cyrilzakka/clinical-trials huggingface dataset:
Pediatric Positive End Expiratory Pressure (PEEP) Titration Using Electrical Impedence Tomography (EIT)

The goal of this clinical trial is to perform a PEEP titration protocol and use EIT to identify the optimal PEEP at which lung overdistention and collapse are most effectively balanced. The primary and secondary aims of the study are as follows:

Identify the difference between the optimal PEEP recommended by EIT metrics and the current guideline recommended approach to identifying optimal PEEP in PARDS. There will be a statistically significant difference in the recommended optimal PEEP identified using the EIT PEEP titration tool and that of the PEEP/FiO2 grid recommendations.

Determine the difference in physiologic metrics between EIT optimal PEEP and the PEEP/FiO2 recommended PEEP.

Participants will undergoing EIT monitoring while being subjected to PEEP titration protocol.


Eligibility Criteria:
Inclusion Criteria:

* Any person who is less than 18 years of age
* is on invasive mechanical ventilation
* is not spontaneously breathing
* meets PARDS criteria

Exclusion Criteria:

* Contraindication to the use of EIT
* Hemodynamic instability
* Contraindications to hypercapnia
* patients with uncuffed endotracheal or tracheostomy tubes
* diagnosis of pneumothorax or bronchopleural fistula
* non-conventional ventilation
* any patient on extra-corporeal membrane oxygenation (ECMO) support
* less than 1 week post-operatively from cardiac surgery
* the following cardiac diagnoses: Glenn or Fontan physiology, significant right to left shunt
* Corrected Gestational Age \< 37 weeks
* pregnancy
Collaborative Nurse-pharmacist Counseling for Self-administered Biologics

The goal of this clinical trial is to learn if nurse-pharmacist counseling can improve patient knowledge and confidence and prevent side effects in patients who start a biologic medication in-office and later continue the medication at home. The main question it aims to answer are:

• Does nurse-pharmacist counseling improve patient-reported knowledge and confidence in biologic self-treatment when moving from in-office to at-home administration?

Participants will attend a brief counseling session in office and respond to a pre-counseling and post-counseling survey to look at medication knowledge and confidence. Participants will be contacted at three months after the survey to ask if they had any side effects related to their biologic medicine. Data will be collected from the participant's medical record at the study institution for up to six months after the study counseling session.


Eligibility Criteria:
Inclusion Criteria:

* Referred to University of Kentucky Specialty and Infusion Services for clinic-administration of a biologic medication
* Biologic medication is omalizumab, risankizumab-rzaa or ustekinumab
* Medication administration will be transitioned to self-administration

Exclusion Criteria:

* Less than 18 years of age
* have previously received the qualifying biologic at another institution
* non-English speaking subjects
* Subject will not be performing self-administration at home
* Does not transition to medication self-administration
Extracardiac Complications After Cardiac Surgery

Hypothesis of the study is that patients undergoing major cardiac surgery can develop extracardiac complications correlated to cardiopulmonary by pass.

To find out which are the main peri operative predictors of acute lung injury and other extracardiac complications, such as kidney injury, that prolonged Intensive Care Unit (ICU) length of stay after cardiac surgery. The main goal is to evaluate whether mechanical ventilation, in particular tidal volume, can be predictor of acute lung injure in this kind of patients.

Eligibility Criteria:
Inclusion Criteria:

* cardiac intervention with cardiopulmonary by pass, age \> 18 years old

Exclusion Criteria:

* off-pump surgery, heart and lung transplantations, patients on mechanical ventilation before intervention or admitted to Intensive Care Unit (ICU) before intervention.
Comparison of Video Laryngoscope Using Miller or Macintosh Approach During Endotracheal Intubation

Video laryngoscope has become recommended option during difficult intubation. Guidelines of ASA at 2013 had suggested using video laryngoscope after failure intubation of direct laryngoscope. Varieties of video laryngoscope had been invented with different curves. We call the one which has the same curve of Macintosh laryngoscope as conventional video laryngoscope in this study. Mostly, the way of using conventional video laryngoscope is suggested as Macintosh method. However, with the front positioning camera, Miller method can theoretically improve the glottic opening. We intend to discuss whether using Miller approach with conventional video laryngoscope can improve glottic opening or not.

