consent, rates of contamination and utilization of co-interventions). The secondary objectives are to determine 1) the mortality rate and the rate of the composite outcome for morbidity of renal, cardiac, neurological and infectious adverse events; 2) the proportion of missing data as a measure of the feasibility of the case report form; and 3) the proportion of blood products utilized (red cells, platelets and plasma).

The results of the multicentre pilot study will be used to 1) maximize enrollment rates to ensure timely completion of recruitment of a definitive large randomized controlled trial, 2) maximize adherence rates, 3) determine event rates for sample size estimation for a definitive study, and to 4) optimize the case report form.


Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* European System for Cardiac Operative Risk Evaluation (EuroSCORE) of 6 or more
* Consent

Exclusion Criteria:

* Pregnancy
* Refusal of blood products
* Participating in autologous blood donation program
* Based on the preoperative hemoglobin, the predicted hematocrit on cardiopulmonary bypass is greater than 33% (hemoglobin concentration of 110 g/L) or less than 18% (hemoglobin concentration of 60 g/L)
Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC

A prospective, randomized, controlled study designed to assess whether digital virtual reality (VR) models, created from existing CT scans and MRIs, provide surgeons with an improved understanding of their patients' anatomy, resulting in more efficient operations (robotic prostatectomy) and improved patient care.


Eligibility Criteria:
Inclusion Criteria:

* Patient is undergoing robotic prostatectomy being performed by participating surgeon
* Patient is willing to be randomized between intervention and control arms

Exclusion Criteria:

* Patients with prior pelvic radiation
* Patients with prior androgen deprivation therapy
* Patients with prior localized ablative therapy
* Patients with prior TURP or other surgical BPH treatment