Kornimate/medical-research-clean huggingface dataset:
reduced planning target volume (ptv) margins for the treatment of prostate cancer using the calypso 4d localization system

Conditions: Prostate Cancer

Summary: this prospective study evaluates the clinical utility of a novel real-time localization system allowing for smaller volumes of normal tissue to be included in radiation field and determines dosimetric parameters and adverse effect profiles of radiation therapy using this technology. subjects will have beacon transponders implanted into the prostate to more precisely localize the position of the organ during radiation therapy. hypothesis: 1. treatment with highly targeted radiation therapy can be delivered in a daily treatment time consistent with routine clinical practice. 2. highly targeted radiation therapy with reduced ptv margin will result in a significant decrease in rectal and bladder volume treated.

this study will seek to establish the clinical feasibility of a novel real-time localization and tracking system for use of reduced ptv margins during intensity modulated radiation therapy (imrt), which will allow treatment of smaller volumes of normal tissue during radiation therapy. such a reduction in the ptv margins and the exposure of healthy tissue during treatment may allow for several future improvements in prostate radiotherapy including: * decreased acute and chronic adverse effects with similar local tumor control * dose escalation to achieve higher cure rates with similar adverse effects to standard dose treatment * hypofractionation to shorten the time of, and lower the expense of, treatment without increased adverse effects.

Eligibility criteria:
inclusion criteria: * histologically confirmed adenocarcinoma of the prostate * low risk: t1a, t1b, t1c, t2a; gleason score less than 7, psa less than or equal to 10 * intermediate risk: t2b, t2c; gleason score less than or equal to 7, psa less than or equal to 15 * ability to comply with study schedule * age 40 or older * zubrod ps 0 or 1 * signed informed consent exclusion criteria: * node positive or metastatic prostate cancer * prior treatment of prostate cancer with surgery, chemotherapy, cryotherapy or brachytherapy * history of prior pelvic radiotherapy * history of abdominoperineal resection * history of hiv infection * history of chronic prostatitis or chronic cystitis * history of bleeding disorder or any active anticoagulation (excluding asa) * pt or inr outside normal range for institution * active implanted devices such as cardiac pacemakers and automatic defibrillators. * prosthetic implants in the pelvic region that contain metal or conductive materials (eg., an artificial hip). * patients with maximum anterior-posterior separation through the torso minus the height of the center of the prostate greater than 17 cm (technical reason for calypso system, see appendix 8). * prior history of androgen deprivation therapy has been deleted and these patients are allowed on study.

Keywords: reduced planning target volume radiation therapy calypso
oral iohexol for fecal/fluid tagging for ct colonography: a study to improve image quality by preventing colonic bubbles

Conditions: Colorectal Neoplasms

Summary: to determine whether colonic bubbles associated with ct colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

ct colonography (ctc) is a recently developed radiological examination to find colorectal neoplasia. fecal/fluid tagging using oral administration of contrast is an essential procedure for ctc. iohexol, which has recently started being used as an agent for fecal/fluid tagging, has great advantages as it has much more tolerable taste and much lower rates of adverse effects such as clamping or diarrhea compared with traditionally used gastrografin/gastroview. however, iohexol is frequently associated with an occurrence of a lot of bubbles in the colon, which makes ctc interpretation more time-consuming and laborious. past experience in colonoscopy field suggests that simethicone, a safety-proven highly inexpensive over-the-counter medicine, might resolve this issue. given the fact that patient convenience is an important factor for a successful ctc and the fact that time-intensive nature of ctc interpretation is one of the major deterrents to wide spread adoption of ctc while ctc also needs to be as time efficient as possible in order to effectively serve the role of population screening for colorectal cancer, investigating the effect of simethicone to prevent the colonic bubbles on the time efficiency of ctc interpretation would be important. if simethicone can resolve the colonic bubble problem, ctc can be performed more conveniently for the patients as well as for the interpreting radiologists. this study is to determine whether colonic bubbles associated with ct colonography performed with iohexol for fecal/fluid tagging could be reduced by adding simethicone to the standard cathartic preparation.