Video scope can provide better glottic opening by increase the tilting angle of the tip, and the position of camera can provide larger vision angle. However, while the angle increases, the endotracheal tube must fallow the curve, which may require learning curve of the operator. In Glidescope as example, increase the tilting angle can help with glottic exposure, however the steep curve will simultaneously increase the difficulty of inserting the tube or using Magill forceps, especially while intubating double lumen or nasal endotracheal tube. Conventional video laryngoscope in this study indicates the video laryngoscope blade which has the same curve as Macintosh laryngoscope. It mainly improves the glottic view by front positioning camera.

Anesthesiologist usually place the tip of the blade at vallecula to expose the glottic which is the conventional ways of using Macintosh blade which we name it as Macintosh method. Placing the tip below the epiglottis and lift it up directly is the way of using Miller blade. Theoretically, the Miller method with conventional video laryngoscope may improve the scale of glottic exposure measured with Cormack-Lehane grade. This is a one-group pretest-posttest study to compare the Cormack-Lehane grade with two different methods in the same patient. This study tends to discuss whether this combination can improve the glottic exposure and preserve the advantage of direct laryngoscope.

Eligibility Criteria:
Inclusion Criteria:

1. Aged\>20
2. Scheduled to received operation that required general anesthesia with endotracheal tube \[3\] ASA I, II

Exclusion Criteria:

1. Emergent surgery
2. pregnant
3. Limited mouth opening
4. Poor dental condition
5. Airway obstruction (oral tumor, hypopharyngeal cancer....etc)
6. Deep neck infection
7. Allergic to any anesthetic
ReShape Intragastric Balloon for the Treatment of Obesity

A prospective, non-randomized, open-label, multi-center study designed to implant up to twenty-six (26) CE-marked ReShape™ Balloons in twenty-six (26) patients with body mass index (BMI) 30-40 to assess the effectiveness of the device. The RIB devices will be used within their labeled indications and as per their instructions for use. Enrolled patients will be followed for seven months. The patient will be prescribed a controlled diet, exercise and counseling. One group of 26 patients will receive treatment as follows: Placement, inflate to 900 cc, remove at 180 days, follow-up 30 days post removal (endoscopic video capture of placement and removal required).


Eligibility Criteria:
Inclusion Criteria:

* The patient is male or female between the ages of 20 and 60 years of age.
* The patient presents with a Body Mass Index (BMI) 30-40 kg/m2.
* The patient is geographically stable and willing to return to the implant center for follow-up visits.
* The patient has been adequately informed of risks and requirements and consents to his/her participation in the post market clinical study.

Exclusion Criteria:

* The patient presents with 20 years \> Age \> 60 years.
* The patient has a progressive disease, which in the Investigator's experience produces an unacceptable increased risk to the patient, or results in a life expectancy of less than 12 months.
* The patient is a pregnant or lactating female.
* The patient presents with a 30 kg/m2 \> BMI \> 40 kg/m2.
* The patient has had previous abdominal surgery.
* The patient has digestive tract disorders such as active peptic ulcers, bleeding disorders, esophageal varices, Crohn's disease.
* The patient presents with psychiatric disorders.
* The patient is participating in concomitant research studies of investigational products that would interfere with this study.
* The patient has inability to return for follow-up assessments.
* The patient is an alcohol or drug abuser.
Structural Brain Abnormalities in Children Born Prematurely: New Detection Methods and Clinical-Pathological Correlates

The purpose of the study is to detect structural brain changes using MRI and to correlate these findings with neurodevelopmental assessments in two-year old children previously enrolled in the NIH sponsored trial of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants. It is hypothesized that this imaging will identify children with previously undiagnosed brain abnormalities and that the presence of structural abnormalities will be associated with deficits in motor, cognitive, and neurosensory development.

