cyrilzakka/clinical-trials huggingface dataset:
Sufentanil NanoTab PCA System/15 mcg for Acute Post-Operative Pain in Vertebral Surgery: A Preliminary Investigation

The Zalviso® Sufentanil Sublingual Tablet System (SSTS) (Grünenthal Italia, Milan, Italy) is a patient-controlled analgesia (PCA) system approved in September 2015 by the European Commission for the management of acute moderate-to-severe pain in adult patients in a hospital setting. This preprogrammed drug/device combination product delivers a fixed dose of 15 mcg of sufentanil tablets as needed, in a non-invasive sublingual dosage form.

Multimodal analgesia is defined as the administration, by one or more routes, of various analgesic medications with different mechanisms of action, thereby providing superior analgesia with fewer side effects. To improve pain control and patient satisfaction, patient-controlled analgesia (PCA) techniques have been developed, i.e. any delivery system which allows patients to self administer predetermined doses of analgesic drug to relieve pain. Over the past decades, intravenous (IV) PCA with morphine has been the gold standard for acute pain control. In our clinical practice, though, not only IV-PCA pumps were frequently prone to technical problems, but also patients and caregivers were not often able to understand or activate them, thus raising important safety issues and profoundly affecting the management of pain control. As a consequence, IV-PCA eventually fell into disuse, although no alternative has emerged until recently. The SSTS should go beyond the above-quoted limitations: it is a non invasive, patient-controlled and easy to use device, with an effective and safe opioid profile. It is, in our thinking, a promising technology.

The aim of this retrospective analysis is to examine the role of the SSTS for management of pain after vertebral surgery, as part of a multimodal approach.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent elective open lumbar arthrodesis surgery (either by an anterior or posterior approach) in degenerative lumbar spine conditions who were between 18 and 75 years old and post-operatively treated with Sufentanil NanoTab PCA system as part of a multimodal analgesic regimen.
* General anesthesia was performed. Perioperative regional anesthetic techniques and local anesthetic wound infiltration in the operating room were not performed.

Exclusion criteria:

* Patients who refused to participate in the study.
Nefopam for Post Video-Assisted Thoracoscopic Lobectomy

Video-assisted thoracoscopic (VATs) lobectomy is mild to moderately pain procedure. For conventional thoracotomy, there are many invasive pain control such as epidural analgesia, paravertebral block. However, for VATs, the invasive pain control somehow are too invasive. Nefopam is non-opioid painkilling medication, Serotonin, norepinephrine, dopamine reuptake inhibitor. Many study were demonstrated positive outcome of nefopam usage in many operation such as abdominal surgery, laparocopic surgery, orthopedic surgery. Nevertheless, nefopam for VATs is not well studied yet.


Eligibility Criteria:
Inclusion Criteria:

* Schedule to video-assisted thoracoscopic surgery : VATs lobectomy
* Can operate a patient-controlled analgesia (PCA) device
* No contraindication for nefopam

Exclusion Criteria:

* Epilepsy, on monoamine oxidase (MAO) inhibitors, glaucoma
* Creatinine clearance \< 60 ml/min
* Liver disease: child-pugh score B or C
* Allergy to nefopam
* Chronic opioid use
n-3 Enriched Nutrition Therapy and Postoperative Cognitive Dysfunction After Cardiac Surgery

Background: Delirium and long-term cognitive dysfunction (CD) are important complications of major surgery and intensive care treatment. Delirium is associated with increased mortality and CD has an important impact on mortality, independency, social interactions, and quality of life. Delirium is an important risk factor for the development of long-term CD. Particularly, patients aged 65 or older undergoing cardiac surgery are at a high risk of developing these problems. There are data suggesting that inflammation plays a key role in the development of delirium and possibly CD. It has been shown that n-3 fatty acids modulate the immune response of patients and have beneficial effects in abdominal surgery.

Working hypothesis: 1. Administration of n-3 enriched nutrition therapy including will modulate the inflammatory response and improve cognitive function after cardiac surgery.

