Kornimate/medical-research-clean huggingface dataset:
high dose steroid therapy to treat flares in patients with inflammatory bowel disease (ibd)

Conditions: Inflammatory Bowel Diseases; Crohn Disease; Ulcerative Colitis; Indeterminate Colitis

Summary: this study will examine whether delivery of high dose steroids, directly into the inflamed bowel via its arterial blood supply, will be better for treating uncontrolled flares of inflammatory bowel disease in patients compared to conventional intra-venous or oral administration of this drug. patients aged 4-25 years of age will be recruited. in this study, the investigator hopes to also learn how this directed steroid delivery during an active flare will improve patient symptoms as well as the appearance of inflamed segments of bowel determined by imaging or biopsy (i.e. at the time of endoscopy). additional data will determine how the blood vessels in the bowel affect, and potentially even drive the mechanisms, of inflammatory bowel disease.


Eligibility criteria:
inclusion criteria: * patients with newly diagnosis of inflammatory bowel disease (ibd) or patients who have an established diagnosis of ibd and are experiencing an acute flare which is not being controlled with first line therapy * patients present with typical ibd symptoms which will include, but are not limited to, abdominal pain, loss of appetite, rectal bleeding, diarrhea, obstruction, or passage of mucus. * patients referred by the gi team. * patients (or guardians/parents) must be able and willing to give consent (or assent where applicable) and be able to attend all study visits. exclusion criteria: * patients with mr unsafe metallic implants that will not be able to undergo the mri portion of the study. * patients with renal function impairment (gfr \&lt; 45 ml/min) preventing contrast administration. * patients with contrast allergy.
mesothelioma early detection by vocs

Conditions: Pleural Mesothelioma; Asbestos Exposure; Pleural Plaque

Summary: this is a two phase study, the first phase (phase 1) will identify potential biomarkers among asbestos exposed individuals with pleural mesothelioma. the second phase (phase 2), is a double blinded case-matched controlled study to determine the predictive capability, sensitivity, and specificity of these biomarkers in detecting early stage pleural mesothelioma. biomarkers in the form of volatile organic compounds (voc) in exhaled breath samples from subjects with either pleural mesothelioma or pleural plaques, will be evaluated. a biomarker present in serum will also be concurrently evaluated in the same cohort. the soluble serum biomarker mesothelin related peptides (smrp), which has been posited as a biomarker for mesothelioma, will be analyzed for its relationship to the breath voc profile.

mesothelioma is a rare, aggressive and treatment-resistant disease and, in the united states, is caused almost exclusively by exposure to asbestos fibers. there is often a lengthy latency period of 40-50 years between exposure and disease onset. the median age of diagnosis is 65 years while the median survival time after diagnosis of pleural mesothelioma without treatment is 9 months. symptoms, where present, may be non-specific, which further contributes to delayed diagnosis. in this study, the volatile organic compound (voc) profile of exhaled breath from subjects with histologically confirmed mesothelioma will be compared against case-matched control subjects with bilateral pleural plaques or bilateral pleural thickening. putative markers will then be tested against a blinded cohort to test predictive value of the markers. this study seeks to identify markers for mesothelioma using a non-invasive technique which samples volatile organic compounds (voc) in the breath of test subjects (owlstone medical ltd, cambridge, england). a comparison of the participant's voc profile will be made with an fda-approved, serum-based assay (lumipulse mesomark®, fujirebio diagnostics inc., malvern, pa) of the participant's soluble mesothelin related peptides (smrp) to discern parameters of efficacy..

