cyrilzakka/clinical-trials huggingface dataset:
Resuscitation Registry in CHD

Children with congenital heart defects are far more likely to suffer a cardiovascular arrest and be in the need of cardiopulmonary resuscitation than healthy children or those with diseases of other organ systems, especially after cardiothoracic surgery. Due to a lack of data, the exact number of resuscitations in this patient cohort, as well as the morbidity and mortality, is unknown. This study aims to register all cardiovascular arrests in pediatric patients with congenital heart disease and study the mortality and morbidity with a special focus on the neurodevelopmental outcome.

Background and aim: Children with heart defects, especially those after heart surgery, have an up to ten times higher risk for an in-hospital cardiac arrest, compared to children without heart disease. Although this patient cohort is particularly vulnerable, these events and outcomes are not systematically monitored in Germany. We designed a prospective multicenter-registry study aiming to record in-hospital cardiac arrests of children with congenital- (CHD) and acquired heart disease in Germany.

Methods: A web-based registry was designed, prospectively collecting data (patient´s demographics, CPR data, post-resuscitation care and clinical course, neurological outcome and follow-up), according to the Utstein template. All children (0-18 years) with heart disease suffering a cardiac arrest requiring resuscitation of ≥ two minutes will be included. The primary outcome is survival to discharge, the secondary outcome is morbidity, with a particular focus on neurological morbidity. An inclusion of 10-20 children/centre/year is anticipated. As this is an observational study, no intervention is planned.

Results: This registry will provide data on the mortality, early and mid-term neurologic outcome, and quality of life after cardiac arrest of children with heart disease in Germany. Correlations between patients´ characteristics, resuscitation characteristics and post-resuscitation care with primary and secondary outcomes will be analyzed.

Conclusions: By systematically recording and analyzing the outcome after in-hospital cardiac arrest in children with CHD, this study is an important first step to close knowledge gaps regarding the risk factors and outcome of cardiac arrest in this patient group, and aims to improve care and outcomes of these vulnerable patients.

Eligibility Criteria:
Inclusion Criteria:

* congenital heart defects, congenital heart arrhythmia, familial cardiomyopathies, inflammatory heart diseases
* pediatric resuscitation (chest compressions ≥2min) in hospital or on arrival in hospital
* age \<18 years
* informed consent of the parents or legal representative

Exclusion Criteria:

* absence or withdrawal of informed consent of the parents or legal representative
* do-not-resuscitate-order (DNR)
Efficacy and Safety of Saturno IIB Association on the Control of Ocular Inflammation Post-phacoemulsification

The purpose of this study is to evaluate the efficacy of Saturno II association on the control of ocular inflammation post-phacoemulsification


Eligibility Criteria:
Inclusion Criteria:

* Participants of both sexes, aged 18 years or more;
* Participants presenting the diagnosis of cataract with indication for surgery by the phacoemulsification procedure;
* Participants who undergo surgery in only 1 eye at a time;
* Participants with intraocular pressure (IOP) ≤ 20 mmHg;
* Signed consent.

Exclusion Criteria:

* Used non-steroidal anti-inflammatory drugs or topical steroids or systemic inhalers within 21 days prior to randomization of the clinical trial;
* Performing the surgery for the second time, to correct the previous procedure or to change the lens;
* Decompensated glaucoma or ocular hypertension with IOP above 21 mmHg;
* Active ocular infectious diseases;
* History hypersensitivity to the active ingredients used in the study;
* Pregnancy or risk of pregnancy and lactating patients;
* History alcohol abuse or illicit drug use;
* Any clinical and laboratory findings that, in the judgment of the investigator, may interfere with the safety of research participants;
* Participation in clinical trial in the year prior to this study.
Non-interventional Observational Study of Pramipexole in Restless Legs Syndrome: Impact on Quality of Life

