cyrilzakka/clinical-trials huggingface dataset:
Evaluating the Impact of Operating Room Simulations on Communication Skills and Patient Safety (EIORS-CPS)

Simulation-based training has emerged as a valuable tool for enhancing communication skills among healthcare professionals. This study aimed to evaluate the impact of operating room (OR) simulations on the development of communication skills for patient safety. The study focused on two key areas: the development of communication skills for patient-centered care and the role of the WHO Surgical Safety Checklist in enhancing communication and patient safety during simulations.

This study will provide valuable insights into student preferences for logbook formats in anesthesiology education, specifically within the MEDI 045 course. By comparing Excel sheet logbooks with traditional paper logbooks, it aims to elucidate how different documentation methods impact student engagement, satisfaction, and learning outcomes.

Understanding these preferences is crucial, as logbooks are not merely administrative tools but integral components of the educational experience that promote reflection, accountability, and skill development in clinical practice.

The findings will contribute to existing knowledge by identifying specific advantages and disadvantages of each format, highlighting the aspects that enhance or hinder student learning. Moreover, the research will inform curriculum designers and educators about effective strategies for logbook implementation, ultimately leading to improved educational tools that better align with students' needs

Eligibility Criteria:
Inclusion Criteria:

Participants must be medical students enrolled in the MEDI 045 course at King Saud University.

Must have prior exposure to basic patient safety and communication skills training.

Age: 18-25 years. Students must voluntarily consent to participate in the study and complete the required simulations and assessments.

Exclusion Criteria:

Students who have already completed formal simulation-based training on communication or patient safety outside the MEDI 045 curriculum.

Students are unable to participate in simulation sessions due to scheduling conflicts or medical reasons.

Participants were unwilling to provide informed consent.
Prospective Evaluation of Forceplate Measured Levodopa-Induced Dyskinesia

Nearly all Parkinson's disease (PD) patients eventually develop abnormal and unwanted movements (dyskinesias; LID) caused by the gold standard treatment, Levodopa. The severity of these movements can range from subtle to extremely debilitating and may or may not interfere with normal activities such as putting on a coat or brushing ones teeth. The purpose of this study is to demonstrate the validity and reliability of objectively measuring dyskinesia with a forceplate.

The main outcome measure of this study are measurements taken every half hour during an inpatient study visit. These measurements include standing on a forceplate for 1 minute while performing a mental task such as reciting the alphabet backwards. During this forceplate stance, a rater will visually score your movements. All participants must be eligible for another Parkinson's disease study at Oregon Health and Science University.

Eligibility Criteria:
Inclusion Criteria:

* Parkinsons disease
* Older than 18

Exclusion Criteria:

* Must be participating in a Parkinsons disease study at Oregon Health \& Science University
Influence of Liraglutide, a GLP-1 Receptor Agonist, on Brown Adipose Tissue (BAT) Activity in Humans

The purpose of this study is to access liraglutide influence brown adipose tissue recruitment and its thermogenic effect through hypothalamic activation in obese individuals.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index over 30 kg/m2.

Exclusion Criteria:

