cyrilzakka/clinical-trials huggingface dataset:
Anesthesia Core Quality Metrics Consensus Delphi Study

To develop a ranked list of up to 20 metrics, which can be used to evaluate the quality of anesthesia, perioperative care, and acute pain management for adult inpatient non-cardiac surgical patients for use in quality improvement and quality assurance, research, and continuing medical education in the Canadian care context.

Background: Improving anesthesiology care and perioperative outcomes is a growing field encompassing quality improvement and quality assurance, research, and continuing medical education. Multiple consensus initiatives have standardized perioperative endpoints. However, no standard set of metrics exist to evaluate the quality of Canadian anesthesiology care delivery.

Objective: Develop a ranked list of up to 20 metrics, which can be used to evaluate the quality of anesthesia, perioperative care, and acute pain management for adult inpatient non-cardiac surgical patients for use in quality improvement and quality assurance, research, and continuing medical education in the Canadian care context.

Methods: First, the steering committee will conduct a scoping review of the literature to identify candidate metrics, according to Preferred Reporting Items for Systematic Reviews and Meta-Analyses extension for scoping reviews (PRISMA-ScR) and Joanna Briggs Institute methodology for scoping reviews. Metrics will include patient-reported outcome and patient-reported experience measures, quality and safety indicators, process metrics, and Canadian Anesthesiologists' Society recommended practice standards. The search strategy will include English-language articles published or in use within the past seven years (2015/Jan-2022/March) in 1) MEDLINE, Embase, CINAHL, Web of Science, and Cochrane Database of Systematic Reviews, 2) grey literature, including guidelines, and 3) existing evaluation metrics used by Canadian departments for quality assurance and improvement. Screening and data extraction will be performed by two independent reviewers using Covidence.

Next, following approval from the Research Ethics Board and with written informed consent from participants, a multidisciplinary panel of anesthesiologists, people with lived surgical experience (patients, caregivers), surgeons, nurses, internal medicine and family physicians, hospital administrators, and researchers will iteratively review the list of candidate metrics using a modified Delphi process. Independent voting, using surveys over three rounds, will be used to identify the most important metrics to define the quality of anesthesia, perioperative care, and acute pain management. Additional cycles may be performed if required.

Eligibility Criteria:
Inclusion Criteria:

* Patient/family participants must have undergone a surgical experience within the past three years, and have the capacity to provide informed consent.
* All other participants must be actively practising in Canada in the disciplines they represent.

Exclusion Criteria:

- Participants with self-declared conflicts of interest with this project.
Pilot Study on the Acceptability of Auricular Vagus Nerve Neurostimulation in Adolescents

Non-suicidal self-injury (NSSI) are acts defined by the DSM-5 (Diagnostic and Statistical Manual of Mental Disorders 5) as intentional and deliberate, occurring outside a psychotic state and directly causing moderate injury.

Their international prevalence is between 13 and 17% in adolescents and young adults, and has recently increased with the COVID-19 health crisis, with the prevalence of NSSI rising to 40% in adolescents. Access to psychiatrists is declining. Drug solutions, meanwhile, lack scientific proof in this indication.

The autonomic nervous system and the hypothalamo-hypophyseal axis are involved in the human response to experimentally-induced pain, as well as in stress regulation, notably via control of cortisol secretion.

Abnormally low levels of the latter hormone have been detected in persons with NSSI disorder.

Transcutaneous neurostimulation of the atrial vagus nerve (taVNS) has been studied for some ten years. The afferent branches of the vagus nerve stimulate the hypothalamic-pituitary axis, leading to the production of cortisol by the adrenals.

The hypothesis of this research is that stimulation of the vagus nerve by taVNS would improve the functioning of the hypothalamic-pituitary axis in patients with NSSI, and thus reduce the frequency of acting out.

