Kornimate/medical-research-clean huggingface dataset:
randomized study to investigate the safety and performance of diaphragm stimulation coupled with mechanical ventilation

Conditions: Diaphragm Issues; Ventilator-Induced Lung Injury; Tracheostomy

Summary: this study is a randomized prospective, single-center feasibility study of the use and benefits of neurx dps in patients undergoing tracheostomy for failure to wean.

15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): cohort a: tracheostomy with no intervention; cohort b: tracheostomy with dps implantation and immediate stimulation and monitoring and cohort c: tracheostomy with dps implantation with monitoring followed with stimulation on day 5.

Eligibility criteria:
inclusion criteria: * patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days * signed written informed consent has been obtained prior to performing any study related procedure(s) * subject is at least 18 years of age * negative pregnancy test if the patient is a female of child-bearing potential. (females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.) exclusion criteria: * diaphragm malformation which makes electrode insertion impossible * presence of an implantable cardioverter-defibrillator * severe chronic obstructive pulmonary disease (copd) * subject is pregnant or breastfeeding * diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy * terminal patients expected to die during their stay in the hospital * participation in other clinical studies that could interfere with the results in the ongoing study

Keywords: mechanical ventilators ventilators, pulmonary failure to wean lung injury, ventilator-induced tracheostomy diaphragm pacing
predictive factors for tolerance to taxane based chemotherapy in older adults affected by metastatic prostate cancer

Conditions: Elderly Patients; Metastatic Prostate Cancer

Summary: aiming to explore predictive factors of fitness to taxane chemotherapy in elderly patients, the investigators collected data from a prospective mono-centric database of patients aged \>/= 70 years old treated in our department, and explored association between baseline age, g8 score and charlson comorbidity index with taxane dose reduction, treatment temporary suspension or definitive interruption.

patients included in the analysis were affected by metastatic prostate cancer with \>/=70 years old. all patients underwent taxane treatment starting with standard treatment schedules (75 mg/m2 or 25 mg/m2 every 3 weeks, respectively). chemotherapy with docetaxel was scheduled for a total of 6-8 cicles in the mhspc-mcrpc setting, respectively, and up to 9 cycles for cabazitaxel treatment. indication to taxane chemotherapy was based on treating physician choice. g8 questionnaires were collected before start and at the end of chemotherapy. charlson comorbidity index was recorded for all patients before chemotherapy start. data comprehensive of age, castrate resistant status , type of taxane used , growth factors use during treatment, previous and following treatment with artas or other taxanes, number of cycles administered, dose reductions , treatment suspension and treatment definitive interruptions unrelated to progressive disease, were collected and reported. logistic regression was performed to explore the association between outcomes and baseline age, cci and g8 score. receiver operating characteristic curves analysis was performed to look for the optimal cut-off value for features significantly associated with treatment outcomes.

Eligibility criteria:
inclusion criteria: * patients affected by metastatic prostate cancer -\>/=70 years old. * patients undergoing taxane treatment with docetaxel or cabazitaxel exclusion criteria: * patients younger than 70 years old. * patients unsuitable for taxane chemotherapy
effect of ketamine/midazolam premedication versus pre-extubation ketofol on recovery profile in pediatrics undergoing adenotonsillectomy.

Conditions: Emergence Delirium

Summary: an optimum recovery profile after at includes a rapid, smooth awakening without emergence agitation (ea), stable vital signs and oxygenation, reduced postoperative nausea and vomiting (ponv), controlled postoperative pain, and patient or parents' satisfaction. ketamine is a low-cost drug with a wide therapeutic window. ketamine is a competitive n-methyl-d-aspartate receptor antagonist with good analgesic properties and periprocedural amnesia. the ketamine/midazolam combination was administered in different ways with controversial results about their effect on the ea and recovery profile. ketofol, a mixture of ketamine and propofol, has been used in different favorable recovery profiles regarding postoperative ea and ponv. this study aims to evaluate the effect of premedication with an intramuscular ketamine/ midazolam combination versus pre-extubation ketofol on the ea and the recovery profile.