In this German non-interventional observational study 1980 patients diagnosed with Restless Legs Syndrome (RLS) will be investigated by 990 General Practitioners across all federal states in Germany. Both moderate to severe RLS patients, with or without previous RLS treatment, suffering from RLS symptoms like a desire to move the extremities usually associated with some discomfort, motor restlessness and worsening of symptoms at rest with at least temporary relief by activity, worsening of symptoms later in the day or at night, are eligible for this study, if it is planned to initiate therapy with pramipexole or to add pramipexole to a previously given, insufficient therapy. Three visits are planned to be documented in this PMS study, one baseline visit, visit two after the end of pramipexole titration and visit three after 12 weeks of treatment. Evaluations and visits are to be carried out and documented only if part of routine medical practice. The main goal of observational studies is to determine how pramipexole treatment works when applied in actual practice and thus maximise external validity. In actual practice patients who have been excluded in the clinical registration trials of PPX in moderate to severe primary RLS (i.e. those with certain disease histories, co-morbidities and/or demographic characteristics) will be treated with PPX. Thus in addition during this observational study information on the efficacy and safety of PPX in those patients will be obtained. The objectives of this PMS study are:

* To evaluate the treatment effect of pramipexole on RLS severity and general improvement as measured by IRLS and CGI-I.
* To evaluate quality of life of RLS patients as measured by the Restless Legs Syndrome Quality of Life questionnaire (RLS-QoL).
* To evaluate the safety profile of PPX in a natural study population.


Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of primary RLS
2. Indication for RLS treatment with Sifrol® (pramipexole)
3. Male or female patients aged at least 18 years.

Exclusion Criteria:

1. Any contraindications according to the Summary of Product Characteristics (SPC): hypersensitivity to pramipexole or to any of the excipients.
2. Ongoing treatment with Sifrol® (pramipexole).
Glucose Variability and Cognition in Prediabetes

This study examines the association of variability in glucose values over a 10-day period with cognitive function and functional status among individuals with prediabetes, aged 50 or older.

Type 2 diabetes (T2DM) is now widely considered a major public health epidemic. T2DM is highly prevalent worldwide, is among the leading causes of death, and is an independent risk factor for dementia and less severe forms of cognitive dysfunction. The investigators are utilizing novel technology to understand the role of variability in glucose on neurocognition and functional status among middle-aged and older adults at risk for diabetes. The central hypothesis is that even before diabetes onset, variability in glucose will be associated with worse cognitive function and lower functional status. Participants will be asked to wear a glucose monitoring device over a 10-day period in their home environment. Assessment of functional status and neurocognitive function, in addition to sociodemographic factors, health habits and mood will also occur over two study visits.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 years and older
* At least 8th grade education

Exclusion Criteria:

* Diagnosed type 1 or type 2 diabetes
* Current use of mediation for diabetes (oral hypoglycemic agents, insulin), or with diabetic properties (e.g., steroids)
* Chronic disorders (cardiovascular disease, peripheral vascular disease, stroke, transient ischemic attack, chronic kidney disease, past year cancer)
* Neurological disorders (e.g., Parkinson's, epilepsy, multiple sclerosis)
* History of dementia or suspected dementia
* Known HIV
* Serious mental illness, psychosis, or use of psychotropic medication
* Heavy alcohol use
CT and Clinical Features of Internal Hernia

Researchers retrospectively reviewed patients with internal hernia that confirmed by surgical exploration between Feb. 2012 and Feb. 2018. and analysis the Medical records and MDCT images to investigate the clinical and radiological features of internal hernia.

51 Patients with definite diagnosis of IH during surgical exploration from Feb. 2012 to Feb. 2018 in our hospital were included in this research. Medical records including MDCT images and intra-operative findings were collected retrospectively. The CT features of different subgroups were also evaluated.

