Kornimate/medical-research-clean huggingface dataset:
topical lidocaine anesthesia for nasopharyngeal sampling

Conditions: Nasopharyngeal Sampling; Local Anesthesia

Summary: introduction: nasopharyngeal sampling is widely used in the diagnosis of the coronavirus disease 2019 (covid-19). the aim of this study is to evaluate the effects of topical lidocaine application for nasopharyngeal sampling, on pain perception, the comfort of the patients, and the application difficulty for healthcare staff. methods: this study is a prospective randomized placebo-controlled study conducted with 100 healthy volunteers (50 participants in lidocaine group and 50 participants in placebo group). two ml of a solution containing 10 mg/ml of lidocaine was applied to each nostril of the participants in the lidocaine group, and the same dose of 0.9% nacl to the placebo group. investigators performed two repeated sampling one hour apart. the first sampling was performed before intervention, and the second was performed five-minutes after intervention. investigators compared the changes in pain intensity and discomfort intensity using two numerical rating scales, the frequency of undesirable reactions, and the judgment of the practitioner staff about the sampling procedure between first and second sampling.

this study is a prospective randomized placebo-controlled study with restricted randomization of an allocation ratio of 1:1. we used random allocation software (ras) for randomization. the study is conducted following the consort guideline and the tenets of the declaration of helsinki we obtained the approval of the ataturk university clinical research ethics committee. also, the written informed consent of all participants will obtained.

Eligibility criteria:
inclusion criteria: - the inclusion criteria of the study is: * being 18 years and older * volunteering to participate in the study. exclusion criteria: * the exclusion criteria of the study is: * taking analgesic drugs before admission, * pregnancy, * lactation, * having a bleeding disorder, \*known allergy to lidocaine, \* previous nasal trauma or operation, * having respiratory tract infection symptoms (such as fever, headache, runny nose, sore throat, cough, sneeze, breathlessness), * having a chronic disease (diabetes, cancer, heart disease, asthma, copd, etc.).

Keywords: lidocaine nasopharyngeal sampling coronavirus disease 2019 testing
clinical trial for optimal novel oral anticoagulant (noac) schedule immediate before catheter ablation for atrial fibrillation

Conditions: Atrial Fibrillation

Summary: this study is to evaluated the interruption schedule of noac in patients who undergo atrial fibrillation ablation. the investigators will compare the bleeding complications were classified as major and minor bleeding, thromboembolic, vascular complications, re-admission and increased in the length of hospital stay during the 30-day post-radiofrequency catheter ablation(rfca) period among patients who interrupt noac 24hours before ablation and patients who stop noac in the morning of the procedure.


Eligibility criteria:
inclusion criteria: 1. patients who consent with study 2. patients with atrial fibrillation (20-80 years old) 3. patients who undergoing catheter ablation of atrial fibrillation due to symptomatic, drug refractory atrial fibrillation 4. patients possible to noac exclusion criteria: 1. patients who do not agree with study inclusion 2. egrf \< 30ml/min 3. impossible to noac 4. structural cardiac disease 5. major hemorrhagic complication 6. cha2ds2-vasc score \> 5 7. patients who have experienced ischemic cerebellar infarction more than 2times
beneficial effect of salicylates: insulin action, secretion or clearance?

Conditions: Pre Diabetes; Insulin Resistant

Summary: the possibility that obesity-associated inflammatory changes may play a role in the pathogenesis of type 2 diabetes (2dm) has led to increased interest in the possibility that salicylates might represent a useful treatment to improve glucose tolerance. several studies, performed in patients with 2dm, as well as in nondiabetic, obese individuals, have demonstrated that salicylates have beneficial effects on glucose and insulin metabolism, but have not led to a coherent view as to the mechanism(s) involved. in this research proposal we will use specific methods to quantify insulin mediated glucose uptake (imgu), glucose-stimulated insulin secretion rate (gs-isr), and insulin clearance (i-cl) in overweight/obese, nondiabetic, insulin resistant individuals. we will use the insulin suppression test (ist) to quantify imgu in nondiabetic, overweight/obese volunteers to identify those individuals who are sufficiently insulin resistant to be enrolled in this study. we will then use the graded glucose infusion technique in these insulin resistant subjects to generate specific measures of both gs-is and i-cl. following these baseline measurements, salsalate or placebo will be administered for one month to the participants, after which time the ist and the graded glucose infusion will be repeated to quantify and compare the changes in imgu, gs-isr, and i-cl that have resulted from salsalate versus placebo. these results will provide for the first time quantitative data of the effect of salicylates on imgu, gs-isr, and i-cl in overweight/obese, insulin resistant, nondiabetic individuals.