Eligibility criteria:
inclusion criteria: * asa physical status i or ii * children scheduled for at under general anesthesia (ga). exclusion criteria: * congenital cardiovascular anomalies * behavioral changes * delayed physical development * children receiving sedatives or anticonvulsants therapy
steady-state pharmacokinetics of ceftazidime/avibactam in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: the purpose of this research study is to characterize the pharmacokinetics of intravenous ceftazidime/avibactam in patients with cystic fibrosis.

cystic fibrosis is a genetic disorder characterized by a chronic cycle of airway infection, obstruction, and inflammation leading to progressive loss of lung function and eventual respiratory failure. the principal pathogen is pseudomonas aeruginosa which is present in the airways of 70% of adult patients with cf. of particular concern is the increasing resistance observed to existing agents. while ceftazidime has been the mainstay of treatment for many years, its efficacy is limited by reduced susceptibility. ceftazidime/avibactam offers a potential advancement in the management of infections involving p. aeruginosa in cf due to its excellent activity, penetration into pulmonary secretions, and reduced potential for development of resistance.

Eligibility criteria:
inclusion criteria: * diagnosis of cf based on positive sweat chloride or know cf mutation * age \> 17 years * able to spontaneously expectorate sputum exclusion criteria: * any clinically significant laboratory abnormality * presence of an ongoing acute pulmonary exacerbation * pregnancy * serious past allergy to a beta-lactam antibiotic

Keywords: pharmacokinetics ceftazidime/avibactam
treatment prior to injection and biopsy of the vulva

Conditions: Vulvar Diseases; Anesthesia; Anesthesia, Local

Summary: this study will compare pre-treatment with ice prior to injection of local anesthetic for vulvar biopsy to no pre-treatment and evaluate pain levels and patient satisfaction with the procedure.

to diagnose skin conditions of the vulva and determine appropriate treatment, a biopsy is often taken as an outpatient procedure. prior to biopsy, the skin is cleansed and injected with a numbing solution. these injections can be quite painful in this sensitive area. ice has been used as topical anesthesia in a number of sites, including the cornea, the skin, and particularly in the mouth prior to anesthetic injections. however, there is no evidence for using ice anesthesia prior to injections of the vulvar tissues. the purpose of this study is to evaluate the efficacy of using ice as pre-treatment prior to the injection of local anesthetic for vulvar biopsy.

Eligibility criteria:
inclusion criteria: * female * 18 years of age or older * undergoing vulva biopsy during clinic visit * willing and able to comply with study protocol * able to understand and provide informed consent exclusion criteria: * inability to provide informed consent

Keywords: vulvar biopsy ice anesthesia pain vulva
a study to evaluate the safety, tolerability, and pharmacokinetics of op-101 after intravenous administration in healthy volunteers

Conditions: Healthy

Summary: a clinical study to measure the effect of op-101 after being administered intravenously in healthy volunteers.


Eligibility criteria:
key inclusion criteria: * body mass index (bmi) between 18 and 32 kg/m\^2. * is in general good health, based upon the results of a medical history assessment, physical examination, vital signs, laboratory profile, and 12-lead electrocardiogram (ecg), as judged by the investigator. * female subjects may not be pregnant, lactating, or breastfeeding. * subjects must have a negative urine test for drugs of abuse, cotinine, and breath alcohol test at screening and check-in. key exclusion criteria: * evidence of clinically significant hematologic, renal, endocrine, pulmonary, cardiac, gastrointestinal, hepatic, psychiatric, neurologic, immunologic, allergic disease, or any other condition that, in the opinion of the investigator, might significantly interfere with the absorption, distribution, metabolism, or excretion of study drug, or place the subject at an unacceptable risk as a participant in this study. * history of malignancy (other than successfully treated basal cell or squamous cell skin cancer). * history or presence of an abnormal ecg that, in the opinion of the investigator, is clinically significant. * has used any product containing nicotine within 90 days prior to screening or intends to use any product containing nicotine during the course of the study. * has used medications that affect gastrointestinal motility or gastric emptying; such as metoclopramide, proton pump inhibitors, and h2 blockers; within 30 days prior to day 1. * has used prescription or over-the-counter medication, vitamins/herbal supplements (with the exception of hormonal contraceptives) within 14 days prior to day 1.