Eligibility criteria:
inclusion criteria * male or female over 18 years of age * clinical diagnosis of pleural mesothelioma or presence of pleural plaques on x-ray * documented exposure to asbestos * must be able to provide breath sample * must be able to provide relevant medical information exclusion criteria * presence of malignancies other that mesothelioma within the past 6 months * treatment for any malignancies other than mesothelioma within the past 6 months * inability to provide past clinical information * inability to perform breath collection procedure * smoking or consuming alcohol within two hours of conducting breath collection procedure

Keywords: pleural mesothelioma bilateral pleural plaques asbestos exposure exhaled breath analysis vocs
pao2 and lung function after orthopedic surgery

Conditions: Postoperative Complications; Orthopedic Disorder

Summary: hypoxia and reduced oxygen partial pressure is commonly occurring after abdominal surgery. this study aims to investigate whether similar changes also occur after orthopedic surgery in the form of upper limb surgery. inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery. exclusion: dementia or cognitive impairment that makes it impossible to participate in studies. arterial blood gas and lung function are undertaken before surgery, the day after surgery and at follow-up.

postoperative hypoxia complicates 30% - 50% of abdominal surgeries. people at particular risk for postoperative pulmonary complications including severe hypoxia are those who undergo abdominal surgery, emergency surgery or have a respiratory failure due to chronic lung disease including obstructive sleep apnea. the cause of postoperative restrictive lung function and hypoxia is unknown. previous studies report that pao2 decreases by an average of 2 kpa after abdominal surgery, while paco2 is unchanged and vital capacity decreases by 35%. the effect of orthopedic surgery on oxygen and carbon dioxide partial pressure and lung function has previously not been investigated. this study aims to investigate possible changes in oxygen partial pressure and vital capacity after orthopedic surgery. design: prospective cohort study inclusion: 60 patients undergoing orthopedic surgery in the form o knee-, hip-, shoulder- or elbow surgery.. exclusion: dementia or cognitive impairment that makes it impossible to participate in studies. method: blood gas measurements and lung function (vital capacity and fev1) the day before surgery, the day after surgery and at follow-up. power analysis: there is a need to investigate 34 patients if the mean (sd) difference is 1 (2) kpa. due to drop-outs the investigators calculate a need to include 60 patients. primary outcome measures: • pao2 from atrial blood gas secondary outcomes * vital capacity * paco2 from atrial blood gas * forced expiratory volume in one second (fev1) other variables examined: age, sex, height, weight, type of surgery, type of anesthesia, smoking status, length of surgery and previous diseases

Eligibility criteria:
inclusion criteria: patients undergoing shoulder or elbow surgery - exclusion criteria: dementia or cognitive impairment that makes it impossible to participate in studies. not willing to participate -
ultrasonography biofeedback for diaphragm training in athletes with non-specific lumbo-pelvic pain

Conditions: Ultrasonography; Low Back Pain

Summary: objective: to determine the effectiveness of diaphragm visual biofeedback reeducation by ultrasonography in conjunction with high-intensity inspiratory muscle training versus isolated high-intensity inspiratory muscle training in athletes with lumbo-pelvic pain. methods: a single blinded randomized clinical trial will be carried out. a total sample of 80 athletes with lumbo-pelvic pain will be recruited and randomized into 2 groups: one group will be treated by isolated high-intensity inspiratory muscle training during 8 weeks, and another group will be treated with diaphragm visual biofeedback reeducation by ultrasonography during 6 weeks in conjunction with high-intensity inspiratory muscle training during 8 weeks. outcome measurements will be diaphragm muscle thickness evaluated by ultrasonography (main outcome measurement), pain intensity, pressure pain threshold, disability, quality of life and respiratory parameters by spirometry, which will be assessed before and after intervention.