* Hypersensitivity to liraglutide or any of its vehicle components;
* History of diabetes or pre-diabetes - either by fasting glycemia, oGTT or HbA1c;
* Previous treatment within the last 3 months with glucagon like peptide-1 agonists, iDPP4 or any medication that is associated with BAT activation, including propranolol and benzodiazepines;
* Liver diseases, except non-alcoholic steatohepatitis (NASH);
* Infection by HIV, hepatitis B or hepatitis C;
* Addiction to cannabis, heroin, morphine, cocaine, benzodiazepines or amphetamine;
* Obesity induced by other disorders such as Cushing syndrome, hypothyroidism, lipodystrophy
* Current or history of treatment with medications that may cause significant weight gain within 3 months prior to screening, including systemic corticosteroids (except for a short course of treatment, i.e. 7-10 days), tricyclic antidepressants, atypical antipsychotic and mood stabilizers (e.g. imipramine, amitriptyline, mirtazapine, paroxetine, phenelzine, chlorpromazine, thioridazine, clozapine, olanzapine, valproic acid and its derivatives, and lithium);
* Current participation (or within the last 3 months) in an organized weight reduction program
* Currently or previous using within 3 months before screening of pramlintide, sibutramine, orlistat, topiramate, or metformin (either by prescription or as part of a clinical trial)
* Participation in a clinical trial within the last 3 months prior to screening
* Simultaneous participation in any other clinical trial of an investigational drug
* Previous surgical treatment of obesity;
* Cancer (past or present, except basal cell skin cancer or squamous cell skin cancer), which in the investigator's opinion could interfere with the results of the trial
* Liver enzyme (ALT and AST) above 2.5 x of reference range
* Pancreatic enzymes (amylase, lipase) above 3 x the reference range
* Chronic kidney disease stages 3, 4, or 5
* Relevant inflammatory or acute or chronic infectious disease; hyperthyroidism; neurological, psychiatric, gastrointestinal, respiratory, renal, hepatic or cardiac relevant disease, that could interfere with trial results per the judgment of investigator
* Any condition that at the discretion of investigator could interfere with treatment adhesion on patient safety
* Blood donation or transfusion within the last 3 months
* Pregnancy or intention of pregnancy
* History of Multiple Endocrine Neoplasia Syndrome Type 2 (MEN 2)
* History of pancreatitis
* Less than 80% of liraglutide adherence
* Calcitonin above the reference range at the screening visit.
Safety of Cultured Allogeneic Adult Umbilical Cord Derived Mesenchymal Stem Cell Intravenous Infusion for Osteoporosis

This trial will study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells for the treatment of Osteoporosis

This patient funded trial aims to study the safety and efficacy of intravenous infusion of cultured allogeneic adult umbilical cord derived mesenchymal stem cells (UC-MSCs) for the treatment of Osteoporosis. Patients will receive a single intravenous infusion of UC-MSCs. The total dose will be 100 million cells. Patients will be evaluated within one month pre treatment and at 1, 6, 12, 24, 36, and 48 months post treatment for safety and efficacy.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Osteoporosis
* Understanding and willingness to sign a written informed consent document

Exclusion Criteria:

* Active infection
* Active cancer
* Chronic multisystem organ failure
* Pregnancy
* Clinically significant Abnormalities on pre-treatment laboratory evaluation
* Medical condition that would (based on the opinion of the investigator) compromise patient's safety.
* Continued drug abuse
* Pre-menopausal women not using contraception
* Previous organ transplant
* Hypersensitivity to sulfur
A Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of a Single Dose of SRP-5051 (Vesleteplirsen) in Patients With Duchenne Muscular Dystrophy (DMD)

The purpose of this study is to evaluate the safety, tolerability, and pharmacokinetics (PK) of 5 escalating doses of SRP-5051 (vesleteplirsen) administered as a single dose to patients with DMD amenable to exon 51 skipping treatment.


Eligibility Criteria:
Inclusion Criteria:

* Has a genetic diagnosis of DMD and an out-of-frame deletion mutation of the DMD gene amenable to exon 51 skipping treatment
* Has been on a stable dose of oral corticosteroids for at least 12 weeks prior to study drug administration with continued dosing of oral corticosteroids while participating in the study\*, or has not received corticosteroids for at least 12 weeks prior to study drug administration and will not initiate dosing of oral corticosteroids while participating in the study

Exclusion Criteria:

* Has a left ventricular ejection fraction (LVEF) less than (\<) 40 percent (%) based on an echocardiogram (ECHO) performed within 3 months prior to Screening or at the Screening visit
* Has a QT interval corrected with Fridericia's method (QTcF) \>= 450 millisecond (msec) on the Screening electrocardiogram (ECG)
* Initiation or change of dosing (except for modifications to accommodate changes in weight) within 12 weeks prior to Screening and while participating in the study for any of the following: angiotensin-converting enzyme (ACE) inhibitors, angiotensin-receptor blocking agents (ARBs), beta-blockers, or potassium
* Requires antiarrhythmic and/or diuretic therapy for heart failure
* Forced vital capacity (FVC) \<40% of predicted value within 3 months of Screening or at the Screening visit
* Known kidney disease or had an acute kidney injury within 6 months prior to Screening
* Treatment with eteplirsen or drisapersen within 6 months prior to Screening, or any experimental gene therapy for the treatment of DMD at any time
* Use of any herbal medication/supplement containing aristolochic acid

Other inclusion/exclusion criteria apply.

