cyrilzakka/clinical-trials huggingface dataset:
Safety and Efficiency of Combined Extracorporeal Blood Purification in Neurosurgical ICU. Prospective RCT

To assess the efficiency and safety of combined extracorporeal blood purification in patients with septic shock in Neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT).

According to studies and modern sepsis treatment guidelines, conventional CRRT has not proved effective in the septic shock treatment.

Effectiveness of other extracoporeal blood purification methods, such as hemoadsorption or combined blood purification (hemoadsorption combined with CRRT) is widely pointed out in current publications: contemporary studies in general ICU patients demonstrated that the use of hemoadsorption or combined extracorporeal blood purification methods is effective for septic shock patients treatment.

It has been proven that cytokines discharged into the systemic blood flow are the key pathophysiological mechanism of septic shock. Hemoadsorption allows for significantly more effective removal of different inflammatory mediators than the traditional methods of CRRT. The combined extracorporeal blood purification method demonstrated similar efficacy in general ICU patients.

The aim of this study is to assess the efficiency and safety of combined extracorporeal blood purification in with septic shock in neurosurgical ICU in comparison with the efficiency and safety of the continuous renal replacement therapy (CRRT) with AN69 membrane.

Study novelty: We have not encountered published studies evaluating the efficiency of combined extracorporeal blood purification methods in neurosurgical patients with septic shock. Furthermore, currently there is not enough data to compare combined extracorporeal blood purification with CRRT for septic shock treatment. The planned study is the first to investigate the safety and efficiency of combined extracorporeal blood purification in patients with septic shock in neurosurgical ICU.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of septic shock according to SEPSIS 3 definition
* Glasgow Coma Scale of 4 and more on admission
* invasive hemodynamics monitoring
* norepinephrine \> 0,1 µg/kg/min or use of 2 vasopressors

Exclusion Criteria:

* age \<18 years
* \>24 hours after diagnosis of septic shock
3D Ultrasound Myocardial Mechanical Wave Measurements

Primary mitral regurgitation (MR) is a frequent disease that can ultimately lead to heart failure. Primary MR represents the second most prevalent cause of cardiac valve surgery in high income countries. Progressive myocardial fibrosis due to chronic volume overload is recognized as a pathophysiological substrate of altered LV function in primary MR. As fibrosis leads to increased myocardial stiffness, ultrasound mechanical wave propagation measurements within the myocardium could provide important clinical information. Natural mechanical wave velocity (MWV) imaging, using High-frame-rate (HFR) echocardiography has emerged as a promising tool to evaluate myocardial stiffness.

The objective is study is to evaluate the correlation between the LV myocardial stiffness (as assessed by 3D ultrasound myocardial MWV mapping) and myocardial interstitial fibrosis as measured using CMR (myocardial extracellular volume measure)

After being informed about the study. All patients giving written informed consent will undergo in a routine practice:

1. echocardiography (2D/3D),
2. CMR imaging,
3. electrocardiogram 24 hours monitoring,
4. blood sampling including brain natriuretic peptide measurement,
5. symptom-limited combined exercise echocardiography and oxygen uptake measurements

Eligibility Criteria:
Inclusion Criteria:

* Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) with class I indication for surgery (symptoms and/or altered conventional parameters of LV function) (n=10 patients)
* Severe primary MR patients (effective regurgitation orifice area ≥ 40mm²) without class I indication of surgery (n=20 patients)
* Mild to moderate primary MR patients as defined by effective regurgitation orifice area ≥ 20mm² and \< 40mm² (n=10 patients)

Exclusion Criteria:

* Permanent atrial fibrillation
* Acute primary severe MR
* Secondary MR
* Previous cardiac surgery of any kind
* Other severe left sided valvular disease
* Coronary artery disease
* Congenital cardiac disorder
Measuring the Impact of an Enhanced Strategy for Daily Disinfection in Acute Care Hospital Rooms

To determine the effectiveness of an enhanced strategy for daily disinfection in acute care hospital rooms comparing the addition of sani24 to routine daily cleaning versus the control of routine daily cleaning.