Eligibility Criteria:
Inclusion Criteria:

* IH confirmed by surgical exploration

Exclusion Criteria:

* diaphragmatic hernia and traumatic IH
T2 and SeptiCyte RAPID Duration Project

Infection with bacteria and other germs in the blood can be deadly. How long germs stay in the blood is important for two reasons. The first is that if they stay in the blood for many days it is a sign that antibiotics may need to be changed. The second is that if they stay in the blood for only a short time it may give doctors confidence to switch to tablets and consider early discharge from hospital. This study is evaluating the diagnostic and prognostic performance of two novel technologies when used to measure the duration of the bloodstream infection.

Bloodstream infection is highly significant and is associated with mortality rates of between 10 and 25%.

For some infection types (for example, Staphylococcus aureus) a longer duration of bacteria being present in the blood is linked to higher mortality. With traditional microbiologic techniques, bloodstream infection with gram-negative bacteria is usually quite brief. However, new culture independent bacteraemia detection systems (such as T2 magnetic resonance assay) are more sensitive than traditional blood culture systems and may show that gram-negative bacteraemia is more prolonged in some patients than has previously been thought. This observational study will investigate the correlation between the duration of bloodstream infection by mean of traditional blood culture techniques with:

1. Duration of the bloodstream infection by mean of the T2 magnetic resonance assay, a new culture independent bacteraemia detection system.
2. Persistence of inflammation as measured by the SeptiCyte RAPID test, a host response assay able to differentiate infectious from sterile inflammation.

The study will also correlate each measure of the duration of bacteraemia with microbiological and clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have proven bloodstream infection with any T2-on panel pathogen (Enterococcus faecium, S. aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa, Escherichia coli and Candida spp.)

Exclusion Criteria:

* Palliative care approach
* Failure to give written informed consent (by patient or their legal representative)
* Polymicrobial index blood culture
A Study to Learn About the Study Medicine Sisunatovir in Adults With Respiratory Syncytial Virus (RSV) Infection

The purpose of this study is to learn about the safety and effects of sisunatovir. Sisunatovir is studied for the possible treatment of Respiratory Syncytial Virus (RSV). RSV is a virus that causes lung infections with cold-like symptoms, but it can cause severe illness in some people. Sisunatovir is studied in adults:

* who are not admitted to the hospital and
* who have high chances of having a severe illness from RSV infection.

This study is seeking participants who:

* Are confirmed to have RSV.
* Have symptoms of a lung infection.
* Are 18 years of age or older.
* Have one or more of the following which increases the chances of RSV illness:
* A long-term lung disease.
* heart failure.
* a condition that weakens the immune system.
* Are 65 years of age or older and do not have any of the conditions above

Half of the participants in this study will receive sisunatovir. The other half will receive a placebo for 5 days. Placebo looks same like the study medicine but does not have any medication. Both sisunatovir and placebo will be taken by mouth. The study will compare the experiences of people receiving sisunatovir to those of the people who do not. This will help decide if sisunatovir is safe and effective.

Participants will attend about 8-10 study visits over 5 weeks. During this time, they will have:

* visits at the study clinic,
* blood work,
* swabs of the nose,
* questionnaires,
* a follow-up phone call.


Eligibility Criteria:
Inclusion Criteria:

* Participants aged 18 years or older at screening.
* Diagnosis of RSV infection collected within 5 days prior to randomization.
* New onset or worsening (if present chronically) of at least one of the following signs and/or symptoms consistent with a viral acute respiratory infection (ARI), within 5 days prior to randomization: nasal congestion, nasal discharge, sore throat, cough, sputum production, shortness of breath, or wheezing.
* Has at least 1 of the following characteristics or underlying medical conditions: a) 65 years of age or older b) Chronic lung disease, c) Heart failure, d) Immunosuppressive disease/condition or immune-weakening medications

Exclusion Criteria:

* Any medical or psychiatric condition that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study or interfere with the evaluation of response to the study intervention.
* Diagnosis of viral respiratory infections other than RSV including influenza and SARS-CoV-2
* Current need for hospitalization or anticipated need for hospitalization for any reason to provide inpatient/acute care within 24 hours after randomization
* Any clinically significant ECG abnormality in the pre-dose ECG that, per investigator judgement, may affect participant safety
* Has hypersensitivity to or other contraindication to any of the components of the study interventions, as determined by the investigator.
Brachial Plexus Block in Post-Op Pain Control After Distal Upper Extremity Fracture: A Prospective Randomized Study

Despite the plethora of literature suggesting that regional blockade provides adequate andimproved postoperative pain control, function and improved intraoperative and postoperative safety in proximal upper extremity surgery, little is known of its benefits for the treatment of forearm and distal radius fractures . The purpose of this randomized, prospective, study is to determine if brachial plexus blockade with general anesthesia is superior to general anesthesia alone in immediate and long-term pain control in patients undergoing operative fixation of distal upper extremity fractures.

The purpose of this study is to compare two (2) different types of anesthesia treatments that are used during surgery for broken arms for post-surgery pain relief. One group will receive general anesthesia (state of total unconsciousness) the other group will get sedation (medicine injected into patient's vein that helps patient fall asleep), and a nerve block (injection of anesthetic drug into the nerves going to patient's arm in order to make patient's arm numb).

Both forms of anesthesia are used for a variety of surgeries to the arm including shoulder and elbow surgeries. Currently it is thought that there are advantages and disadvantages to both types. The advantage of not using the nerve block in addition to general anesthesia (current standard or care) is that it decreases the potential risk for bleeding, infection and nerve injury. Alternatively, the advantage of using the nerve block with sedation (research-related procedure) is that it can potentially offer better post-operative pain control. This study will examine whether there is added benefit with the addition of nerve block for anesthesia for decreasing pain after surgical treatment of lower arm fractures.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at least 18 years old.
2. Male or Female
3. All racial and ethnic groups
4. Fractures and fracture/dislocations of the elbow, forearm, wrist and hand
5. Montaggia and Galleazzi variants
6. Patients who opt for surgical treatment of their fractures.
7. Patients who consent to be randomized.
8. Patients who are willing to follow-up for a minimum of 52 weeks.

Exclusion Criteria:

1. Patients younger than 18 years old.
2. Patients who are unwilling to follow-up for a minimum of 52 weeks.
3. Limitation in upper extremity function that would affect outcome scoring
4. Neurologic condition that could interfere with pain sensation
5. Patients with a contraindication to one of the anesthesia protocols
6. Patients who refuse a specific anesthesia protocol
Comparison of the Effect of Ondansetron and Combined Ondansetron and Betahistine on Postoperative Nausea and Vomiting After Gynecological Laparoscopy

Many patients undergoing gynecologic laparoscopic surgery experience postoperative nausea and vomiting (PONV) despite prophylaxis and treatment with HT3 receptor antagonists such as ondansetron. Involvement of multiple types of receptors and factors may be a reason for inadequate control of PONV with a single agent. Betahistine, a histamine antagonist at H1 receptor and antagonist at H3 receptor, is widely used as a treatment of dizziness. Dizziness is one of the cause of nausea and vomiting. This study is to compare the effects of ondansetron and combined ondansetron and betahistine in preventing PONV in high-risk patients receiving intravenous opioid-based patient-controlled analgesia (IV-PCA) after gynecological laparoscopic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Patient scheduled for elective gynecological laparoscopic surgery
* American society of Anesthesiologists physical class I, Ⅱ, between the ages of 20 and 70 years

Exclusion Criteria:

* hepatorenal disease
* BMI \> 35 kg/m2
* allergy to ondansetron or betahistine
* gastrointestinal disease
* vomiting within 24h
* administration of antiemetics or opioids within 24h
* QT prolongation (QTc \> 440ms)
* Pheochromocytoma
* pregnant
* problem with communication
Comparison of Two Videolaryngoscopes (C-MAC vs Airtraq) for Awake Intubation

Patients with anticipated difficult airway are recommended to be managed with an awake tracheal intubation. Initially fibreoptic bronchoscopy was considered the gold standard, but in the last decade videolaryngoscopes have been demonstrated to be an efficacy alternative technique. Recently, a systematic review and meta-analysis was published investigating the efficacy and safety of videolaryngoscopy compared with fibreoptic bronchoscopy for awake tracheal intubation. Eight prospective, randomized studies were included, with different videolaryngoscopes (C-MAC, GlideScope, Pentax AWS, McGraft, and Bullard). However, a direct comparison of two different videolaryngoscopes for awake tracheal intubation in patients with anticipated difficult airway has not been performed.