Eligibility criteria:
inclusion criteria: * adult patients who are schedule to undergo colonoscopy for a suspicion of colonic neoplasia at the investigators' institution * those who agree to participate in the study exclusion criteria: * colonoscopy for reasons other than detecting colonic neoplasia, e.g. evaluation of inflammatory bowel disease * contraindications to iodinated contrast including renal insufficiency, hypersensitivity, and hyperthyroidism * acute severe colonic obstruction which is likely preclude safe and successful performance of ctc * patient who is suspicious for colonic perforation * pregnancy * phenylketonuria (contraindication to simethicone)
safety of regional citrate anticoagulation (sarca study)

Conditions: Acute Kidney Injury; ESRD

Summary: this is an open-label, prospective, multicenter study to assess the safety of regional citrate anticoagulation delivered by the multifiltratepro system in adult patients requiring continuous renal replacement therapy (sarca study).

in short, aki is a major complication in intensive care patients, often occurring in the context of multiple organ failure, and some of these patients may need crrt. the major advantage of crrt is improved hemodynamic stability compared to intermittent hd. continuous anticoagulation during crrt may be needed to prevent premature clotting of the circuit and deliver the prescribed dialysis dose. unfractionated heparin is the most commonly used anticoagulation during crrt mainly as a result of familiarity, low cost, and ease of administration. but the main drawback is the risk of bleeding. an alternative technique to avoid systemic anticoagulation is regional extracorporeal anticoagulation with citrate (rca). the advantages of rca are improved circuit patency and fewer bleeding complications. the use of rca may also reduce the icu staff workload. studies have shown longer filter running times which reduced circuit change and set-up time. in addition, anticoagulation related bleeding, and crrt-related blood transfusions were minimized. therefore, crrt with rca might be more economical than conventional anticoagulation. the study is to explore the possibility of using the multifiltrate pro system with the ci-ca module, cifoban® (trisodium citrate 4%), calrecia® (calcium chloride dihydrate), ci-ca dialysate k2 and k4, av1000 (disposable cassette), and multibic solution in subjects who are critically ill and receiving crrt in an acute setting.

Eligibility criteria:
inclusion criteria: 1. signed informed consent form by * the subject or * a legally authorized representative (lar), if the subject is unable to consent 2. adult patients ≥ 18 years old 3. diagnosis of aki or end-stage kidney disease (eskd) requiring crrt 4. vascular access - dialysis catheter with size and location per institutional practice exclusion criteria: 1. metabolic alkalosis as defined by serum bicarbonate greater than 30 mmol/l and arterial ph greater than 7.55 2. a female who is pregnant or breast feeding 3. severe liver disease defined as international normalized ratio (inr) greater than 2.0 and total bilirubin greater than 5 mg/dl, and both aspartate aminotransferase (ast) and alanine aminotransferase (alt) greater than 3 times upper limit of normal 4. subjects currently enrolled in or who have completed any other investigational drug or device study within last 30 days prior to signing informed consent 5. previous participation in a similar or the same study. 6. subjects already on continuous renal replacement therapy 7. subjects with active covid-19 infection 8. subjects cannot tolerate citrate therapy defined as severe liver disease (see exclusion criteria #3), shock with muscle hypoperfusion and known hypersensitivity to citrate
green and healthy schools

Conditions: Cognitive Function 1, Social; Cognitive Change; Emotions; Weight, Body; Pollution; Exposure

Summary: this project aims to investigate the health effects of making schools greener and more biodiverse. we will mainly focus on cognitive effects, well-being, and bmi. the research hypothesis is that greening schools positively influences the health of children through more exercise and cleaner air.

