cyrilzakka/clinical-trials huggingface dataset:
Acute Myocardial Infarction: Prognostic and Therapeutic Evaluation

AMIPE is both a retrospective and prospective study which was designed in order to collect data of patients with acute coronary syndromes and myocardial injury and to improve the knowledge about these conditions.

AMIPE is an observational, multicenter and both retrospective and prospective study enrolling a cohort of consecutive incident patients admitted to participating hospitals with a diagnosis of acute coronary syndrome or myocardial injury from 01/01/2016 to 31/12/2023.

The aim of this study is to create a database including a comprehensive characterization of these patients in order to obtain new scientific evidence about these conditions. Informations about the patients will be gathered from in-hospital medical records. A written informed consent is needed for every prospective patients enrolled in the study,

In particular, the main objectives of the study are:

* document the characteristics of all patients presenting with acute coronary syndrome and myocardial injury;
* document the long term outcome rates;
* document the therapeutic regimens and investigation conformity of treatment with already established guidelines.

Every diagnostic or therapeutic intervention will be in accordance with established guidelines and good clinical practice.

Statistics will be conducted utilizing univariate and multivariate analysis for outcomes. In particular for what concerns univariate analysis, ordinal variables will be analysed with t-test and Mann-Whitney Test, whereas categorical responses with Fischer Exact Test and with Pearson Chi-square test.

Multivariate analysis will be conducted with logistic regression for dichotomous variables, with mixed generalized linear model for ordinal or nominal variables and with ANOVA or MANOVA for continuous variables.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged \> 18 years old
* Acute coronary syndrome or myocardial injury
* Written informed consent

Exclusion Criteria:

* under age or not able to give informed consent
Safety and Efficacy of Ipamorelin Compared to Placebo for the Recovery of Gastrointestinal Function

Post-operative administration of ipamorelin is expected to reduce time to recovery of Gastrointestinal (GI) function in patients who have undergone partial small and/or large bowel resection.


Eligibility Criteria:
Inclusion Criteria:

* Able to freely give written informed consent to participate in the study and have signed the Informed Consent Form
* Males or females, 18 to 85 years of age inclusive at the time of study screening
* American Society of Anesthesiologists (ASA) Class I-III
* Have undergone a scheduled small and/or large open partial bowel resection based on a documented incision size greater than or equal to (≥) 10 cm with primary anastomosis
* Females must not be pregnant as confirmed by a serum pregnancy test at screening and by a urine pregnancy test on the day of surgery
* Body weight must be between 40-150 kilograms (kg)

Exclusion Criteria:

* Any procedure which requires a diverting stoma
* Primary anastomosis not performed at the time of surgery
* Epidural or intrathecal anesthesia
* Significant liver disease (ALT and/or total bilirubin \> 2-fold upper limits of normal) or kidney disease (serum creatinine \> 2.5 mg/dL) at screening
* History of irritable bowel syndrome
* Patients with a history of Crohn's disease or ulcerative colitis (UC) who have had multiple GI-related surgeries (Note: surgery naïve Crohn's or UC patients may be included)
* History of colonic volvulus
* History of gastroesophageal surgery, gastrectomy, gastric bypass, total colectomy, short bowel syndrome, or multiple complex abdominal surgeries performed by an open procedure (uncomplicated cesarean section and appendectomy would not be considered complex)
* Patients who have received prior abdominal radiation and/or pelvic radiation
Effect of a Music Therapy Intervention on Mood

The hypothesis is that the music therapy intervention has a positive impact on the critical patients' mood as it has a reassuring effect that allows a connection with emotions, helps to communicate and affects the welfare of patients. It also reduces pain and the consumption of painkillers and sedatives, as well as vasoactive drugs in critical patients.

The aim of the study is to assess the effect of a personalised music therapy intervention with standard treatment on critical patients' mood compared to those who just receive the standard treatment. Moreover, the effect of the different interventions on pain and sedative, analgesic and vasoactive drugs will also be assessed.

This is a randomized, parallel and open clinical trial that will compare: a) a music therapy intervention combined with the standard care (experimental group), with b) standard care (control group), on critical patients admitted to the General, Cardiac and Coronary Intensive Care Unit of the Santa Creu I Sant Pau Hospital.

The expected number of patients expected to be included in this trial is 164. Patients will be included and randomized the day the music therapy intervention is to take place, once a week. Patients' mood will be assessed with a validated questionnaire in Spanish for adults, the POMS (Profile of Mood States) survey that consists of a self-report built on the basis of a multidimensional conception of mood and has a Likert 5-points type format (0 to 4)

Eligibility Criteria:
Inclusion Criteria:

* Patients who are oriented in time, space and person
* Glasgow Coma Scale of 15 or 11+intubated
* Negative the Confusion Assessment Method for the ICU (CAM-ICU)
* Richmond Agitation-Sedation Scale of 0
* Patients who are at least conscious and oriented for 48 hours in the ICU.

