Kornimate/medical-research-clean huggingface dataset:
an all-comers observational study of the microstent™ peripheral vascular stent system in subjects with peripheral arterial disease

Conditions: Peripheral Arterial Disease; Critical Lower Limb Ischemia

Summary: non-randomized, multicenter, combined prospective and retrospective cohort analysis consisting of a single arm treated with the microstent™ system.

subjects with peripheral arterial disease (pad) whom the investigator has treated or intends to treat with the microstent™ system per the current instructions for use (ifu), and who have given written informed consent, will be enrolled in this study. up to 300 subjects will be enrolled: the objective of this post market registry is to evaluate procedural and long-term clinical outcomes for subjects undergoing intervention with the microstent® system for treatment of lower extremity peripheral arterial disease (pad), presenting with below-the-knee lesions.

Eligibility criteria:
inclusion criteria: 1. any subject with below the knee, at the ankle level or below the ankle peripheral arterial lesions previously treated or intended to be treated with the microstent® system per the current indications for use 2. for across the ankle joint intervention, distal runoff to digital branches or arcuate arteries must be present on angiography prior to microstent deployment 3. subject's age is ≥ 18 years. 4. subject must be willing to sign a patient informed consent form. exclusion criteria: 1. subject is pregnant or planning to become pregnant during the study duration 2. subject has a life expectancy of less than one (1) year 3. subject has a known allergy to concomitant medication, contrast agents (that cannot be medically managed), anti-platelet, anti-coagulant or thrombolytic medications 4. subject is enrolled in another study that has not reached its primary endpoint at the time of enrollment.

Keywords: microstent below the knee cli below the ankle clti
accuracy of half of the usual radiotracer dose in spect

Conditions: Coronary Artery Disease

Summary: there has been a shortage of nuclear isotopes, not only in canada but around the world. new, more sensitive spect cameras can obtain better images in shorter scan times. these cameras have also shown the ability to use a smaller dose of radioisotope to obtain the images. new software has been tested on the standard camera, the ge infinia-hawkeye spect/ct. the diagnostic imaging department of the university of ottawa heart institute has also acquired a new camera, the discovery nm530c czt and has been doing heart scans in shorter times. the investigators will now be looking at the quality of images using less isotope during spect myocardial perfusion imaging for diagnostic and prognostic purposes.

spect mpi is well accepted as a reliable and cost-effective tool for diagnosis, risk stratification and management of patients with suspected or known coronary artery disease (cad) (1;2). mpi represents approximately 40% of nuclear medicine patient studies and most of these use 99mtc-sestamibi or 99mtc-tetrofosmin(3). rest/stress mpi using 99mtc-sestamibi and 99mtc-tetrofosmin uses more tracer doses than many other nuclear medicine tests and thus account for \>50% of injected radiotracer activity(3). thus, interruptions in the supply of 99mo, the parent isotope of 99mtc, significantly affect stress mpi imaging and associated patient care. alternatives to 99mtc-sestamibi and 99mtc-tetrofosmin for perfusion imaging include 201tl for spect imaging and 82rb or 13nh3 for positron emission tomography (pet) imaging (4;5). mpi using 201tl has similar diagnostic accuracy but image interpretation is more difficult due to greater scatter and attenuation. moreover, the patient effective radiation dose for mpi using a standard injected dose of 3.5mci of 201tl is \~20 msv. this radiation dose is twice that of 99mtc tracers which typically deliver an effective dose of \~10 msv. pet imaging with 82rb or 13nh3 is another alternative, but is much more expensive and not routinely available in canada due to a very limited install base of pet scanners and associated cyclotrons. the number of spect cameras operational in canada is more than 40 times the number of pet scanners.

