Kornimate/medical-research-clean huggingface dataset:
study comparing the dover silver foley catheter to a standard of care catheter and a marketed silver coated foley catheter

Conditions: Urinary Tract Infections

Summary: the purpose of the study is to determine if the commercially available device called the dover™ silver foley catheter prevents infections of the urinary tract.

over 1 million catheter-associated urinary tract infections (cautis) occur annually in u.s. healthcare facilities and account for approximately 40% of the nosocomial infections. this investigation is a multi-center, blinded, prospective, randomized, controlled, parallel comparison of the intervention catheter (tyco healthcare dover silver foley catheter) to a usual care catheter and another commercially available silver-coated catheter. 1000 subjects total will be randomized at the multiple study centers.

Eligibility criteria:
inclusion criteria: * subject is at least 18 years of age. * subject is expected to be catheterized with a 14, 16 or 18 french foley catheter for at least 72 hours. * subject or his/her legally authorized representative is able to grant informed consent to participate in this investigation. exclusion criteria: * subjects who present with ongoing, active, symptomatic uti. * subjects with a known or suspected allergy to silver or silver compounds causing delayed hypersensitivity reactions or contact dermatitis. * subjects with a known or suspected allergy to natural rubber latex or natural rubber latex compounds causing delayed hypersensitivity reactions or contact dermatitis. * subjects known to be pregnant. * prisoners.

Keywords: urinary catheterization
sublingual misoprostol in reduction of caesarean blood loss

Conditions: Post Partum Hemorrhage

Summary: caesarean delivery is inevitably associated with a higher amount of blood loss vis-à-vis primary postpartum haemorrhage, when compared to vaginal delivery. oxytocin use in tropical developing countries for the reduction blood loss at caesarean section have been met with challenges of ineffectiveness due to poor transportation, inadequate storage and drug adulteration. therefore, there is a need for an effective, temperature stable uterotonic with a lesser risk of adulteration. the study is aimed at evaluating the effectiveness and safety of adjunctive sublingual misoprostol in reducing intraoperative blood loss at caesarean section.

it would be a double blind randomized controlled trial. one hundred and fifty-two pregnant women at term who have indications for caesarean section and have risk factors for primary postpartum haemorrhage, as well as meet the eligibility criteria would be randomized equally into two study arms (misoprostol study arm and placebo study arm) after informed consent. the misoprostol study arm will receive 400 mcg of sublingual misoprostol as two 200 mcg misoprostol tablets. the placebo study arm would receive two sublingual placebo tablets similar to the misoprostol tablets. the misoprostol and the placebo tablets will be given in each study arm at the point of starting the uterine incision at caesarean section. both study arms would receive routine intravenous oxytocin at the time of clamping of the umbilical cord. the outcome measures will be estimated intraoperative blood loss, the need for additional intraoperative oxytocic, blood transfusion, the occurrence of side effects, and incidence of primary postpartum haemorrhage.

Eligibility criteria:
inclusion criteria: * pregnant women at term (37+0 weeks to 41+6 weeks gestational age) for elective or non-elective caesarean sections * pregnant women who have risk factor for primary postpartum haemorrhage * pregnant women who consent to participate in the study exclusion criteria: * pregnant women who withhold consent to participate in the study * caesarean sections for dire emergencies (umbilical cord prolapse, suspected fetal distress and active antepartum haemorrhage) * previous caesarean sections or other uterine surgeries * pregnant women with no risk factor for primary postpartum haemorrhage * allergy to misoprostol use * known history of hepatic, renal and haematological disorders * caesarean section to be done under general anaesthesia * fever (temperature ≥ 37.5 degrees centigrade) * pre-operative anaemia (pre-operative haematocrit level \< 30 %) * pregnant women who are unconscious or have eclampsia
the incremental risk of intraoperative fentanyl on ponv

Conditions: PONV

Summary: the aim of this quality control study is to describe the presence and intensity of postoperative nausea and vomiting (ponv) and its correlation with intraoperative fentanyl dosing. additionally, the investigators will examine pain scores.