Specific Aims: This project will test the impact of perioperative enteral n-3 fatty acids ProSure, Abbott Nutrition) in elderly patients undergoing elective cardiac surgery. Primary endpoint is CD one week postoperatively.

Methods: The investigators will investigate 400 patients aged 65 or older undergoing elective cardiac surgery. Half of these patients will receive supplementary of n-3 fatty acids to modulate the inflammatory response; the other half will receive an isocaloric nutritional supplement without n-3 fatty acids (Ensure Plus, Abbott Nutrition). Otherwise the treatment of the patients will not be influenced by this study. Cognitive function will be assessed preoperatively, 7 days and three months postoperatively. C-reactive protein, IL-6, IL-8, IL-10, S-100B, and neuron specific enolase will be monitored as markers of systemic inflammation and delirium.


Eligibility Criteria:
Inclusion Criteria:

* Patient's undergoing elective cardiac procedure with extracorporeal circulation
* Age 65 or older

Exclusion Criteria:

* No informed written consent
* "Redo" operation
* Deep hypothermic cardiac arrest
* Operation including carotid endarterectomy
* Known allergy to n-3 fatty acids
* History of cerebrovascular disease
* Preoperative Mini mental score \< 23
* Long term neuroleptic medication
Normative Data of Brain Network Activation in Adolescents and Young Adults

Establish normative data of ElMindA's Brain Network Activation (BNA) using evoked response in two age groups: adolescents and young adults.

Currently, there is no reliable, practical, and non-invasive method for assessing changes in electrophysiological activity of the brain associated with brain-related pathologies, e.g., concussion, ADHD, autistic spectrum disorders (ASD), etc. Event Related Potentials (ERPs), which are temporal reflections of the neural mass electrical activity of cells in specific regions of the brain that occur in response to stimuli, may offer such a method, as they provide both a noninvasive and portable measure of brain function. The ERPs provide excellent temporal information, but spatial resolution for ERPs has traditionally been limited. However, by using high-density electroencephalograph (EEG) recording spatial resolution for ERPs is improved significantly. The paradigm for the current study will combine neurophysiological knowledge with mathematical signal processing and pattern recognition methods (BNA) to temporally and spatially map brain function, connectivity and synchronization.

The need of objective measures that will help the clinician in its decision making in brain-related pathologies is recognized. BNA is a new imaging modality that has been developed to fill this gap.

Eligibility Criteria:
Inclusion Criteria:

* Age 15-24 years.
* Willingness to participate and able to give informed assent (child) and/or consent (parent for minors or adult 18+ years of age for self).

Exclusion Criteria:

* Currently participate in a contact sport (e.g., football, hockey, soccer, rugby, lacrosse, martial arts).
* Currently with lice, open wounds on scalp.
* Any chronic disease.
* Any psychiatric disorder, e.g., depression, bipolar disorder, schizophrenic disorder, etc.
* Any CNS neurologic disorder, e.g., epilepsy, seizures, etc.
* Any neuropsychological disorders, e.g.: ADHD, Autistic Spectrum Disorder (ASD), etc.
* History of Special education, e.g., reading disorder (dyslexia), writing disorder (dysgraphia), math disorder (dyscalculia), nonverbal learning disorder.
* History of any medication affecting CNS within the last 3 months, e.g., antidepressants, anticonvulsants, psychostimulants, first generation antihistamines, etc.
* Substance abuse in the last 3 months.
* Significant sensory deficits, e.g., deafness or blindness.
* History of any brain trauma.
Warrior CARE: Cannabis Behavioral Health

This study is a randomized, controlled clinical trial to examine the therapeutic potential of cannabinoids for treating veterans with PTSD and suicidal ideation.