Eligibility criteria:
inclusion criteria: * healthy volunteers, * bmi 25-35kg/m2, * without severe anemia, kidney, liver disease or any current gi ulcers or bleeding * or on any medication contraindicated with salsalate exclusion criteria: * recent history of gi bleed or ulcers, * cvd or on anticoagulants * severe kidney or liver disease * allergies to aspirin * taking aspirin or anti inflammatory medication on a regular basis and cannot be taken off for the duration of the study

Keywords: insulin resistant
icu delirium: a one-week snapshot of burden across the eastern uk region

Conditions: Delirium

Summary: icu delirium negatively impacts on patient outcomes, as well as on resources and clinical workflow of the icu. effective healthcare resource planning requires reliable (i.e., multicentre) data that can inform on both of these. the purpose of this study was to determine the impact of icu delirium in terms of both patients and beds. the study was carried out prospectively, over a one-week period, at adult icus comprising the norfolk, suffolk, and cambridgeshire critical care network (nsc ccn).

previous delirium prevalence research has been carried out at single sites and yielded highly variable results (between 3-87%). reliable multisite data can be obtained cost-effectively using a point-prevalence ("snapshot") approach. purpose: to obtain reliable data informing on prevalence of icu delirium, in terms of both patients and beds, across the eastern uk region. design and setting: this one-week observational prospective cohort study was carried out between june 25, 2012 (start of icu day shift) to july 01, 2012 (end of night shift). nine icus comprising the norfolk, suffolk, and cambridgeshire critical care network (nsc ccn) took part. cambridgeshire 2 research ethics committee approved the study (rec reference: 10/h0308/116) and waived the need for informed consent. patients and procedure: all adults treated over the study week at participating icus were considered eligible for inclusion. delirium screening was carried out by patients' direct care clinicians using the confusion assessment method for the icu (cam-icu). all sites used this tool as part of their routine clinical practice and had delirium management guidelines in place at the time of the study. patients who screened positive for delirium were treated according to local hospital practice.

Eligibility criteria:
inclusion criteria: * adult patients treated within study time frame on intensive care units across norfolk, suffolk, and cambridgshire, uk exclusion criteria: -

Keywords: delirium intensive care unit critical illness
functional imaging in the acute phase of transient ischemic attacks

Conditions: Transient Ischemic Attack

Summary: the aim of the study is to find a radiological biomarker of transient ischemic attacks (tia) thanks to functional magnetic resonance imaging (fmri) done within the 24 hour after symptoms onset.


Eligibility criteria:
inclusion criteria: * patient admitted in for a transient neurologic deficit and suspicion of tia of carotid circulation * prescription for conventionnal mri exclusion criteria: * contraindication to mri * previous neurological disease (with lesions) * severe psychiatric disease

Keywords: transient ischemic attack stroke functional magnetic resonance imaging
a study of tirzepatide in adolescents with obesity and weight-related comorbidities (surmount-adolescents-2)

Conditions: Obesity; Weight Gain

Summary: the goal of the study is to assess how tirzepatide impacts bodyweight and cardiovascular risk factors when used in conjunction with healthy nutrition and physical activity in adolescents with obesity and multiple weight related comorbidities. the study will last approximately 76 weeks and may include up to 23 visits.

the main purpose of this study is to evaluate the safety and efficacy of tirzepatide in adolescents that have obesity with multiple weight related comorbidities.

