cyrilzakka/clinical-trials huggingface dataset:
Mechanomyography Reloaded? A Randomized Prospective Agreement Study

Neuromuscular monitoring is used to evaluate neuromuscular function intraoperatively and to ensure complete neuromuscular recovery at the end of anaesthesia. Therefore, the lack of reliable neuromuscular monitoring devices that are not cumbersome to use is a major shortcoming for anaesthesia. A recently developed mechanomyography (MMG) device may meet these partially unmet needs due to its measurement of the patient's contractile force instead of its surrogates (i.e., acceleration, velocity), including the response to physiologically relevant tetanic stimulation. However, it is unclear whether the reliability of the newly developed MMG device is similar to or better than the currently available gold standard of neuromuscular monitoring based on electromyography (EMG).

The MEMORY trial is a randomized clinical agreement study which will prospectively enrol thirty ASA 1 or 2 patients ≥ 18 years scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions. The patient's neuromuscular function is measured on one hand with MMG and the other hand with EMG in a randomised fashion. Additionally, randomisation will be stratified the domination of one hand.

In the MEMORY trial we will test the hypothesis, that a newly developed MMG sensor provides not less reliable measurements of neuromuscular function compared to EMG in adult patients. Reliability includes agreement, precision, and the absence of staircase phenomenon and idiosyncratic responses to train-of-four (TOF) stimulation. In addition, we will explore if measurement of tetanic fade will provide more precise information about complete neuromuscular recovery than the current standard of TOF ratio \>0.9.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 18 years
* ASA \< 3
* scheduled for non-cardiac surgery requiring general anaesthesia and neuromuscular blockade for optimisation of surgical conditions
* positioning during surgery with intraoperative access to both arms

Exclusion Criteria:

* allergy to muscle relaxants and reversal agents
* neuromuscular disease
* procedure is scheduled outside the operating room
* need of endotracheal intubation prior to surgery
* need of rapid sequence induction
* pregnancy, breastfeeding or 30 days postpartum
* surgical procedure or examination findings which are a contraindication for a supraglottic airway device
* employee of the investigator or study site directly involved in this study or other studies under the direction of the investigator or study site
* family member of the investigator
* custodial accommodation
* alcohol or drug abuse
* patients with preceding injuries impairing muscle or nerve function of the arm
* Participation in other studies with investigational drugs or devices within 4 weeks prior to screening or missing agreement not to participate in any other study at the same time or within a period of one month after the MEMORY study
Study to Evaluate Safety, Pharmacokinetics and Pharmacodynamics of CHF5074 in Healthy Young Male Subjects

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of CHF5074 in young healthy male volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Subject is judged to be in good health on the basis of medical history, complete physical examination including vital signs, 12-lead electrocardiogram (ECG) and standard laboratory tests.

Exclusion Criteria:

* Medical history (within the last 10 years) of major cardiovascular, hepatic or renal disease.
* Abnormal results of liver function tests, renal function tests or thyroid tests performed at screening.
* Significant allergic conditions that require medical treatment
* Use of any psychoactive, recreational or prescription drug within the 4 weeks prior to study drug administration.
* Use of ibuprofen, sulindac sulfide, indomethacin, flurbiprofen within 2 weeks prior to study drug administration.
Brain Effects of Opiate Agonist and Antagonist

This study will look at the short-term effect of morphine on brain response to food.

Chronic low back pain patients and healthy controls will be recruited for this study. Participants' brain will be scanned at baseline and then again on a different day after the administration of an oral dose of 30 mg morphine in an open label design. Participants will receive morphine 60 minutes prior to the start of the second scanning session. The brain scans will include structural scans, functional scans at rest and functional scans during the ingestion of a highly caloric drink.

Eligibility Criteria:
Inclusion Criteria:

* Healthy participants
* Patients in pain: suffering from persistent pain more days than not, 3/10 in intensity on a numerical rating scale, for at least 6 weeks or more.