Eligibility criteria:
inclusion criteria: * consecutive patients presenting for clinically indicated spect perfusion scan * patients presenting to sites with a functional czt camera. available sites are ottawa (ohi), mississauga, and calgary. * age \>18 years old exclusion criteria: * patients with a life expectancy less than 1 year, from non cardiac cause * age \< 18 years old or lack of consent * allergy or contraindication to dipyridamole * refractory angina or infarction or need for urgent angiography * known pregnancy * uncontrolled atrial fibrillation

Keywords: single-photon emission computed tomography myocardial perfusion imaging rest/stress treadmill persantine half-dose radiotracer tetrofosmin thallium cadmium zinc telluride diagnostic prognostic
bilateral transversus abdominis plane block with exparel verus continuous epidural analgesia with bupivacaine

Conditions: Pain, Postoperative; Major Abdominal Surgery

Summary: comparison of bilateral transversus abdominis plane block with exparel versus continuous epidural analgesia with bupivacaine

the investigator goal is to compare the analgesic efficacy of tap blocks with liposomal bupivacaine (exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. to assess whether tap block with exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.

Eligibility criteria:
inclusion criteria: * written informed consent * 18-85 years old * asa physical status 1-3 * scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries * anticipated hospitalization of three nights * expected requirement for parenteral opioids for at least 72 hours for postoperative pain * able to use iv pca systems. exclusion criteria: * hepatic disease, e.g. twice the normal levels of liver enzymes * kidney disease, e.g. twice the normal level of serum creatinine * bupivacaine sensitivity or known allergy * women who are pregnant or breastfeeding * anticoagulants considered to be a contraindication for epidural or tap blocks. * surgeries with high port sites will be excluded
androgen deprivation therapy study

Conditions: Hypogonadism; Metabolic Syndrome; Diabetes; Inflammation

Summary: the purpose of this study is to examine the link between low testosterone and insulin resistance/diabetes in men undergoing androgen deprivation therapy for prostate cancer. the study will also evaluate other cardiovascular risk factors in these men.

lowering of testosterone levels, by medications or surgery (androgen deprivation therapy or adt), is commonly used in the treatment of prostate cancer. the adverse effects of low testosterone include decreased sex drive, impotence, decreased lean body mass and muscle strength, increased fat mass, decreased quality of life and osteoporosis. an increase in body fat and decrease in lean body mass may contribute to a decrease in the body's ability to use insulin effectively, leading to insulin resistance and diabetes. low testosterone levels are also associated with elevated total cholesterol, ldl-cholesterol and triglycerides. two groups of non-diabetic men will be studied: 1. men with known history of prostate cancer who were treated with surgery and/or radiation therapy and are now in remission and not receiving androgen deprivation therapy (non-adt group). 2. men with newly diagnosed or known history of prostate cancer who are being advised by their physicians to begin androgen deprivation therapy (adt group). the non-adt group and half of the adt group will be observed for the development of insulin resistance/diabetes. the other half of the adt group will receive a diabetes medication called pioglitazone (actos) to evaluate any beneficial effects of this medication in the prevention of metabolic dysfunction. the study will consist of a screening visit and 6 additional study visits throughout one year. procedures during this study include blood draws, mri, ct, dexa scan, insulin clamp procedures, oral glucose tolerance tests, carotid imt, pulse wave velocity, neuropsychological testing, physical exams and an optional muscle biopsy.

Eligibility criteria:
inclusion criteria: * men 18 years of age or older with prostate cancer * planning to undergo long-term (at least 12 months) adt * no known history of diabetes * no history of adt exclusion criteria: * history of adt or any prior diagnosis of hypogonadism * fasting glucose or oral glucose tolerance test results in the diabetic range * heart failure (ny classification iii or iv) * testosterone level less than 250 ng/dl on screening * history of heart attack or open-heart surgery within the past 6 months * use of steroids within the past 3 months, including prednisone, cortisone injections, inhaled steroids (topical steroids are acceptable) * use of anabolic steroids (testosterone, dhea, dheas) or any growth promoters (growth hormone itself or analogs of growth hormone) in the past 12 months * liver function tests more than 3 times upper normal limits * undergoing intermittent adt * uncontrolled thyroid disease (hyper- or hypo-thyroidism) * anemia, defined as hematocrit less than 38% * not physically capable of completing the tests

Keywords: hormone therapy
xenon inhalation for treatment of posttraumatic stress disorder

Conditions: Post Traumatic Stress Disorder

Summary: this study is a double-blind, randomized, placebo-controlled, clinical trial in parallel groups in patients with ptsd.