Although taVNS is an easy-to-access technique that patients can implement at home, the question of adherence to this treatment in adolescents has not yet been evaluated. The aim of this pilot study is to assess whether adolescents with NSSI will adhere to taVNS treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adolescents aged between 13 and 17 years old
* Patients with NSSI disorder as defined by DSM-5
* Patient affiliated to a social security scheme
* Patient who parents or guardians have signed a free and informed consent form
* Patient able to understand neurostimulation instructions

Exclusion Criteria:

* Contraindication to taVNS:
* Malformation, skin pathology of the external ear. (piercings in the area concerned must be removed during the neurostimulation session).
* Children with sleep apnea syndrome treated with NIV (non-invasive ventilation)
* Presence of epileptic seizures
* Proven cardiac pathology on the advice of the attending cardiologist
* History of venous or arterial thrombosis
* Adolescent with pacemaker or defibrillator
* Adolescent with an active implantable device
* Pregnancy (based on anamnestic criteria, checked by blood test if necessary)
* Patients with psychotic episodes, confusional states or severe neurodevelopmental disorders
* Patients with an allergic skin reaction to silicone (component of the ear electrode)
* Patients with a cochlear implant on the stimulation side
* Pregnant or breast-feeding women
* Minor under guardianship
* Minor under judicial measure or sanction
Resting-state Functional Connectivity Changes During Migraine Treatment

The purpose of this study is to determine whether reduced frequency of migraine attacks are associated with signal alternation and connectivity of cerebral cortex.

Patients with migraine show reduced cortical thickness in regions subserving pain processing, and it is related to increasing headache frequency. In the past, only one study has shown a reversibility consequence of chronic nociceptive transmission, which normalizes when the pain is adequately treated. However, little is known whether these changes predispose to migraine or represent the effect of repeated migraine attacks. Our region of interest is reduced frequency of migraine attacks are associated with reversibility of signal alternation and functional connectivity of cerebral cortex.

In 30 migraineurs with 8-14days with headache per months who already performed brain magnetic resonance imaging will be recruited. Treatment medications such as frovatriptan and topiramate will be used for 6 months. After 6 months, follow-up brain magnetic resonance imaging will be performed.

The primary outcome is the longitudinal changes in functional connectivity in pain-processing/modulating brain regions. The secondary outcome is following: 1)longitudinal changes in structural and morphological alterations in brain regions of pain processing; 2)structural, morphological, and functional correlates of treatment response; 3)changes in monthly migraine days, migraine frequecies, headache days, and headache frequencies after treatment; 4)responses to acute migraine treatment.

Eligibility Criteria:
Inclusion Criteria:

* Premenopausal Women
* Aged 18-50
* Drug-naïve high frequency episodic migraineurs (8-14 attacks/m)
* Performed a baseline interictal brain MRI

Exclusion Criteria:

* Medication overuse
* Chronic pain other than migraine
* On treatment of major depression, bipolar, schizophrenia, or BDI\>25
Statins for the Early Treatment of Sepsis

We propose a Phase II, randomized, placebo-controlled clinical trial to test the hypothesis that treatment with once-daily statins has a beneficial effect on inflammatory cytokines and clinical outcomes in adults hospitalized with sepsis. As our animal models suggest pretreatment with statins are required for their beneficial effects, we propose a study design intended to identify patients and initiate treatment early in their hospital stay. This Phase II study is intended to assess the feasibility of conducting a large-scale investigator-initiated translational research protocol that involves multiple clinical services within the Department of Medicine.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Initial presentation to the Emergency Department or University of Chicago MD office/Dialysis Center for current hospital admission
* Sepsis (ACCP/SCCM criteria)

  1. Clinically suspected infection as per the treating physician or confirmed infection
  2. 2 or more of the following: Temperature 38ºC (100.4ºF)or 36ºC (96.8ºF), Heart rate (HR) \> 90/min, Respiratory rate (RR) \> 20/min or PaCO2 \< 32 mmHg, White blood cell count \> 12,000/mm3 or \< 4000/m3 or \> 10%immature neutrophils
* Initiation of antibiotics by treating physician for sepsis
* Hospitalized from the Emergency Department or University of Chicago MD office/Dialysis Center to an inpatient medical service (intensive care unit (ICU)or non-ICU service) OR admission to the medical ICU (MICU) from a non-ICU inpatient medical floor.
* Assent of the primary treating physician at the time of enrollment.
* The meeting of SIRS criteria is due to an infection as per the treating physician.