Exclusion Criteria:

* Any DSM diagnosis
* diabetes
* food allergies
* lactose intolerance
* participants seeking to quit smoking or to lose weight
* participants on any psychotropic medication including opiate based analgesics (e.g. oxycodone, methadone, suboxone)
* pregnant or nursing women
* pacemaker or other implanted electrical devices
* Participants with a past history of head trauma or seizures
* Any past history of illegal drug or alcohol misuse
* Participants who cannot undergo an MRI scan.
Neurohumoral Mechanism of Deferent Frequency Transcutaneous Electrical Acupoint Stimulation(TEAS)

The purpose of this study is to explore the neurohumoral mechanism of deferent frequency TEAS pretreatment.

Patients were randomly assigned to three groups, receiving TEAS 30min before anesthesia. The frequency of high frequency group is set to 10/50HZ, low frequency group is 2/10HZ, and the fake stimulation group only attach electrodes without electric current. Acupoint selection is bilateral Neiguan points(PC6). Venous blood is collected 4ml before and immediately after TEAS respectively. Heart rate variability is monitored continuously during the 30min TEAS. The adverse events recorded.

Eligibility Criteria:
Inclusion Criteria:

* Age 18yrs-65yrs
* ASA 1-2
* Scheduled for elective operation under general anesthesia
* BMI 18-30kg/m2
* Informed consented

Exclusion Criteria:

* Contraindications to TEAS
* Communication difficulty with researchers
* Addicted to alcohol, analgesics or other drugs
* Cardiac insufficiency or high blood pressure without controlled
* Hepatic or renal dysfunction
* Participate in the other clinical trial 3 month before the enrollment
Coagulation and Fibrinolysis as Virulence Factors for Invasive Staphylococcus Aureus and Streptococcus Infections

the aim of this study is to investigate the role of staphylokinase, streptokinase and MMP activation in invasive staphylococcal and streptococcal infections.


Eligibility Criteria:
Inclusion Criteria:

* all patients that undergo surgical treatment for invasive streptococcal or staphylococcal infections, including acute infective endocarditis and necrotizing fasciitis, from the UZ Leuven University Hospital

Exclusion Criteria:

* none
Immunogenicity of ND1.1 by Delivery Directly to the Ileum

The purpose of the study is to determine the safety and tolerability of ND1.1, an adjuvanted adenoviral-based avian influenza vaccine, when delivery is targeted to the ileum, using a radio controlled capsule. The secondary objective is to evaluate the immune response (cellular and humoral) of two doses of ND1.1 oral vaccine.


Eligibility Criteria:
Inclusion Criteria:

* Able and willing to complete informed consent
* Healthy, as established by medical history, physical exam, and laboratory assessments
* Has normal bowel movements
* Willing to abstain from caffeine and xanthine containing substances for 24 hours before procedure until after discharge

Exclusion Criteria:

* Ability to donate up to 550 ml of blood over several months
* Exposure to any investigational drug or vaccine 8 weeks prior to study
* Has traveled to Asia within 8 weeks of enrollment
* Abnormal ECG findings
* History of irritable bowl or any other inflammatory gastrointestinal disorder
* Any individual with increased risk for bowl obstruction
* Radiation exposure above target values 50 mSv within the past 30 days or a cumulative dose above 150 mSv in the past 12 months
* History of substance abuse
* Subject unwilling to use an approved method of contraception during study and for 2 months after study
* Positive for HCV, HIV, or HBV
* Presence of an implantable device that is sensitive to radio frequencies (e.g. pacemakers)
* History of an autoimmune disorder, or an immunosuppressive disorder
* Stool sample with occult blood at baseline
* Any other medical, psychiatric, social condition, or occupation, in the judgement of the investigator, is a contraindication to the compliance of the protocol or informed consent
The Burn Glove Trial - Hand Burn Dressing Pilot

Specific Aim 1: To determine if one of three burn dressings provides a less painful healing experience for partial thickness hand.

Specific Aim 2: To evaluate if one of three dressings provides greater functionality during and after healing of partial thickness hand burns.

Specific Aim 3: To determine if one of three burn dressings promotes aesthetically superior healing results for partial thickness hand burns.