Infants born prematurely are at significant risk for hemorrhagic and ischemic brain injury. Despite improved survival rates among this population in recent years, these forms of brain injury remain frequent and have considerable consequences. Periventricular leukomalacia (PVL), a disease characterized by necrosis of the cerebral white matter in a characteristic distribution, is one of the most common types of brain injury seen in premature infants. MRI technology now allows for better anatomical resolution resulting in improvements in diagnostic accuracy. The current standard practice is not to perform routine MRI examinations on premature infants, nor is it routine to perform surveillance brain imaging in children after leaving the NICU. In their 2002 Practice Parameter for neuroimaging in the neonate, the American Academy of Neurology and the Practice Committee of the Child Neurology Society acknowledge the superiority of MRI in detection of brain lesions in premature infants, but fall short of recommending routine MRI scanning on the basis of a lack of information correlating MRI findings to neurodevelopmental outcomes. We now have a unique opportunity to help provide such information.

Eligibility Criteria:
Inclusion Criteria:

* must be participants in trial (NHLBI-UO1-HL62514-05A1 and FDA IND # 58,146 - Roberta A Ballard PI) of inhaled Nitric Oxide (iNO) for the prevention of Chronic Lung Disease in preterm ventilated infants
* gestational age between 24 months and 27 months

Exclusion Criteria:

* history of allergy to sedation agents
* medical conditions which may pose a threat to airway integrity (i.e., Pierre-Robin sequence, intercurrent respiratory illness)
* other conditions which may otherwise place subjects at increased risk for complications from sedation and MRI examination
A Study of Pegasys (Peginterferon Alfa-2a) Added to Nucleos(t)Ide Analogue Treatment in Participants With HBeAg-Negative Chronic Hepatitis B Genotype D Showing Stable Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) Suppression

This open-label, single-arm, multicenter study will evaluate the efficacy and safety of adding Pegasys (peginterferon alfa-2a) to nucleos(t)ide analogue (NAs) treatment in participants with HBeAg-negative chronic hepatitis B genotype D showing stable HBV DNA suppression. After a 12-week Lead-in period on treatment with NA, participants with a HBsAg decline \<0.5 log10 IU/ml will enter the Add-on period to receive Pegasys 180 mcg subcutaneously weekly for 48 weeks in addition to their current NA treatment. Follow-up will be a further 48 weeks, during which the participants will continue their NA treatment.


Eligibility Criteria:
Inclusion Criteria:

* Adult participants, 18 - 65 years of age
* Chronic hepatitis B
* Negative for HBeAg
* On monotherapy with any nucleos(t)ide analogue (NA) but telbivudine at enrolment, and HBV DNA persistently below 20 IU/ml for at least 12 months
* HBsAg \>100 IU/ml at the beginning of the Lead-in phase, confirmed before addition of Pegasys
* Showing a steady HBsAg kinetic (HBsAg decrease \<0.5 log10 IU/ml from Week -12 to start of the Add-on phase)
* Negative pregnancy test for women of childbearing potential
* Women of childbearing potential and fertile males with female partners of childbearing potential must be using reliable contraception during and for 3 months after the Add-on phase

Exclusion Criteria:

* Coinfection with Hepatitis A virus (HAV), Hepatitis C virus (HCV), Hepatitis D virus (HDV), Human Immunodeficiency virus (HIV)
* Evidence of decompensated liver disease (Child-Pugh \>/=6)
* History or other evidence of a medical condition associated with chronic liver disease (e.g. hemochromatosis, autoimmune hepatitis, alcoholic liver disease, toxin exposure)
* Known hypersensitivity to peginterferon alfa-2a
* Pregnant of breastfeeding women
* Evidence of alcohol and/or drug abuse
* History of severe psychiatric disease, especially depression
* History of immunologically mediated disease
* History or evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
* History or evidence of severe pulmonary disease associated with functional limitations
* History of severe cardiac disease
* History of severe seizure disorder or current anticonvulsant use
* Evidence of an active or suspected cancer or a history of malignancy (other than basocellular carcinoma or in situ cervical carcinoma) within 5 years prior to study entry
* History of having received any systemic anti-neoplastic (including radiation) or immunomodulatory (including systemic corticosteroids) treatment \</= 6 months prior to the first dose or the expectation that such a treatment will be needed at any time during the study
* History or other evidence of severe retinopathy
Post Operative Pain Control After Pediatric Hip Surgery

Hip surgery in children is painful and the optimal modality for managing post-operative pain has not been established. This prospective randomized controlled trail compares lumbar plexus catheter (LPC), lumbar epidural catheter (LEC) and continuous patient-controlled analgesia (PCA) with intravenous morphine.