\*The dose of steroids must remain constant except for modifications to accommodate changes in weight.
Assessment of adherenCe tO Medical theraРy and Its infLuence on Long-term Outcomes In pAtieNts With Heart Failure

The aim of this prospective cohort study is to assess the adherenсe to medical therapy and its influence on long-term outcomes in patients with chronic heart failure in the outpatient registry

Registry PROFILE is a patients database with cardiovascular diseases who consistently apply to the specialized cardiology department of the "National Medical Research Center for Preventive Medicine" for consultation or to assess their possible participation in clinical trials The purpose of this study is to assess adherence to medical therapy and its impact on long-term outcomes in patients with chronic heart failure enrolled to PROFILE registry from 01 January 2016 to 01 July 2020. The patients who were enrolled between 01 January 2016 to 01 December 2019 will be invited to clinical visit by phone. For patients who will join PROFILE registry after 01 December 2019 the first visit of this study is the day of enrollment to PROFILE registry.

The first visit (V1) is an inclusion in the study. During this visit assess adherence to medication therapy General and to specific medications. The main factors affecting treatment adherence will be identified.

The second visit (V2) is planned for each patient 1 year after the first visit (V2). During the second visit the adherence to the therapy and frequency of Secondary Outcome Measures will be estimated. Impossible to visit repeated, a telephone interview can be done

Eligibility Criteria:
Inclusion Criteria:

* All patients with documented Сhronic heart failure who were included in register PROFILE from from Junuary 1, 2016 to July 31, 2020
* Ejection fraction \<50% or
* Ejection fraction ≥ 50% plus increase of BNP\>500 ng/l or NT-proBNP \<50 years - 450 ng/l , 50-75 years \> 900 ng/l; \>75years \> 1800 ng/l

Exclusion Criteria:

* Patients whose life status is defined as "dead"
* Patients who refused to participate in our study
* Refusal to sign informed agreement
Comparison of Sirolimus Alone With Sirolimus Plus Tacrolimus in Type 1 Diabetic Recipients of Cultured Islet Cell Grafts

Proof of concept study in islet transplantation, two treatment arms (ATG SIR-TAC versus ATG SIR) each consisting of ten type 1 diabetic patients


Eligibility Criteria:
Inclusion Criteria:

* Type 1 insulin-dependent diabetic patients
* C-peptide \< 0.15 nmol/l (\<0.45 µg/l) 6 min. after glucagon IV (1mg) (glycemia \> 180 mg/dl)
* diabetic nephropathy
* hypoglycaemic unawareness

Exclusion Criteria:

* smoker before transplantation
* plasma creatinine \> 2 mg/dl
* albuminuria \>1000 mg/24 hrs
* abnormal liver function
* history of thrombosis or pulmonary embolism
* history of malignancy, tuberculosis or chronic viral hepatitis
* history of any other serious illness which could be relevant for the protocol
* HLA antibodies
* EBV antibody negative
* HIV 1 \& 2 antibody positive
Biofeedback Based Virtual Reality Intervention to Manage Postoperative Pain

To develop and refine a technology based treatment protocol for preoperative education and training and postoperative care in children and adolescents undergoing surgery.

This is a 2-phase study aimed to refine a perioperative treatment protocol for a technology-based intervention (Aim 1) and to understand whether technology-based interventions can be used to help treat pain in children following surgery (Aim 2). Patients will participate in only one phase of the study, and when patients are enrolled will determine what Phase of the study they are in.

In Phase 1, all patients will use the same technology, and no randomization will occur. Primary and secondary outcome measures of Aim 1 are assessed in Phase 1. Actual enrollment for Phase 1 was 23 patients.

