cyrilzakka/clinical-trials huggingface dataset:
Volumes of Administration for Intranasal Midazolam

The purpose of this study is to determine exactly how much drug volume should be administered into each nare, so that the drug absorption can be maximized and the amount that runs out of the nose, or is swallowed, is minimized, thereby optimizing the effectiveness of any drug given intranasally. The investigators will determine this ideal "volume of administration" by studying intranasal midazolam in children who require sedation to facilitate laceration repairs. The investigators will evaluate both clinical outcomes as well as pharmacokinetic outcomes associated with each volume of administration. We will block randomize children to receive intranasal midazolam in maximum aliquots of one of the three following VOA: 200 microliters (mcL), 500 mcL, or 1000 mcL.

The intranasal route is an effective means of administering sedative medications for children. However, sometimes the child has to receive a certain dose that requires a very large volume to be administered into the nose, because of the types of concentrations of drugs that are available. Most drugs are not concentrated enough so that small volumes can be consistently given, so as a result, sometimes a very large amount of medication is administered intranasally. When the amount is too large, most of the medication either runs back out the nose, or down the back of the nose and throat and is swallowed, instead of being absorbed in the nasal cavity, where it can be quickly absorbed and produce optimal effectiveness.

Eligibility Criteria:
Inclusion Criteria:

* 1 to 7 years of age, inclusive.
* Require intranasal midazolam for minimal sedation to facilitate laceration repair.

Exclusion Criteria:

* Weight less than 10 kg.
* Known allergy to midazolam.
* Presence of intranasal obstruction (e.g. mucous or blood) that cannot be readily cleared
* Inability to speak English or Spanish
* Developmental delay, psychiatric illness, neurologic impairment, or altered mental status; or illnesses associated with chronic pain (e.g. sickle cell disease, inﬂammatory bowel disease).
* Foster children or wards.
Effect of Re-esterified Triglyceride (rTG) Form Omega-3 Supplements on Dry Eye Following Cataract Surgery

To evaluate the clinical outcomes of the systemic re-esterified triglyceride (rTG) form of omega-3 fatty acids in patients with dry eye symptoms after cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* Non complicated cataract surgery
* Patients with dry eye symptom

Exclusion Criteria:

* Using steroid eyedops,
* Using antibiotics eyedrops
* Surgery other than Cataract surgery
* Contact lens wearer
* Other systemic disease
Drug Eluting Balloon Angioplasty for Dialysis Access Treatment

The aim of the study is to compare the feasibility and the effectiveness, by means of immediate and long-term results, of drug eluting balloon (DEB) versus conventional balloon angioplasty for the treatment of failing dialysis access.

In total 40 patients already diagnosed with hemodynamically significant stenosis of the dialysis AVF or AVG (including venous outflow lesions), programmed to undergo percutaneous transluminal angioplasty by our department, will sign informed consent and will be randomized to either receive DEB (Paclitaxel eluting balloon), or conventional balloon therapy. The protocol includes the description of patient's demographics (age, gender,dialysis access details, risk factors) and procedural details, as well as immediate results and long-term follow up.

Eligibility Criteria:
Inclusion Criteria:

* Angiographic and clinical diagnosis of dysfunctional dialysis access due to one or more stenotic lesions.
* Patients with AVF or AVG
* Fistula or graft or vessel diameter ranging from 3 mm up to 12 mm

Exclusion Criteria:

* Fistula or graft or vessel diameter \< 3 mm and \> 12 mm
* History of severe allergic reaction to contrast media
* Intolerance to aspirin and/or clopidogrel
* Systemic coagulopathy or hypercoagulation disorders
Assess the Effect of Treating Periodontal Disease on Cardiovascular Function in Young Adults

We propose to examine a population of Native Americans who have had little or no dental care, and to determine if periodontal disease is associated with early signs of vascular dysfunction or systemic inflammation. We then propose to treat the periodontitis and re-evaluate vascular function. We will determine if gingivitis or mild/moderate periodontitis is associated with detectable vascular dysfunction. Microbial metagenomics will be correlated with vascular function.


Eligibility Criteria:
Inclusion Criteria:

* American Indian/Alaskan Natives seeking health care at the Indian Health Council, Inc.
* Males and females aged 21-40 years.