Approximately 1 in 1,000 children born in the US have hip dislocation and 10 in 1,000 have hip subluxation requiring surgical intervention. Pain after major hip surgery in children is severe, yet there is no agreement on the most effective method for pain control. Post-operative pain modalities including lumbar epidural catheters (LEC), lumbar plexus catheters (LPC) and intravenous patient controlled analgesia (IV-PCA) have been described. IV-PCA has historically been the standard of care in spite of its numerous associated side effects. Regional anesthesia modalities have gained popularity because of superior pain control with lower opioid requirements.

In this study, the investigators describe the first prospective randomized controlled trial comparing lumbar plexus catheter to alternatives for post-operative pain management in children after major hip surgery. The investigators hypothesized that LPC would be as safe and efficacious as LEC and IV-PCA with the added advantage of a decreased length of stay. The investigators primary aim was to compare hospital length of stay. Secondary aim was to compare pain scores, opioid consumption and opioid-related side effects.

Eligibility Criteria:
Inclusion Criteria:

* Children undergoing unilateral hip surgery, including pelvic innominate osteotomies, proximal femoral osteotomies, and arthrotomies (for open reduction, loose body removal, labral debridement or labral repair).

Exclusion Criteria:

* History of a previous spine surgery, spina bifida, coagulopathy, skin infection, allergies to study medications (i.e. local anesthetics and opioids), patients taking opioids at the time of enrollment and, those having concurrent procedures distal to the hip.
Training Improves Balance Control

The purpose of this study was to evaluate the effect of a group-based functional and specific balance training program on balance function in healthy older adults. It is commonly considered difficult to improve balance function in healthy older adults. The program included dual-task exercises; physical training exercises and a cognitive task (e.g. reading or reciting a story) performed simultaneously, as well as perturbation exercises, where balance is challenged in unexpected ways.

The investigators hypothesized that following the proposed training, older adults would improve their speed of taking a step in both single and dual task conditions, refine their ability to control balance when standing still and improve their self-reported physical function.


Eligibility Criteria:
Inclusion Criteria:

* 65 years or older
* Independently ambulatory (cane acceptable; not walker)
* Score better than 45 on the Berg Balance Scale
* Higher than 24 Mini-Mental Score

Exclusion Criteria:

* Severe focal muscle weakness or visual impairment
* Known neurological disorders (including stroke, Parkinson disease)
* Metastatic cancer
* Use of medication that impairs balance or strength
A Validation Study of the German Autobiographical Memory Interview

Electroconvulsive therapy (ECT) is recommended for the treatment of severe depression. But, despite the high remission rates the use of ECT is strongly limited by the social stigma and treatment-emergent cognitive side effects in patients. The most relevant is retrograde amnesia (RA), because it can persists for months and years. To measure RA after ECT the short-form of the Autobiographical Memory Interview (SF-AMI) is commonly used. However, the validation of the German SF-AMI has not yet been carried out. Thus, the aim of this study is to validate the German SF-AMI in depressed patient and healthy controls.

The investigators hypothesize that the German SF-AMI is reliable and valid to quantify RA.

To measure retrograde amnesia of autobiographical memory after ECT, various tests were used so far. Currently, the short form of the Autobiographical Memory Interview (AMI-SF) was used most frequently internationally. In Germany there is no validated translation of the AMI-SF. However, in order to be able to systematically record the cognitive side effects of ECT in clinical practice as well as in research in the German-speaking area, it is important to have validated test procedures that can be successfully used in repeated measurements. In this study, the German version of the AMI (D-AMI), i.e. the specificity of the German short version of the autobiographical memory in patients with depression will be investigated. It is also known in healthy people that autobiographical memory contents can no longer be called up over time. Therefore, the aim of this study is to investigate whether a change in autobiographical memory over the course of time in depressed patients differs from healthy control subjects. It should also be shown whether this German short version for examining autobiographical memory (D-AMI) can be carried out.