The study Investigator will evaluate the effectiveness of a) adding sani24 to the standard daily cleaning and b) routine daily disinfection in acute care hospital rooms to measure the reduction in bioburden. In other words, the study aims to answer the following research question: does the addition of an additional disinfection technology (Sani24) decrease the environmental bioburden in inpatient hospital compared to routine disinfection?

This trial was conducted in acute care hospital rooms at Duke University Hospital in Durham, North Carolina from November 2021 to March 2022. Room surfaces were divided in two (e.g., right vs. left), allowing each patient room to serve as its own control. The intervention was a quaternary ammonium salt-based 24-hour continuously active germicidal wipe, Sani-24 (PDI Healthcare, Woodcliff, NJ) that was applied in addition to routine disinfection. The control arm received no intervention beyond routine disinfection. Environmental services were blinded to study arms and no changes to routine cleaning protocols occurred during the study period. Room contamination was measured immediately before the application of the disinfectant (study day 0) and 24-hours later (day 1). Secondary outcomes included evaluation for clinically important pathogens (CIP), including methicillin-resistant staphylococcus aureus (MRSA), vancomycin-resistant Enterococcus (VRE) and carbapenem-resistant Enterobacteriaceae (CRE)

Eligibility Criteria:
Inclusion Criteria:

* Inpatient rooms housing adult patients on contact precautions

Exclusion Criteria:

-
The Effect of Needle Placement on Muscle Stiffness, Gait, Balance, Pain and Functional Outcomes in Individuals With Injury to the Ankle and/or Hindfoot

The purpose of this randomized controlled trial is to assess the effect of DN at either the site of the identified myofascial trigger point/s (MTrP) of in the same muscle, but away from the MTrP site/s in individuals with ankle and/or hindfoot injury. Assessments will be of self-reported outcomes, self-reported pain, gait, balance, muscle stiffness, and pain pressure threshold. The secondary purpose of this study is to determine the validity of dry needling specific muscles of the lower extremity based upon needle placement, location relative to anatomical structures and accuracy of needle placement in muscle using ultrasound imaging.

Few studies have assessed the validity of needling muscles of the lower extremity. For muscles such as the tibialis posterior that are not easily accessible or directly palpable secondary to the deep anatomical position and due to the proximity of the tibial nerve and the posterior tibial artery within the deep compartment, examining accurate needle placement is clinically relevant. In addition, DN has been shown to be a beneficial management strategy for individuals with lower extremity condition; however, the investigators may be able to optimize these beneficial effects by performing DN on the MTrP versus other sites within the same muscle.

If needling directly into the MTrP is more effective than needling away from the MTrP but into the same muscle, it is possible that the improved efficiency could help to optimize management of patients with injury to the ankle/hindfoot with less visits and potentially decreasing health care costs.

Eligibility Criteria:
Inclusion Criteria:

* Participants with a previous lower extremity injury occurring to the ankle and/or hindfoot within the previous 12 months AND
* pain greater than 3 out of 10 on the numeric pain rating scale (NPRS) OR
* limited weightbearing dorsiflexion range of motion of greater than 2.0 cm side-to-side difference as measured by the ankle lunge test (ALT) OR
* greater than 3.5% side-to-side difference as assessed by the Y-balance test.

Exclusion Criteria:

* Operative fixation within the past 3 months to the lower extremity
* Have received DN of the lower extremity within the past 30 days
* Current pregnancy
* Have a history of systemic disorders in which DN would be contraindicated (bleeding disorders or current anticoagulant medication use)
* Immunocompromised
* Decline participation
Iguratimod in Kidney Transplant Recipients

The objective of the study is to evaluate the effect of iguratimod concomitant with conventional immunosuppressive drugs on preventing antibody-induced rejection in HLA Highly mismatched Kidney Transplant recipients.


Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged ≥18, \<65 years
* At least 2 weeks post kidney transplantation from deceased or living donor
* Stable renal graft function, i.e., serum creatinine undulation for 3 consecutive test \<±10%
* Serum creatinine\<1.5×upper limits of normal(ULN)
* Number of HLA mismatches ≥ 4
* Panel Reactive Antibody(PRA) value pre-transplantation \<10%
* Concentration of conventional immunosuppressive drugs reach target ranges
* Subjects are willing to participate in the study, fully informed, and sign informed consent form(ICF)
* Women of childbearing potential (WOCBP) must have a negative pregnancy test within 24 hours prior to the start of study medication, and agree to use an acceptable method to avoid pregnancy for the entire study period and for up to 3 months after the last dose of study medication.

Exclusion Criteria:

* Pregnant or nursing women
* Currently clinical acute rejection;
* Graft function hasn't recovered for delayed graft function (DGF), or primary non-function (PNF)
* Second or subsequent kidney transplant or multi-organ recipients (e.g. kidney and pancreas)
* Subjects with Liver failure
* Abnormal hepatic, renal and hematopoietic function,

  1. Alanine transaminase(ALT), Aspartate transaminase(AST)\>1.5×ULN
  2. White blood cell(WBC)\<3.5×10\^9/L
  3. Hemoglobin(HGB)\<80 g/L
  4. Platelet count(PLT)\<80×10\^9/L.
* Severe clinically relevant disease,

  1. Abnormality in chest X ray image, such as Tuberculosis, Pulmonary interstitial fibrosis, or symptom or physical sign of clinical significance
  2. Serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy 3）History of serious cardiovascular, hepatic, hematological, endocrinal disease, or malignancy

  4) Immunodeficiency, uncontrolled active infection, and active gastrointestinal disease.
* Women or men of childbearing potential plan to be pregnant recently;
* Allergic with study drug, or excipient
* Subject with psychiatric illness, which may put him/her into unacceptable risk in the opinion of investigators
* Has received or is receiving Rituximab treatment
* Iguratimod treatment within 1 week pre-transplantation, or during screening period
* Received live vaccines in the previous 3 months, or plan to receive live vaccines during the study.
Effectiveness of an Automated Falls-Risk Screening and Referral Tool in the Emergency Department (ED)

The purpose of this retrospective cohort study is to evaluate the effectiveness of an EHR-based clinical decision support system (CDS) for automatically screening older adult ED patients for risk of future falls and providing ED clinicians opportunity to place referrals orders to the UW Health Mobility and Falls Clinic for those at highest risk prior to discharge.

This CDS tool has already been implemented at the UW Hospital ED, and as a QI initiative will be implemented in a staged process at two other UW Health-affiliated emergency departments (The American Center and Swedish American Hospital).

The specific aim of this retrospective cohort study is to test the effectiveness of the automated screening and referral intervention on completed referrals to the UW Health fall prevention clinic and rates of injurious falls, using a limited dataset created from EHR and Medicare claims data. The investigators hypothesize that ED patients referred using the falls risk CDS tool will have decreased healthcare use due to fall-related injuries, and that the intervention will have similar levels of effectiveness across different types of patient characteristics. The investigators will also systematically examine barriers to patients completing their clinic referrals, as well as clinic scheduling and pre-visit planning protocols that may have excluded patients from receiving Falls Clinic services.

Effectiveness will be assessed based on examination of a limited dataset consisting of EHR and Medicare claims data measuring rates of (1) patient referrals at each ED, (2) completed referrals to the Mobility and Falls Clinic (i.e., a completed clinic appointment), and (3) healthcare visits for fall-related causes occurring within the six months following the initial ED visit.

