cyrilzakka/clinical-trials huggingface dataset:
Management of Pain Respiratory Distress at the End of Life in Newborn Palliative Care in the Delivery Room

The newborn feels pain and the newborn at the end of life, in the delivery room, is potentially exposed to pain and respiratory distress.

Protocols for the management of end-of-life symptoms in the delivery room are used in current practice with very few validation studies. The protocol used in delivery rooms in Alsace uses fentanyl and midazolam intranasally. It has been used for 3 years and seems to provide satisfactory relief to newborn babies. In doing so, it seems to reassure parents about the quality of support and it seems to meet the expectations of professionals in these anxiety-provoking contexts. Scientific validation of these practices would allow wider dissemination to other maternity teams.


Eligibility Criteria:
Inclusion Criteria:

* Premature or term newborn
* In the delivery room
* In palliative care
* No parental opposition to data collection

Exclusion Criteria:

* Parental refusal or inability to express their consent
* Minor parents
* Very probable survival beyond the delivery room
* Impossibility of giving informed information to the subject (subject in an emergency situation, difficulties in understanding the subject, etc.)
* Subject under safeguard of justice
* Subject under guardianship or curatorship
Human Breastmilk in Young Children With Norovirus Infection of the Gut

Human Breast milk in young children with Norovirus Infection

The investigators hypothesize that children with clinically significant norovirus infection of the gut who receive enteral human milk will more successfully clear the virus or experience improved symptoms compared to children not receiving human milk.

Eligibility Criteria:
Inclusion Criteria:

* Children with at least two stool samples taken at least 7 days apart that are positive for norovirus
* Child has an underlying disease or has received immunosuppressive medication or chemotherapy such that clearance of norovirus is expected to be impaired.

Exclusion Criteria:

* The presence of other pathogens causing diarrhea that have specific treatments does not preclude enrollment. However, specific treatment should be offered in addition to human milk.
Dexmedetomidine vs. Propofol for Cataract Surgery

The use of dexmedetomidine in cataract surgery is still limited and to date only one study has examined anesthetic technique in this patient population. This pilot study will therefore compare the use of dexmedetomidine and propofol in subjects undergoing cataract surgery. The primary endpoint will be based on simple cardiorespiratory measures often associated with complications from sedation as well as assessment of the achieved sedation by the attending anesthesiologist and surgeon.


Eligibility Criteria:
Inclusion Criteria:

1. Normal renal function
2. No chronic use of narcotics
3. ASA PS1-3
4. Males or females age 18 or older

Exclusion Criteria:

1. Liver disease (Child Pugh classification 1-3)
2. History of chronic use of sedatives, narcotics, alcohol or illicit drugs or allergy to any the study medications
3. History of 1st and 2nd degree heart block (not paced)
4. Any patient with EF \< 30%
5. Patients with active seizure history
6. Pregnant patients (women of child bearing potential will have a preoperative pregnancy test as is standard of practice)
A Study Of Intravenous Sulopenem And Oral PF-03709270 In Community Acquired Pneumonia That Requires Hospitalization

The purpose of this study is to test if intravenous sulopenem and an oral drug, PF-03709270 are safe and effective in patients that are hospitalized with community acquired pneumonia.


Eligibility Criteria:
Inclusion Criteria:

* Hospitalized male or female patients 18 years of age or older.
* Female patients of childbearing potential must not be pregnant.
* Must exhibit at least two pre-specified clinical symptoms/signs of pneumonia.
* Must require hospitalization for the pneumonia.
* Chest Xray must be suggestive of a pneumonia.

Exclusion Criteria:

* Hospital or ventilator associated pneumonia.
* Patients with cystic fibrosis, pneumocystis carinii pneumonia or active tuberculosis.
* Previous treatment for the current pneumonia episode received for more than 24 hours.
* Allergies to penems or beta lactams.
The Accuracy of CHOLINE PET CT in the Diagnosis of Urological Malignancies

PET CT is one of the imaging tools that are used for staging of urological malignancies.