Eligibility criteria:
inclusion criteria: * athletes with non-specific lumbopelvic pain during 6 weeks exclusion criteria: * neural disorders * systemic disorders * cognitive disorders
a comparison of impingement free range of motion with ct scan after manual and robotic total hip replacement

Conditions: Hip Osteoarthritis; Post-traumatic Osteoarthritis; Inflammatory Arthritis; Congenital Hip Problems; Avascular Necrosis of Hip

Summary: single-blinded randomised controlled trial comparing impingement with ct scan for manual and robotic total hip replacement. a pilot study of 50 participants.

this will be a two-arm, single blind (assessor blind), randomised controlled group study. it will take place in the nhs hospital setting. stratification will be performed for age and sex by means of a minimisation technique during randomisation for each subject entering the trial. arm 1: manual total hip replacement with conventional templating arm 2: robotic total hip replacement in the study 25 participants will receive manual thr with conventional templating; the other 25 will receive robotic thr. following recruitment in outpatient clinics, participants will undergo baseline assessments, including imaging and clinical assessment. all participants will then undergo thr surgery, which will likely entail an inpatient hospital stay of 1-2 days. post-operative rehabilitation will be in line with the normal standard care for all participants. post-operatively participants will make two visits to clinic at 6 weeks and 12 months (standard of care).

Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the trial * male or female, aged 18 to 85 years at recruitment into trial * diagnosed with hip oa, post-traumatic oa, inflammatory arthropathy, , or congenital or developmental hip disease, avascular necrosis of the hip * listed for total hip replacement * suitable for accolade 2 stem and trident cup prostheses * female participants of child bearing potential must be willing to ensure that they use effective contraception during the trial * in the investigator's opinion, is able and willing to comply with all trial requirements * willing to allow his or her general practitioner and consultant, if appropriate, to be notified of participation in the trial. exclusion criteria: * inability to provide informed consent * previous surgery to the ipsilateral hip and implantation of metalwork. * significant co-morbidities that would make follow up difficult or uncomfortable * scheduled elective surgery or other procedures requiring general anaesthesia during the trial. * pregnancy or intention to become pregnant within the trial period.

Keywords: hip replacement thr robotic arthroplasty hip surgery range of motion
long term follow-up study for raav-gad treated subjects

Conditions: Parkinson's Disease

Summary: the purpose of this observational study is the long term follow-up of parkinson's patients who participated in a clinical trial in which they received aav-gad gene transfer into the subthalamic nucleus (stn) region of the brain. patients will be followed once a year for up to five (5) years. the study will monitor and evaluate the long term effects of aav-gad and provide long term safety information.


Eligibility criteria:
inclusion criteria: * participated in a clinical trial where they received aav-gad * able to give informed consent to participate in the study exclusion criteria: * received deep brain stimulation after receiving aav-gad * received any experimental device in the brain after receiving aav-gad * had any type of brain surgery after receiving aav-gad * received any experimental therapy (drug or biologic) for parkinson's disease or any other indication after receiving aav-gad
dental anxiety in during different dental treatments (denanx)

Conditions: Dental Anxiety

Summary: the aim of this observational cross-sectional study is to evaluate the dental anxiety levels of participants aged 18-70 years who will scheduled for different dental treatmentsthe main question it aims to answer is: does the type of dental treatment make a difference in the level of dental anxiety in participants? within the scope of their dental treatment, participants who have already been planned to assign any of the filling, root canal treatments, scaling, tooth extraction and implant placement will have their anxiety levels recorded through a questionnaire just before starting treatment.


Eligibility criteria:
inclusion criteria: * voluntary participation * sufficient turkish literacy * no recent psychiatric diagnoses within the previous year * no psychotherapy in the past six months, * and no use of psychotropic drugs or illicit substances that could affect mental health in the previous year. exclusion criteria: -to stop volunteering until the study is completed.
effect of ephedrine vs. norepinephrine on prevention of fetal acidosis during cesarean section under spinal anesthesia

Conditions: Cesarean Delivery Affecting Newborn; Acidosis; Maternal Hypotension; Spinal Aneshtesia

Summary: this study compares the effects of two medications, ephedrine and norepinephrine, on the baby (fetus) when used to treat low blood pressure (hypotension) during cesarean section under spinal anesthesia. hypotension is a common side effect during spinal anesthesia, and it can affect the blood flow to the baby. both medications are commonly used to manage this condition. the goal of the study is to determine which medication is more effective and safer for the baby, by measuring the ph level in the umbilical artery after birth. the study will also examine maternal blood pressure, heart rate, and the baby's apgar scores.

