cyrilzakka/clinical-trials huggingface dataset:
Safety Incident Reporting System for Students During Their Clinical Internship (SAFEST)

Patient safety is a priority in Europe. The World Health Organization's World Alliance for Patient Safety has included incident reporting systems as indispensable tools for patient safety. These systems are widespread in healthcare facilities throughout Europe. While in some countries trainees in healthcare disciplines are able to report incidents, in others they are unable to do so. In many cases, they do not have adequate information about the reporting systems, there is low motivation to report, or there is a fear that reporting may lead to problems in their studies.

Until now, there have been no interventions designed and validated to achieve the objective of promoting incident reporting among students of health disciplines. Nor there were tools for these students to participate in the analysis of the causes of these incidents and in the identification of barriers to prevent their recurrence.

Researchers currently have tools from the digital world (artificial intelligence and gamification) whose application in this area can be useful for improving patient safety.

In this context, the investigators have developed an incident notification system aimed at students and trainees in order to familiarize this group with the notification process and thus contribute to improving patient safety. Students will be encouraged to participate with the incentive of earning Miguel Hernández University nanocourse credits or direct prizes. Once the notification is made, their role will be to evaluate and give feedback to notifications made by other peers, so they will get points. After finishing, those students with the most points will be rewarded with the prizes mentioned above.


Eligibility Criteria:
Inclusion Criteria:

* Students with Clinical Practices.

Exclusion Criteria:

-
Comparison of Ultrasound-guided Quadratus Lumborum Block and Iliohypogastric/Ilioinguinal Nerve Block for Postoperative Pain Management in Patients Undergoing Cesarean Section

The purpose of this study is to compare the analgesic effect of ultrasound-guided quadratus lumborum block and iliohypogastric/ilioinguinal nerve block for postoperative pain management in patients undergoing cesarean section.


Eligibility Criteria:
Inclusion Criteria:

* singleton pregnancy
* gestation of at least 37 weeks
* American Society of Anesthesiologists (ASA) physical status I or II
* finish Pfannenstiel section under combined spinal and epidural anesthesia

Exclusion Criteria:

* pruritus existed before the surgery
* allergic to lidocaine, ropivacaine or dexamethasone
HIIT vs HRV-based Training for Rehabilitation After Stroke

Consequences of stroke are manyfold but all of them are important factors on the long-term outcomes of rehabilitation, becoming an important health problem with requires health strategies with advanced age. High intensity interval training (HIIT) is an efficient training protocol used in cardiac rehabilitation programs, but owing to the inter-individual variability in physiological responses to training associated to cardiovascular diseases, the exercise dose received by each patient should be closely controlled and individualized to ensure the safety and efficiency of the exercise program. The heart rate variability (HRV) is actually being used for this purpose, as it is closely linked to de parasympathetic nervous system activation. In this way, higher scores in HRV are associated with a good cardiovascular adaptation. The objective of this protocol is to determine the effect of HIIT compared with HRV-guided training on cardiorespiratory fitness, heart rate variability, functional parameters, body composition, quality of life, inflammatory markers, cognitive function, and feasibility, safety and adherence in patients after stroke undertaking an 8-week cardiac rehabilitation program. This will be a cluster-randomized controlled protocol in which patients after stroke will be assigned to an HRV-based training group (HRV-G) or a HIIT-based training group (HIIT-G). HIIT-G will train according to a predefined training program. HRV-G training will depend on the patients' daily HRV. The peak oxygen uptake (VO2peak), endothelial and work parameters, the heart rate variability, the functional parameters, the relative weight and body fat distribution, the quality of life, the inflammatory markers, the cognitive function, and the exercise adherence, feasibility and safety will be considered as the outcomes. It is expected that this HRV-guided training protocol will improve functional performance in the patients after stroke, being more safe, feasible and generating more adherence than HIIT, providing a better strategy to optimize the cardiac rehabilitation interventions.