The primary analysis to evaluate effectiveness of the fall-risk CDS tool will include data from older adult patients (age ≥65) who visit study EDs during the intervention period at each site, have a UW Health System-affiliated primary care provider, and are discharged from the ED or ED observation unit (not admitted). Members of the UWH Applied Data Science team (not part of the study team) will extract data from patient EHR to create a limited dataset including: past falls and fall-related injuries (in the 12 months pre-visit, including the index ED visit), post-visit falls and fall-related injuries (in the 6 months following the index ED visit), patient demographics (age, gender, race/ethnicity, insurance), comorbidities, active medications, and utilization (e.g., primary and specialty care visits). Education and income levels will be approximated using census track data. Area Deprivation Index will also be employed based on patient address. These variables will be extracted retrospectively and stored on secure servers.

Eligibility Criteria:
Retrospective analysis will include data from:

* ED patients 65 years or older
* discharged from the ED (not admitted)
Study of Prevention of Postoperative Delirum to Reduce Incidence of Postoperative Cognitive Dysfunction

Postoperative cognitive dysfunction describes a condition where cognitive functions such as attention, perception, concentration, learning, abstract thinking and problem solving are impaired postoperatively. These changes can be resolved after weeks and months, but in some cases may be permanent.

The aetiology is multifactorial. One risk factor for developing POCD is the occurrence of postoperative delirium.

A total of 638 consecutive patients will be enrolled in the study. Patients will be followed up at 7 days, 3 months and 1 year postoperatively. The cognitive function will be tested and compared to tests done before surgery. Postoperatively (from the day of operation until the 7th day and except of day 6) the grade of sedation; agitation; signs of delirium; pain; cardiac; respiratory; renal and infectious complications will be recorded.

As possible influencing factors, the investigators will document diagnosed depression; comorbidities; intraoperative blood loss; length of hospital stay; 1-year-mortality; number of operations/anaesthetics undergone after the initial operation.

Parameters that could trigger either depressive symptoms, neurocognitive dysfunction, anxiety, fatigue or lack of concentration will be recorded. These include: anaemia, hypercalcaemia, thyroidal gland hormones, electrolytes, creatinine, urea, glomerular filtration rate, cortisone therapy and adrenal cortical insufficiency.

The methods include a neuropsychological test battery: TAP 2.3 (attention), Trail Making Test (TMT )A+B (attention), Digit span (memory), (Visual Learning and Memory Test (VLMT) (memory), Regensburgerwortfluessigkeitstest/fluency (RWT) subtests (executive function), Mehrfach-Wortschatz-Intelligenztest/vocabulary (MWT-B) (premorbid IQ).

Other measures are Hospital Anxiety and Depression Scale (HADS-D) (depressive symptoms and anxiety), Mini Mental State Examination (MMSE) 2 (dementia), Confusion Assessment Method (CAM-ICU) (delirium), Richmond Agitation and Sedation Scale (RASS) (sedation and agitation), Numeric Rating Scale (NRS) (pain) and Short Form Health Survey (SF-12) (health related quality of life).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 60 years
* Cardiac surgery (on-pump/off-pump, standard/minimal invasive)
* Written informed patient's consent

Exclusion Criteria:

* Non-German speaking or not their first language
* Illiteracy
* Mental disability
* Non-corrigible vision impairment
* Non-corrigible hearing impairment
* Illegal substance abuse (current or past history)
* Alcohol abuse (current or past history)
* Chronic benzodiazepine use
* Psychosis (current or past history)
* Parkinson Disease
* Dementia
* Multiple sclerosis
* Epilepsy (current or past history)
* Cerebral tumor (current or past history)
* Apoplexy or intracranial bleeding (current or past history)
* Severe traumatic brain injury (current or past history)
* Severe liver disease (Child Pugh B, C, liver insufficiency)
* Severe kidney disease with dialysis
* Mini Mental Status Examination \< 24 points
Family Impact of Polyhandicap: a Mixed Methodological Approach