Keywords: adrenoleukodystrophy (ald) childhood cerebral adrenoleukodystrophy (ccald) op-101 dendrimer n-acetyl-cysteine (nac)
efficacy and safety of spn-812 (viloxazine extended-release capsule) in children with adhd

Conditions: Attention-Deficit/Hyperactivity Disorder (ADHD)

Summary: this was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of spn-812 (viloxazine extended-release capsule) in children 6-12 years of age with adhd.

this study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of spn-812 (viloxazine extended-release capsule) as monotherapy in the treatment of attention-deficit/hyperactivity disorder (adhd) in children (6-12 years of age). subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg spn-812). the primary objective is to assess the efficacy of spn-812 in reducing adhd symptoms as measured by the attention-deficit/hyperactivity disorder rating scale, 4th edition (adhd-rs-iv).

Eligibility criteria:
inclusion criteria: 1. healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of adhd according to the diagnostic and statistical manual of mental disorders-iv (dsm iv), confirmed with the mini international neuropsychiatric interview for children and adolescents (mini-kid). 2. adhd-rs-iv-parent version: investigator administered and scored score of at least 26. 3. cgi-s score of at least 4 4. weight of at least 20 kg. 5. free of medication for the treatment of adhd or any psychosis for at least one week prior to enrollment. exclusion criteria: 1. current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, tourette's disorder, or psychosis not otherwise specified. 2. currently meeting dsm-iv criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis. 3. significant systemic disease. 4. evidence of suicidality within the six months before screening or at screening. 5. bmi greater than 95th percentile for the appropriate age and gender. 6. pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (focp). 7. substance or alcohol use during the last three months. 8. positive urine screen for cotinine, alcohol, or drugs of abuse at screening.
safety and efficacy of high flow nasal canula in patients with mild hypercapnia

Conditions: Hypercapnia

Summary: evaluate safety and efficacy of application ( high flow nasal canula) in cases with mild hypercapnia, included 30 patients who were hospitalized in mansoura university chest department with mild hypercapnia (pco2 range 45-60 mmhg and power of hydrogen not less 7.30) of different pulmonary disease categories (chronic obstructive pulmonary disease acute exacerbation, pneumonia, interstitial lung diseases, etc).


Eligibility criteria:
inclusion criteria: * patients with mild hypercapnia exclusion criteria: * excluded cases had age less than 18 years or pediatric group . * patients with their mental state altered, confused, comatose, severe agitation or non cooperative * cases with moderate or severe hypercapnia * cases in need for immediate invasive mechanical ventilation * cases with respiratory rate more than 35 breath per minute. * cases with respiratory exhaustion , fatigue , excess use of respiratory accessory muscles * shock , hemodynamic instability, post arrest cases, * cases with facial trauma or severe nasal deformity, * patients with sleep breathing disorders or upper airway obstruction * patients with history of home ventilation prior admission

Keywords: hypercapnia high flow nasal canula
study of at-752 in healthy subjects

Conditions: Dengue

Summary: this study will assess the safety, tolerability and pharmacokinetics (pk) of at-752 in healthy subjects

a first-in human, randomized, double-blind, placebo controlled single and multiple ascending dose study to evaluate the safety, tolerability, and pharmacokinetics of at-752 in healthy subjects

Eligibility criteria:
inclusion criteria: 1. body mass index (bmi) of 18-29 kg/m2 2. must agree to use protocol-specified methods of contraception 3. negative pregnancy test 4. willing to comply with the study requirements and to provide written informed consent exclusion criteria: 1. pregnant or breastfeeding 2. abuse of alcohol or drugs 3. use of other investigational drugs within 30 days of dosing 4. other clinically significant medical conditions
alternate-day buprenorphine administration. phase viii - 9

Conditions: Opioid-Related Disorders

Summary: the purpose of this study is to evaluate open buprenorphine dosing with dose choice.