spending time in nature has been associated with improved physical and mental health and well-being. developing nature-based health-promoting interventions such as providing more nature in schools to improve children's well-being will lead to benefits for society in our rapidly urbanizing world. although the benefits of exposure to nature have been demonstrated, knowledge of integrating exposure to nature into public health guidelines is scarce. the latter requires an interdisciplinary approach that integrates the impact of nature-based interventions both on health and on the cost-effectiveness of interventions. little is known about the health effect of greening and, in particular, increasing biodiversity in schools and we want to investigate further with this study. this project, therefore, aims to investigate the health effects of greening primary schools and increasing biodiversity and will mainly focus on the effects on cognition, well-being, and bmi. for this, all children from 4th to 6th grade in the participating schools will be invited to participate in this study (belgium). this study comprises control schools and intervention schools, the schools are examined before the greening and after the greening. when the informed consent form is signed by the parents, they complete a questionnaire that assesses the child's diet, physical activity, and general questions. a urine sample will be taken for the determination of black carbon particles. the child will also perform computer tests measuring different aspects of "cognition". during these tests, we will also look at the eye movements that play an important role in the cognitive ability of the child. to get an idea of a possible effect on bmi, height and weight will be measured. the child fills in a welfare questionnaire and a questionnaire about the perception of nature itself.

Eligibility criteria:
inclusion criteria: * being in 4th, 5th, or 6th grade * signed informed consent form by a legal representative exclusion criteria: * no knowledge of dutch

Keywords: greening of schools biodiversity cognition bmi
randomized controlled trial (rct) of open debridement versus tenex

Conditions: Orthopedic Devices Associated With Misadventures

Summary: lateral epicondylitis (tennis elbow) can cause pain and keep individuals from completing their daily activities and require them to miss work. there are currently different treatment options to address tennis elbow. however surgeons do not know if one is better than the other. this study will compare two treatment options for tennis elbow. participants will either be treated by ultrasound-guided percutaneous tenotomy technique or open surgical debridement. traditional open surgical debridement is a surgical procedure that requires the surgeon to make an incision to remove the damaged tissue. this procedure is done under anesthesia in a surgery center. in the tenex procedure, the surgeon inserts a special needle into the damaged portion of the tendon under ultrasound guidance. ultrasonic energy vibrates the damaged tissue and it can be suctioned out. this procedure is done with local anesthesia in surgeon's office.

during the initial screening visit, the physician will obtain your medical history and perform a physical exam. if you pass the screening, you will be randomized into either ultrasound-guided percutaneous tenotomy technique or open surgical debridement. it will be a 50% chance. it will be compared to flipping a coin. once you have been placed in your treatment group, your treatment will be scheduled. you will then undergo your procedure and provided referral for physical therapy. you will also have follow up appointments with your physician to monitor your progress at 3 week(visit 3), 5 weeks (visit 4), 3 months (visit 5) 6 month (visit 6), and 12 month (visit 7) time points. you will also be requested to complete two patient questionnaires about your progress at visits 3-7.

Eligibility criteria:
inclusion criteria: * individuals 18-70 years of age * clinically documented chronic lateral epicondylitis with a minimum of 6 months of persistent elbow pain that impedes daily activities. * failed alternative treatment for \> 3 months. exclusion criteria: * surgical procedure on affected extremity within last six months. * dermatological disorder in affected area * currently pregnant, confirmed via pregnancy test. * blood disorders, autoimmune disorders, disorders requiring immunosuppression, cancer, malignancies, an ongoing infectious disease, or sickle cell or other blood disorders. * failed prior surgical procedure on the affected joint. * no prior effort to treat (stretching, rest, medication) or implementation of external protocol in an effort to improve condition (physical therapy, massage treatment, rehabilitation techniques).
phase i study of the clinical pharmacology of azithromycin in buffy coat of hiv-infected subjects.