the primary aims of this quality control study are: 1. to determine whether there is an independent association between the intraoperative administration of fentanyl (both as a continuous and categorical variable) and ponv within 24 postoperative hours 2. determine whether or not the intraoperative fentanyl amount can be used to successfully restratify patients for ponv beyond the simplified apfel score for ponv all required data is collected in regular daily practice. the following variables will be assessed by univariable models: preoperative variables (e.g. patient characteristics) surgical/anesthesia variables (e.g. type/length of surgery, antiemetics) outcome variables (ponv, worst pain as delineated in the outcomes section), intraoperative fentanyl measured 1) as a continuous variable and 2) by predefined limits of 0 to 0.2mg, \>0.2-0.5mg, \>0.5 to 0.8mg, and \>8mg. finally for the multivariable model, the investigators will adjust for confounders, specifically for sex (m/f), history (hx) of ponv (y/n), hx of motion sickness (y/n), current smoker (y/n), age (years), expected duration of surgery (min; \>60 min), postoperative opioids (y/n), the use of preemptive ponv therapy (0,1,2 medications), propofol vs. inhalative agents (y/n), and surgery type (3 kinds) from the patient's electronic record. in the event that insufficient event rates are observed, we will collapse the variables into the simplified apfel score to assess the independent value of fentanyl in predicting ponv. in addition to a logistic model as delineated above, we will conduct the following: 1. receiver operating characteristic (roc) curves of the logistic model without fentanyl, with fentanyl (continuous), and with fentanyl (categorical). 2. additionally, rocs of a simplified model using the apfel score, the apfel score with fentanyl (continous), and the apfel score with fentanyl (categorical) will be made. comparison of area under the receiver operating characteristics(aurocs) by delong 3. net reclassification improvement (nri) of both the logistic model with and without fentanyl as well as the apfel score with and without fentanyl to assess pain and administered fentanyl, we will examine pain scores by the numeric rating scale (nrs).

Eligibility criteria:
inclusion criteria: * in-patients with an expected simplified apfel score of 2 or higher, * aged \>= 18 years, and * undergoing general anesthesia (with or without neuraxial or regional anesthesia.) * in abdominal, gynecological or otorhinolaryngological surgery exclusion criteria: * outpatients * patients with chronic pain, defined as recurring pain requiring intermittent hospitalization or regular intake of pain medication. * non-opioid naïve patients, defined as a history of abuse or having taken opioids within the last 30 days

Keywords: fentanyl, opioids
imaging of peri-operative (periop) lung injury

Conditions: Acute Lung Injury; Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of study is to determine if 99mtc annexin v-128 (axv- 128/tc) single photon emission computed tomography (spect)-computed tomography (ct) can detect perioperative lung injury. the investigators will study patients undergoing major surgery, specifically whipple procedures (pancreatico-duodenectomies) and compare axv-128/tc spect-ct scans before and after surgery in chronic obstructive pulmonary disease (copd) and non-copd patients.

lung injury is commonly not detected unless structural damage has occurred. spect-ct scanning using a specific tracer that lights up when it detects apoptosis (programmed cell death) has been used to detect even minor lung injury for example by smoke inhalation in animals and may be more sensitive to detect a less severe injury. the present study aims to study spect-ct scan using a tracer for apoptosis, 99mtc annexin v-128 (axv- 128/tc), to detect lung injury after major surgery. prolonged ventilation during surgery can cause minor lung injury but is usually not clinically detected. the investigators are planning to study 40 patients (20 patients with pre-existing lung disease-copd and 20 patients with normal preoperative lung function) who are undergoing whipple operations or other major surgery. the investigators will obtain spect-ct scans before and then 2-3 days after surgery and compare the uptake of a radioactive tracer with plasma markers of lung injury (soluble receptors for advanced glycation end products (srage), interleukin 6 (il-6), clara-cell 16 and lung surfactant protein d (sp-d) among others). the investigators will ask the subjects to undergo spirometry testing, blood draws and urine collection. in addition, a spect-ct scan that lasts approximately 1 hour will be performed prior to surgery and 2-3 days post-operatively (while still hospitalized). the total effective dose from the combined spect and ct scans is 6.2 millisievert (msv). this effective dose is below what a patient receives during a standard 2 dose rest and stress cardiac nuclear imaging study and well within the range of current clinical nuclear imaging tests. the exact long term risk for development of cancer from diagnostic radiological procedures is currently under debate but all imaging procedures in this study are aimed to keep total radiation burden as low as reasonably achievable (alara).