Eligibility criteria:
please contact site for information.
sodium nitrate for muscular dystrophy

Conditions: Becker Muscular Dystrophy

Summary: the investigators' previous work in males with becker muscular dystrophy shows that functional sympatholysis is restored by acute inorganic nitrate supplementation. this was translated from work using the mdx mouse model of dystrophinopathy. recent work has shown that there is a frank improvement in grip strength when mdx mice are treated with an inorganic nitric oxide (no) donor. the purpose of this study is to determine if chronic treatment with an inorganic no donor can benefit patients with muscular dystrophy beyond blood flow regulation.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of muscular dystrophy * age 15-45 years of age * ambulatory * no clinical evidence of heart failure * maximum voluntary contraction, measured by hand grip dynamometer, of 20-40 kg exclusion criteria: * hypertension, diabetes, or heart failure by standard clinical criteria * elevated b-type natruiretic peptide level (\>100 pg/ml) * left ventricular ejection fraction \< 50% * wheelchair bound * cardiac rhythm disorder, specifically: rhythm other than sinus, supraventricular tachycardia, atrial fibrillation, ventricular tachycardia * continuous ventilatory support * liver disease * renal impairment * contraindications to no donors (use of nitrates, alpha-blockers, cyp3a inhibitors, amlodipine, or phosphodiesterase type 5 (pde5) inhibitors) glucocorticoid therapy and prophylactic use of angiotensin converting enzyme (ace) inhibitors and beta-blockers for cardiac protection will not be exclusion criteria. * maximum voluntary contraction of less than 20 kg or greater than 40 kg * ventilation devices (continuous positive airway pressure (cpap), bilevel positive airway pressure (bipap))

Keywords: becker dystrophy
a wearable with photoplethysmography and 6-lead electrocardiography for atrial fibrillation detection

Conditions: Atrial Fibrillation

Summary: a single center prospective case-control study to evaluate ability of a wearable to differentiate between atrial fibrillation (af) and sinus rhythm (sr).


Eligibility criteria:
inclusion criteria: * participants with current ecg-based diagnosis of atrial fibrillation, sinus rhythm or sinus rhythm with frequent (at least once in 2 minutes) premature atrial or ventricular contractions. * age is between 18 - 99. exclusion criteria: * participants who refuse to sign an informed consent. * participants with atrial fibrillation who are currently in a paced rhythm.

Keywords: wearable electrocardiography photoplethysmography
adalimumab intralesional in intestinal strictures of crohn's disease patients

Conditions: Crohn's Disease

Summary: we study if the administration of intralesional adalimumab (directly injected in the stricture) associated to endoscopic dilatation has a higher success rate at week 8 compared with placebo in patients with crohn's disease who had confirmed intestinal stenosis (3 stenosis as maximum)


Eligibility criteria:
inclusion criteria: * patients of both sexes older than 18 years * patient diagnosed of crohn´s disease * patient with intestinal stenosis length equal or less than 5cm previously confirmed with bowel magnetic resonance imaging (3 stenosis as maximum) * stenosis no permeable for endoscopy(12mm in case of accessible stenosis with conventional colonoscopy and 10mm in case of accessible stenosis with balloon enteroscopy) * dilated stenosis according to endoscopist criteria (pass or no the endoscopy) * patient capable of participate in the examinations required by the study * patient after being informed, give his/her informed consent in writing exclusion criteria: * patients with large intestinal stenosis (more than 6cm) and multiples * patients with previous or actual treatment with anti-tumor necrosis factor (anti-tnf) drugs * patients with positive serology to hepatitis b virus(hbv),hepatitis c virus (hcv), or hiv * patients with positive screening to tuberculosis(positive ppd) * established contraindication to anti-tnf drugs * existence of fistulous tracts associated with intestinal stenosis * neoplastic process associated with stenosis or in another location * pregnancy or breastfeeding

