Kornimate/medical-research-clean huggingface dataset:
a dosimetry study of lutetium (177lu) rhpsma-10.1 and lutetium (177lu) vipivotide tetraxetan (pluvicto®) in patients with non-curative metastatic prostate cancer

Conditions: Metastatic Prostate Cancer

Summary: a randomised, multi-centre, intra-patient imaging and dosimetry crossover study of lutetium (177lu) rhpsma 10.1 and lutetium (177lu) vipivotide tetraxetan (pluvicto®) in patients with non-curative metastatic prostate cancer


Eligibility criteria:
inclusion criteria: * male patient aged ≥60 years old at visit 1 (screening). * patient has non-curative psma-positive prostate cancer that has spread outside of the prostate gland and is undergoing or being planned for radioligand therapy. * at least 1 psma-positive lesion that can be outlined on pet or ct and ≥1 cm in the short axis measured on either modality, for the purpose of dosimetry. * adequate normal organ function as demonstrated by: * absolute neutrophil count ≥1.5 × 109/l * platelets ≥100 × 109/l * haemoglobin ≥9 g/dl * total bilirubin \<2 × the institutional upper limit of normal (uln). for patients with known gilbert's syndrome, ≤3 × uln is permitted. * alanine aminotransferase (alt) or aspartate transaminase (ast) ≤3.0 × uln or ≤5.0 × uln for patients with liver metastases. * estimated glomerular filtration rate (using chronic kidney disease epidemiology collaboration creatinine equation \[2009\]) \>50 ml/min. * willing to provide signed and dated written informed consent form (icf) prior to any study specific procedures * male patients must agree not to father children or donate sperm during the study and for at least 14 weeks after the last study treatment. exclusion criteria: * known hypersensitivity to lutetium (177lu) rhpsma 10.1 or lutetium (177lu) vipivotide tetraxetan, or any of the constituents. * previous treatment with any radiopharmaceutical therapy in the 42 days or 5 half-lives prior to visit 1 (screening). * any significant metallic implants or objects, which may in the opinion of the investigator, affect image quality and/or dosimetry calculations. * severe claustrophobia, inability to lie flat or fit into the scanner, or any other inability to tolerate the spect/ct scan protocol * any change to prostate cancer medication or new prostate cancer therapy, prostate cancer surgical procedure within 42 days prior to screening or during the study. * any medical or psychiatric condition, including rapidly progressive prostate cancer, that in the investigator's judgment, makes the patient unsuitable for the study * participation in other studies involving other imps within 42 days or 5 half lives (whichever is longer) prior to visit 1 (screening) and/or during study participation
effect of intraoperative and awakening electroencephalogram on awakening agitation after general anesthesia in children

Conditions: Emergence Agitation; Anesthesia; Children's Surgery

Summary: the purpose of this study was to analyze the relationship between intraoperative and awakening electroencephalogram waveforms and awakening agitation after general anesthesia in children


Eligibility criteria:
inclusion criteria: 1. the age of the child is 1-10 years old, regardless of gender; 2. asa grading i to ii; 3. children undergoing hernia, appendix, or small orthopedic surgery under selective general anesthesia exclusion criteria: 1. respiratory infection occurred within 1 week before surgery; 2. potential or existing contraindications to general anesthesia; 3. significant abnormalities in blood routine or biochemical indicators; 4. patients with cognitive function, mental illness, or neurodevelopmental delay; 5. unable to cooperate in completing the test, the child's guardian refused to participate; 6. other reasons why researchers believe it is not suitable to participate in this experiment.
gut flora dependent metabolism of dietary phosphatidylcholine and cardiovascular disease

Conditions: Nutrition

Summary: the purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). this study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt).

the purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). this study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt). metabolism is a process that turns foods we eat into fuel for our bodies. choline is nutrient found in a type of fat commonly found in foods. there is evidence that choline metabolism by bacteria in the intestines may be linked to cardiac risk. the purpose of this study is to see if intestinal bacteria plays a role in choline metabolism (a form of choline monitored in this study is called phosphatidylcholine, also known as lecithin). this study will help to determine if choline metabolism is affected by short-term antibiotic therapy, and/or can be altered by probiotic therapy (e.g. in the form of eating yogurt). this single center study will randomize 30 normal, healthy volunteers to 1 of 3 groups: group 1: antibiotics for 1 week, followed by probiotics for 3 weeks; group 2: antibiotics for 1 week, followed by no probiotics for 3 weeks. group 3: no antibiotics for 1 week, followed by probiotics for 3 weeks. the antibiotics to be used will be metronidazole (500 mg twice daily) and ciprofloxacin (500 mg daily) for one week. the probiotics to be used will be one serving size of standard flavored yogurt (approximately 170 g) twice daily for up to three weeks. study visits will occur at baseline, 1 week, and 4 weeks. blood and urine samples will be collected at the start of each visit. subjects will then eat 2 hard boiled eggs and be given a standard medical isotope. additional blood samples will be obtained at 1, 2, 3, 4, and 6 hours, and a urine sample will be collected at 6 hours. samples will be analyzed for choline levels, its byproducts, and isotope levels.