Various products are on the market and available for use on partial thickness burns to the hand/s. Our current institutional standard of care is to use Xeroform Gauze (Coviden, Mansfield, MA) and Bacitracin Ointment (Fougera, Melville, NY) to promote a moist antibacterial healing environment with the ability to monitor the healing progress daily. However, silver (AG) based dressings that employ nanocrystalline technology with hydrofiber (Aquacel AG burn; ConvaTec, Princeton, NJ) or soft silicone foam (Mepilex AG ; Molnlycke Health Care, Dunstable, United Kingdom) have been well accepted as alternative dressing solutions. These dressings have longer interval times between changes, leading to a reported increase in patient comfort, diminished skin shearing/stripping, and rapid re-epithelialization.

Given the anatomic intricacies, partial thickness burns to the hand present a challenge in dressing selection. Recently, ConvaTec unveiled the Aquacel AG Burn Glove for use on partial thickness hand burns. In line with this idea, our institution has now begun to fashion a novel burn glove out of Mepilex Transfer AG with good success. To date there are no known studies that compare Xeroform/Bacitracin, Aquacel AG burn glove or Mepilex Transfer AG dressing. The goal of this study is to compare these three burn dressings used to treat partial-thickness hand burns and their impact on pain, function, and aesthetic outcomes. We will also explore psychosocial issues related to hand burn dressing changes.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting at Memorial Medical or Southern Illinois University (SIU) Health Care
* Patients with partial-thickness burn injuries to the dorsum and/or palm of the hand/s that exceeds ½% total body surface area (TBSA) for at least one hand.
* \< 10% TBSA 2nd and 3rd degree burn injuries
* Initial clinical presentation \< 5 days post burn injury

Exclusion Criteria:

* \< ½ % TBSA involving the hand
* \> 10%TBSA burn injuries
* \> 60 years of age
* \< 8 years of age
* Patients (or parents of minors) without cognitive capacity to comprehend informed consent
* Presentation \> 5 days post-burn injury event
* Pregnant women
* Full thickness/3rd degree burns to the dorsal and/or palmer hand/s
* Exposed vital structures (tendons, nerves, bone, vessels)
* Uncontrolled Type II Diabetes
* Type I Diabetes
* History of Chronic Obstructive Pulmonary Disease
* Have a known allergy to silver products
* Signs of infection on initial clinical presentation (presence of purulent drainage, significant cellulitis, and/or fever)
* Smoke/inhalation injuries requiring ventilation
* Critically ill patients requiring intensive care
Bioequivalency Study of Meloxicam Tablets Under Fed Conditions

The objective of this study was the bioequivalence of a Roxane Laboratories' Meloxicam tablets, 15 mg, to Mobic® Tablets, 15 mg (Boehringer Ingelheim) under fed conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence crossover design.


Eligibility Criteria:
Inclusion Criteria:

* No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening.

Exclusion Criteria:

* Positive test for HIV, Hepatitis B, or Hepatitis C.
* Treatment with known enzyme altering drugs.
* History of allergic or adverse response to Meloxicam or any comparable or similar product.
A Randomised Multi-centre Study to Compare the Short-term Outcomes of Minimally Invasive and Conventional Surgery in Primary Total Hip Replacement

The purpose of this study is to compare the short-term outcomes of two surgical techniques, minimally invasive and conventional, when used in the treatment of patients with hip joint disease requiring a total hip replacement. Patients who enter the study will be randomly allocated to undergo surgery using the minimally invasive or conventional surgical technique and will be evaluated at regular intervals following hip surgery using patient, clinical and x-ray assessments with a focus on short term rehabilitation.


Eligibility Criteria:
Inclusion Criteria:

i) Male or female subjects, aged between 18 and 75 years inclusive.

ii) Subjects who are able to give voluntary, written informed consent to participate in this investigation and from whom consent has been obtained.

iii) Subjects who in the opinion of the Investigator, are able to understand this investigation, co-operate with the investigational procedures and are willing to return to the hospital for all the required post-operative follow-ups.

iv) Subjects with a primary diagnosis of osteoarthritis.

v) Subjects considered suitable for a primary total hip arthroplasty and are considered suitable for a minimally invasive surgical procedure.