Eligibility criteria:
inclusion criteria: * have body mass index (bmi) equal to or above the 95th percentile for age and sex (on age and gender-specific growth chart for diagnosis of obesity) with at least 2 of the following predefined weight-related comorbidities: hypertension, prediabetes and hypertriglyceridemia. * have history of at least 1 self-reported unsuccessful dietary effort to lose weight. * are capable of giving signed informed consent by a legal representative or assent by a study participant (when applicable). exclusion criteria: * have undergone or plan to undergo a weight reduction procedure during the study, such as, but not limited to * gastric bypass * sleeve gastrectomy * restrictive bariatric surgery, such as lap-band gastric banding, or * any other procedure intended to result in weight reduction. * have a self-reported, or by parent or legal guardian where applicable, decrease in body weight greater than 5 kg (11 lbs) within 90 days before screening irrespective of medical records * have type 1 diabetes or history of ketoacidosis, or hyperosmolar state * have type 2 diabetes or have a hba1c \> 6.4% at screening * have a history of chronic or acute pancreatitis * have a family or personal history of medullary thyroid carcinoma or multiple endocrine neoplasia syndrome type 2
prophylactic mastectomy: prospective evaluation of the correlation between skin flap thickness, residual glandular tissue and skin necrosis by imaging and clinical examination

Conditions: Prophylactic Mastectomy

Summary: breast cancer is the most common form of cancer among women. five to ten percent of all breast cancers are due to hereditary factors, with pathogenic variants in the breast cancer genes brca1/2 accounting for 2-5% of all breast cancer. women with pathogenic variants in brac1/2 and other pathogenic gene mutations leading to an increased risk of breast cancer can undergo prophylactic mastectomy, reducing the risk of breast cancer up to 90%. among women who have undergone prophylactic mastectomy, 1-1,9% are diagnosed with breast cancer, but little is known about the correlation between residual glandular tissue and skin flap thickness, as well as the oncological risk of residual glandular tissue. furthermore, there is a balance between how much subcutaneous tissue should be resected to achieve maximal reduction of glandular tissue, while leaving viable skin flaps. in addition, there are established surveillance guidelines for women with pathogenic variants in brca1/2 who do not undergo risk-reducing surgery, but no published consensus or guidelines regarding appropriate medical follow-up for those who opt for prophylactic mastectomy. the aim of this study is to investigate the correlation between skin flap thickness, residual glandular tissue and skin flap necrosis following prophylactic mastectomy in women with results from postoperative magnetic resonance tomography, ultrasound and physical examination, as well as evaluate patient satisfaction and quality of life pre- and postoperatively with different questionnaires.


Eligibility criteria:
inclusion criteria: * women that are recommended prophylactic mastectomy at the department of plastic surgery at umeå university hospital due to hereditary factors that have been investigated by clinical geneticists. * age between 18-74 years exclusion criteria: * women undergoing mastectomy due to cancer. * age \ 74 years.
prediction of neonatal hyperbilirubinemia

Conditions: Hyperbilirubinemia, Neonatal

Summary: objective: to develop an evidence-based strategy for assessing the risk of significant hyperbilirubinemia in healthy term and near-term (late-preterm) neonates. hypothesis: a stepwise strategy which combines clinical parameters and serial non-invasive transcutaneous bilirubin (tcb) values could reliably predict significant neonatal hyperbilirubinemia. methods: data from neonates \>34 weeks' gestation included in the registry for neonatal hyperbilirubinemia of the well-baby nursery of the university hospital of patras, from january 2008 to december 2010 will be reviewed. the registry includes prospectively collected data such as sex, gestational age, gestation and perinatal information, mother's and infant's abo group and rh, g6pd deficiency, coombs test, type of delivery and complications, birthweight, postnatal medications and interventions, type and volume of feeding (daily), extension of jaundice, tcb measurements at intervals of 12+/-4 hours until discharge, total serum bilirubin values (if obtained), tcb or tsb measurements at follow-up, weight at discharge, need of phototherapy (inpatient or after discharge). tcb and tsb values are plotted on a hour-specific chart. a novel predictive nomogram based on tcb measurements (varvarigou et al. pediatrics 2009;124:1052-9) will be used to classify tcb values as high, intermediate, and low risk. significant hyperbilirubinemia will be defined as a tsb value above the phototherapy threshold level according to the aap 2004 guidelines statistics: independent and joint effects of various clinical factors on the development of significant hyperbilirubinemia will be evaluated by logistic regression analysis cluster analysis and chi-squared automatic interaction detection (chaid) tree method will be used to develop the strategy. at each step, chaid chooses the independent (predictor) variable that has the strongest interaction with the dependent variable. categories of each predictor are merged if they are not significantly different with respect to the dependent variable.