C11 Choline is a novel isotope with the advantage of its minimal secretion in the urine. This advantage makes it a potentially better metabolic marker then others such as FDG. Preliminary studies showed \~95% sensitivity in the diagnosis of TCC. Our Goal is to continue the evaluation of this method as a diagnostic and follow up tool in different urological malignancies.


Eligibility Criteria:
Inclusion Criteria:

* Patients older then 18 years of age
* Full consciousness and awareness
* suspected to suffer from urological malignancy and a candidate for a surgical procedur

Exclusion Criteria:

* known secondary malignancy
OLGA and OLGIM Stage System for Gastric Cancer

To validate OLGA and OLGIM staging system with serum pepsinogen for estimating GC risk according to Lauren's histologic classification in South Korea. Also attempted to estimate synergistic interaction among the several risk factors to help establish surveillance strategy.

To validated the OLGA and OLGIM staging system with serum pepsinogen to estimate gastric cancer risk according to Lauren's histologic classification in South Korea, where the incidence rate of GC is high. In addition, the investigators attempted to investigate the interaction among the several risk factors including OLGA or OLGIM staging system for the risk of GC to help establish surveillance strategy.

Eligibility Criteria:
Inclusion Criteria:

* Control group

  * those who were between 25 and 80 years old and did not have any evidence of gastric cancer and gastric dysplasia, esophageal tumor and MALToma in upper gastrointestinal endoscopy
* Gastric cancer group

  * Patients diagnosed as gastric cancer in the upper gastrointestinal endoscopy at the time of participating in the study between 25 and 80 years old.

Exclusion Criteria:

* history of previous gastrointestinal surgery,
* any other malignancy
* cardia cancer
* who do not perform endoscopic biopsy
* pathologically proven gastric dysplasia
Study of BH4, a New and Simple Treatment of Mild PKU

The main purpose is to test whether treatment with BH4-tablets can replace the protein restrictive diet in patients with mild PKU caused by a certain frequent mutation.

PKU, phenylketonuria, is a rare, inherited metabolic disorder that results in mental retardation if not a very strict low-protein diet is started within the first weeks of life.

The conversion of phenylalanine, phe, to tyrosine is defect, phe accumulates, leading to brain damage. There are different degrees of severity, reflecting the spectrum of mutant genes. BH4, tetrahydrobiopterin, is a co-enzym for the conversion of phe to tyrosine. It is known that BH4 can lower phe in some patients with milder forms of PKU.

The main purpose is to test whether treatment with oral BH4 can replace the protein restrictive diet in patients with mild PKU caused by the frequent mutation Y414C in the phenylalanine hydroxylase gene.

Eligibility Criteria:
Inclusion Criteria:

Diagnosed mild PKU with 2 known mutations in the PAH gene, hereof at least one Y414C From the age of eight Informed consent -

Exclusion Criteria:

Less than 8 years of age Pregnancy or treated with the intensive diet of pregnancy

-
A Study Evaluating the Efficacy and Safety of CKD-506 in Adult Subjects With Moderate-to-Severe Rheumatoid Arthritis and Inadequate Response to Methotrexate

The primary objective of this study is to evaluate the effects of CKD-506 on signs and symptoms of RA in subjects with moderate-to-severe RA who are inadequate responders to methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of RA for at least 6 months prior to Screening, currently meet the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) criteria for RA, and are ACR functional class I-III.
* Have active RA
* Ongoing treatment with a stable dose of MTX as described below:

  1. Use of oral or injectable MTX on a continuous basis for at least 12 weeks prior to Baseline and on a stable dose and route of administration between 15 mg and 25 mg/weekly for at least 8 weeks prior to Baseline and planned during the study.
  2. Subjects should be on an adequate and stable dose of folic acid for at least 4 weeks prior to first administration of study treatment and planned during the study.
* Women of childbearing potential must use a medically acceptable means of birth control and agree to continue its use during the study and for at least 12 weeks after the last dose of study treatment.
* Women of childbearing potential must have a negative serum pregnancy test at Screening and urine pregnancy test at Baseline
* Sexually active men, if not surgically sterile, must agree to use a medically acceptable form of contraception during the study and continue its use for at least 12 weeks after the last dose of study treatment.

