cyrilzakka/clinical-trials huggingface dataset:
International Prospective Study on Morphine-induced Adverse Drug Reactions in Emergency Departments.

Morphine is the gold standard for treatment of severe acute pain but it has a number of adverse effects.

No study has so far managed to identify the morphine-induced adverse drug reactions. The primary objective of this study is to determine predictive factors of morphine-induced adverse drug reaction when it is used in emergency departments.

We want to study a large cohort of morphine-induced adverse drug reactions patients, the consequences for patients, mainly in terms of severity, and predictive criteria. This will allow us to identify some patients most at risk of morphine-induced adverse drug reactions, and thus to adapt morphine titration and monitoring of these patients. Leading to a better understanding and a better prediction of adverse effects in patients, it is possible that part of the "opiophobia" which persists in emergency services disappear. Finally, it is toward a better security but also a better efficiency in the management of pain patients in emergencies that leads this study.

The secondary objectives are:

To determine the frequency and severity of adverse events related to morphine. To establish an inventory of morphine use in emergency departments in the different centres studied.

Eligibility Criteria:
Inclusion Criteria:

All patients aged 18 years or older who require treatment with morphine for pain control will be considered for entry into the study.

Conscious without life threatening at the inclusion

Exclusion Criteria:

Patients who receive morphine during or after an orotracheal intubation, altered level of consciousness, inability to give consent or refusal of patient.
Choosing Tests Wisely in Rheumatology

This is a randomized study intended to produce a reduction in ordering of inappropriate tests by general practitioners as determined by recommendations from the CRA's Choosing Wisely guidelines. This reduction of inappropriate testing is expected in referrals to the rheumatologists randomized to the intervention group. This study will further explore which recommendations from the Canadian Rheumatology Association (CRA)/Canada Choosing Wisely campaign have the most impact on regional referring physicians to the Rheumatology clinic at St. Joseph's Hospital, London.

This a randomized study in that 6 rheumatologists (30 referrals each) will be randomized to one of two groups: intervention or control. Referring physicians to the intervention group will be faxed a brief Choosing Wisely form (intervention) based upon the recommendations of the Canadian Rheumatology Association's (CRA) Canada Choosing Wisely campaign, while referring physicians from the control group will not receive the form (non intervention). Analysis will be based upon the results of a three question survey faxed to all referring physicians at year one and at year two and on future referrals from the referring physicians to determine if there is a reduction in the group of ordering physicians that received the intervention (Choosing Wisely form).

Eligibility Criteria:
Inclusion Criteria:

* Ordering physicians who recently made a referral to the Rheumatology clinic at St. Joseph's Health Care.

Exclusion Criteria:

* N/A, all recent referrals will be included.
Fracture Evaluated in Emergency Room by Ultra Sound

The purpose of this study is to compare fracture diagnostic, conventional x-ray versus ultrasound.

to compare fracture diagnostic, conventional x-ray versus ultrasound in an emergency room department.

Eligibility Criteria:
Inclusion Criteria:

* Recent trauma to the wrist, ankle or fingers
* clinical exam by ER staff and x-ray indication.
* informed concent

Exclusion Criteria:

* open fracture
* wounds
* unstable fractures requiring cast immobilisation before x-ray
* multi traumatised patients
Evaluation of Sacral Neuromodulation (SNM) in the Treatment of Active Ulcerative Colitis (PRIMICISTIM)

Efficacy of ulcerative colitis to induce remission in patients with moderate to severe active ulcerative colitis.

Neuromodulation is a validated option for the treatment of fecal incontinence. Safety of this original approach has been confirmed by several studies. New indications for this minimally-invasive procedure are actually under evaluation particularly in the fields of irritable bowel syndrome and chronic constipation with promising results. Its mechanism of action remains partially unknown and the target of neuromodulation is not limited to the anal sphincter but the whole colonic motility seems to be influenced by this therapeutic approach. Moreover, recent experimental studies have shown that neuromodulation was able to reinforce the intestinal epithelial barrier involved in the pathophysiology of ulcerative colitis.