Eligibility Criteria:
Inclusion Criteria:

* left ejection fraction higher than 30% after stroke
* aged between 18 and 80 years old

Exclusion Criteria:

* presence of absolute or relative contraindications for accomplishing the treadmill test, indicated by the Spanish Society of Cardiology
* being treated for other diseases, or regularly taking a drug(s) that has a direct or indirect effect on the nervous system (e.g., anxiolytics, antidepressants or neuroleptics)
* absence of medication to control the cardiovascular disease or its modification during the intervention
* people who are participating or have participated in the previous three months in other similar exercise programs
* not performing at least 80% of the workouts during the intervention
SPATAX: Clinical and Genetic Analysis of Cerebellar Ataxias and Spastic Paraplegias

Cerebellar ataxias (CA) and spastic paraplegias (SP) are genetically and clinically very heterogeneous. More than 40 loci are already known but the number of phenotypes is even greater suggesting further genetic heterogeneity. These progressive disorders are often severe and fatal, due to the absence of specific therapy. The SPATAX network combines the experience of European clinicians and scientists working on these groups of diseases. Over the past year, they have assembled the largest collection of families and achieved a number of tasks (initiation of a clinical and genetic database, distribution of DNA to participating laboratories, mapping of three new loci, and refinement of several loci). In addition to clinicians from Europe and Mediterranean countries, who play a major role in collecting families according to evaluation tools developed and validated by the SPATAX members, the group includes major European laboratories devoted to the elucidation of the molecular basis of these disorders. Each laboratory will centralize all families with a subtype of autosomal recessive (AR) CA (n=116) or SP (n=207) in order to efficiently map and identify the responsible gene(s). Genome-wide scans are already underway in 61 families. Given the expertise of the participants, the researchers expect to map and identify several genes during the course of this project. The spectrum of mutations and phenotype/genotype correlations will be analysed thanks to this unique series of patients with various phenotypes. The knowledge gained will be immediately applicable to patients in terms of improved positive diagnosis, follow-up and appropriate genetic counselling. In the long term, models for genetic entity will be developed in order to understand the pathophysiology and to identify new targets for treatment. The series of patients assembled and the precise knowledge of natural history will facilitate the implantation of therapeutic trials based on rational approaches.


Eligibility Criteria:
Inclusion Criteria:

* Progressive ataxia or paraplegia

Exclusion Criteria:

* Lack of signed informed consent
Learning From Errors During Simulation-based Ultrasound Training

During the past decades, simulation-based training has become essential for making trainees fit for clinical practice. Traditionally, trainees are instructed to practice with as few errors as possible during simulation-based training. However, recent evidence from the field of psychology suggests that transfer of learning may improve if trainees are encouraged to commit errors during training. The aim of this study is to assess on performances with real patients the effect of error-management instructions compared to error-avoidance instructions during simulation-based virtual reality ultrasound training.

This study is planned as a randomized controlled trial. Participants include medical students with no prior simulation practice at the fifth or sixth year of medical school. All participants receive 3 hours simulation-based ultrasound training focusing on fetal weight estimation. The participants (N=60) are randomized into two groups: Participants in group 1 are instructed to follow the simulator program step-by-step to achieve the highest possible simulator metric scores by making as few errors as possible. Participants in group 2 are instructed to experiment and explore and to deliberately make errors during training. A simulation-based pre- and post-test is administered before and after training.

Participants are scheduled to perform a transfer test seven to ten days after simulation training. The transfer test consists of fetal weight estimation on a real patient. The primary outcome is weight deviation of participant measurements compared to expert findings. Secondary outcomes include performance assessments of pre-, post- and transfer test performances by blinded ultrasound experts using the Objective Structured Assessment of Ultrasound Skills (OSAUS) scale. Using an alpha level of 0.05, an effect size of 0.80, and a power of 0.80, 25 participants are needed in the two study groups. Loss to follow-up of up to 20% of study participants is anticipated, resulting in 30 participants in each study group.