Exclusion Criteria:

* Treatments for RA as follows: JAK inhibitors at any time; use of any currently licensed biologics with DMARD properties at any time.
* Use of oral steroids at a dose \>10 mg/day of prednisone or prednisone equivalent or at a dose that has not been stable for at least 4 weeks prior to Screening.
* Use of nonsteroidal anti-inflammatory drugs (NSAIDs) which have not been at a stable dose or route of administration for at least 2 weeks prior to Baseline and planned during the study.
* History of tuberculosis (TB) infection.
* Positive serology for human immunodeficiency virus 1 or 2, hepatitis B virus or hepatitis C virus.
* Currently active infection or history of infection within the last 2 weeks of Screening or Baseline
External Nasal Dilator and Oxygen Therapy in Respiratory Failure

Acute respiratory failure secondary to bronchiolitis and asthma is one of the most common diagnoses in children admitted to pediatric intensive care unit.

Objectives: The primary outcome of the study is to compare the respiratory parameters between patients on HFNC and HFNC with ENDs.

Methods: This is a prospective randomized controlled trial. All children admitted to Loma Linda University Children's Hospital due to acute respiratory failure secondary to bronchiolitis and asthma are eligible for inclusion in the study. Multiple respiratory parameters will be collected as part of the study. The investigators anticipate that use of END will have a positive impact on the respiratory status of children with acute respiratory failure. Appropriate statistical analysis of the data will occur after the data has been de-identified.

Acute respiratory failure secondary to bronchiolitis is one of the most common diagnoses in children admitted to pediatric intensive care unit.

Objectives: The primary outcome of the study is to compare the respiratory parameters between patients on high flow nasal cannula (HFNC) and HFNC with an external nasal dilator (END).

Methods: This is a prospective randomized controlled trial. All children admitted to Loma Linda University Children's Hospital between July 2015 and May 2017 for approximately 22 months due to acute respiratory failure secondary to bronchiolitis are eligible for inclusion in the study. Two arms will be studied, one with HFNC and the other with HFNC and ENDS. Modified Bronchiolitis Severity Score will be used to assess respiratory parameters as part of the study. The investigators anticipate that use of END will have a positive impact on the respiratory status of children with acute respiratory failure. Appropriate statistical analysis of the data will occur after the data has been de-identified.

Eligibility Criteria:
Inclusion Criteria:

* children less than 18years
* acute respiratory failure

Exclusion Criteria:

* immediate intubation
* \>18years
Effect of Probiotics on Sputum Inflammation and Pulmonary Infections in Patients With Cystic Fibrosis

Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients.

Patients with Cystic Fibrosis have multiple pulmonary infections and repeated antibiotic treatment. These factors taken together with high sputum viscosity and slow motility of the gastrointestinal tract-may change the pathogenicity and consistency of the intestinal pathogens. Part of the pulmonary infections in CF patients are due to intestinal pathogens. A pilot study performed by the researchers using probiotics in CF patients showed a decrease in the rate of pulmonary infections. Therefore,we planned a double-blind placebo-controlled trial to examine the effect of probiotics on pulmonary infections, sputum bacteria and sputum inflammatory markers in CF patients. The study will be a cross-over study of probiotic and placebo arms.