Exclusion Criteria:

* Pregnancy
* ALT \>3 times above the upper limit of normal
* Elevated creatine phosphokinase (CPK) (\>3 times the upper limit of normal)
* Concurrent treatment with any of the following drugs: daptomycin, fenofibrate, ketoconazole,triaconazole, amiodarone, clarithromycin, cyclosporine, erythromycin,nefazodone, niacin, protease inhibitors, telithromycin, verapamil,danazol, gemfibrozil
* History of allergy or intolerance to statins
* Greater than 16 hours after meeting inclusion criteria
* Use of 1 more doses of statins in the previous 4 weeks
* Clinical indication for treatment with statin during hospital admission (per treating physician)
* Sufficiently poor prognosis prior to enrollment that treating physicians have elected to employ comfort care or plan to discharge to hospice
* Transfer from surgical service to medical service
* Needing transfusion for either active bleeding or severe hemolysis.
Neuromuscular Electrical Stimulation and Strength Training in Patients With Knee Osteoarthritis

The purpose of this study is to compare the efficiency of neuromuscular electrical stimulation and of resisted exercises on increasing quadriceps strength, decreasing pain and on recovering motor function of patients with knee osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* American College of rheumatology criterion for osteoarthritis diagnosis

Exclusion Criteria:

* Patients that have done knee replacement or are about to do.
* Patients with health conditions that are not compatible with the interventions
* Patients that have done intraarticular corticoid
MIdazolam Versus MOrphine in Acute Pulmonary Edema (MIMO Trial)

Acute pulmonary edema (APE) is a common condition in the emergency room, associated with considerable mortality. The use of intravenous morphine in the treatment of APE remains controversial and Benzodiazepines have been suggested as an alternative for morphine to relieving dyspnoea and anxiety in the patients with APE. The MIdazolan versus MOrphine in APE trial (MIMO) is a multicenter, prospective, open-label, randomized study designed to evaluate the efficacy and safety of morphine in patients with APE.


Eligibility Criteria:
Inclusion Criteria:

* Patients with acute pulmonary edema with dyspnoea and anxiety

Exclusion Criteria:

* Patients with known severe liver disease.
* Patients with known severe renal disease.
* Patients with expectation of death from other illness during the course of the trial.
Hematological Disorder in Patients With Angiodysplasia

The study aim will be to assess the association between GIT angiodysplasia with any hematological disorders such as any specific coagulation disorders or anemia.

Angiodysplasia is a vascular GI tract abnormality tortous thin walled blood vessels seen in mucosa and submucosa highly prone to rupture resulting in GIT bleeding and hematological disorders ,Impaired coagulation profile and anemia are main changes in angiodysplasia . (An overview of angiodysplasia: management and patient prospects,Grainne Holleran et al. Expert Rev Gastroenterol Hepatol. 2018 Sep.) Gastrointestinal angiodysplasia is a major cause of recurrent bleeding. Haemostatic abnormalities have been implicated in the haemorrhage from these common vascular lesions but their precise contribution remains to be established. (Gastrointestinal angiodysplasiaG Dodda et al. J Assoc Acad Minor Phys. 1997) Angiodyplasia and aortic stenosis are both conditions that are highly prevalent in elderly people and can often co-exist. Recent studies suggest that this association is related to subtle alterations in plasma coagulation factors . The von Willebrand factor is the strongest link between aortic stenosis and bleeding associated with gastrointestinal angiodysplasia. With an aging population, the disease burden of aortic stenosis and its association with angiodysplasia of the bowel makes this an incredibly under-diagnosed yet important condition. This association when dealing with elderly patients presenting either with unexplained anemia, gastrointestinal bleeding or with aortic stenosis should be considered. A high index of suspicion and appropriate diagnostic techniques followed by appropriate and prompt treatment could be life-saving. (Heyde Syndrome Complicated by Essential Thrombocythemia: A Case Report) Chronic hematologic diseases increase the fragility of blood cell components, leading to the progressive destruction of blood cells at the site of aortic stenosis . In this process, further destruction of large multimers of von Willebrand factor may lead to coagulation disorders and gastrointestinal bleeding, such as Heyde syndrome.