Eligibility Criteria:
Inclusion Criteria:

* are enrolled during the fifth or sixth year of medical school
* provide written informed consent

Exclusion Criteria:

* have clinical or simulator ultrasound experience
Sliding Sign in Late Trimester Ultrasound Evaluation of Intra-abdominal Adhesions in Women Undergoing Repeat CS

Predicting the presence of severe adhesions may also assist clinically in several ways: first, it allows allocation of more complicated surgeries to experienced surgeons; second, the surgeons can plan and prepare better for the surgery if they know in advance whether they are going to operate a complicated surgery; third, a difficult surgery may be scheduled to be performed in an experienced center, preparing cross match blood units, and alerting the general surgeon and urologist of the potential risk for surgical complications, saving time if intervention is required.

This information can permit preoperative planning by a multidisciplinary team of surgeons and allow the patient to be informed of the potentially high risk of complications.

The incidence of repeat cesarean delivery is on the rise worldwide, approximately 90% of women with a prior cesarean delivery undergo a planned repeat cesarean delivery in their next pregnancy.

Post-cesarean adhesions are a major complication in subsequent surgeries, causing an increased risk for bladder and bowel injury (0.1-0.3%), hemorrhage (0.1-1.4%), infection (0.4-1.6%), and even hysterectomy (0.1-1.4%).

In addition to the risk associated with the pelviabdominal surgical procedure itself, adhesiolysis may result in injury to adjacent viscera, blood loss, and in case of emergency cesarean delivery, to the perinatal adverse outcome associated with delayed delivery of the neonate. This represents a considerable healthcare issue, as it has a significant impact both on the patient, increasing morbidity and mortality, and on healthcare costs. It is therefore important for surgeons to detect patients at high risk of having adhesions.

Women suspected to have severe intra-abdominal adhesions may benefit from appropriate preparation of blood products, better assignment of surgeons, request for preoperative surgical assistance of other medical specialties, and possibly performance of a midline skin incision to enter the peritoneal cavity. It is therefore important for surgeons to detect patients at high risk of having adhesions.

Various means have been proposed to predict adhesions prior to surgery, including analysis of patient characteristics and appearance of the scar, as well as the intraoperative peritoneal adhesion index.

Eligibility Criteria:
Inclusion Criteria:

1. History of previous cesarean section.
2. Gestational age: Full-Term.
3. Scheduled to undergo elective cesarean section.

Exclusion Criteria:

1. Body mass index more than 40 on admission.
2. Abnormal placental invasion.
3. Having known collagen disease.
4. Unplanned or emergency repeated cesarean delivery.
5. History of abdominal surgery.
Ice Application for Postoperative Pain

The purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial.

The purpose of the proposed study is to investigate the effectiveness of cryotherapy as an additional form of pain control in women undergoing laparoscopic hysterectomy for benign gynecologic conditions through a randomized trial. The following aims will be pursued:

Primary Aim: To determine if cryotherapy patients will have lower pain scores on VAS compared to standard pain management patients.

Primary Hypothesis: Patients receiving cryotherapy will have lower VAS scores compared to patients receiving pain management.

Secondary Aim 1: To determine if cryotherapy will reduce the number of morphine milligram equivalent (MME) compared to patients with standard pain management.

Secondary Hypothesis 1: Patients receiving cryotherapy will have lower MME values compared to patients with standard pain management.

Secondary Aim 2: To determine if cryotherapy will result in earlier return to baseline activity as measured by Quality of Recovery Questionnaire (QoR).

Secondary Hypothesis 2: Patients receiving cryotherapy will return to baseline activity level sooner than those receiving standard pain management.

Secondary Aim 3: To determine if cryotherapy will result in a faster time to discharge as determined by duration between admission to postanesthesia care unit (PACU) and discharge home.

Secondary Hypothesis 3: Patient receiving cryotherapy will be have a shorter stay in PACU.