Exclusion Criteria:

* Auditory deficit
* Patients that have participated in the study previously
Peculiarities of Pain in Patients With Gunshot Wounds Depending on the Localization of the Wound at the Stages of Treatment

Chronic pain, in turn, is associated with a whole cohort of mutually aggravating factors - this can lead to the development of extremely serious long-term consequences. The features of pain in this category of patients have not been sufficiently studied. Taking into account continuity and consistency, clear and high-quality pain treatment is necessary at all stages of treatment.

The peculiarities of pain in patients with gunshot wounds, depending on the localization of the wound at the stages of treatment, need to be studied, because the subjective feelings and emotional experiences experienced by patients during the wounding in combat conditions through the prism of psychological disorders have their own characteristics.

Eligibility Criteria:
Inclusion Criteria:

* the presence of gunshot wounds

Exclusion Criteria:

* no gunshot wounds
The Effects of Vitamin B6 Supplementation on Pain Thresholds and Tolerance

This clinical trial aims to explore the effect of Vitamin B6 supplementation on pain thresholds and tolerance in healthy adults using thermal and electrical stimulation. Researchers will compare a placebo group to high-dose Vitamin-B6 to see if vitamin B6 increases pain thresholds and tolerance.

The main questions it aims to answer are:

* How does vitamin B6 affect pain thresholds and tolerance following a single 100mg dose?
* How does vitamin B6 affect pain thresholds following daily supplementation for up to a month?
* Does vitamin B6 supplementation affect measures related to the experience of pain, such as state anxiety, sleep, diet, and mood at different time points

Eligibility Criteria:
Inclusion Criteria:

* Over the age of 18 years
* Fluent speaker of English language

Exclusion Criteria:

* Under 18 years
* Presence or history of chronic pain
* Presence of neuropathic/nerve pain
* Raynaud's syndrome
* Using any vitamin supplementations that contain Vitamin B6 at more than the RDA, or combinations of B vitamins.
* On any medication that is GABA agonistic
* Any use of analgesic/anti-inflammatory medication up to 48 hours prior to any of the testing sessions.
* Any heart conditions
* Newly acquired tattoos on the pain stimulation site
Effect of Oral Enteral Nutrition on Cerebral Small Vessel Disease

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia. Compared to NGT, IOE, as an enteral nutrition support mode, in CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy, showed advantages in improvement in dysphagia, nutritional status, ADL, QOL, pneumonia, and adverse events, which should be considered as the preferred approach.

Nasogastric tube feeding (NGT) has been widely used in cerebral small vessel disease (CSVD) patients with dysphagia but has a significant risk of complications. Intermittent Oro-esophageal Tube Feeding (IOE) is an established enteral nutrition approach that can be used with comprehensive rehabilitation therapy. This study aims to explore the clinical effect of IOE vs. NGT on CSVD Patients with Dysphagia.

This was a randomized controlled study with 60 CSVD Patients with Dysphagia who received comprehensive rehabilitation therapy. Patients enrolled were randomly divided into the observation group (with IOE, n=30) and the control group (with NGT, n=30). At admission and after treatment, Video Fluoroscopic Swallowing Study (VFSS) and Functional Oral Intake Scale (FOIS), body mass index (BMI), serum albumin (Alb), and hemoglobin (Hb), Modified Barthel Index (MBI) and World Health Organization Quality of Life Assessment Instrument Brief Version (WHOQOL-BREF) were recruited to assess and compare dysphagia, nutritional status, activities of daily living (ADL) and quality of life (QOL). The incidence of pneumonia was recorded and compared.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Cerebral Small Vessel Disease;
* Must be able to cooperate with treatment and questionnaire investigation;
* Clinical diagnosis of dysphagia through the Functional Oral Intake Scale (FOIS) and Video Fluoroscopic Swallowing Study (VFSS);
* Age between 40 and 70 years;
* Enteral nutrition support was required and feasible.
* No history of prior stroke.

Exclusion Criteria:

* Dysphagia related to other cerebrovascular diseases or caused by neurodegenerative diseases;
* Complicated with severe liver and kidney failure, tumors, or hematological disorders;
* Simultaneously need to undergo other therapy that might affect the outcomes of this study;
* Pregnant or nursing females.
Effectiveness-Implementation Evaluation of Acute Kidney Injury Decision Support

Study Purpose: This study is testing an artificial intelligence (AI)-powered clinical decision support (CDS) system designed to help emergency department (ED) doctors detect and manage acute kidney injury (AKI) earlier. The goal is to see whether the tool improves patient care, clinician decision-making, and hospital outcomes when used in real-world ED settings.