Subsequently, preliminary results in human have shown improvement of inflammation in patients suffering from inflammatory bowel diseases. In fact, despite recent improvement in medical therapies in inflammatory bowel diseases and particularly in ulcerative colitis, several patients are suffering from disabling chronic active disease. In those cases of refractory diseases, the only alternative treatment is a pan-proctocolectomy and ileal pouch surgery. This approach is a curative option, but leads to a significant morbidity and frequent functional disorders in the long-term follow-up (permanent stoma in 7 to 10% of the cases). Moreover, in limited distal disease (left colon and rectum) the surgical option seems to be unadapted and many patients remain symptomatic and suffer chronic active disease.

The aim of this study will be to assess in a prospective pilot study the efficacy of ulcerative colitis in inducing the remission of chronic active ulcerative colitis limited to the left side of the colon and improving the quality of life of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Active Ulcerative Colitis diagnosed on criteria Lennard Jones (31) for at least 1 year
* \> 18 yo
* E1 - E2 disease or extended to transverse colon but not beyond the hepatic flexure (endoscopic pictures)
* resistant to medical treatment: active after introduction for at least 8 weeks of maintenance treatment (immunosuppressive or anti-TNF)
* Activity score \>5 and endoscopic score \>2
* Absence of bacterial infection in progress (Clostridium difficile)
* Affiliated with a social protection scheme and had signed an informed consent

Exclusion Criteria:

* Severe forms requiring hospitalization an intravenous treatment or immediate surgery
* infectious colitis or proctitis
* Prednisone\> 20 mg / d
* Contraindications to the use of neuromodulator
* Corticosteroid therapy by intravenous route
* Pregnant women
* Major Trust
Comparative Effectiveness of a Peer-led O2 Infoline for Patients and Caregivers

About 1 million individuals in the US have a prescription for supplemental oxygen (O2). Using O2 can prolong life and increase quality of life. Patients often do not use their oxygen as prescribed, which means that they are not benefiting as much as they could be from this therapy. The purpose of this study is to evaluate whether a PEer-Led O2 Infoline for patients and CAregivers (PELICAN) will increase adherence to supplemental oxygen prescription and improve health in patients with chronic obstructive pulmonary disease (COPD).

The COPD Foundation operates a peer-led telephone-based information line, but its effectiveness in promoting adherence to O2 therapy and patient-centered outcomes is unknown. Our overall hypothesis is that a patient-centered Peer-Led O2 InfoLine for patients and CAregivers (PELICAN) will increase adherence and improve health. We have developed a broad-based collaboration with patients/caregivers, advocacy groups, a national O2 supplier, and others to conduct a 3-arm pragmatic clinical trial, to evaluate the comparative effectiveness of proactive vs. reactive PELICAN interventions vs. usual care on adherence to O2 (primary outcome) and on other patient-centered outcomes (secondary outcomes).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 years or older.
2. Physician diagnosis of COPD
3. Physician prescription for home O2 for 24hrs/day, 7 days/week
4. Willing to use home O2.
5. Working telephone number.

Exclusion Criteria:

1. Unable to read and speak English.
2. Discharge to home hospice or expected survival less than 6 months.
CPPopt Guided Therapy: Assessment of Target Effectiveness

Despite improvements in management, mortality in severe traumatic brain injury (TBI) remains 25% and only 40% of patients survive without major handicap. Medical/surgical interventions aim to maintain adequate brain perfusion, which is critically dependent on cerebral perfusion pressure (CPP); calculated as the difference between mean arterial pressure (MAP) and intracranial pressure (ICP). Current guidelines aim for a CPP above 50 mmHg, based on population means. However, this 'one size fits all' approach is flawed, because the relation between CPP and brain perfusion varies between individuals. Further, this approach takes no account of autoregulation, a key protective mechanism that maintains cerebral perfusion despite CPP fluctuations.

Autoregulation is variably preserved following TBI, and there are large between patient variances in the 'optimal' CPP (CPPopt) at which autoregulation operates best. Individual CPPopt can be retrieved automatically by plotting autoregulation data against the CPP over a certain time window. The investigators have shown that maintenance of CPP close to CPPopt is associated with improved outcomes. These data pose the hypothesis that optimisation of management in individuals may be achieved by using the zone of optimal autoregulation as a basis for defining individualised CPP targets.