Eligibility Criteria:
Inclusion Criteria:

* Women undergoing laparoscopic hysterectomy for benign indications within 8 weeks of enrollment
* Women \>18 years of age
* Non-emergent surgery
* Non-pregnant
* Women undergoing laparoscopic hysterectomy with the minimally invasive surgery team

Exclusion Criteria:

* Requires surgery for urinary incontinence
* Has acute angle glaucoma
* Has severe cardiac/respiratory disease
* Current chronic pain condition (ie chronic pelvic pain, fibromyalgia, chronic low back pain)
* Chronic use/abuse of opioid medications for greater than 1 week preceding procedure
* Chronic NSAID use
* Current treatment of opioid dependence with methadone or buprenorphine
* Non-English or Non-Spanish speaking
* Procedure converted to laparotomy
Clinical Trial to Evaluate the Safety and Pharmacokinetics of JP-1366 in Healthy Adult Volunteers

To evaluate the safety and the pharmacokinetics of the JP-1366 20 mg tablet and capsule oral administration in healthy adult volunteers.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects ≥ 19 years of age
2. Subjects who weigh ≥ 50 kg (or ≥ 45 kg in the case of females) with body mass index (BMI) of ≥ 18.0 kg/m2 and ≤ 30.0 kg/m2

Exclusion Criteria:

1. Subjects with clinically significant diseases or a medical history related to the digestive system, cardiovascular system, endocrine system, respiratory system, blood and tumor, infections diseases, kidney and urinary system, psychiatric and nervous system, musculoskeletal system, immune system, otorhinolaryngology, skin, and ophthalmological system
2. Subjects who have a history of gastrointestinal surgery (except simple appendectomy or herniotomy) or have gastrointestinal disorders that may affect the absorption of the drug
3. Subjects who received inducers or inhibitors of drug metabolizing enzymes
4. Subjects who have hypersensitivity to this drug, ingredients of this drug, or benzimidazoles, or have a medical history thereof
5. Patients receiving drugs containing atazanavir, nelfinavir, or rilpivirine
6. Subjects who are judged ineligible to participate in this study by the principal investigator
Autonomic Modulation in Patients Undergoing Assisted Mechanical Ventilation: Comparison Between PAV+ and PSV

The aim of the study is to investigate autonomic modulation in terms of heart rate variability (i.e., HRV) in patients undergoing assisted mechanical ventilation in PSV mode, compared to patients assisted in PAV+ mode. The hypothesis is that the greater patient-ventilator synchrony of the latter mode may represent an advantage in reducing the imbalance of autonomic modulation.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the ICU, ≥18 years old, undergoing invasive controlled mechanical ventilation for at least 72 hours, eligible for assisted support but not yet ready for extubation or spontaneous breathing.

Exclusion Criteria:

* Successful completion of a spontaneous breathing trial (SBT) and spontaneous breathing within 24 hours of enrollment
* Acute ischemic heart disease, cardiac rhythm abnormalities, and/or patients with pacemakers and/or treated with anti-arrhythmic drugs
* Hemodynamic instability
* Chest drainage
* Severe anemia (Hb \&lt;7g/dL)
* Pregnancy
* Severe head trauma, dementia
* High spinal cord injury
* Neuromuscular disorders
* Lack of consent
Post Partum Thyroiditis 2: Long Term Observations

The study tries to determine if post partum thyroiditis has marked long term (20 years after partum) risk for developing hypothyroidism.

This is study where we follow up women who in 1985 were checked for the occurrence of post partum thyroiditis 6 week after labour. The former patients have been invited to participate by answering a questionnaire and by providing results from blood tests.

Eligibility Criteria:
Inclusion Criteria:

* Defined group of women who tested positive for post partum thyroiditis in 1985.
* Control group randomly picked from those who tested negative.