this is a prospective, randomized, double-blind, controlled clinical trial designed to compare the effects of ephedrine and norepinephrine on fetal acidosis during cesarean section performed under spinal anesthesia. maternal hypotension is a frequent complication associated with spinal anesthesia, and the management of this condition is critical for maintaining adequate uteroplacental perfusion. while both ephedrine and norepinephrine are commonly used vasopressors, there is ongoing debate regarding their relative safety and efficacy, particularly in terms of fetal outcomes. the primary aim of this study is to evaluate the incidence of fetal acidosis, defined as an umbilical artery ph \< 7.20, in patients receiving either ephedrine or norepinephrine. secondary outcomes include maternal blood pressure control, heart rate, incidence of maternal and fetal tachycardia, apgar scores at 1 and 5 minutes, and the need for additional vasopressor support. a total of 100 pregnant women undergoing elective cesarean section will be enrolled, with 50 participants in each treatment group. all participants will receive standardized spinal anesthesia, and vasopressors will be titrated according to protocol. the study is designed to inform clinical decision-making regarding optimal vasopressor selection in obstetric anesthesia, with a focus on balancing maternal hemodynamic stability and fetal well-being.

Eligibility criteria:
inclusion criteria: * pregnant women aged between 18 and 45 years * singleton pregnancy at ≥ 37 weeks of gestation * scheduled for elective cesarean section under spinal anesthesia * asa (american society of anesthesiologists) physical status classification i or ii * ability to understand and sign the informed consent form exclusion criteria: * history of allergy or hypersensitivity to ephedrine or norepinephrine * multiple gestation pregnancies * diagnosis of pre-eclampsia, eclampsia, or other hypertensive disorders of pregnancy * known cardiovascular disease or arrhythmia * placental abnormalities (e.g., placenta previa, placental abruption) * fetal structural or chromosomal anomalies * morbid obesity (bmi \> 40 kg/m²) * refusal to participate or inability to provide informed consent

Keywords: fetal acidosis maternal hypotension ephedrine norepinephrine
catheter analgesia trial phenazopyrdine vs. placebo: a randomized controlled trial

Conditions: Catheter-related Bladder Discomfort

Summary: the primary aim of this randomized clinical trial is to compare the utility of phenazopyridine hcl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean vas measurments.

this is a randomized clinical trial to determine whether phenazopyridine hcl reduces catheter-related bladder discomfort, using mean vas scores and overall pain medicine requirements in women catheterized following in-patient gynecologic surgery. hypothesis and aims: we plan to test the null hypothesis that there is no difference in post-operative pain as measured by vas pain scores and pain medication requirements in women with a foley catheter following gynecologic surgery that are given phenazopyridine hcl vs. placebo. the primary aim of this randomized clinical trial is to compare the utility of phenazopyridine hcl vs. placebo in reducing catheter-associated discomfort during the post-operative period in the gynecologic patient using mean vas measurements.

Eligibility criteria:
inclusion criteria: 1. adult women undergoing gynecologic surgery who are expected to tolerate oral medication within 12 post-operative hours and require an indwelling catheter for a minimum of 12 post operative hours after start of oral medication. exclusion criteria: 1. hypersensitivity to phenazopyridine products (defined as a having a previous anaphylaxis reaction to phenazopyridine products). 2. known contraindications to phenazopyridine hcl: * renal failure or insufficiency (defined as having abnormal renal function on previous laboratory testing (bun/cr) or as having a known renal disease). * history of hepatic disease or failure (defined as having known liver disease or having elevated lfts on previous laboratory testing. patients who would not otherwise have such testing are not required to undergo special study labs). * known glucose-6-phosphate dehydrogenase deficiency. 3. simultaneous suprapubic catheterization. 4. inability to take oral medication within 12 hours after surgery. 5. pregnant women.