Eligibility criteria:
inclusion criteria: * patients with a current diagnosis of ptsd (documented diagnosis of ptsd based on diagnostic and statistical manual of mental disorders, fifth edition \[dsm-5\] criteria and a clinician administered ptsd scale \[caps-5\] total severity score of \>30). * male and female patients between the ages of 18 and 85 years. exclusion criteria: * history of schizophrenia, bipolar and other psychotic disorders. * patients with underlying pulmonary disease, chronic obstructive pulmonary disease (copd), asthma or any other respiratory conditions / diseases that may affect the respiratory function. * currently undergoing ptsd-targeted psychotherapy. * currently undergoing exposure-based psychotherapy for any condition.
sars-cov-2 nucleic acid detection kit clinical performance study

Conditions: COVID-19; Coronavirus Disease 2019; COVID-19 Pandemic; Diagnoses Disease

Summary: sars-cov-2 nucleic acid detection kit is an in vitro diagnostic (ivd) medical device intended for rna detection of sars-cov-2 in human specimens using multiplex real-time polymerase chain reaction (rt-pcr) technology. the conserved regions of orf1ab and n genes are used as target sites of the primers and probes according to the indications provided in the instructions for use (ifu).

the sars-cov-2 nucleic acid detection kit is an in vitro diagnostic (ivd) medical device intended for qualitative rna detection of sars-cov-2 using multiplex real time rt-pcr technology for professional use. the kit is available in two different formats (48 tests/kit or 200tests/kit), and it can be stored at -20±5ºc away from light for 12 months. this kit includes a pcr reaction mix, pcr enzyme mix, sars-cov-2 pcr primer/probe mix and a negative/positive control. transgen sars-cov-2 nucleic acid detection kit is intended for in vitro qualitative detection of orf1ab and n genes from the sars-cov-2 virus in nasopharyngeal swab specimens collected from covid-19 suspected cases, suspected clusters of cases or other individuals who need sars-cov-2 infection diagnosis or differentiation diagnosis. the definitions of covid-19-related groups, such as "suspected cases" or "suspected clusters of cases", are detailed in the diagnosis and treatment protocol for novel corona virus pneumonia, surveillance protocol for novel corona virus pneumonia or other covid-19 documents from the centers for disease control and prevention (cdc). the transgen sars-cov-2 nucleic acid detection kit should comply with the requirements of diagnosis and treatment protocol for novel corona virus pneumonia, protocol for prevention and control of covid-19 and other covid-19 documents from the cdc. the biosafety requirements should be strictly followed as well. specimens used for this clinical performance study will be remnants of specimens taken for purposes of standard of care (leftover or archived) through a nasal swab from male and female subjects. specimens may come from persons suspected of sars-cov-2 infection but also from those who need a diagnostic test due to other reasons such as medical intervention, blood donors, or travel for which a negative test is requested.

Eligibility criteria:
inclusion criteria: * specimen collected with a nasal swab. * negative samples from specimens confirmed sars-cov-2 negative by the gold standard, or positive samples from specimens confirmed sars-cov-2 positive by the gold standard. exclusion criteria: * specimens that have been stored at 4ºc for more than 24h * specimens stored at -70ºc that have been under more than 2 freeze/thaw cycles * specimens that have been stored at -20 for more than 10 days * contamination and/or deterioration of the specimen that, in the investigator's opinion, may impact its handling and/or analysis
nicu parent education program

Conditions: Language Development; Premature Infant; Neurodevelopmental Outcomes

Summary: the purpose of this study is to adminster one of two education programs to parents of preterm infants in the nicu to evaluate language and cognitive outcomes of their infants.