Exclusion criteria:

* Recent (within 6 months) periodontal treatment
* History of high blood pressure or existing heart disease
* Xerostomia
* Currently receiving treatment for cancer
* Currently taking anti-inflammatory medications (except H2 blockers, statins, or medications that can affect periodontal status
* Immunosuppressed due to medication or HIV infection, or presence of active infection such as hepatitis or tuberculosis
* Fewer than 20 teeth in functional dentition, excluding third molars, or other gross oral pathology
EVALUATION OF BIOMARKERS OF TRAUMATIC BRAIN INJURY EXTENSION STUDY

The primary objective of this study is to evaluate Ubiquitin C-terminal Hydrolase-L1 (UCH-L1) and Glial Fibrillary Acidic Protein (GFAP) biomarker levels in a population of CT-positive subjects (as determined by an independent Neuroimaging Review Committee) presenting acutely with traumatic brain injury (Glasgow Coma Scale score 9-15).


Eligibility Criteria:
Inclusion Criteria:

* The Subject is at least 18 years of age at screening.
* The Subject has presented to a Health Care Facility (HCF) or Emergency Department (ED) with a suspected traumatically induced head injury, as a result of insult to the head from an external force.
* A Glasgow Coma Scale score of 9-15 at the time of Informed Consent.
* The subject is CT-positive for acute intracranial lesion(s) based on the local neuroradiologist's review of the subject's head CT scan.
* The CT scan and CT report used to determine eligibility must be available.
* The blood sample is collected as close to the time of head injury as possible, but no later than 12 hours.
* The Subject or their legal representative is willing to undergo the Informed Consent process prior to enrollment into this study

Exclusion Criteria:

* Participating in an interventional, therapeutic clinical study that may affect the results of this study (an observational study would be acceptable).
* Time of injury cannot be determined.
* Primary diagnosis of ischemic or hemorrhagic stroke.
* Venipuncture not feasible (i.e., skin integrity compromised at the venipuncture sites, blood vessel calcification (i.e., IV drug users, advanced atherosclerosis) both upper limbs missing (congenital or amputee)).
* The subject has a neurodegenerative disease or other neurological disorder including dementia, Parkinson's disease, multiple sclerosis, seizure disorder, or brain tumors.
* The subject has a history of neurosurgery within the last 30 days.
* Administration of blood transfusion after head injury and prior to the study blood draw.
* The subject is a female who is pregnant or lactating.
* The Subject is otherwise determined by the Investigator to be an unsuitable candidate for participation. If this criterion applies, a reason must be provided
Impact of Lucentis on Psychological Morbidity in Patients With Retinal Vein Occlusion

This is a prospective, single-center, non-randomized clinical study on the impact of intravitreally administered ranibizumab (Lucentis) treatment on vision-related functioning and emotional well-being in subjects with central or branch retinal vein occlusion.


Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent and comply with study assessments for the full duration of the study
* Evidence of central retinal vein occlusion, defined as documented retinal hemorrhage into all four quadrants with dilated veins, or branch retinal vein occlusion, as documented on clinical exam
* Age 18 years or over
* Central macular edema on clinical exam as well as imaging with a central thickness of ≥ 250 microns
* Visual acuity ranging from 20/8000 to 20/40
* Media clarity and patient cooperation sufficient to allow adequate testing utilizing OCT and FA
* No previous treatment that might compromise or confound assessment of the study outcomes
* Ability to speak and read English

Exclusion Criteria:

* Acute illness or cognitive or other impairment that, in the opinion of the investigator, would interfere with study requirements
* Concurrent ocular conditions likely to significantly compromise vision and contribute the macular compromise
* History of grid/focal laser in the study eye
* History of vitreal surgery
* Previous treatment with triamcinolone acetonide in either eye
* Previous use of bevacizumab, pegaptanib, or ranibizumab in either eye
* Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, pulmonary, renal, hepatic, endocrine, or gastrointestinal disorders
* History of cerebrovascular accident within 1 year prior to Day 0
* Inability to comply with study or follow-up procedures
* Any cognitive defect as a result of mental disease, previous injury, or disease process that may interfere with interpretation of study results
* Visual acuity better than 20/40
* Pregnancy (positive pregnancy test) or lactation
* Inadequate contraception in premenopausal women
The Correlation of Reduction of Levodopa and Non-motor Symptoms of Parkinson's Disease After Deep Brain Stimulation

Patients with parkinson disease (PD) usually reduced the dose the levodopa after received deep brain stimulation (DBS). However, studies seldomly mentioned about the influences on non-motors systems after the reduction. Our study focused on the changes after DBS and attribute them to the levodopa variety.