Eligibility criteria:
inclusion criteria: * patients with moderate copd (global initiative for chronic obstructive lung disease (gold) stage ii: forced expiratory volume 1 (fev1)/forced vital capacity (fvc) \<0.70 and fev1 50-79% normal) undergoing whipple procedures or other major surgeries * patients with normal lung function undergoing whipple procedures or other major abdominal surgeries exclusion criteria: * age \< 18 years

Keywords: acute lung injury chronic obstructive pulmonary disease (copd) whipple procedures pancreatico-duodenectomies
remifentanil versus sufentanil for intubation condition without myorelaxant

Conditions: Anaesthetic Induction

Summary: the main objective is the comparison of intubation conditions after anesthetic induction bolus of propofol-sufentanil when compared to injection of propofol-remifentanil in patients undergoing surgery for tooth extraction. intubation without myorelaxant with propofol and sufentanil is classic but less efficient than induction with curare on achieving perfect intubation conditions. the use of a protocol without curare is sometimes justified for short gestures or when you want to avoid allergia. remifentanil often provides excellent intubation conditions without myorelaxant. however, remifentanil was never compared to sufentanil in terms of intubating conditions without muscle relaxant.


Eligibility criteria:
inclusion criteria: * patients 18 to 60 years * american society of anesthesiology (asa) 1 or 2 * scheduled for surgical tooth extraction under general anesthesia with intubation * signed consent form exclusion criteria: * criterion of difficult ventilation or intubation * chronic alcoholism or opiate use * beta-blockers or calcium channel blockers treatment * allergy to paracetamol or ketoprofen * patient under protection of justice

Keywords: anesthetic induction intubation conditions tooth extraction propofol sufentanil remifentanil
effectiveness of nature walks in depressed adults

Conditions: Experimental

Summary: over the past few years, a growing number of campaigns from around the world, including canada, are highlighting the positive impact of spending time in nature on well-¬being. indeed, mounting evidence suggests that spending time with nature is associated with a myriad of affective and cognitive benefits. surprisingly few studies to date have tested the assumption that walking in nature versus in urban settings could alleviate stress and depressive symptoms in clinically depressed adults. the main purpose of this study is to investigate the effectiveness of walking in nature versus in urban settings to improve depression related symptoms and reduce stress. the trial initially included 2 primary outcomes: patients stress levels (salivary cortisol) and depression-related symptoms (eg, affect, rumination, executive functioning). however, due to hygienic concerns in light of the covid-19 pandemic in 2020, the collection of saliva samples (and in turn, the measurement of stress levels via salivary cortisol) was removed from the study's procedure. the main outcome was changed to effects on positive and negative affect.


Eligibility criteria:
inclusion criteria: * men and women aged between 18 and 65 years, inclusively; * ability to speak french or english; * diagnosis major depressive disorder (dsm-iv); exclusion criteria: * acute psychotic symptoms; * acute suicidal intent (within 48 hours); * unable to walk for 60 min or serious medical reasons (e.g. major surgery) * heart condition as per history or detected on electrocardiogram

Keywords: clinical depression stress group-walking walking condition (nature vs urban)
a study of early markers of choroidal neovascularization

Conditions: Choroidal Neovascularization (CNV); Age-related Macular Degeneration (AMD); Early Markers