Eligibility Criteria:
Inclusion Criteria:

* Adults (above 18 years) and elderly

  * Both genders
  * Admitted to GIT Unit with manifestations of GIT angiodysplasia diagnosed by upper endoscopy and Colonoscopy.
  * bleeding git symptoms

Exclusion Criteria:

* other causes ofGIT bleeding

  * bleeding git ulcers
  * hematological disorder causing bleeding tendency ex hemophilia
Intrafractional Vaginal Dilation in Anal Cancer Patients Undergoing Pelvic Radiotherapy

A commercially available vaginal dilator set will be used as measuring device. The grading of vaginal stenosis will be determined as difference of the diameter of vaginal dilator to the baseline. A reduction of the diameter of \<20% is defined as vaginal stenosis Grade 1, a reduction of 20-35% as Grade 2, a reduction of \>35-49% as Grade 3 and a reduction \>/=50% as Grade 4. The investigators hypothesize that the rate of vaginal stenosis Grade 1 or higher 12 months after radiotherapy is lower in the group using extended vaginal dilation during radiotherapy (Arm A). Rates of vaginal stenosis of 50% have been observed in previous patient collectives and the investigators hypothesize that a reduction to 25% is possible in the experimental group.

The study is designed as a prospective, randomized, two-armed, single-center phase-II-trial. 60 patients will be included in the study. Patients fulfilling the inclusion criteria will be randomized into one of the two arms, which differ only in the diameter of a tampon used for vaginal dilatation during treatment. All patients will receive standard (chemo)radiotherapy with a total dose of 45-50,4 Gy (single dose 1,8-2 Gy) to the pelvic and inguinal (if required) lymphatic drainage with a boost to the anal canal up to 54-60 Gy (single doses 1.8-2.2 Gy). The primary objective is the assessment of the incidence and grade of vaginal fibrosis 12 months after (chemo)radiotherapy for anal cancer depending on the extent of intrafractional vaginal dilatation. Secondary endpoints are clinical symptoms and toxicity according to the Common Toxicity Criteria (CTC) version 5.0, assessment of clinical feasibility of daily use of a tampon for vaginal dilatation, assessment of the compliance for the use of a vaginal dilatator and quality of life assessed with the EORTC-QLQ30/-ANL27 questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Female patient
* Histologically confirmed squamous anal cancer
* Indication for definitive or postoperative radiotherapy
* ECOG 0-2
* Age \> 18 years
* Written informed consent

Exclusion Criteria:

* patients refusal or incapability of informed consent
* no vaginal dilatation possible prior to radiation treatment start
* prior pelvic irradiation (if direct field border or even overlap of radiation fields assumed)
* participation in another clinical trial which might influence the results of the DILANA trial
* pregnancy/nursing period or inadequate contraception in women with child bearing potential
A Single and Multiple Dosing Study Targeting Biparatopic Antibody CD38 in Healthy Volunteers

This is a Phase 1, Double blind, Single ascending and Multiple ascending dose (SAD and MAD) escalation study in Healthy Volunteers.

TNB-738 is a fully human bispecific antibody used to inhibit human CD38 enzyme.

The study will consist of 2 arms (A and B). The SAD arm (Arm A) of the study consists of sequential single dose escalation cohorts, whereas the MAD portion (Arm B) of the study consists of sequential dose escalation cohorts receiving study drug once every 4 weeks for 3 doses. In both Arm A and Arm B, subjects will be randomized to receive either TNB-738 or matching placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female
2. Age 18 - 75
3. Body mass index (BMI) ranging between 18 and 35 kg/m2, inclusive
4. Female subjects of child-bearing potential must agree to use one of the study-approved effective contraceptive methods for the duration of the study
5. Male subjects must practice true abstinence or agree to use a condom while participating in the study through End of study (EOS)
6. If female, a negative serum pregnancy test at Screening and urinary pregnancy test at Day -1 is required
7. Able to read, understand, and provide signed informed consent
8. Able to communicate adequately with the investigator and to comply with the requirements for the entire study.