The investigators propose, together with collaborators in the CPPopt study group (Maastricht, Cambridge, Leuven and Aachen) to set up a pilot (multicenter) feasibility study to develop a protocol for a definitive outcome randomized controlled trial (RCT). This study aims to develop protocols for CPPopt guided critical care, and show that they maintain patients closer to their optimum perfusion levels than standard protocols which keep above a population CPP threshold of 60 mmHg.

Hence, the main objective is to offer clinicians monitoring and therapy algorithms that achieve individualized optimal CPPopt targets and potentially improve TBI outcome.


Eligibility Criteria:
Inclusion Criteria:

* Any adult severe TBI patient requiring multimodality monitoring and ICP-directed therapy for at least 24 hrs on the assessment of the recruiting team.
* Start randomization within 24 hrs after ICU admission.
* Deferred informed consent or deferred proxy assent from relatives/legal representative (consultee).
* Exception for enrolling a patient past the 24 hour window: A patient who is admitted to the hospital and later experiences neuro-worsening that is not due to a systemic insult, (e.g. myocardial infarction, arrhythmia, pulmonary embolus, systemic hemorrhage) but due to a presumptive intracranial cause, and subsequently requires an ICP monitor, may be screened for enrolment. Consent, randomization, and monitor placement must be done within 48 hours from injury in order for the patient to qualify.

Exclusion Criteria:

* Patients \< 18 years old.
* Known pregnancy.
* Moribund at presentation (e.g. bilaterally absent pupillary responses)
* Patients with primary decompressive craniectomy.
* Patients already enrolled in \> 1 other research studies.
The Effect of VTC-G15 (a Pentapeptide Cleavage Product og GLP-1) on Whole Body Glucose Metabolism in Man

To asses the modulating properties of the cleaved pentapeptide product of GLP-1 amide.

The investigators have previously demonstrated that infusion of the pentapeptide during hyperglycemic clamps in dogs significantly increases the glucose infusion rate necessary to maintain stable hyperglycemia without any significant differences in insulin or glucagon secretion. The present study's aim is to examine whether this also occurs in humans. It may be necessary to examine a dose response curve. Specifically, in twenty healthy volunteers glucose infusion rate during the peptide infusion will be compared to the glucose infusion rate during saline administration during a 4 hour hyperglycemic clamp, in a cross over design(mg/kg/min).

Eligibility Criteria:
Inclusion Criteria:

* BMI 18.5-25;
* 33-38

Exclusion Criteria:

* T2D
* T1D
* Hypoglycemic agents
Adaptation of Melodic Intonation Therapy to Spanish

This study was conducted in three phases:

The first phase involved creation of a Spanish adaptation of the Melodic Intonation therapy; the second phase consisted of a pilot non-randomized intervention study to analyse its feasibility for use with 4 Spanish patients with poststroke nonfluent aphasia; the third phase consisted of a pilot randomised, crossover, intervention pilot trial in a different set of patients with poststroke nonfluent aphasia (N=20)


Eligibility Criteria:
Inclusion Criteria:

Patients diagnosed with nonfluent aphasia due to unilateral stroke in the left hemisphere without neuroimaging evidence of lesions in the right hemisphere who fulfilled the following criteria:

* The time elapsed since the stroke exceeded 6 months.
* Patient had received a standard program of conventional speech therapy after stroke.
* Persistent nonfluent aphasia with the following characteristics:

  * Severely restricted language, which might be limited to meaningless stereotypy; unlike that observed in verbal tasks, the patient might produce some real and relevant words when singing familiar songs.
  * Poor repetition, even for single words.
  * Moderately preserved language comprehension.
  * The nonstereotyped language was produced with a slurring of speech.
  * The total score for the repetition did not exceed the 70th percentile in the Boston Diagnostic Aphasia Examination. The score was obtained from the average score in three areas: repetition of words and repetition of phrases; listening comprehension exceeding the 15th percentile of Boston Diagnostic Aphasia Examination; and from the average score obtained in three areas: word comprehension, commands and complex ideational material.
* The patient was motivated, emotionally stable and had good attention.
* Signed informed consent was provided.