In this clinical trial, we will recruit veterans with PTSD who report using cannabis or have interest in trying cannabis for symptom relief. Veterans will be randomized into one of four different groups: THC (∆9-tetrahydrocannabinol), CBD (cannabidiol), THC+CBD, and Placebo, and undergo a 12-week treatment phase where they will be asked to vaporize their assigned cannabis dose every day for 12 weeks. Participants will complete weekly questionnaires regarding their mood, behavior and drug consumption. Furthermore, there is a laboratory component that will assess cognition, fear conditioning, and other PTSD-related measures.

Eligibility Criteria:
Inclusion Criteria:

* able to provide informed consent, IQ Score \>80,
* served in branch of the US armed forces, report using cannabis,
* report using cannabis (no more than 2x in last month and no more than 100 lifetime use episodes)
* meet DSM-5 criteria for PTSD w/ Sx of at least 6 months duration

Exclusion Criteria:

* urine drug screen positive for any other drugs
* systolic/diastolic BP \>140/90 mmHg?
* any clinically significant medical problems,
* any current or past serious psychotic or bipolar disorder diagnosis as determined by SCID-5
* at immediate high risk for suicide based on the C-SSRS
* current SUD other than Nicotine Use Disorder and Alcohol Use Disorder (mild or moderate)
* pregnancy, lactating
* unable to provide informed consent
Ibrutinib and Acalabrutinib Use and Risk of Atrial Fibrillation in Patients With Chronic B-cell Malignancies

Background. Ibrutinib and acalabrutinib are both associated with an increased risk of atrial fibrillation (AF) but AF comparative risk between these 2 BTK inhibitors (BTKis) remains largely unknown.

Objectives. Our aim was to examine the risk of developing incident AF with ibrutinib exposure compared with acalabrutinib exposure.

Methods. Using the TriNetX research network database, authors will conduct a retrospective cohort analysis of deidentified, aggregate adult patients with chronic B-cell malignancies and exposed to ibrutinib or acalabrutinib. Patients will be divided into 2 groups based on ibrutinib or acalabrutinib exposure. After propensity score matching (PSM), hazard ratios (HRs) and their associated 95% confidence intervals (CIs) will be used to compare AF risk during follow-up between the matched 2 groups.


Eligibility Criteria:
Inclusion Criteria:

* adult patients
* diagnose with chronic B-cell malignancies using ICD-10-CM codes C91 (lymphoid leukemia), C88.0 (Waldenström macroglobulinemia), C83.1 (mantle cell lymphoma), C81-C96 (malignant neoplasms of lymphoid, hematopoietic and related tissue) or C95 (leukemia of unspecified cell type)
* expose to ibrutinib or acalabrutinib determined by the Anatomical Therapeutic Chemical codes

Exclusion Criteria:

-
Respiratory Muscle Training in ICU Patients

Respiratory muscle weakness is common after mechanical ventilation and occurs early. This can limit functional recovery. Respiratory muscle training is often neglected in clinical practice. Some data indicates that inspiratory muscle training increases inspiratory muscle strength and quality of life. The aim of the study is to assess the impact of combined inspiratory and expiratory muscle training on inspiratory muscle strength. The second aim is to assess the impact of this training program on expiratory muscle strength.


Eligibility Criteria:
Inclusion Criteria:

* patient from mechanical ventilation after at least 24 hours of support
* collaborative patient

Exclusion Criteria:

* confusion, mental disorder
* not french speaking
* pulmonary surgery in the past 12 months
* external ventricular drain
* previous pneumothorax or pneumothorax not drained
* rib fractures
* alveolar hemorrhage
* hemodynamic instability
* labial occlusion impossible (face burn, facial paralysis)
* patient refusal
Impact of a Decision Aid on Patient Decision Making in Emergency Department Chest Pain Patients

We are doing a study to assess the impact of including patients in making decision regarding their own medical care in the emergency department. We will randomly assign them to either receive a decision aid or usual care. In doing this, we aim to increase patient satisfaction and safely decrease medical cost.


Eligibility Criteria:
Inclusion Criteria:

* Adults with a primary complaint of chest pain.
* Treating clinician's next consideration is observation unit admission for cardiac stress testing.