Keywords: crohn disease
online program for social anxiety

Conditions: Social Anxiety

Summary: the purpose of this study is to investigate the efficacy of an online program in reducing symptoms of social anxiety, unhelpful thoughts, avoidance behaviours, fear of negative evaluations and improving quality of life in students with above-average social anxiety.

while there are many benefits to online programs in treating a variety of health issues (i.e., implementation in remote areas, cost-effectiveness, etc.), the primary challenge for online formats is to imitate real-life interactions while promoting a reduction in symptoms. this will be attempted in a six-month online program for social anxiety. the present study will assess the efficacy of a six-month online program through measures of social anxiety, fear of negative evaluations, unhelpful thoughts, avoidance behaviours and quality of life. this information will be collected from students at baseline and upon completion of the online program.

Eligibility criteria:
inclusion criteria: * registered ubc student * achieve an above-average score on a validated screening tool for social anxiety exclusion criteria: * not a registered ubc student * clinical diagnosis of a mental illness

Keywords: social anxiety cognitive behaviour therapy online program
psma-pet imaging for detecting early metastatic prostate cancer in men w/ high decipher test scores

Conditions: Prostate Cancer; Recurrent Prostate Cancer

Summary: this study will enroll 60 patients previously enrolled to mcc#18523, "a validation study on the impact of decipher® testing on treatment recommendations in african-american and non-african american men with prostate cancer: (vandaam)" that had high risk decipher test results (decipher score \>0.45). patients with a high genomic classifier (gc) score at diagnosis will be approached for formal consenting for psma-pet imaging at 2 years post treatment.

normally, some patients with prostate cancer undergo imaging tests to determine the extent (spread) of their disease. these imaging tests often give good information, but not in all patients and not every time. this study deals with a new imaging test known as f-dcfpyl-prostate-specific membrane antigen (psma) positron emission tomography (pet), or f-dcfpyl-psma pet. the objective of this study is to evaluate safety and usefulness of using f-dcfpyl in detecting recurrent/metastatic prostate cancer. the f-dcfpyl pet imaging technique is used in some parts of the world but is not currently standard imaging care. better understanding how this new imaging test performs in identifying recurrent/metastatic prostate cancer may lead to better management of prostate cancer patients in the future.

Eligibility criteria:
inclusion criteria: * this study will enroll 60 patients previously enrolled to mcc#18523, "a validation study on the impact of decipher® testing on treatment recommendations in african-american and non-african american men with prostate cancer: (vandaam)" that had high risk decipher test results (decipher score \>0.45). * eastern cooperative oncology group (ecog) performance status: 0-1 * previously enrolled to mcc#18523 * genomic classifier (gc) testing successfully completed on biopsy and/or surgical specimen * decipher score from participation on the mcc#18523 study meets the criteria for high-risk (\>0.45) * treated with radical prostatectomy (rp) or radiation therapy (rt) (+/- short-term androgen deprivation therapy (adt)) with ≥2 years follow up * age \> 18 exclusion criteria: * no follow up information available post treatment * unable to undergo pet imaging due to pre-existing comorbidities and/or claustrophobia * administration of any radioisotope within 5 physical half-lives or any iv x-ray contrast medium within 24 hours or any high-density oral contrast medium (oral water contrast acceptable) within 5 days prior to study drug injection

Keywords: radioactive diagnostic imaging