Exclusion Criteria:

i) Subjects who, in the opinion of the Investigator, have an existing condition that would compromise their participation and follow-up in this study, or extend their time to discharge beyond that required for their hip replacement surgery.

ii) Women who are pregnant.

iii) Subjects who are known drug or alcohol abusers or with psychological disorders that could effect follow-up care or treatment outcomes.

iv) Subjects who have participated in a clinical study with an investigational product in the last 6 month(s).

v) Subjects who are currently involved in any injury litigation claims.

vi) Subjects with a Body Mass Index (BMI) \> 30.

vii) Subjects with a malunion, arthrodesis or severe dysplasia with superior femoral head migration.

viii) Subjects requiring a simultaneous bilateral total hip arthroplasty.

ix) Subjects undergoing the second stage of a staged bilateral who are less than 9 months post-arthroplasty
A Database Study to Estimate the Risk of Multiple Sclerosis Following Vaccination With Arepanrix™ in Manitoba, Canada

The purpose of this database study is to assess if Arepanrix™ vaccination during the 2009 pandemic was associated with an increased risk of multiple sclerosis (MS) in Manitoba, Canada.

This observational, retrospective, propensity-score matched cohort study using the Manitoba Immunization Monitoring System (MIMS) and the hospital, physician, and prescription claims databases of the Manitoba Health (MH) Database System will assess if Arepanrix™ vaccination during the 2009 pandemic was associated with an increased risk of multiple sclerosis (MS) and other demyelinating conditions not ultimately leading to a multiple sclerosis diagnosis in Manitoba, Canada.

The data will be collected form the following linked databases:

* Manitoba Health (MH) administrative databases
* Manitoba Immunization Monitoring System (MIMS)
* Manitoba Health Population Registry (MHPR)
* Drug Program Information Network (DPIN)
* Hospital Abstract Database
* The Medical Services database

Eligibility Criteria:
Inclusion Criteria:

* The entire population of Manitoba is considered for inclusion.

Exclusion Criteria:

* Individuals less than or equal to 6 months of age;
* Having less than one year of insurance coverage before the enrolment period;
* Not registered with MH during the enrolment period;
* Physician or hospitalization records indicating a diagnosis of any demyelinating condition between 1971 (earliest year for which information is available) and the index date.
Indirect Comparison of Tobramycin Solution for Inhalation Versus Aztreonam Lysine for Inhalation in the Treatment of Cystic Fibrosis

Matching-adjusted indirect comparison of tobramycin solution (TIS) versus aztreonam lysine (AZLI) using TIS patient level clinical trial data and AZLI aggregated clinical trial data from published literature.


Eligibility Criteria:
Inclusion Criteria:

* ≥ 6 years of age with a documented Cystic fibrosis (CF) diagnosis,
* moderate-to severe lung disease,
* the ability to perform reproducible pulmonary function tests,
* Pseudomonas aeruginosa (PA) airway infection.

Exclusion Criteria:

Other protocol-defined inclusion/exclusion criteria may apply.
Optimizing Cimzia in Crohn's Patients

The purpose of this study is to determine if increasing the dose and/or dosing frequency of certolizumab pegol (Cimzia) is effective in regaining and optimizing response in patients with moderate to severe Crohn's disease.

This open label study for patients with moderate to severe Crohn's disease will evaluate treatment options to improve capture of initial response and to regain loss of response to certolizumab pegol (Cimzia). It is a 26 week open label clinical trial that may be extended to 52 weeks in patients who respond to treatment during the initial 26 week study. The following dosing options will be tested: 1) Re-induction (one supplemental dose of 400mg) 2) Dose splitting (200mgQ2W) and 3) Dose Escalation (400mg Q2W. The highest dose in the study, 400mg Q2W, has been used in a large phase III trial (WELCOME) without any new safety signals. Efficacy and safety measures will be monitored.

Eligibility Criteria:
Inclusion Criteria:

* ileal and/or colonic Crohn's disease
* moderate to severe Crohn's disease

Exclusion Criteria:

* short bowel syndrome
* ostomy
* anti-TNF therapy within 4 weeks
* prior certolizumab therapy
Deimplementing CXR After CVC (DRAUP) in the ICU

This study proposes adapting and testing an innovative, behavioral theory-driven deimplementation program called DRAUP in two intensive care units for proof of concept and support that the program can help providers and hospital organizations address context determinants of deimplementation. Study data will be used to optimize the intervention for a subsequent larger trials.