Eligibility criteria:
inclusion criteria: * healthy term and late-preterm neonates exclusion criteria: * admission to the nicu
tci999 in the efficacy verification program of hair and body health care

Conditions: Hair Loss

Summary: to assess tci999 on hair and body health care


Eligibility criteria:
inclusion criteria: * healthy adults aged above 20 years old exclusion criteria: * subject who is not willing to participate in this study. * patients with diseases of the skin, liver, kidney. * subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. * female who is pregnant or nursing or planning to become pregnant during the course of the study. * the students taught by the pi. * subjects who have wounds on the scalp and subjects who have used drugs to treat the scalp, received hair transplants or other scalp treatments within six months
esophageal self-expandable metal stent for malignant strictures: a safety and efficacy study

Conditions: Oesophageal Cancer

Summary: a single center prospective observational non-randomized clinical study to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (sems) for palliation of patients with malignant dysphagia.

objective: to assess the safety and efficacy of placement of a new esophageal self-expandable metal stent (sems) for palliation of patients with malignant dysphagia. study design: single center prospective observational non-randomized clinical study. study population: a total of 20 patients with malignant dysphagia will be included. sample size calculation does not apply for this type of study. outcome of the study (efficacy and safety) will be compared to our historic esophageal stent database, including over 1000 patients.

Eligibility criteria:
inclusion criteria: * patients presenting with dysphagia due to a non-curable malignant obstruction of the esophagus or esophagogastric junction including extrinsic malignant compression and recurrence in post-esophagectomy patients; * requiring treatment for dysphagia (ogilvie score of 2-41); * life expectancy of less than 12 months; * written informed consent; * age ≥ 18 years. exclusion criteria: * stenosis after laryngectomy; * distance between the upper edge of the stent less than 2 cm from the upper esophageal sphincter; * tumor length of more than 14 cm; * previous stent placement for the same condition; * coagulopathy (not corrected prior to stent placement); * patients with eosinophilic esophagitis or an esophageal motility disorder; * nickel titanium (nitinol) allergy.
a comparative study between vacuum therapy dressing and conventional dressing in management of diabetic wounds

Conditions: Diabetic Wound

Summary: diabetes is a global epidemic and a leading cause of death by disease. an estimated 366 million people worldwide had diabetes in 2011.(1).the incidence of diabetic foot ulcers (dfus) and diabetic complications increases as the age increases.(2).up to 25% of patients with diabetes will suffer from a foot ulcer during their lifetime. ulceration is a pivotal factor in the causal pathway to infection and amputation.(3,4).diabetic foot ulcers (dfus) are the main cause of hospitalization in diabetic patients and they are considered a worldwide health problem. in recent years, the improvement in diabetes therapy and the reinforcement of guidelines have reduced the amputation rate.(5).the etiology of dfu is complex and rarely unifactorial. in general, foot ulcers are the cumulative result of repetitive trauma that wears a hole in the skin. the triad of neuropathy, foot deformity, and minor considers as the major contributing factors of ulcer development.(6).vacuum therapy or negative pressure wound therapy is a technology uses a piece of foam in contact with the wound bed, covered by an occlusive dressing and placed under sub atmospheric pressure.(7).in other words npwt is a non-invasive therapy system that uses controlled negative pressure using a vacuum device to promote wound healing by removing fluid from open wounds through a sealed dressing or a foam dressing connected to a collection container using sub-atmospheric pressure.(8).the system produces granular tissue that has a characteristic rough appearance. the device can decrease the depth and area of large diabetic foot wounds into a shallow, smaller wound.(8,9).npwt was first proposed by argenta and morykwas in 1997. from then it has been approved as an effective modality of dressing in chronic wounds.(1).npwt is a safe modality of dressing it has shown a few complications. minor complications encountered in the vacuum-treated patients : erosion of adjacent tissue due to increased local pressure underneath the tubing ,mild reactions of the peri-wound area (i.e. maceration and eczema) , and sudden increase in body temperature.(10)