Eligibility Criteria:
Inclusion Criteria:

* MDD
* HDRS \> 17
* Age 18-80
* Ability to give informed consent

Exclusion Criteria:

* Drugs or drug abuse or addictions
* Use of benzodiazepine equivalent to lorazepam\> 1.5 mg per day
* Cognitive impairments
* History of traumatic brain injury
* Relevant organic disease, e.g. Multiple sclerosis, Parkinson's disease
* Bipolar illness, dementia or schizophrenic disorder
* German is not the mother tongue
* Inability to give informed consent
A Study to Assess the Analgesic Properties of a Sublingual Wafer Formulation of Ketamine Following Third Molar Extraction

This is a Phase 2, randomized, multicenter, parallel group, double-blind, dose-ranging, placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post operative pain after undergoing third molar extraction.


Eligibility Criteria:
18- 38 years of age Scheduled to undergo two ipsilateral third molar extractions
Paclitaxel Plus Pembrolizumab vs. Paclitaxel Weekly in ER+ Luminal B Metastatic Breast Cancer

PELICAN is a randomised phase II trial that aims to evaluate the efficacy and safety of paclitaxel plus pembrolizumab relative to paclitaxel alone, in patients with locally advanced or metastatic ER-positive, HER2-negative, Luminal B breast cancer who have received no prior chemotherapy for advanced or metastatic disease.

Patients will be randomised (2:1) to one of the two treatment arms:

* Pembrolizumab plus Paclitaxel
* Paclitaxel


Eligibility Criteria:
Inclusion Criteria:

1. Willing and able to provide written informed consent
2. Ability to comply with the protocol
3. Female ≥ 18 years of age
4. Histologically confirmed metastatic or locally advanced breast cancer that is Luminal B, ER+ve, HER2-ve.
5. Patients must have measurable disease.
6. Representative formalin-fixed paraffin embedded breast tumour samples from the primary or recurrent cancer.
7. ECOG performance status 0-1
8. Adequate haematologic and end-organ function within 28 days prior to the first study treatment
9. Patients of childbearing potential are eligible provided they have a negative serum or urine pregnancy test on Day 1 Cycle 1 (within 72 hours) of study treatment, preferably as close to the first dose as possible.

Exclusion Criteria:

1. Luminal A breast cancer
2. Prior chemotherapy for advanced or metastatic disease
3. Prior treatment with paclitaxel in the (neo)adjuvant setting within 12 months from the end of paclitaxel treatment and randomisation into this study
4. Patients with neuropathy ≥ Grade 2
5. Previous systemic treatment for other neoplasms within 5 years prior to randomisation.
6. Patients with prior allogeneic stem cell or solid organ transplantation.
7. Prior treatment with CD137 agonists, AKT inhibitors, anti-CTLA-4, anti-OX-40, anti-programmed death-1 (PD-1), or anti-PD-L1 therapeutic antibody or pathway-targeting agents.
8. Patients must not have a diagnosis of immunodeficiency or receiving chronic systemic steroid therapy.
9. Received therapeutic oral or intravenous antibiotics within 14 days prior to randomisation.
10. Administration of a live vaccine within 30 days prior to the first dose of study drug.
11. Treatment with systemic immunostimulatory agents (including but not limited to interferons or interleukin \[IL\] -2) within 28days or five half-lives of the drug, whichever is shorter, prior to randomisation.
12. History of autoimmune disease.
13. History of idiopathic pulmonary fibrosis, drug-induced pneumonitis, organizing pneumonia requiring steroids, or evidence of active pneumonitis on screening chest CT scan.
14. Active infection requiring systemic therapy.
15. History of HIV infection
16. Known active hepatitis infection.
17. Known history of active tuberculosis