In Phase 2, patients will be randomized to receive 1 of 2 technology-based interventions. The perioperative treatment protocol developed in Phase 1 (Aim 1) will be used in Phase 2 to assess the primary and secondary outcome measures of Aim 2. This phase is anticipated to enroll up to 70 participants.

This is not an FDA-regulated drug or device trial as the technology used in this study is categorized as a relaxation device by the FDA and considered "minimal risk", thus exempt from both NDE and IDE.

Eligibility Criteria:
Inclusion Criteria:

* Ages 12 -18 years
* Scheduled to undergo surgery anticipated to cause moderate to severe pain with expected length of stay \> or = to 2 days
* Able to read, understand and speak English
* Patients requiring management by the Acute Pain Service
* Possession of a mobile device/computer available for study participation

Exclusion Criteria:

* Outside the age range (\< 12 or \> 18 years)
* Non-English speaking
* History of significant developmental delay, uncontrolled psychiatric conditions associated with hallucinations or delusions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting)
* History of vertigo, dizziness, seizure disorder, and/or severe motion sickness
* History of chronic pain
* Are chronically using opioids and or benzodiazepines for the management of pain
* Are actively experiencing nausea or vomiting
* Conditions such as craniofacial abnormalities or surgeries of the head and neck
* Previous participation in this study
Study Evaluating a Heated Lidocaine and Tetracaine Topical Patch in the Treatment of Patients With Patellar Tendinopathy

The purpose of the study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy.

The purpose of this pilot study is to explore the potential usefulness of a heated lidocaine 70 mg and tetracaine 70 mg topical patch for the treatment of pain associated with patellar tendinopathy. A number of efficacy variables will be employed to evaluate their utility for assessing painful responses in this population. The study will be a 2-week, open-label study conducted at a single study site in patients with pain associated with patellar tendinopathy in a single knee. During this out-patient study, patients will apply one study patch to the affected tendon twice daily for approximately 14 days. Patches will be applied morning and evening (applications separated by approximately 8-10 hours) and removed after 2-4 hours.

Eligibility Criteria:
Inclusion Criteria:

* be at least 18 years of age
* have pain associated with patellar tendinopathy in a single knee (minimum 2-week duration)
* have tenderness at the proximal insertion of the patellar tendon in the affected knee

Exclusion Criteria:

* have any history of surgery in the target knee
* have used any topically applied pain medication on the target treatment area within 3 days preceding the Screening/Baseline Visit
* have had any injected steroids in the target knee within 3 months of the Screening/Baseline Visit
* have used any injected pain medication within 14 days preceding the Screening/Baseline Visit
* are receiving class 1 antiarrhythmic drugs (ie, tocainide, mexiletine, etc.)

Other protocol-defined inclusion/exclusion criteria may apply.
Investigating the Equivalence of the EORTC QLQ-C30 and the QLQ-F17

The EORTC QLQ-C30, a patient-reported outcome measure (PROM) that is available in 110 different languages, has been used in thousands of clinical cancer trials worldwide. The QLQ-C30 is composed of six functioning scales (including a measure for global quality of life), three symptom scales, and six single items.

Researchers and regulatory bodies came up with the idea to construct a shortened EORTC questionnaire that solely consists of functioning scales and to use additional symptom items according to the side effect profile of the specific medication under investigation.

This shortened form termed QLQ-F17 includes the Physical Functioning (PF), Role Functioning (RF), Emotional Functioning (EF), Cognitive Functioning (CF), and Social Functioning (SF) scales as well as the Global Health Status/Quality of Life (QL) scale in their original wording. This functioning questionnaire can be amended with symptom-specific items taken from the EORTC item library. This method provides a flexible and economic testing strategy that fits the demands of regulators and users in industry and academia.

It is an open question, however, whether the QLQ-F17 is equivalent to the QLQ-C30 in terms of measurement properties. Based on empirical research on response biases and order effects, one might argue that elimination of the symptoms between RF and CF-Dyspnea (DY), Pain (PA), Fatigue (FA), Insomnia (SL), Appetite (AP), Nausea/Vomiting (NV), Constipation (CO), and Diarrhea (DI)-and of the Financial difficulties (FI) item between SF and QL may alter the manner in which subsequent items are completed.