We calculated that group sample sizes of 126 patients (63 in group 1; 63 in group 2) would provide 80% power to reject the null hypothesis of equal means when the mean difference is -5(10-15) with standard deviations of 10 for test group and 10 for control group at a two-sided alpha of 0.05. Given an anticipated dropout rate of 20%, total sample size required is 158 (79 in reduction; 79 in non-reduction group).

Written informed consent was obtained from all participants. After the baseline measurement, we informed the eligible patients the assigned randomization group with sealed opaque envelopes marked with the inpatient numbers .

Within 12 months after STN-DBS, the LEDD of the intervention group was consistent with that before operation, and gradually decreased under the guidance of physician according to the expert consensus of DBS after 12 months. The compliance problem was solved by determining the actual number of antiparkinsonian medications returned by participants.

Eligibility Criteria:
Inclusion Criteria:

* Participants underwent neuro-ophthalmologic examinations, including ocular fundus photography, automated perimetry, and OCT. Patients undergoing deep brain stimulation (DBS) took an extra VIPD-Q after the operation.

Exclusion Criteria:

* secondary causes of parkinsonism, prior brain surgery (except DBS), glaucoma, intraocular surgery, diabetes and other diseases affecting the visual field or neurologic systems, and the current use of medications affecting visual function.
A Phase 1 Single-Dose Escalation Study of PF-04308515 in Healthy Volunteers

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (understanding how a drug is absorbed and moves through the body) and pharmacodynamics (understanding the effects of a drug on certain target sites of activity in the body).


Eligibility Criteria:
Inclusion Criteria:

* Healthy males between 18 and 55 years, inclusive
* Healthy females between 18 and 44 years, inclusive.
* Women need to be surgically sterile

Exclusion Criteria:

* Evidence or history of clinically significant disease
* Post-menopausal women
* History of intolerance or significant adverse effects with glucocorticoids
Evident, Occult and no Demonstrated USI and UDS Findings in Women With ≥Stage II Cystocele

Prevalence rates of urodynamic urinary incontinence (USI) subtypes and their related clinical and urodynamic findings in women with ≥ pelvic organ prolapse quantification stage II cystocele are important for clinical consultation, especially for occult USI. Misdiagnosis of occult USI before cystocele repair might lead to occurrence of de novo stress urinary incontinence after cystocele repair. Thus, the aim of this study was to elucidate the above findings and between-group associations.

Between November 2011 and January 2017, medical records of all women with ≥stage II cystocele who underwent urodynamic studies in a medical center were reviewed. ANOVA test and post-hoc testing with bonferroni's correction were used for statistical analysis. USI is noted during filling cystometry and is defined as the involuntary leakage of urine during increased abdominal pressure, in the absence of a detrusor contraction. The recruited patients with cystocele were classified into three groups (i.e.,evident USI, occult USI and no demonstrated USI) according to pad weight results before and after prolapse reduction.

Eligibility Criteria:
Inclusion Criteria:

1. Age \>20y/o
2. Cystocele \> stage II
3. Complete urodynamic study

Exclusion Criteria:

1. Pregnancy
2. Urinary tract infection
3. Previous pelvic reconstruction surgery
Danish Multicenter Study of Adalimumab in Spondyloarthritis

Spondyloarthropathies (SpA) are often diagnosed with a considerable delay (often 8-10 years from symptom onset), because the available clinical, biochemical and radiological methods are not sufficiently sensitive. TNF-a antagonists have recently been introduced for treatment of SpA, and current data indicate a higher efficacy than previously available therapies. The improved treatment options have increased the need for improved methods for diagnosis, monitoring and prognostication of these diseases, so that the efficient therapies can be initiated at the optimal time point and monitored optimally. Magnetic resonance imaging (MRI) and a number of biomarkers are promising, but not yet sufficiently studied, methods for this.