Exclusion Criteria:

1. Subject has any significant medical condition that would prevent the subject from participating in the study.
2. Subject is pregnant or breastfeeding.
3. Subject is currently receiving treatment with a biologic agent.
4. Subject has a history of anaphylactic reactions to biologic agents.
5. Subject has been dosed with another investigational drug study within 60 days prior to study drug administration.
6. Subject has current or recent (within 4 weeks prior to screening) signs or symptoms of infection that require antibiotic administration.
7. Subject has evidence of COVID-19 infection and/or subject is deemed at risk for the coronavirus disease in the opinion of the investigator or the subject has participated in another clinical study involving treatment(s), which may increase such risk.
8. Subject has used any prescription (excluding hormonal birth control) drugs within 14 days or illicit drugs within 30 days, or 5 half-lives (whichever is longer), prior to study drug administration.
9. Subject has a positive urine drug test or alcohol breath test at screening.
10. Subject has donated or lost more than 1 unit of blood (500 mL) within 60 days or more than 1 unit of serum within 7 days before the study drug administration.
11. Subject is HIV, HBV, or HCV positive.
12. Subject has received a live virus vaccine within 4 weeks of dosing
Class I Medical Device on Post-surgical Scars

To compare the effect of a class I pullulan based medical device containing Allium cepa \& HA versus a class I medical device silicone gel on new post-surgical wounds

A head-to-head, randomised, pivotal controlled trial evaluating the appearance of post-surgical scars for 12 weeks. The study was developed in 10 months, including recruitment, evaluation every 4 weeks and evaluation of the secondary objective in the third month (T2). The primary endpoint was the evaluation of the effectiveness of the class I medical device contain onion (Allium cepa) extract compared to the silicone gel used in the treatment of post-surgical scars for the prevention of hypertrophic scars. Objective scar assessment using the Vancouver Scar Scale (VSS), Manchester Scale, Patient and Observer Scar Assessment Scale (POSAS), itching, redness and pliability were performed after 4,8 and 12 weeks of treatment. Safety was also evaluated by gathering adverse events related to application of the gel. The statistical analysis of the data was carried out by applying parametric or non-parametric tests depending on the distribution of the data that was going to be obtained. The one-way analysis of variance ANOVA test was used to evaluate the reduction/increase of clinical parameters in the pre-established observation times (T0, T2, T3 and T4) for each treatment, whereas comparison between treatments was performed via t-test analysis. Correlation tests were also used. The differences were considered statistically significant for p values \<0.05.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged between 18 and 70 who have undergone surgery for the excision of skin lesions at least 20 days before the start of the protocol.

Exclusion Criteria:

* Subjects affected by spontaneous keloids

  * Diabetic subjects with a previous history of disorders in the repair of wounds;
  * Subjects with overinfected wounds after the first week after surgery;
  * Subjects with documented sensitivity to silicone gel;
  * Subjects affected by collagen disorders (e.g. Pseudoxantoma elasticum, poikilodermatosis).
Clinical Assessment of a Customized Free-form Progressive Addition Lens Spectacle

The purpose of this study was to compare objective clinical measures of visual performance and subjective measures of satisfaction and preference between standard progressive addition lens (PAL) spectacles and a new type of free-form surfaced, optically customized PAL spectacle.

In a double-masked crossover trial, 95 experienced wearers wore customized free-form PAL spectacles (Test) and standard non-free-form PAL spectacles (Control) for one week each. All subjects wore both Test and Control spectacles, and the pair to be worn first was randomly assigned. At dispensing and after 1 week of wear, subjects were tested for distance and near visual acuity (VA) under both high and low contrast; in addition, 30 degree off-axis VA was measured using a novel apparatus, as was the horizontal extent of undistorted vision at reading distance. Subjects also completed a set of questionnaires detailing their satisfaction levels, adaptation times, and preferences for Test or Control spectacles for different visual tasks.

Eligibility Criteria:
Inclusion Criteria:

* Presbyope
* Experienced PAL spectacle wearer
* Correctable to at least 20/25 in both eyes
* Able and willing to use Test and Control spectacles for 1 week each as primary form of presbyopia correction
* Able and willing to complete all laboratory measurements and questionnaire batteries

Exclusion Criteria:

* Purchasing free-form PAL spectacles from the UC Berkeley Eyewear Center
* Having eye conditions or diseases that could potentially cause a decrease in visual acuity over the course of participation in the study
* Having eye conditions or diseases that could potentially interfere with ability to use Test and Control spectacles as primary form of presbyopia correction