Study Design:

The AI tool will be gradually introduced at three hospital EDs:

Johns Hopkins Hospital (JHH) Bayview Medical Center (BMC) Howard County General Hospital (HCGH)

Before the tool is activated, it will run in the background to collect baseline data without influencing care. Once implemented, doctors will receive training, and researchers will track how often the tool is used and whether it improves AKI care.

What the Study Measures:

Process Outcomes: Does the tool help doctors identify AKI sooner, avoid harmful medications, and improve decision-making about hospitalization?

Clinical Outcomes: Does the tool reduce the number and severity of AKI cases and improve kidney-related health outcomes?

Implementation Outcomes: Do ED doctors find the tool useful? Does it fit into the ED doctor's workflow without slowing the ED doctor's down?

Expected Impact: If successful, the AI tool could be expanded to other hospitals and used to improve early detection and treatment of AKI, reducing kidney complications and improving patient care nationwide.


Eligibility Criteria:
Inclusion Criteria:

Participants must meet all of the following conditions to be eligible for the study:

1. Emergency Department Visit

   Patients presenting to one of the three study site emergency departments (EDs):

   Johns Hopkins Hospital (JHH) Bayview Medical Center (BMC) Howard County General Hospital (HCGH) Serum Creatinine Measurement
2. At least one serum creatinine (sCr) test performed during the ED visit.
3. Age: Adults (≥18 years old) at the time of ED visit.
4. Follow-Up Data Available: To be included in analysis for the investigator's secondary effectiveness outcome (new or progressive AKI) patients must have repeat creatinine concentration measurement available within 72 hours

Exclusion Criteria:

1. No ED Serum Creatinine Data: Patients who do not have a measured serum creatinine (sCr) value during the ED visit will not have decision support provided during the ED stay.
2. Patients Discharged Without Follow-Up Data: Patients discharged from the ED who do not undergo a follow-up serum creatinine test within 72 hours will be excluded from analysis of new or progressive AKI outcome assessment.
3. Age \<18 Years
4. End-Stage Kidney Disease (ESKD) or Chronic Dialysis: Patients with a documented history of end-stage kidney disease (ESKD), (patients receiving chronic dialysis (hemodialysis or peritoneal dialysis) will will be excluded from analysis of new or progressive AKI outcome assessment).
The Antidepressant Effect of Right Temporal Low Frequency rTMS Compared to Sham

The aim of the present study is to compare the antidepressant effect of low frequency rTMS applied over the right temporal cortex with sham stimulation.

TMS complies focal stimulation of the brain through a time varying magnetic field. Clinical controlled trials indicate that rTMS of the dorsolateral prefrontal cortex may have an antidepressant effect and no serious side effects. Several clinical controlled studies investigating the antidepressant effect of low as well as high frequency rTMS of the right and left prefrontal cortex have been carried out with varying results.Research on the issue suffer from small and selected study populations.There is a need for additional clinical controlled studies on larger samples and methodological investigations to clarify what is the optimal stimulus design for the treatment of depressed patients.

Recent research indicates that Depression is associated with an increased metabolic activity of subcortical areas especially the right hippocampus of the brain.

Remission of depression symptoms is associated with normalisation of the described subcortical hyperactivity.

Low frequency rTMS has shown to be associated with sustained reduction in neuronal activity.

There may be an association between the activity decreasing effect of low frequency rTMS and reduction in psychiatric symptoms.

The investigators want to test the hypothesis that low frequency rTMS of the right temporal subcortical areas (Hippocampus and and the parahippocampal part of CNS) may perform an antidepressant effect by normalizing the described hyperactivity of the subcortical areas in depressed patients.

In addition the investigators want to test whether blood concentration of Brain Derived Neurotropic Factor( BDNF), the BDNF-genotype and saliva cortisol may be of predictive value in depressed patients.

Eligibility Criteria:
Inclusion Criteria:

* Inpatients admitted to Århus university Hospital , Risskov or outpatients from the psychiatry district centres or practising specialist in the area.
* Moderate - severe depression according to ICD-10/ DSM-IVR
* Age 18-80 years
* Total Hamilton score ( 17-items) of ≥ 18 or subscale score ≥ 9
* Right handed

Exclusion Criteria:

* Organic brain disease
* Epilepsy in growing age
* Metallic objects as the result of a chest or Brain surgery
* Cardiac pacemakers
* Somatic diseases associated with brain dysfunction
* Pregnancy
* Suicide risk of severe degree
* Severe agitation or delirium
* Alcohol and drug dependency
* Ongoing Electroconvulsive treatment
Proof of Concept - Digital Electro-optical Surgical Platform as Replacement for Operational Microscopes

Evaluate the use of Elbit's digital electro-optical systems for generating detailed high quality video imaging during surgery, and thus improving the surgeon's visualization, performance and outcome.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18.
* Pseudophakia patients with silicone oil in the vitreous cavity.
* Silicone oil density of 1500 centistoke or 5500 CS.
* Good corrected visual acuity (\> 6/10) in the second eye.
* Lack of additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).