Eligibility Criteria:
Inclusion Criteria:

* cystic fibrosis mild to moderate
* at least 3 pulmonary exacerbations requiring antibiotics per year
* Pseudomonas aeruginosa in the sputum
* able to produce sputum

Exclusion Criteria:

* severe pulmonary disease
* less than 3 pulmonary exacerbations per year
* unable to produce sputum
Tau Pet Imaging in the Aging Brain Cohort Dedicated to Diversity Study

We will conduct a Tau PET scan in cognitively normal older adults, enrolled in the Aging Brain Cohort Dedicated to Diversity Study (ABCD2-Tau) study at the University of Pennsylvania's Penn Memory Center/Alzheimer's Disease Core Center (PMC/ADC).Study duration will generally be a one-day study visit for PET imaging, but all subjects will be followed annually as part of their participation in the ABCD2 study. Findings from this study will likely provide insight into the mechanisms and distinctions of age-related cognitive decline and that of preclinical Alzheimer's Disease.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females African Americans ≥ 65 years of age.
2. Part of the ABCD2 longitudinal cohort, protocol 844047, of the PMC/ADCC with consensus conference designation of normal cognition.
3. ABCD2 longitudinal visit must be completed or scheduled to be completed within 1 year prior to the \[18F\]AV-1451 TAU PET scan.
4. A brain MRI must be performed within 1 year prior to their study \[18F\]AV-1451 TAU PET scan date and be deemed of adequate quality that the scan may be used for study analysis, including 3T high-resolution imaging of medial temporal lobe structures.
5. An amyloid PET scan completed or scheduled within 1year of their study \[18F\]AV-1451
6. Women must be post-menopausal or surgically sterile.

Exclusion Criteria:

1. Have any medical or psychiatric conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study, including major depression and prior head trauma.
2. Have evidence of structural abnormalities such as major stroke or mass on MRI that is likely to interfere with analysis of the PET scan.
3. Inability to tolerate or contraindication to imaging procedures in the opinion of an investigator or treating physician.
4. Have a history of significant ongoing alcohol or substance abuse or dependence based on self-report.
5. Women of child bearing potential

   * The inclusion / exclusion criteria will be ascertained through self-report in conjunction with any medical history available through the participant's medical or research records (EPIC or the ADC database)\*
Dynamic Cardio-vascular, Cerebro-vascular and Cortical Interaction in Healthy Adult Subjects

IDEALE aims to assess the status of autonomic function, cerebral autoregulation (CA) and cortical activity in healthy subjects and correlate these functions with the psychological dimension of the subjects.

To this end, parameters of cardiac, cortical, vascular and cerebrovascular variability derived from electrocardiographic, electroencephalographic, respiratory movement, blood pressure, transcranial Doppler signals will be acquired and analysed for each healthy volunteer (TCD) and Laser-Doppler transcutaneous, during a phase of clinostatism (REST) and one of active orthostatism (STAND). In addition, volunteers will be submitted to psychometric tests (Chieti Affective Action Videos, CAAV) to assess the presence of depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

* age older than 18 years
* spontaneous sinus rhythm
* signed informed consent

Exclusion Criteria:

* Definite diseases of the Autonomic Nervous System (SNA) or the cardiovascular system
* Central nervous system disorders
* subjects under drug therapy that may affect the cardiovascular system
* pregnancy
* previous diagnosis of depression
Nitrous Oxide for Analgesia During Office Urethral Bulking

This study is designed to determine primarily if there is a difference in perceived pain in patients receiving urethral bulking with calcium hydroxylapatite using local lidocaine versus local lidocaine plus nitrous oxide gas. Patients will be randomized to a control group (local lidocaine plus room air) or a intervention group (local lidocaine plus 50% nitrous oxide/50% oxygen inhaled mixture). Their pain will be assessed immediately after the procedure, and their recollection of pain will also be assessed at their 2 week post-procedure visit. There are other secondary outcome measures as well; please see outcome measures section for full description.