Exclusion Criteria:

* patients with a history of a previous stroke other than the index event or with any clinical condition (e.g., short life expectancy, coexisting disease) or other characteristics that precluded appropriate follow-up in the study
* patients participating in any therapeutic intervention clinical trials evaluating poststroke recovery
* use of psychotropic drugs that interfere with patient evaluation.
Evaluation of Effectiveness of Blue Code Team After In-hospital Cardiopulmonary Arrest

This study aimed to retrospectively examine patients evaluated by the Code Blue team on a Code Blue call in our hospital between 2016-2017.

Primary outcome: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2016-2017.

Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.

This study aimed to retrospectively examine patients evaluated by the Code Blue team on a Code Blue call in our hospital between 20016 and 2017.

Primary outcome: an examination of the survival rates and demographic data of the patients evaluated as an emergency by a Code Blue call in the period 2016-2017.Secondary outcome: to determine the rates of false Code Blue calls, the clinics giving Code Blue calls and the relationship between the times of Code Blue calls and mortality.Inclusion criteria: patients throughout the whole hospital for whom a Code Blue form was completed and who were evaluated by the Code Blue team on a Code Blue call.

Eligibility Criteria:
Inclusion criteria:

-Patients intervened by code blue team

Exclusion criteria:

* Cardiac arrest in the anesthesiology and reanimation intensive care unit
* Cardiac arrest in the newborn intensive care unit
* Out-of-hospital cardiac arrest
Safety, Tolerability, and Immunogenicity of a 24-Valent Pneumococcal Conjugate Vaccine (VAX-24) in Healthy Infants

The objective of the study is to evaluate the safety and tolerability of 4 injections of VAX-24 (at 3 dose levels) compared to PCV15 in infants at 2, 4, 6, and 12-15 months of age, in addition to receiving routine US concomitant vaccines. Stage 1 of the study will comprise 3 dose ascending cohorts. Stage 2 of the study will enroll the remainder of the sample size.


Eligibility Criteria:
Inclusion Criteria:

1. Healthy male or female infant ≥42 days to ≤89 days (inclusive).
2. Full-term infant at least 37 weeks gestational age at birth.
3. Afebrile for ≥72 hours with a rectal temperature \<38.0°C (\<100.4°F) or axillary temperature \<37.8°C (\<100.0°F) before receipt of study vaccine.\*
4. Able to attend all scheduled visits and comply with the study procedures.
5. Subject's parent/legal guardian is able to read and understands the study procedures, alternate treatments, risks and benefits, and provides written informed consent.
6. Subject's parent/legal guardian is able to fill out an ediary of solicited AE and take daily axillary temperature and measurements of local injection site reactions for the 7 days after each study vaccination.
7. Subject's parent/legal guardian has an e-mail address and access to a computer or smartphone with internet to complete the ediary.

Exclusion Criteria:

1. History of invasive pneumococcal disease (positive blood culture, positive cerebrospinal fluid culture, or other sterile site) or known history of other culture positive pneumococcal disease.
2. Previous receipt of a licensed or investigational vaccine (excluding 1 dose hepatitis B vaccine).
3. Known hypersensitivity to any vaccine.
4. Known or suspected impairment of immunological function (e.g., asplenia, HIV, primary immunodeficiency).
5. Use of any immunosuppressive therapy (Note: topical and inhaled/nebulized steroids are permitted).
6. History of failure to thrive.
7. Subject has a coagulation disorder contraindicating IM vaccination.
8. Subject or his/her mother have documented hepatitis B surface antigen-positive.
9. Has a known neurologic or cognitive behavioral disorder.
10. Has a known clinically significant congenital malformation or serious chronic disorder.
11. Receipt of a blood transfusion or blood products, including immunoglobulins.
12. Receipt of any investigational study product since birth, currently participating in another interventional investigational study, or having plans to receive another investigational product(s) while on study.
13. Any infant who cannot be adequately followed for safety according to the protocol plan.
14. Any other reason that in the opinion of the investigator may interfere with the evaluation required by the study.
Deep Squat, Cross-Legged Sitting and Low Back Pain

The goal of this randomized experimental study is to learn if regular deep squat or cross-legged sitting practice can improve mobility, reduce pain, and enhance visceral functions in adults with chronic low back pain (LBP). The main questions it aims to answer are:

Does practicing deep squat or cross-legged sitting increase joint mobility (hip, spine, ankle) and flexibility? Does it reduce pain levels in the lumbar spine and hip region? Does it improve visceral functions related to digestion and bowel movements? Researchers will compare a deep squat group, a cross-legged sitting group, and a control group to see if these interventions lead to significant improvements in mobility, pain reduction, and visceral function compared to no intervention.