Conditions: Bacterial Infections; HIV Infections

Summary: to compare the uptake of azithromycin in white cells relative to plasma concentrations in hiv-infected patients.

patients are randomized to receive azithromycin orally or intravenously, with crossover to the alternate treatment after a 21-day wash-out period.

Eligibility criteria:
inclusion criteria concurrent medication: allowed: * antiretroviral agents, provided regimen has been stable for at least 1 month. patients must have: * hiv infection. * cd4 count \<= 200 cells/mm3. * no active opportunistic infection (pending discussion with pfizer clinician). prior medication: allowed: * prior antiretroviral agents. exclusion criteria co-existing condition: patients with the following symptoms or conditions are excluded: * active intercurrent illness (pending discussion with the pfizer clinician). * allergies to macrolide antibiotics. * signs and symptoms of severe illness that would preclude treatment. patients with the following prior conditions are excluded: * history of clinically significant allergic, hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, or neurological disease. * clinically important change in baseline status within 4 weeks prior to study entry. * condition affecting drug absorption (e.g., ulcers, gastrectomy, hiv-associated enteropathies) within 4 weeks prior to study entry. prior medication: excluded: * investigational drugs including treatment ind drugs within 4 weeks prior to study entry. known drug or alcohol dependence.

Keywords: acquired immunodeficiency syndrome azithromycin bacterial infections
analysis of body composition in patients with hepatocellular carcinoma in radioablation

Conditions: Liver Carcinoma

Summary: number of shows: 20 patients track: a month with three visiting intervention: nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, psychometric hepatic encephalopathy score and critical flicker frequency.

there will be a prospective, longitudinal, comparative. it included 20 patients diagnosed with hepatocellular carcinoma. as there are a finite number of active patients at the institute, and no studies with sample size well established, has seen a sample size of 20 patients. the duration of individual monitoring shall be one month to three visits (baseline, week 2 and week 4 after receiving the first radiofrequency ablation). each visit will be a nutritional assessment including anthropometry, bioelectrical impedance, biochemical tests, psychometric hepatic encephalopathy score (phes) and critical flicker frequency (cff). anthropometric measures to be taken are weight, height and arm circumference average. bioelectrical impedance will be using a single frequency impedance meter (425 to -50 khz, range 0 to 10,000) bioelectrical body composition analyzer quantium ii rjl systems. the team measured the subjects' impedance, resistance, reactance and phase angle by lean body program provided by the manufacturer. hepatic encephalopathy be evaluated by testing phes and was measured cff, also also be measured ammonium, tumor necrosis factor, il-1, il-6, il-10, renin angiotensin aldosterone.

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of hepatocellular carcinoma, treatment-naive and who are referred to the radiology department for radioablation as first therapy. * outpatients. * willingness to participate in the project. exclusion criteria: * patients with hepato-renal diseases. * patients diagnosed with hepatocellular carcinoma undergoing chemoembolization treatment, or who have received more than one session radioablation. * patients with depression or psychiatric illnesses * patients who do not agree to participate in the project. exclusion criteria: * incomplete applied tests * disagreement of the person to perform any of the tests * monitoring breach * hospitalization or death after the first session radioablation.

Keywords: hepatocellular carcinoma radioablation
a study of alrt 1057 topical gel in patients with aids-related kaposi's sarcoma

Conditions: Sarcoma, Kaposi; HIV Infections

Summary: the purpose of this study is to see if alrt1057 gel is safe and effective in treating kaposi's sarcoma (ks) when applied to skin .

this is a phase 3 double-blind study. ks patients are randomized to 1 of 2 treatment arms. they receive either alrt1057 gel or placebo for 12 weeks. if progressive disease for ks is noted before week 12, patients are switched to the other blinded treatment arm. if a response or disease progression that has not persisted for at least 4 weeks as of week 12 occurs, treatment on the blinded arm is continued for up to 4 additional weeks, or until response of disease progression is confirmed. after that time or after 12 weeks of treatment, open-label alrt1057 may be received.