Eligibility criteria:
inclusion criteria: * adult patients with diabetic non ischemic wounds which match the criteria suitable for the procedure. exclusion criteria: * • patients with chronic limb ischemia non-palpable distal pulsation. * lack of good hemostasis in the wound. * patients with malignant ulcers. * hepatic patients and patients receiving radio or chemotherapy. * wounds over untreated osteomyelitis. * wounds with fistulae to organs or body cavities. * presence of necrotic tissue. * exposed arteries/nerves/anastomotic site/organ
the hiho study: hospital inpatient vs home rehabilitation after total knee replacement

Conditions: Osteoarthritis

Summary: total knee replacement (tkr) surgery is a common and highly effective treatment option for alleviating the pain and disability caused by chronic arthritis. the associated rehabilitation costs, however, impose a significant burden on the health system. in particular, inpatient rehabilitation - utilised by approximately 43% of private tkr recipients in nsw and 29% australia-wide is of greatest concern, costing, on average, $7000 (au) per inpatient episode. the overarching aim of this study is to establish whether inpatient rehabilitation is necessary after tkr for patients with osteoarthritis (oa) who could otherwise be discharged directly home. the main hypothesis to be tested by the proposed study is that tkr recipients who receive inpatient rehabilitation in addition to participating in a home programme, compared to patients who participate in a home programme only, will achieve a superior level of mobility. if superiority is shown, a cost-effectiveness analysis will be undertaken. secondary hypotheses to be tested relate to patient-reported knee pain and function, health-related quality of life, functional ambulation, and knee joint mobility. superiority in these outcomes will be evident at six months after surgery.

as preferences for therapy can be a confounder in rcts, patients will be asked their preference for rehabilitation post tkr, prior to randomisation. patients will be randomised once a hospital bed is available.

Eligibility criteria:
inclusion criteria: * consecutive patients presenting for elective, primary, unilateral tkr at the whitlam joint replacement centre (fairfield hospital) will be screened for eligibility at the pre-admission clinic by the study project manager (pm). * primary diagnosis of oa exclusion criteria: * predisposition for requiring prolonged inpatient supervision (eg requiring assistance with at least one personal activity of daily living or lack of social support) * inability to comprehend the study protocol. * catastrophic complication arising post-surgery which precludes rehabilitation commencing within 2-3 weeks of surgery
comparison of sofosbuvir/velpatasvir fixed dose combination for 12 weeks with sofosbuvir and ribavirin for 24 weeks in adults with chronic genotype 3 hcv infection

Conditions: Hepatitis C Virus Infection

Summary: the primary objectives of this study are to compare the efficacy of treatment with sofosbuvir/velpatasvir (sof/vel) fixed-dose combination (fdc) for 12 weeks with that of sofosbuvir (sof) + ribavirin (rbv) for 24 weeks and to evaluate the safety and tolerability of each treatment regimen in participants with chronic genotype 3 hepatitis c virus (hcv) infection.


Eligibility criteria:
inclusion criteria: * willing and able to provide written informed consent * hcv rna ≥ 10\^4 iu/ml * hcv genotype 3 * chronic hcv infection (≥ 6 months) * females of childbearing potential must have a negative serum pregnancy test * males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception exclusion criteria: * current or prior history of clinically-significant illness (other than hcv) that may interfere with subject treatment, assessment or compliance with the protocol * screening ecg with clinically significant abnormalities * laboratory results outside of acceptable ranges at screening * pregnant or nursing female or male with pregnant female partner * chronic liver disease of a non-hcv etiology (e.g., hemochromatosis, wilson's disease, alfa-1 antitrypsin deficiency, cholangitis) * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv)

Keywords: sofosbuvir velpatasvir sof/vel gs-5816 hepatitis c hcv cirrhosis genotype 3