Thus, from a methodological point of view, it is essential to confirm the psychometric properties of the QLQ-F17 and to present evidence that scale values derived from the QLQ-F17 are equivalent to those of the QLQ-C30. Only in the case of equivalence may studies using either of the two basic questionnaires be compared directly. The present project is designed to address this research question.

This is an international multicenter survey study that will include respondents with cancer from Australia, Finland, France, Germany, Italy, Poland, Romania, Spain, Sweden, and United Kingdom. A randomized cross-over design will be applied, enabling between-patients as well as within-patients comparisons of the QLQ-C30 and the QLQ-F17. One group of respondents will first fill in the QLQ-C30 followed by the QLQ-F17, the other group will start with the QLQ-F17 followed by the QLQ-C30.

A sample size of 1.500 cancer patients is sufficient to get precise estimates with narrow confidence intervals regarding item and scale-level agreement. Thresholds and margins to be used for the analyses in this study will be consented by a statistical advisory group. Reliability and psychometric properties can also be precisely estimated with a sample of this size. The present study is based on the hypothesis that the QLQ-F17 and the QLQ-C30 questionnaires are equivalent.


Eligibility Criteria:
Inclusion Criteria:

Patients suffering from cancer or in remission

Exclusion Criteria:

none
Natural Killer Cells Functions, Tumoral Escape to Immune System and Regulation of Natural Cytotoxixity Receptors in Haematological Malignancies

The NK cells participate in the innate immunity against infectious agents or transformed cells that are recognized as "no self" by the absent, weak or abnormal expression of human leukocyte antigen (HLA) class I molecules. According to the "missing self hypothesis", a negative signal is delivered to NK cells when their inhibitory receptors are engaged by the specific HLA class I molecules. NK activation requires a positive signal delivered by the engagement of activating receptors, more particularly of the "Natural cytotoxicity receptors" or NCRs who are directly involved in the natural cytotoxicity of Natural Killer. The activating receptors include NKp46, NKp44 and NKp30, also called NCR 1, 2 and 3 respectively. NKp46 and NKp30 are constitutively expressed on the surface of the NK, the expression of NKp44 is observed only after activation of cells NK. NK cells from most (80%) healthy donors express a high quantity of NCR on their surface, corresponding to the NCRbright phenotype while only 20 % present the NCRdull phenotype. In sharp contrast, most patients (80%) having leukaemia have the NCRdull while only 20 % patients have the NCRbright phenotype. The culture of NK from healthy donors ( NCRbright) with leukaemic cells result in decreased expression of the NKp30 while there is no difference on expression if these same NK are cultivated with cells from healthy donors. Moreover, study of AML patients showed that the NCRdull phenotype was acquired during leukemia development because it was observed its complete (for NKp46) or partial (for NKp30) reversibility in patients achieving complete remission (CR). Reversibility of the NCRdull phenotype after CR suggested that leukemia cells might be involved in NCR down-regulation. In line with these observations, we aim to study the mechanism of NCR down-regulation by cultivating NK NCRbright from healthy donors with leukaemic cells or healthy haematopoietic cells, in order to observe the appearance of the NCRdull phenotype and verify by qPCR if this down-regulation is transcriptionnal. If this hypothesis is be verified, we will study the regulation of NCR by focusing on the implication of genes NCR transcription factors via bio-informatic analysis of putative transcription factors fixation sequences in the promoters of these genes, followed by the verification of the capacity of identified sequences to bind transcription factors. Ultimately, we will verify the real implications of these transcription factors by studying the effect of their silencing by RNA interference experiments.


Eligibility Criteria:
Inclusion Criteria:

* Grown-up patients having a leukaemia aigue myéloïde (LAM) in the diagnosis, whatever is LAM's subcategory (FAB or cytogenetics).
* The patients that must be informed at the same time, willing, and having given their agreement in writing.

Exclusion Criteria:

* Refusal of the patient.
* Phénotypage NK not corresponding to the quotas dull / bright required.