the long term goal of this research is to determine the language environment necessary in the nicu for very preterm infants to optimize their long-term language and cognitive development. this study will pilot an early language intervention with parents of preterm infants in the nicu the purpose of which is to provide a structured curriculum for the family to guide their language interactions with their infant. the aim is to increase the adult word counts and conversational turns in the nicu and to improve bayley iii language and cognitive scores at 12 months and 24 months corrected age. the hypotheses is that increasing early language exposure in the nicu will result in improved lanugage and cognitive scores. the investigators plan on testing the hypothesis by the following specific aims. 1. determine the effectiveness of a structured language curriculum with parents of preterm infants in the nicu on increasing the amount of early language exposure. 2. test the the hypothesis that increased early language exposure will result in higher bayley iii language and cognitive scores.

Eligibility criteria:
inclusion criteria: * receiving care at women \& infants' hospital nicu, * providence ri gestational age 23 - 32 weeks, * ri resident exclusion criteria: * unable to understand or speak english, * congenital or chromosomal disorder likely to affect cognitive or speech development, * parental loss of custody
hervin: trastuzumab and vinorelbine in metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the combination of vinorelbine with weekly trastuzumab has produced high response rate in her2 overexpressing metastatic breast cancer (mbc). the present phase 2 study was planned to test activity of the same combination, with trastuzumab given every 3 weeks, rather than weekly.

the schedule of treatment includes vinorelbine (30 mg/m2 on days 1 \& 8 every 21 days) and trastuzumab (8 mg/kg on day 1 and then 6 mg/kg every 21 days). vinorelbine is planned for maximum 9 cycles, while trastuzumab can be continued until progression. this study is a single-stage phase 2 design, and patients eligible for response evaluation are required.

Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed breast cancer * stage iv * no prior or not more than one prior chemotherapy for metastatic disease * overexpression of her-2 (3+ on immunohistochemical exam) or amplified genetic expression of c-erbb2/neu (positive by fish method) * performance status 0-2 (ecog) exclusion criteria: * absence of measurable disease * life expectancy \< 3 months * concomitant malignancy or malignancy within previous 5 years (except basal cell or spinocellular skin cancer and in situ cervical cancer if they have been adequately treated * previous treatment with trastuzumab or vinorelbine * neutrophils \< 1500/mm3 or platelets \< 100000/mm3 or haemoglobin \< 8 g/dl * creatinine \> 1.5 x the value of the upper normal limit * got and/or gpt \> 2.5 x the value of the upper normal limit and/or bilirubin \> 1.5 x the value of the upper normal limit in the absence of liver metastases * got and/or gpt \> 5 x the value of the upper normal limit and/or bilirubin \> 3 x the value of the upper normal limit in the presence of liver metastases * left ventricular ejection fraction \< 50% (measured by ultrasound or muga angiography) * concomitant conditions that contraindicate the use of the drugs in the protocol * male gender * pregnancy or lactation· * incapacity or refusal to provide informed consent * inability to comply with followup

Keywords: her2 overexpression combination therapy
bleaching procedures performed during treatment with brackets and clear aligners

Conditions: Tooth Discoloration

Summary: the aim of this study is to compare the effectiveness of different whitening methods used during orthodontic treatment with fixed appliances and clear aligners. it also aims to examine the effect of different whitening methods on white spot lesions and the color change they cause in the teeth.

during orthodontic treatment, if oral hygiene is not properly maintained or in long-term treatments, tooth discoloration may occur. in clear aligner treatment, failure to regularly clean the aligners or the consumption of staining foods and beverages while wearing the aligners can lead to staining and yellowing of the tooth surfaces. the aim of this study is to compare the effectiveness of different whitening methods used during orthodontic treatment with fixed appliances and clear aligners. it also aims to examine the effect of different whitening methods on white spot lesions using quantitative light-induced fluorescence (qlf) and to evaluate the color changes in the teeth during the treatment process.