Eligibility Criteria:
Inclusion Criteria:

* Female patients
* greater than or equal to 18 years old
* with demonstrable stress incontinence on supine stress test
* undergoing calcium hydroxylapatite injection for urethral bulking for the first time
* able to consent to the study and procedure

Exclusion Criteria:

* \< 18 years old
* prior urethral bulking therapy
* predominant urge incontinence symptoms
* contraindications to nitrous oxide
* pre-existing significant cardiopulmonary disease
* hypotension defined as systolic blood pressure (BP) \< 90 or diastolic BP \<50 on initial BP in the office
* chronic pain disorders (specifically fibromyalgia, chronic pelvic pain, sciatica or chronic low back pain, painful bladder syndrome)
* chronic narcotic use (defined as taking a narcotic medication \>3 days per week during the past two weeks)
* pregnancy
* conditions of air trapping (bullous emphysema, bowel obstruction, pneumothorax, intracranial air, middle ear conditions, status post recent diving, recent eye surgery)
* lidocaine allergy
* neurologic diseases impairing pain perception.
Comparison of IONM Between Remimazolam and Propofol

Inhalation anesthetics significantly can delay latency and reduce amplitude of cortical MEPs and SSEPs signals compared to intravenous anesthetics by acting on not only GABA (γ-aminobutyric acid) receptors but also NMDA (N-methyl-D-aspartate) receptors, so total intravenous anesthesia (TIVA) have been more preferred for neurophysiological monitoring follow-up during surgery. However, just less than inhalation anesthetics, the decrease of amplitude and the delay of latency also occur according to the dose dependant of propofol. Moreover, it can cause various adverse effects such as delayed recovery after anesthesia or propofol infusion syndrome, consequently, combined methods with other agents or conversion to other relative anesthetics are being made. Remimazolam is a ultra-short-acting benzodiazepine, and unlike conventional benzodiazepine drugs, it is rapidly metabolized in plasma and not accumulates in the body for long periods of infusion or even with high dose administration. Recently, there have been repored that continuous infusion of 0.5-1.5 mg/kg of remimazolam has little effect on the motor evoked potential (MEPs) of cervical spine surgery patients, but this is a case report without the control group; further prospective studies are definitely needed. Therefore, in the case of using propofol or remimazolam for total intravenous anesthesia, we aim to investigate which intravenous anesthetic is more appropriate for intraoperative neurophysiological monitoring by comparing the results of the somatosensory evoked potential (SSEPs) and MEPs according to these anesthetics.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients who aged 20-70 years with ASA-PS 1-3, diagnosed of ossification of the posterior longitudinal ligament or cervical spondylotic myelopathy, in need of intraoperative neurophysiological monitoring

Exclusion Criteria:

* Tolerance or hypersensitivity to benzodiazepine or propofol
* Dependence or addiction to psychotropic drugs or alcohol
* Previous brain-related neurosurgery
* Inserted status of pacemaker
* Inserted status of intracranial device
* Steroids use during surgery
* Pregnant women, subjects who lack the ability to make decisions and susceptible to voluntary participation decisions
Surgical Treatment of Obstructed Defecation Syndrome

Obstructed Defecation is a profoundly disabling condition. Many different surgical procedures has been introduced to treat patients affected by this disease. The most used are STARR and ventral rectopexy. Because of the heterogenity of studies and overall the lack of comparison trials, there is no accepted standard surgical treatment.PRO-REST aimed to compare these two procedures (STARR and Ventral Rectopexy) evaluating functional and anatomical results.


Eligibility Criteria:
Inclusion Criteria:

* Patients affected by Obstructed Defecation with ODS score \>11
* Symptomatic rectal Intussusception and/or defecographic finding of rectocele\>2 cm
* Failure of at least 6 months of medical therapy
* Exclusion of neoplasm by rectosigmoidoscopy/colonoscopy

Exclusion Criteria:

* Patients affected by complete rectal prolapse
* Patients affected by slow transit constipation
* Patients affected by anismus
* Patients affected by pelvic organ prolapse
* Patients with previous rectal or anal surgery