Polyhandicap (PLH) is a complex disability condition corresponding to a chronic affliction occurring in an immature brain, leading to the combination of profound mental retardation and serious motor deficit, resulting in an extreme restriction of autonomy and communication. In a preliminary work, we demonstrated that French families reporteda deterioration of the quality of life. This first study, based on a cross-sectional study and quantitative methods, did not allow to explore: 1) the dynamic aspect and the evolution over time of this experience, 2) the mechanisms underlying the difficulties encountered, the needs and expectations of families


Eligibility Criteria:
Inclusion Criteria:

* Familial caregivers: member of a family of a polyhandicapped person aged from 8 to 35 years old
* Patients: with severe polyhandicap defined by the combination of motor deficiency and intellectual impairment associated with everyday life dependence, restricted mobility and age at onset of cerebral lesion below 3 years old
* Written consent signed by caregivers for participation

Exclusion Criteria:

* caregivers refusing to participate
AZD8529 Single Ascending Dose Study

This is a study to evaluate safety, tolerability, PK and PD effects of orally administered AZD8529 after single ascending doses


Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female subjects aged 18 to 45 years (inclusive) on Day 1. Female subjects must be of non-child bearing potential.

Exclusion Criteria:

* Has received another new chemical entity (defined as a compound which has not been approved for marketing) or has participated in any other clinical study that included drug treatment within 3 months of the first administration of investigational prod
* Plasma donation within one month of screening or any blood donation/blood loss \> 500mL during the 3 months prior to screening
* Clinically relevant abnormalities in physical examinations, vital signs, ECG, clinical chemistry, hematology or urinalysis
A Study to Demonstrate the Clinical Accuracy of the Smartphone Vital Signs System (SVSS)

A medical device study to assess the clinical accuracy and equivalence to reference devices of the SVSS to satisfy the requirements of the recognised applicable international standards.

The SVSS is designed to measure and display 5 vital signs: pulse rate, blood oxygen saturation (Sp02), blood pressure, body temperature and respiration rate. These results will be compared for accuracy with the results obtained using standard vital sign measurement equipment on the same subject.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers, male or female, 18 yrs or older, willing and able to participate and sign the informed consent form.

Exclusion Criteria:

* None.
Patient-controlled Versus Anesthesiologist-controlled Propofol-remifentanil in Awake Craniotomy

Awake craniotomy for removal of brain tumour is performed because the tumour may be located close to areas of the brain that control specific functions such as movement or speech. Local anaesthesia (freezing) and sedation are required to make the patient comfortable and free of pain, but also to be able to cooperate for testing of brain function (speaking, moving) in order to preserve these areas while removing the brain tumour. The patient will be administered routine anesthetic drugs (sedatives (propofol) and pain killers (remifentanil)). The amount of sedation and analgesia (pain killer) is individually tailored to each patient as each person has different requirements. The usual way to give these medications is by the anesthesiologist assessing pain level, watching the patient and monitoring blood pressure and heart rate. Another way to give this medication is now available. This is with a special device, known as a patient-controlled analgesia pump (PCA). This device allows the patient to push a button to give pain medicine through an intravenous line and is frequently used for pain treatment after surgery and for other types of procedures. This device may be helpful during awake craniotomy, as it would allow patient-controlled administration of pain medicine and relaxing medicine whenever required. The amount of medication can be increased by more presses of the pump. At all times during the operation, the anesthesiologist will monitor the patient.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients more than 18 years of age
2. ASA I, II or III
3. Scheduled to undergo awake craniotomy for elective supratentorial tumor resection.

Exclusion Criteria:

1. patients with allergy to the drugs being used.
2. patients at risk for pulmonary aspiration eg patients with history of GERD, gastroparesis (eg diabetic) and obesity.
3. patients with BMI 35 or above
4. patients with severe cardiovascular or respiratory diseases (ASA IV or higher).
5. patients who are pregnant.
6. patients with alcohol or substance abuse.
7. patients who could not understand the concept of PCSA.
8. patients who do not understand and are unable to follow instructions for the study due to a language barrier
9. lack of informed consent.