Participants will:

Be randomly assigned to one of three groups (deep squat, cross-legged sitting, or control).

Practice their assigned position for 20 minutes per day, 6 days a week, for 6 weeks.

Undergo baseline and post-intervention assessments, including mobility tests, pain evaluation, and quality-of-life questionnaires.

This randomized experimental study explores the effects of deep squat and cross-legged sitting practice on musculoskeletal mobility, pain perception, and visceral functions in adults with chronic low back pain (LBP). By examining these interventions over a six-week period, the study seeks to determine their potential role as non-pharmacological strategies for managing chronic pain and mobility limitations.

Participants will receive structured guidance to ensure proper execution of the assigned positions and adherence to the intervention protocol. Standardized assessments will be conducted before and after the intervention to evaluate changes in joint mobility, flexibility, pain levels, and quality of life.

The study is designed to contribute to evidence-based rehabilitation practices, offering insights into how simple, posture-based exercises might improve physical function and well-being. Findings may have implications for physiotherapy, rehabilitation, and self-management strategies in individuals with chronic LBP.

Eligibility Criteria:
Inclusion Criteria:

* age 20-60 years, chronic lower back or hip pain lasting at least 3 months, presence of bowel problems at least twice a month for at least 3 months)

Exclusion Criteria:

* acute health problem, pregnancy, hip or knee TEP, patellofemoral syndrome or recent lower limb surgery
Study to Evaluate Pharmacokinetic and Bioavailability of Envarsus® vs. Advagraf® in Liver Transplant Recipients

Single centre, open-label, randomized, controlled, cross over study to evaluate the pharmacokinetic and bioavailability of Envarsus® in comparison to Advagraf® in de novo liver transplant recipients

Using an open-label, randomized, controlled, 2-period cross-over design, two treatments (Envarsus® and Advagraf®) will be compared (with regard to PK profile and bioavailability) after administration of IMP to 20 de novo transplanted recipients. The patients will be randomly assigned to one of the two treatments as treatment period 1 and afterwards switched to treatment period 2 (Group 1: Envarsus® - Advagraf®; Group 2: Advagraf® - Envarsus®).

Eligibility Criteria:
Inclusion Criteria:

1. Ability to understand the patient information and to personally sign and date the informed consent to participate in the clinical trial, before completing any clinical trial related procedures.
2. Male or female recipients ≥ 18 years of a liver graft from a deceased or living donor
3. The patient must receive a twice daily Tacrolimus based immunosuppression treatment.
4. Females of child-bearing potential who agree to comply with any applicable contraceptive requirements of the protocol or females who are permanently sterilized (at least 6 weeks post sterilization).
5. Non-pregnant, non-lactating female.
6. Recipients of a first or re-liver transplant in the last 30 days
7. The patient is co-operative and available for the entire clinical trial.

Exclusion Criteria:

1. Patients with a known hypersensitivity to any of the drugs used in the study.
2. Patients who are not able to take oral medication at the time point of randomization.
3. Recipients of combined organ transplants.
4. Patients who are recipients of AB0 incompatible transplant grafts.
5. Currently participation in a clinical trial and any IMP intake within the last four weeks.
6. Patients who use drugs known to strongly interact with the cytochrome P-450 3A4 pathway and therefore influence the tacrolimus blood level are not allowed during Envarsus®/Advagraf® treatment period.
7. Patient with renal impairment with need of dialysis treatment at the time point of randomization.
8. Patient with a quick value \< 30 %
9. Patient with a thrombocytopenia \<20 Mrd./L
10. Patients with a leukopenia \< 1.0 Mrd. / L
11. Patients with inability of oral food intake.