Summary: identify early markers of choroidal neovascularization (cnv) in the fellow eye of a patient with cnv in the other eye due to age-related macular degeneration with the expectation of being able to identify patients in need of intervention.

cnv in one eye and dry amd in the other

Eligibility criteria:
inclusion criteria: * sub-, extra- or juxta-foveal choroidal neovascularization (cnv) or macular scar due to amd in the non-study eye. * no cnv or geographic atrophy in the study eye. * best corrected visual acuity in the study eye of greater than 20/40 or better than 70 etdrs letters. * sufficiently clear ocular media and adequate pupillary dilatation to permit good quality fundus imaging of the study eye. * subjects of either sex, aged 50 years. * evidence of a signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial. * willing and able to comply with scheduled visits, laboratory tests, and other trial procedures. exclusion criteria: * subjects presenting with any of the following will not be included in the study: * evidence of manifest cnv by fa, color photography or icg angiography in the study eye. * any prior treatment for cnv to the study eye (excluding vitamins and areds formula). * significant media opacities, including cataract, which might interfere with visual acuity assessments, or fundus imaging in the study eye. subjects should not be entered if there is likelihood that they will require cataract surgery within the following 2 years. * presence of other causes of choroidal neovascularization in the fellow eye, including pathologic myopia (spherical equivalent of -8 diopters or more negative, or axial length of 25 mm or more), the ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, and multifocal choroiditis. * any progressive eye disease other than amd (eg, glaucoma, diabetic retinopathy) in the study eye. * presence of subretinal hemorrhage, serous or hemorrhagic pigment epithelial detachments, subretinal fibrosis or pigment epithelial tears or rips in the study eye. * any medical condition that would interfere with the patient's ability to complete the trial. * concurrent enrollment in any other observational or interventional clinical study. * any treatment with an ocular or systemic investigational agent in the past 60 days for any medical condition. * known serious allergies to the dye used in fluorescein angiography or icg.

Keywords: exploratory observational non-interventional study age-related macular degeneration (amd) choroidal neovascularization (cnv)
sustained immunity to covid-19 as measured by sars-cov-2 serology assays

Conditions: Covid19

Summary: the primary objective is to assess the ability of covid-19 igg and igm assays to detect an immune response in covid-19 patients in the henry ford health system (hfhs), both during hospitalization and over the following 12 months.

the design strategy for this study is to validate the detection of covid-19 antibodies in subjects at hfhs who test positive with rt-pcr for sars-cov-2 using fully automated test systems already in the core automated laboratory at hfh. this is a study of the immune response and kidney health of subjects who have recovered from covid-19 infection. there are 4 aims: aim 1. assess detection of covid-19 antibodies in subjects before discharge from hfhs who tested positive with rt-pcr for sars-cov-2 using fully automated immunoassays. aim 2. evaluate emergence of immunity over a one-year period in subjects who tested positive with rt-pcr for sars-cov-2 using a fully-automated immunoassays. aim 3. monitor renal function and kidney health at 6 and 12- months post diagnosis with covid-19. aim 4. determine if sar-cov-2 can be detected in the saliva of patients over a one year period after a positive pcr test.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age * positive covid-19 by rt-pcr sars-cov-2 assay * patients must have a serum sample stored by pathology or within the tcrc biorepository around the date of their covid-19 rt-pcr positive test exclusion criteria: * \< 18 years of age * negative for rt-pcr * no serum sample

Keywords: sars-cov-2 antibodies seroprevalence
prospective study of colon serrated polyps

Conditions: Colon Polyps

Summary: with this study, the investigators plan to review the clinical, epidemiology, pathology, and endoscopic features of colon serrated lesions as well as outcome of endoscopic resection of these lesions. the findings will help us define the natural history of colon serrated lesions, develop techniques for endoscopic management of patients with serrated lesions, and identity areas for improvement. the data will be used for continuing quality improvement and presenting our outcomes at academic meetings and publishing our results in peer reviewed journals.