Eligibility criteria:
inclusion criteria: * no previous orthopedic or orthodontic treatment * mild or moderate malocclusion * non-smokers and non-alcohol consumers * consumes no more than 3 cups of tea or coffee per day * good oral hygiene and healthy periodontal tissues * no cavities, restorations, pigmentation, or white spot lesions on the anterior teeth * chronological age between 16-30 years, regardless of bone age exclusion criteria: * individuals requiring extraction-based treatment * individuals who have previously undergone whitening treatment * individuals with endogenous tooth discoloration * individuals with genetic tooth pigmentation * individuals in the mixed dentition phase

Keywords: clear aligner treatment bleaching home bleaching
progesterone for the treatment of covid-19 in hospitalized men

Conditions: COVID-19; Sars-CoV2

Summary: the purpose of this study is to assess safety and efficacy of progesterone for treatment of covid-19 in hospitalized men.

hospitalized men with covid-19 who meet the eligibility criteria will be informed about study and the potential risks. all the patients giving written informed consent will be randomized in 1:1 ratio to progesterone (100 mg sq twice daily) plus standard of care or standard of care alone.

Eligibility criteria:
inclusion criteria: 1. laboratory-confirmed covid-19 with in 72 hours prior to randomization 2. respiratory symptoms or abnormal lung exam or abnormal chest imaging and oxygen saturation ≤94% on room air, or requiring supplemental oxygen less than 50% high flow 3. understands and agrees to comply with planned study procedures 4. agrees to the collection of venous blood per protocol 5. must agree to be placed on prophylactic dose of anticoagulation for prevention of deep venous thrombosis (dvt) while hospitalized exclusion criteria: 1. alt or ast \>5 times the upper limit of normal 2. history of blood clots 3. history of breast cancer 4. allergy to progesterone or betacyclodextrin 5. use of supplemental oxygen prior to hospital admission 6. requiring higher than 50% supplemental oxygen by high flow nasal cannula or mechanical ventilation
recovery of bladder and sexual function after spinal cord injury

Conditions: Spinal Cord Injuries

Summary: bladder and sexual dysfunction consistently ranks as one of the top disorders affecting quality of life after spinal cord injury. the insights of how activity-based training affects bladder function may prove to be useful to other patient populations with bladder and sexual dysfunction such as multiple sclerosis, parkinson's, and stroke, as well as stimulate investigations of training's effects within other systems such as bowel dysfunction. locomotor training could help promote functional recovery and any insights gained from these studies will enhance further investigation of the effect of bladder functioning after spinal cord injury. in addition, as suggested by a study of one of our initial participants, a reduction in the use and/or dosage of medication to enhance sexual function is a possible outcome, medications which carry risks and side effects.

objectives: to determine the effects of weight-bearing task-specific training for locomotion (stepping on a treadmill) after traumatic incomplete and complete spinal cord injury in humans on a) urodynamic parameters and b) sexual function outcomes. weight-bearing (stand-only) and non-weight-bearing exercise (i.e. arm crank) will serve as controls.

Eligibility criteria:
criteria: inclusion criteria: * stable medical condition without cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training * no painful musculoskeletal dysfunction, * unhealed fracture, contracture, pressure sore or urinary tract infection that might interfere with training * no clinically significant depression or ongoing drug abuse; * clear indications that the period of spinal shock is concluded determined by presence of muscle tone, deep tendon reflexes or muscle spasms and discharged from standard inpatient rehabilitation * non- progressive suprasacral spinal cord injury * bladder and sexual dysfunction as a result of spinal cord injury exclusion criteria: * unstable medical condition with cardiopulmonary disease or dysautonomia that would contraindicate locomotor training, stand, or non-weight bearing training; * painful musculoskeletal dysfunction, unhealed fractures, contractures, pressure sores or urinary tract infections that might interfere with training * clinically significant depression or ongoing drug abuse; * clear indications that the period of spinal shock has not concluded and not discharged from standard inpatient rehabilitation * progressive spinal cord injury * no bladder and sexual dysfunction as a result of spinal cord injury

Keywords: bladder sexual function