There are millions of critically ill patients annually who require imaging confirmation after central venous catheter insertion. Emerging literature demonstrates that ultrasound is a faster alternative to historical chest xray, thus serving as the ideal confirmation for catheter use. When able to confirm catheter position, ultrasound decreases the number of unnecessary chest radiographs, cumulative resources (technologist, radiologist, equipment), and patient care delays. However, providers are not adopting this practice. Previously, we developed and initiated a successful evidence-based deimplementation program for ultrasound in lieu of chest xray called DRAUP in the Emergency Department. We now move to adapt the deimplementation bundle in the new environment of the Intensive Care Unit (ICU) with hopeful continued success.

In experiment 1, qualitative analysis will be employ a systematic approach to DRAUP component refinement dosed to the unique context of the Intensive Care Unit and implementation outcomes as well as cost will be evaluated. In experiment 3, mixed methods will be used to evaluate the mechanism of impact of the refined program in the new environment.

Eligibility Criteria:
-Measure the effectiveness and cost effectiveness of DRAUP on discontinuation of CXRs

Inclusion Criteria for DRAUP training:

(1) ICU faculty, fellows, senior residents (post graduate year 3) and advanced practice practitioners

* ICU inclusion for DRAUP program:
* Availability of ultrasound machines with archiving capability (DICOM)
* A minimum of 100 supradiaphragmatic CVC insertions annually in adult patients (age \>18)
* Capacity to access digital archiving (PICOM)
* Patient inclusion for DRAUP program:
* supradiaphragmatic CVC placed
* Patient exclusion for DRAUP program:
* severe instability (cardiac arrest, severe shock) where CVC would be used without CXR,
* level 1 trauma;
* burn patients with no viable skin surface for imaging
Distal Renal Denervation to Prevent Renal Function Decline in Patients With T2DM and Hypertension

The aim of this study is to test the hypothesis that distal renal denervation (RDN) may delay or prevent the progressive decline of renal function in patients with type 2 diabetes mellitus and hypertension

Detailed Description: Diabetes mellitus and hypertension are two major causes of chronic kidney disease (CKD) that starts as subclinical decline in renal function that silently progresses to symptomatic advanced stages associated with irreversible significant damage of the kidney structure. Recent major improvements in pharmacotherapy of hypertension and diabetes have substantially reduced the prevalence of cardiovascular complications, yet, the frequency of CKD remains largely unchanged. Renal denervation is a new minimally invasive method to create regional blockade of the renal sympathetic nerves that is currently used as non-pharmacological therapy of hypertension. The CKD is likewise mediated by overactivity of renal sympathetic system so that RDN has strong potential to prevent development or progression of CKD. The new anatomically optimized distal RDN may have additional benefit in this regard. Denervation of the distal vessels involved in tonic regulation of renal blood should cause a significant drop in renal vascular resistance and proportional increase in blood and oxygen supply to the kidney preventing/reducing chronic hypoxia of renal tissue that is major mechanism of CKD. The aim of this study is to prove the aforementioned concept. For this purpose the eligible patients with type 2 diabetes mellitus and hypertension will undergo distal renal denervation performed using dedicated radiofrequency catheter Symplicity Spyral. The changes in the kidney function and structure as well as BPs (office and ambulatory) will be assessed at baseline, 6 and 12 months post-procedure

Eligibility Criteria:
Inclusion Criteria:

* informed consent of participation in the study;
* systolic BP \> 140 or diastolic BP \> 90 mm Hg;
* type 2 diabetes mellitus (glucose tolerance test \> 11.0 mmol/l, HbA1c\>6,5%);

Exclusion Criteria:

* secondary hypertension;
* type 1 diabetes mellitus;
* acute renal failure;
* traumatic kidney injury;
* toxic kidney injury;
* CKD G4 and G5 according to the KDIGO 2012;
* infectious diseases requiring active antibacterial and/or antiviral therapy;
* other severe diseases and conditions