our goal is to collect data from our endoscopy reports and electronic medical record system to complete a descriptive analysis of the demographics, colonoscopy resection procedure, and outcome of resection - immediate and delayed complications, tumor recurrence, and cancer during follow-up 010/01/2014 - 12/31/2025. specific variable to be reviewed: 1. patient demographics: age, sex, race, height, weight, bmi (patient privacy will be acknowledged). 2. indications for colonoscopy (screening, surveillance, symptoms or tertiary referral \[emr\]). 3. comorbid conditions: cancer and surgical history, medical conditions. 4. colonoscopy procedure: quality of colon preparation (using the boston bowel preparation scale) 0 - 3 for each section of the colon (ascending, transverse, descending and total colon), cecal intubation rate, cecal intubation and total procedure time, type of colonoscope (if co2 was used in the procedure and techniques for colonoscope insertion, including position changes. 5. examination findings: number of polyps and nature of polyps removed (site, size, surface, vascular pattern); type of polyp removed (serrated and sessile (flat); optical features and histology of polyps. 6. resection techniques: biopsy, snare resection, endoscopic mucosal resection, endoscopic submucosal dissection etc. 7. including pathology report findings so that a comparison can be made of the optical features and actual pathology report. 8. outcomes of colonoscopy: complete or incomplete resection, local recurrence, need for surgery, etc. 9. outcome of colonoscopy: complications (bleeding and perforation).

Eligibility criteria:
inclusion criteria: 1. all patients with a serrated polyp (hyperplastic polyps above sigmoid colon, sessile serrated adenoma, traditional serrated adenoma) exclusion criteria: n/a

Keywords: colon serrated polyps serrated polyp hyperplastic polyps above sigmoid colon sessile serrated adenoma traditional serrated adenoma colonoscopy endoscopy data collection data review
effect of scar release techniques on chronic scar pain and mobility post cesarean section

Conditions: Cesarean Section Complications

Summary: purpose of the study: the aim of this study is to determine the effect of scar release techniques on chronic scar pain and mobility post cesarean section. hypothesis: * h0: there is no effect of scar release techniques on chronic scar pain and mobility post cesarean section. * ha: there is effect of scar release techniques on chronic scar pain and mobility post cesarean section.

a vicious impediment on quality of life including psychological and functional disability, and interference with baby care and bonding may occur among women who experience chronic post-caesarean section pain (cpcsp) . structural alterations of the skin and subcutaneous tissues with scarring result in reduced mobility and viscoelasticity that could cause compression of the sensory receptors and nerve ﬁbers and disrupt their signaling. the viscoelastic properties could potentially be modiﬁed when the skin and scars are stressed and/or strained by manual therapies and this can affect the sensitivity threshold of the mechanosensitive and nociceptive receptors. there are limited studies about the effect of various scar release techniques on chronic post cesarean section scar pain and mobility and their impact on quality of life on the affected women . so, this study will be helpful and of valuable benefits for medical services organizations and increase body of knowledge of physical therapists in scientific field. this study will be conducted on forty women suffering from chronic post cesarean section scar pain and restricted scar mobility , they will be referred from department of obestetrics and gynaecology in elmansoura international hospital, egypt.

Eligibility criteria:
inclusion criteria: * women with a well healed, old , transverse cesarean section scar (more than 6 months resulted in chronic scar pain). * pain can be intermittent or constant at rest or with activity, and it is reported to be at least at a level of about 3/ 10 on visual analogue scale at recording sites will be marked on the c-section scar at 2.5 cm intervals . * women identified that the pain is either located in the cesarean section scar or caused by palpation of scar and it presents since the time of surgery not prior to the cesarean section. * their ages will range from 25-35 years old. * their bmi will be 18.5-29.9 kg/ m². * voluntary acceptance to participate in the study. exclusion criteria: * women will be excluded if they have : * acute and subacute cesarean section. * delayed wound healing. * history of abdominal or pelvic cancer. * active pelvic or abdominal infection. * skin irritation/inflammation at the site of scar. * currently pregnant women.