See brief summary

Eligibility Criteria:
Inclusion Criteria:

1. Diagnosis of spondyloarthritis according to the European Spondyloarthritis Study Group (ESSG) criteria
2. Clinical active disease, defined as a BASDAI score \> 4 despite concurrent NSAID therapy
3. Presence of sacroiliitis on conventional radiography or MRI.
4. Among other issues: Age \>18 years; adequate birth control; no contraindications for anti-TNFa-therapy, no previous TNFa-antagonists

Exclusion Criteria:

1. Previous TNFα inhibitor therapy
2. Treatment with disease modifying anti-rheumatic drugs within 4 weeks before screening
3. Oral, intraarticular, intramuscular or intravenous glucocorticoid within 4 weeks before screening
4. Pregnancy or lactation
5. HIV, hepatitis B or C, tuberculosis, other infections
6. Malignancies
7. Other serious concomitant diseases (uncontrolled/severe kidney, liver, haematological, gastrointestinal, endocrine, cardiovascular, pulmonary, neurological ore cerebral disease (including demyelinating disease)
8. Contraindications to anti-TNFa-therapy
9. Contraindications to MRI
Computer Assisted Planing of Corrective Osteotomy for Distal Radius Malunion

This study is designed as a multi-center randomized controlled trial, comparing two groups of patients with symptomatic extra-articular malunited distal radius fractures. One group of patients will undergo corrective surgery of the distal radius, with preoperative computer-assisted planning and virtual osteotomy, and the other group will undergo corrective surgery, with conventional (non-computer-assisted) preoperative planning. The investigators hypothesize that computer-assisted surgical planning will result in a better functional outcome.


Eligibility Criteria:
Inclusion Criteria:

* Extraarticular distal radius malunion requiring surgery
* Adult patient (\> 18 yo)
* Fluent in English

Exclusion Criteria:

* Pregnant patient
* Prisoner
* Abnormal contralateral forearm
Nitric Oxide Administration for Acute Respiratory Distress Syndrome

This research project is an open-label, randomized study for the use of Nitric Oxide in pediatric patients with acute respiratory distress syndrome (ARDS). The study examines whether nitric oxide (NO) treatment impacts the the P:F ratio (arterial partial pressure of oxygen (PaO2) divided by fraction of inspired oxygen (FiO2) in patients with ARDS. The goal of the study is to evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.

At low concentrations, nitric oxide(NO) functions as a cellular messenger and regulator of microcirculation. NO may have an important role in the pathogenesis of ARDS as well as its treatment. NO may be primarily useful in improving matching of ventilation and perfusion in the lung. The aims of the study are to attempt to show that NO will improve oxygenation as evidenced by improvement in PaO2/FiO2. Secondary aims are to see if the improvement in oxygenation allows there to be decreased time on FiO2\>0.60, evaluate whether the order of NO therapy will have any effect on response, and evaluate the characteristics of patients who respond to NO compared to those who do not.

Subjects will be randomized to receive either nitric oxide first (nitric oxide for the first 4 hours, then no intervention/no nitric oxide for the next 4 hours) or delayed treatment with nitric oxide (no intervention/no nitric oxide for the first 4 hours, then nitric oxide for the next 4 hours)..

Blood gases were monitored once an hour during study participation (total of 8 hours). Final PaO2/FiO2 levels will be compared after 8 hours of study treatment in each group.

Eligibility Criteria:
Inclusion Criteria:

* Patient is intubated and mechanically ventilated in the Pediatric Intensive Care Unit with a PaO2/FiO2 ratio less than or equal to 100, FiO2 greater than or equal to 0.60, PEEP greater than or equal to 10, and a Murray score greater than or equal to 2.5.

Exclusion Criteria:

* Neonates (1 week to 28 days) and/or patients on extracorporeal membrane oxygenation
Adjuvant Adenoidectomy for the Treatment of Chronic OME in Children

This study aims to verify the efficacy of adjuvant adenoidectomy for children with chronic OME who become candidates for tympanostomy tube placement, and explore potential factors associated with the efficacy of adjuvant adenoidectomy.