Eligibility criteria:
information not available
omega3 pufa in head trauam

Conditions: Traumatic Brain Injury

Summary: traumatic brain injury (tbi) is major health problem that stands as a significant cause of death and permanent disability. tbi is considered as global public health epidemic. on pathophysiologic basis, tbi is described as occurring in two phases, primary and secondary. once a primary insult occurs like trauma or ischemia, the secondary injury begins though main four mechanisms; ischemia, brain edema, axonal injury and neuro-inflammation. omega-3 pufas (polyunsaturated fatty acids) are postulated to have neuroregenerative properties with the ability to impact all four main mechanisms of the secondary injury patients will be allocated into one of two groups through a random table generation; control group in which patients will follow our local protocol for tbi management without smof-lipid infusion. smof-lipid group in which patients will receive 0.5 g/kg smof lipid 10% emulsion (lipid emulsion for intravenous nutrition containing; 6% soybean oil / 6% medium chain triglycerides / 5% olive oil / 3%fish oil) daily over 12 hours starting once admitted to icu for 7 days


Eligibility criteria:
inclusion criteria: * mild to moderate head trauma exclusion criteria: * sensitivity to smof lipid severe head trauama
eoe(eosinophilic esophagitis)

Conditions: Eosinophilic Esophagitis; Dysphagia

Summary: to evaluate quantitative magnetic resonance imaging(mri) as a potential non-invasive, radiation-free diagnostic tool for evaluating esophageal wall remodeling (thickness and stiffness) and response to treatment in children and adolescents with newly diagnosed eosinophilic esophagitis (eoe) presenting with dysphagia (difficulty swallowing) and food impaction.

eosinophilic esophagitis(eoe) is a form of chronic inflammation affecting the esophagus which often results in wall thickening and esophageal stiffening and is associated with complications, such as esophageal tears and strictures (narrowings). chronic dysphagia and acute food impaction (swallowed food stuck in the esophagus) are common symptoms of eoe and are associated with esophageal wall thickening and stiffness. current diagnostic techniques such as endoscopy with biopsy give only limited information about changes in the esophageal wall in eosinophilic esophagitis(eoe). in routine clinical practice, repeat endoscopic evaluation with biopsy is commonly performed about 3-6 months after initial therapy for eosinophilic esophagitis(eoe). however, follow-up endoscopy with biopsy has drawbacks as it is invasive, costly and typically requires deep sedation or general anesthesia. we propose to evaluate quantitative mri as a potential non-invasive diagnostic option for evaluating esophageal wall remodeling in patients with eosinophilic esophagitis(eoe).

Eligibility criteria:
inclusion criteria: 1. pediatric patients ages 8 to 18 years of age. 2. pediatric patients with dysphagia(difficulty swallowing) or an episode of food impaction. 3. pediatric patients newly diagnosed with eosinophilic esophagitis - exclusion criteria: 1. are not able to undergo an mri without needing sedation or general anesthesia 2. are allergic to gadolinium-based contrast material 3. have an ongoing acute kidney injury 4. have chronic kidney disease with an estimated glomerular filtration rate(egfr)of \<40 ml/min. 5. have a presence of eosinophilia involving the stomach and/or esophagus. 6. have a prior history of caustic ingestion 7. have a prior history of esophageal surgery, including history of tracheoesophageal fistula. 8. have known celiac disease 9. have known crohn's disease 10. have known malignancy 11. have hypereosinophilic syndrome 12. have recent history of parasitic infection 13. have known inflammatory bowel disease -
substantial equivalence study for kai medical non-contact respiratory rate monitor

Conditions: Respiration

Summary: the purpose of this study is to determine whether the respiratory rate provided by kai medical non-contact respiratory rate monitors are as accurate as that provided by the currently used methods, including respiratory chest bands.


Eligibility criteria:
inclusion criteria: * every patient undergoing an overnight polysomnography study can be included. exclusion criteria: * none