Eligibility criteria:
inclusion criteria: * men and women age 18 years or above. * able to provide informed consent and comply with study protocol exclusion criteria: * significant chronic illness or end-organ dysfunction, including known history of heart failure, renal failure, pulmonary disease, or hematologic diseases. * active infection or received antibiotics within 2 months of study enrollment * use of otc probiotic within past 2 months, or ingestion of yogurt within past month * chronic gastrointestinal disorders, or intolerance to probiotic therapy * allergies to eggs.

Keywords: choline metabolism gut flora phosphatidylcholine lecithin
fdg pet/ct and directed metabolic core needle biopsy in the management of lymphoma

Conditions: Lymphoma

Summary: fdg-pet/ct is an established modality in various stages of management of lymphoma but definitive information regarding the diagnosis, prognostication, and further management is provided by histopathological examination. combining the two modalities may provide an incremental benefit by identifying better sites for targetting biopsy and for better verification of sites and causes of fdg uptake seen during pet/ct.

written informed consent was obtained from all the participants for pet/ct-guided biopsy. the procedure details, related risks, and benefits were explained to all the participants. a multidisciplinary team including hemato-oncologists, nuclear medicine physicians, and pathologists were involved in the project. a hemato-oncologist decided the biopsy indication after discussing it with the nuclear medicine physician. fdg avid lesions in a clinically suspected case of lymphoma or a suspicious, residual fdg avid lesion detected at the time of follow-up pet/ct imaging in a patient with a prior diagnosis of lymphoma were sampled. the per and post-procedural complications and management were maintained in the institutional pet data registry and the final histopathological diagnosis obtained was also collected.

Eligibility criteria:
inclusion criteria: * fdg avid lesion in a clinically suspected case of lymphoma. * suspicious, residual fdg avid lesion detected at the time of follow-up pet/ct imaging in a patient with a prior diagnosis of lymphoma either at the end-of-treatment or during surveillance. exclusion criteria: * deranged coagulation profile. * inaccessibility of the lesion for a percutaneous biopsy. * resolution of the lesion at the time of biopsy planning. * participant is not willing for the procedure. * pregnant females and participants less than 18 years of age.

Keywords: positron emission tomography computed tomography image-guided biopsy fluorodeoxyglucose f18 biopsy-core needle
study to investigate the efficacy and safety of fab122 (daily oral edaravone) in patients with amyotrophic lateral sclerosis

Conditions: Amyotrophic Lateral Sclerosis

Summary: multicenter, multinational, double-blind, randomized (2:1), placebo-controlled phase iii study to investigate the efficacy and safety of 100 mg fab122 once daily as oral formulation in als patients.


Eligibility criteria:
main inclusion criteria: * age 18 - 80 years (both inclusive), male or female; * diagnosis of definite, probable, probable laboratory supported or possible als as based on the el escorial and the revised airlie house diagnostic criteria for als; * onset of first symptoms\* no longer than 24 months prior to randomization; \*date of onset is the date the patient reported one or more of the following symptoms: * muscle weakness in limbs * speech/swallowing difficulties * respiratory symptoms: dyspnea was noticed * svc equal to or more than 70% of the predicted normal value for gender, height and age at screening visit; * change in alsfrs-r score between 0.35 points and 1.5 points per month (both inclusive) in the period from onset of first symptoms to the screening visit; * capable of providing informed consent and complying with trial procedures. main exclusion criteria: * diagnosis of primary lateral sclerosis; * diagnosis of frontotemporal dementia; * diagnosis of other neurodegenerative diseases (e.g. parkinson disease, alzheimer disease); * diagnosis of polyneuropathy; * other causes of neuromuscular weakness; * have a significant pulmonary disorder not attributed to als and/or require treatment interfering with the evaluation of als on respiratory function; * use of intravenous (iv) edaravone within 6 months of the screening visit; * depend on mechanical ventilation (invasive or non-invasive) or require tracheostomy at screening; * renal impairment as indicated by a creatinine clearance of less than 50 ml/min as calculated by the cockcroft gault equation; * subject has a history of clinically significant hepatic disease, hepatitis or biliary tract disease, or subject has a positive screening test for hiv, hepatitis b or c;
asthma control in elderly patients with montelukast