Exclusion Criteria:

* Additional ocular pathology that would reduce the quality of vision during surgery (corneal scar, Posterior Capsular Opacity, low transmission in the implantable lens, non-expanded pupil).
* The presence of heavy silicone oil (OXANE) in the vitreous cavity.
* Posterior segment pathology in the second eye.
* Special populations (children under the age of 18, pregnant women)
TPF Machine Learning Algorithms

To adopt a machine learning technique to decide whether operative or non-operative treatment will result in the best patient-outcome.

The overall goal is to adopt a machine learning technique to decide whether operative or non-operative treatment will result in the best patient-outcome.

The primary objectives are to identify the most suitable machine learning algorithm to predict the best treatment for future patients. Whether conservative or operative treatment will lead to the best patient outcome, will be decided on the predicted KOOS score. Several input factors, such as treatment (conservative or operative), number of fracture fragments, location of the fracture, soft tissue involvement,...for each patient will be used as training data for the algorithm. Some of these input data will be derived from CT-scans. Therefore, the CT scans will be segmented in Mimics, for which UZ Leuven recently purchased licenses. The output variable of the training data will be the KOOS score of each patient. Based on the input and output variable, the algorithm will determine a relation between these. For future patients of which the input variable are known, the output variable (=KOOS score) will be predicted both in case of operative and conservative treatment. We hypothesize that the prediction will be improved by adding more input data over time.

To secondary objective is to identify clinical and radiological factors that help predicting the best treatment for future patients.

As an outlook, the machine learning technique could be implemented in the future in clinical practice and utilized as a patient-specific planning tool for tibial plateau fracture management by aiding the surgeon to select the best treatment for a given case. The collected data in this registry will be used to validate the machine learning model. Patients will not yet be treated based on the results of the developed model, the trauma surgeon is responsible to decide which treatment option is best for the patient.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Proximal tibia plateau fracture
* Patient is able to attend follow-up visits

Exclusion Criteria:

* Age \< 18 years
* Bilateral fractures
* Neurologic disorders (ie paraplegia, CVA, dementia etc.)
* Not understanding Dutch or English
Our Anesthesia Experiment Applied to Child Earthquake Victims in the February 6, 2023 Earthquake

The study aimed to investigate anesthesia management of pediatric patients in the Ankara Bilkent City Hospital during the earthquake disaster of February 6.

In this study, The investigators planned to retrospectively investigate the anesthesia management of pediatric patients who were transferred to or admitted to the Ankara Bilkent City Hospital in the earthquake disaster of February 6. The anesthesia data on pediatric earthquake victims were insufficient in the literature.The investigators aimed to share our experiences to guide anesthesia management in future possible disasters.

Eligibility Criteria:
Inclusion Criteria:

* Child earthquake victims between the ages of 0-18
* Participants who had surgery and anesthesia between 9 February 2023 and 9 August 2023

Exclusion Criteria:

* The exclusion criterion is child earthquake victims patient who did not undergo anesthesia.
Micro-osteoperforations on the Rate of Canine Retraction

the study aimed to clinically evaluate the effect of micro-osteoperforations on the rate of tooth movement, as evaluated by its effect on the rate of canine retraction.

Ten adult patients requiring maxillary first premolars' extraction were enrolled in this split-mouth randomized controlled clinical trial.

Micro-osteoperforations were randomly assigned to one side of the maxillary arch at the canine-premolar region, and the contralateral side served as the control.

Mini-screws were used for anchorage reinforcement, and canine retraction was performed using nickel-titanium closed coil springs, delivering a force of 150 grams per side.

The primary outcome was the measurement of canine retraction rate throughout the study period from digital dental models obtained every 3 weeks.

The secondary outcome was the detection of possible canine tipping during retraction.

Eligibility Criteria:
Inclusion Criteria:

* healthy systemic condition with no chronic diseases
* no previous orthodontic treatment
* adequate oral hygiene
* have a healthy periodontium
* signed an informed consent

Exclusion Criteria:

* have a chronic disease
* previous orthodontic treatment
* poor oral hygiene or periodontal conidition
Study Evaluating Venlafaxine Extended Release in Elderly Depressed Patients

In this study we will assess as a primary objective the effect of venlafaxine retard treatment on primary care attended elderly patients with depressive syndrome. We will also study secondarily its effects on anxiety, somatic and painful symptoms of depression.


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 60 years
* Depressive syndrome with associated anxiety symptoms, according to a symptoms intensity HAM-D17³14

Exclusion Criteria:

* Participation in other studies in the last 3 months before the start of the study
* Known hypersensibility to venlafaxine
* Clinically significant abnormalities according to the venlafaxine labeling