Exclusion Criteria:

-
A Study of the Effect Efavirenz on the Plasma Levels of MK-7602 in Healthy Participants (MK-7602-005)

The goal of the study is to learn what happens to levels of MK-7602 in a healthy person's body over time. Researchers will compare what happens to MK-7602 in the body when it is given with or without another medicine called efavirenz, and when it is given with or without a meal.


Eligibility Criteria:
Inclusion Criteria:

The key inclusion criteria include but are not limited to the following:

* Has a body-mass index (BMI) of 18 to 32 kg/m\^2.

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

* Has a history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and seizures) abnormalities or diseases.
* Has a history of cancer (malignancy)
* Has positive test(s) for hepatitis B surface antigen, hepatitis C antibodies, or human immunodeficiency virus (HIV)
Study to Compare Efficacy and Safety of LUBT010 and Lucentis® in Patients With Neovascular AMD

This study is designed to compare the efficacy, safety and immunogenicity of LUBT010 with Lucentis® given as once monthly intravitreal injection in patients with neovascular age-related macular degeneration (AMD).

This is a global, phase III, double blind, randomized controlled study to compare the efficacy, safety \& immunogenicity of LUBT010 with Lucentis® in patients with neovascular age-related macular degeneration.

Eligible patients will be randomly assigned in 1:1 ratio to receive once monthly intravitreal injection of LUBT010 or Lucentis® for 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory male or female participants with age ≥ 50 years at the time of screening
2. Capable of understanding and giving written informed consent
3. Primary or recurrent (anti-VEGF naïve) active CNV lesions involving the foveal center secondary to AMD
4. BCVA between 20/40 and 20/200 (Snellen equivalent) in the study eye, using ETDRS testing
5. Willingness and ability to undertake all scheduled visits and assessments

Exclusion Criteria:

1. Known hypersensitivity to ranibizumab or any of the components of study medication
2. Known history of allergy to fluorescein dye
3. Scar, fibrosis, or atrophy involving the center of the fovea in the study eye
4. Subretinal hemorrhage in the study eye that involves the center of the fovea
5. Uncontrolled glaucoma
6. Use of prohibited treatments

Other In-/Exclusion criteria may apply
Rasburicase as a Uricolytic Therapy for Hyperuricemia in Patients With Leukemia or Lymphoma

The primary objectives of the study are to evaluate the safety and the efficacy in patients with malignant lymphoma or acute leukemia who are repeatedly administered for SR29142 5 days in two dosage groups.

Secondary objectives are to determine the pharmacokinetic (PK) parameters of SR29142 , to assess anti-SR29142 antibody production in patients with malignant lymphoma and acute leukemia, and to estimate the optimal dosage of SR29142 for Japanese patients from the results of efficacy and safety evaluations.


Eligibility Criteria:
Inclusion Criteria:

Patient suffering from:

* acute leukemia with white blood cell (WBC) count≥ 20,000/mm3 without regard to uric acid level ; or
* lymphoma,Stage ≥ III without regard to uric acid level; or
* lymphomas, Stage II with bulky disease; or
* lymphoma or leukemia, without regard to classification or morphology, with uric acid level ≥ 8.0 mg/dL, and lactate dehydrogenase (LDH) level ≥ twice the upper limit of normal (ULN).
BÜHLMANN FPELA in the Diagnosis of Exocrine Pancreatic Insufficiency

The study shall determine the clinical performance of the BÜHLMANN fecal pancreatic elastase (fPELA) assays in the diagnosis of exocrine pancreatic insufficiency (PEI).

This is a observational and cross-sectional performance study. Specimens and clinical data are collected by a single study site.

Included are subjects for which pancreatic elastase testing was indicated due to a suspected exocrine pancreatic insufficiency and which were at least 18 years of age. Subjects which suffered from diarrhea (stool water content ≥ 75%) at the time of sample collection are excluded from the study.


Eligibility Criteria:
Inclusion Criteria:

* suspected exocrine pancreatic insufficiency
* at least 18 years of age.

Exclusion Criteria:

* diarrhea (stool water content ≥ 75%) at the time of sample collection