Keywords: phenazopyrdine post operative bladder catheritization vas scores bladder pain related to indwelling foley catheters. bladder irritaion related to indwelling foley catheters.
evaluation of safety and reduction of ear pain in adults with acute otitis media and reduction of ear pain in adults with acute otitis media

Conditions: Acute Otitis Media

Summary: the purpose of this study is to evaluate the safety and reduction of ear pain in adults with acute otitis media.


Eligibility criteria:
inclusion criteria includes but is not limited to: 1. aom diagnosis with moderate to severe bulging of the tm and recent (\< 48 hours \[h\]) onset of ear pain. 2. moderate to severe ear pain in the affected ear(s), defined as a score of ≥ 5 (on a scale of 0 10) on the nrs 11 as evaluated by the subject at screening. 3. generally good health (other than aom) as determined by evaluation of medical history and physical examination at screening. 4. negative urine pregnancy test at screening for all female subjects of childbearing potential. 5. able to read and sign written informed consent prior to study participation. exclusion criteria includes but is not limited to: 1. presence of a perforated tm at screening or had a perforated tm within 6 months (mo) prior to screening as determined by medical history 2. subjects with tympanostomy tubes 3. acute or chronic otitis externa 4. chronic otitis media defined as confirmed presence of middle ear effusion for 12 weeks or longer 5. disorders with decreased mucociliary clearance or higher viscosity of the mucous (eg, cystic fibrosis, primary ciliary dyskinesia, kartagener's syndrome) 6. clinically relevant blockage of 1 or both nasal passages, as determined by the investigator's medical judgment 7. permanent hearing loss irrespective of otitis media 8. subjects with medical conditions that may affect interpretation of the safety or efficacy of study drug as determined by the investigator's medical judgment 9. subjects with craniofacial abnormalities (eg, cleft palate, down's syndrome) 10. subjects with erythema of the tm without other evidence of otitis media 11. seborrheic dermatitis involving the affected external ear canal or pinna 12. use of medications with known vasoconstrictive properties (eg, decongestants \[afrin®, sudafed®\]) currently or within 2 h prior to screening 13. use of oral analgesics \ 2 h are permitted as long as ear pain criteria are met per inclusion criteria)
does mirabegron have a positive impact on sexual function in females with overactive bladder

Conditions: Females With Overactive Bladder Symptoms, Urgency & Urge Incontinence

Summary: 80 female patients evaluated for sexual function after receiving mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

80 female patients evaluated for sexual function after receiving mirabegron 50 mg once daily for 6 months for treatment of overactive bladder symptoms

Eligibility criteria:
inclusion criteria: * any female with overactive bladder symptoms, urgency and urgency incontinence exclusion criteria: * neurologic abnormalities * weak bladder contractility * diabetics
the artery first approach for resection of pancreatic head cancer

Conditions: Pancreatic Head Cancer

Summary: to show whether the artery first approach leads to equal or less rate of positive resection margins in pancreatic head cancer than the standard technique (ppwhipple only with standard kocher's manoeuvre)

this is a prospective non-randomized trial with two study groups. the trial is designed to show if the artery first approach reduces the rate of r1 resections in patients undergoing surgery for cancer of the pancreatic head. after the diagnosis of cancer of the pancreatic head by clinical, laboratory and imaging evaluation patients who are scheduled for resection will be screened for inclusion into the trial. informed consent is obtained at least on the day before surgery and patients meeting the eligibility criteria will be enrolled into the study.

Eligibility criteria:
inclusion criteria: * pancreatic head cancer (diagnosis by clinical, laboratory and radiological evaluation) * patients scheduled for curative resection * no evidence of distant metastases * age equal or greater than 18 years * informed consent exclusion criteria: * expected lack of compliance * impaired mental state or language problems * patient having had neoadjuvant radiochemotherapy