Exclusion Criteria:

* Initial cardiac troponin T value \>99th percentile (\>0.01ng/mL)
* History of coronary artery disease
* coronary revascularization procedure within the previous 30 days
* cocaine use within 72 hours by the clinician's initial history
* pregnancy
* patient cannot read English or have, in their clinician's judgment, major learning barriers, such as visual or hearing impairment or dementia that would compromise their ability to give written informed consent (or use the decision aid)
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus

This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.

This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 18 years
* Having a diagnosis of progressive keratoconus
* Signed written informed consent
* Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
* Willingness and ability to comply with schedule for follow-up visits

Exclusion Criteria:

* Corneal pachymetry at the screening exam that is \<400 microns at the thinnest point
* Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
* A history of delayed epithelial healing in the eye(s) to be treated
* Pregnancy or lactation during the course of the study
* A known sensitivity to study medications
F-18 Rhodamine 6G PET Imaging for Myocardial Blood Flow

Use of novel radio-pharmaceutical Rhodamine 6G to determine myocardial blood flow

Using Rhodamine 6G to determine myocardial blood flow in normal volunteers and patients with coronary heart disease.

Eligibility Criteria:
Inclusion Criteria:

* Male and female, 21-75 years of age and any race.
* Capable of giving written informed consent.
* "Healthy adult volunteer subject" is someone who is volunteering to undergo imaging procedures and based on screening procedures has no known significant health problems.
* Stable patients with known or suspected coronary artery disease that are scheduled to have or have undergone a clinically indicated conventional rest/stress SPECT MPI and no intervention between SPECT and PET.
* Female subjects must not be pregnant or lactating.

Exclusion Criteria:

* Has any condition that, in the opinion of the Sponsor-Investigator or designee could increase risk to the subject, limit the subject's ability to tolerate the research procedures, or interfere with collection of the data.
* Have abnormal findings on any screening/baseline procedure, e.g. physical examination, laboratory tests, electrocardiogram that suggest the subject might have a condition that could, in the opinion of the Sponsor-Investigator, affect the subject's response to the radiopharmaceutical or related research procedures.
* Is deemed likely to be unable to perform all research procedures for any reason, (e.g., subjects unable to lie still or inability to tolerate up to 60 minutes in a supine position with arms up during the PET imaging procedures due to chronic back/shoulder pain or arthritis as assessed by physical examination and medical history).
* Has a history of hypersensitivity to Fluorine-18 or other radiopharmaceutical or any of its excipients.
* Have contraindications to cardiovascular PET/CT imaging such as claustrophobia.
* Have high blood pressure (\>200/110)
* Have Epilepsy
* Have major kidney or liver problems
* Have current or past history of major medical illness
* Currently using recreational drugs
* Body weight of \> 300 lbs. (weight limit of the PET/CT table)
* Stable Cardiac Disease: Rest/Stress Group only:

  * Cardiac patients who suffer an intervening clinical event such as worsening angina pectoris or myocardial infarction or whom undergo a myocardial revascularization procedure or have myocardial ischemia at rest.
  * Sinus node disease (e.g. SA block) or symptomatic bradycardia, second or third degree atrioventricular (AV) block.
  * Pre-existing obstructive lung disease (e.g. asthma) that precludes the safe administration of the pharmacological stressor according to the approved label.
  * Uncontrolled and severe hypertension (e.g. systolic blood pressure \>200 mmHg, diastolic blood pressure \>110 mmHg).
  * Baseline hypotension (e.g. systolic blood pressure \< 90 mmHg, diastolic blood pressure \<50 mmHg).
  * Seizures
  * The use of caffeine, nicotine or over the counter cold medicines within 12 hours prior to stress imaging day with regadenoson.
  * The theophylline-based medications or dipyridamole within 48 hours prior to each imaging day.
Pregnancy Monitoring Using Mobile Application

The goal of this Randomized Controlled Trial is to compare the health condition of pregnant women through pregnancy monitoring in the implementation of pregnancy class. The main question it aims to answer are:

How is the condition of the mother and baby after pregnancy monitoring using the REST mobile application (Risk identification, Evaluation counseling, Systematic monitoring, Trobleshooting)

Participants will be monitored for the condition of their pregnancy from 20 weeks of pregnancy until delivery. Participants will attend in the pregnancy class as many as 3 meetings and a pregnancy check-up by the midwife.