Otitis media with effusion is a common condition in children, and tympanostomy tube placement is the first-line treatment for those who requires surgical interventions. Adenoidectomy proves to be helpful to children over 4 years old, but the risks of adjuvant surgery is believed to somehow offset its benefits. This study is meant to verify if concurrent adenoidectomy provides extra benefits in resolving MEE, reducing AOM, and improving hearing and patients' quality of life to children who become candidates for TT.

Eligibility Criteria:
Inclusion Criteria:

* 1. Children 4-12 years of age.
* 2. Diagnosed with chronic OME. Diagnostic criteria: I. Middle ear effusion detected by otoscopy; II. Type B or C tympanograms; III. Symptoms/signs of OME persisted for \>3 months;
* 3. Documented hearing loss ≥20dB (average threshold of 500Hz, 1000Hz and 2kHz in pure tone audiometry).
* 4. Adenoid hypertrophy (A/N ratio\> 0.5 in lateral radiography of the nasopharynx).
* 5. Informed consent given by the patients and their guardians.

Exclusion Criteria:

1. Cleft palate or other systemic disorders.
2. Patients are diagnosed with other nose, sinuses or ear diseases that are eligible for surgical treatment.
3. Patients are diagnosed with OSAHS, tonsil hypertrophy ≥II° or scheduled for tonsillectomy.
4. History of tympanostomy tube placement.
5. Infection of the upper respiratory tract or acute rhinosinusitis over the past 7 days.
6. Sensorineural hearing loss.
7. Other situations that the investigators find unsuitable for the trial.
Parenteral Ascorbic Acid Repletion in TransplantatIon

A single-center, randomized, double-blinded placebo-controlled trial is proposed to investigate administration of supraphysiologic doses of ascorbic acid (vitamin C, AA) to patients undergoing liver transplantation. Participants randomized to the intervention group will receive intravenous (IV) AA 1500 mg every 6 hours for 48 hours. Participants randomized to the control group will receive a saline placebo. The primary study outcome will be a change in the Sequential Organ Failure Assessment (SOFA) score from baseline to three days after the first dose of drug (dSOFA3). Secondary outcomes will include total vasopressor dose in norepinephrine equivalents, 30-day and 1-year mortality, and serum AA levels.

HYPOTHESIS: Administration of supraphysiologic doses of parenteral AA in the perioperative period for patients undergoing liver transplantation will improve Sequential Organ Failure Assessment (SOFA) scores, vasopressor usage and biochemical, cellular and clinical end-organ damage.

Specific Aim: Determine the clinical response to parenteral AA supplementation in patients undergoing liver transplantation by a randomized, double-blinded, placebo-controlled clinical trial.

Study Design: This study is a prospective, single-center, randomized trial in which 90 participants will be enrolled at the University of Wisconsin Hospitals and Clinics (UWHC). Participants must meet study eligibility criteria and be scheduled to undergo primary deceased donor solitary liver transplantation. Participants will be randomized to receive 8 doses of 1500 mg AA IV or volume-equivalent placebo every 6 hours for 48 hours, in addition to standard medical management.

Eligibility Criteria:
Inclusion Criteria:

* The subject is scheduled to undergo primary deceased donor solidary liver transplantation

Exclusion Criteria:

* Non-English speaking
* Known or believed to be pregnant
* Subject is a prisoner
* Impaired decision-making capacity (i.e., current encephalopathy)
* Known allergy to AA
* Concurrent organ transplantation (i.e., simultaneous liver-kidney transplantation)
* Planned veno-venous bypass use in the operating room
* Prior parenteral or oral AA repletion
* History of nephrolithiasis or oxaluria
* Vitamin C supplement use or administration (including HAT therapy) within the last month prior to transplantation
* Glucose-6-phosphate dehydrogenase (G6PD) deficiency
* Sickle cell anemia
* Hereditary hemochromatosis
* Preoperative anuria or creatinine \>2.5mg/dL in patient not on renal replacement therapy
* Current enrollment in another research study