This is a clinical prospective randomized-controlled trial. The aim of this study is to compare two different devices (C-MAC videolaryngoscope and Airtraq videolaryngoscope) for awake tracheal intubation in patients with difficult airways scheduled for surgery. The primary endpoint will be to compare first-attempt intubation success rate between the two videolaryngoscopes. Secondary outcomes will be to compare: difference in the overall success rate, number of intubation attempts, Cormack-Lehane grade of glottic view, incidence of complications related to intubation, difficulty experienced by the operator, patient's tolerability of the procedure.

Eligibility Criteria:
Inclusion Criteria:

* 18 years and older
* Patients with anticipated difficult airway requiring awake intubation under local anaesthesia and conscious sedation for general anesthesia.
* Written informed consent from the patient or proxy (if present) before inclusion or once possible when patient has been included in a context of emergency.

Exclusion Criteria:

* Pregnancy
* age \<18 years
* refusal of the patient
* patient's respiratory failure
Fentanyl Effect on Blood Pressure in Elderly Patients After Induction of General Anesthesia

Hypotension is frequently encountered after induction of general anesthesia. It can be pronounced in elderly patients and can require administration of vasopressor agents including ephedrine and phenylephrine. Intraoperative hypotension, especially prolonged episodes, can contribute to an increase in morbidity and mortality in the postoperative period as suggested by some former studies. The investigators hypothesize that fentanyl can contribute to the decrease in blood pressure (BP) that is seen after induction of general anesthesia in older patients. This hypotension may be due to fentanyl blocking effect on the sympathetic nervous system.

This study will be the first one to examine the effect of fentanyl administration on blood pressure in elderly patients with induction of general anesthesia prior to the start of surgery. If the study shows that fentanyl contributes to hypotension during this period, it may lead to a change in practice and better patient outcomes and mortality rates.

This is a prospective double-blinded randomized controlled trial (RCT) where patients will be assigned randomly by the investigational pharmacist. Patients will be assigned to one of three groups: (1) A control group that receives 0.9 mcg/kg sodium chloride (NaCL), (2) a fentanyl group that receives 1 mcg/kg fentanyl, or (3) a fentanyl group that receives 2 mcg/kg fentanyl.

The definition of intraoperative hypotension in this study is defined as a mean blood pressure (MAP) less than 25% compared to the baseline value (i.e., the participants' first blood pressure reading after entering the operating room). All study drug agents will be dispensed by the pharmacy in five milliliter syringes labeled as "study medication". The volume of any of the three study medication will be adjusted by the pharmacist to reflect an equal volume.

Eligibility Criteria:
Inclusion Criteria:

* Age: 60 years and older
* Patients coming from home (including those who will be admitted post-operatively)
* Surgeries with general anesthesia alone or if combined with peripheral nerve blocks
* Patients must be seen at the Russo operating room at Loyola Medical Center (Maywood, IL)

Exclusion Criteria:

* Age less than 60
* Patient refusal
* Inpatient or emergency cases
* Patients having combined general anesthesia and epidural anesthesia
* Patients with a pre-induction mean arterial blood pressure (MAP) less than 50 or greater than 150
* Patients who will receive rapid sequence induction with succinylcholine
* Patients scheduled for cardiovascular surgery
* Patients scheduled for inhalational induction
* Patients with weight greater than 125 kg
* Patients with a history of chronic opioid use