Researchers will compare intervention group to see if normal delivery methods, birth weight of the baby (\>2500), antenatal care visits (\>6 times), and prevention of pregnancy complications were better than the control group.

The research will involve pregnant women and midwives. The midwife will conduct a pregnancy check-up which includes 10 pregnancy checks (height and weight, blood pressure, upper arm circumference, uterine fundus height, Tetanus immunization, Fe tablets, fetal presentation and fetal heart rate, counseling, laboratory tests, case handling). The examination is carried out every class meeting of pregnant women. The results of the examination will be inputted into the mobile application. Pregnant women will fill in the mobile application if the mother does antenatal care at a health facility. This activity will last until the mother's delivery.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with a gestational age of 20-22 weeks.
* Pregnant women who have a pregnancy check-up at a health facility
* Plan to settle in the research area for at least the next 2 years
* Willing to participate in the research by signing an informed consent form.

Exclusion Criteria:

* Suffering from chronic diseases that require special pregnancy care
* It is certain that it cannot give birth normally
* Unable to operate an android phone
Interferon Gamma-1b in Friedreich Ataxia (FRDA)

Friedreich ataxia (FRDA) is a progressive neurodegenerative disease of children and adults for which there is presently no therapy. Recently, a study reported that interferon gamma (IFN-g) could raise frataxin protein levels in both cell lines derived from patients with Friedreich ataxia and in a mouse model with Friedreich ataxia. The present study will test whether IFN-g is safe, tolerated and potentially efficacious in a heterogeneous cohort of children with FRDA.

Study Objectives:

Primary:

• To assess the effect of Interferon Gamma-1b (IFN-g) on increasing frataxin expression and protein in children with FRDA.

Secondary:

* To assess the effect of IFN-g on neurological outcomes (FARS, performance measures, and hearing) in subjects with FRDA.
* To assess the effectiveness of IFN-g on quality of life in subjects with FRDA.
* To assess the safety and tolerability of IFN-g at the currently approved dose in the FRDA population.

Study Phases:

Screening - During screening, subjects will be assessed for inclusion and exclusion criteria.

Intervention - Subjects will begin treatment at baseline visit and the dose of study medication will be increased to the maximum dose over four weeks. The subjects will be maintained at the maximum dose for 8 weeks. After 12 weeks, treatment will stop. Study medication will be administered via subcutaneous injections three times per week for 12 weeks.

Follow-up - Follow-up visits will occur at 7 and 28 days after the subject has completed the 12 weeks of active treatment.

Eligibility Criteria:
Inclusion Criteria:

* Subjects with FRDA confirmed by genetic testing with 2 expanded Guanine-adenine-adenine repeats
* Females who are not pregnant or breast feeding, and who do not intend to become pregnant. Females of child-bearing potential must use a reliable method of contraception and must provide a negative urine pregnancy test at screening
* Stable doses of all medications, vitamins and supplements for 30 days prior to study entry and for the duration of the study
* Parent/guardian permission (informed consent) and child assent

Exclusion Criteria:

* Any unstable illness that in the investigator's opinion precludes participation in this study
* Use of any investigational product within 30 days prior to enrollment
* Subjects with a history of substance abuse
* Presence of clinically significant cardiac disease
* History of hypersensitivity to IFN-g or E. coli derived products
* Presence of severe renal disease or hepatic disease
* Clinically significant abnormal White blood cell count, hemoglobin or platelet count
* Any subject planning a scheduled surgical procedure during the study