Conditions: Persistent Asthma; Elderly

Summary: to compare the efficacy of combination therapy of montelukast plus low dose inhaled budesonide and single therapy of medium dose inhaled budesonide on asthma control such as inflammatory markers and clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma


Eligibility criteria:
inclusion criteria: * patients aged 60 - 75 years * patients diagnosed with asthma (nih, 2007) over six months ago * patients maintaining monotherapy of low dose inhaled budesonide (pulmicort 400µg/day or ciclesonide 160 µg/day or fluticasone 250 µg/day) or combination of low dose inhaled budesonide and laba (seretide® 250 µg/day or symbicort® 320 µg/day ) for over a month before the participation in this trial * patients not reaching 'well controlled asthma status' with four-week monotherapy of low dose inhaled budesonide (pulmicort 400 µg/day) * patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by irb of ajou university medical center before the participation in this trial exclusion criteria: * patients who show a symptom of an acute disease within 28 days before the beginning of this trial (administration of trial medication) * volunteers who are found to be unsuitable through screening tests * patients with history of hypersensitivity to montelukast or budesonide * patients participating in other clinical trial within three months before the beginning of this trial (administration of trial medication) * current smokers having more than 10pys of smoking history * patients needing administration of a medication which can affect asthma control such as systemic and immunoregulatory drugs (cyclosporin, omalizumab, etc.) due to a disease except asthma

Keywords: asthma control in elderly patients age 60-75
bedside ultrasound by anesthesiologists for screening deep venous thrombosis

Conditions: DVT

Summary: the study is designed as a prospective comparative study. all patients will receive prophylactic anticoagulation according to routine hospital protocol after surgery. a bedside ultrasound examination will be performed by a trained anesthesiologist prior to the surgery and then daily beginning on postoperative day 2 until patient discharge.

recent studies conducted at the emergency department evaluated the usefulness of an abbreviated bedside compression ultrasound test for diagnosis of deep venous thrombosis (dvt) in the proximal region. this abbreviated ultrasound test conducted in the groin and popliteal regions to assess the compressibility of the femoral and popliteal veins required as little as 3.5 min to complete 15 and can be easily mastered by residents with minimum training. these studies showed a promising sensitivity ranging from 70% to 100% and a specificity ranging from 75.9% to 99.6%. anesthesiologists are now well-trained in performing ultrasound scans as they perform ultrasound-guided peripheral nerve blocks routinely. scanning for significant proximal dvt could potentially be anesthesiologists' extended role as they follow up patients who underwent orthopedic surgeries for postoperative pain control as part of the acute pain service.

Eligibility criteria:
inclusion criteria: * asa physical status i-iii * 18-85 years of age, inclusive * 50-110 kg, inclusive * 150 cm of height or greater * patients who are scheduled to have surgical repair of the fractured hip and those who will have unilateral or bilateral, primary or revision, hip or knee arthroplasty. exclusion criteria: * the presence of indwelling femoral vascular catheter or dialysis vascular shunts in the operative leg * an above-knee amputation * the inability to access all two landmarks (femoral and popliteal veins) for two-point ultrasonography because of the presence of a cast, external fixation apparatus, or other obstacles

Keywords: dvt tka tha hip fracture high risk ultrasound u/s
automated diabetes registry tools to enhance patient self-management and provider performance feedback

Conditions: Diabetes

Summary: can we improve diabetes outcomes through 1) report card mailings to patients 2) point of care distribution of report cards to patients and 3) provider performance feedback with patient level data?

our federally qualified health care center serves over 7000 diabetic patients, many of whom are uninsured (43%) or on medicaid (18%) or medicare (26%). the population is 54% latino, 25% caucasian, and 14% african american. we excluded patients older than 75; those without english or spanish as a first language; and the homeless. the remaining 5457 patients were randomized to this one-year study which ended january 1, 2009. one-half of the enrolled patients received quarterly mailed report cards on their hga1c, blood pressure, and lipid performance. they were asked to pick from a list of self-management goals and to see their provider if their last visit was more than 2 months prior to the mailing. in a 2x2 design, our eight clinics were randomized to i) on-site printing of patient report cards or no on-site printing and ii) standard provider performance report cards or enhanced provider report cards. the standard provider report cards included data on provider performance on hga1c, ldl, and blood pressure compared to other providers. the enhanced provider report card also included a list of up to 10 patients not at hga1c, ldl, or blood pressure goal. the provider report cards were distributed on a quarterly basis, and the point of care patient report cards were distributed at every clinic visit. we are analyzing the impact of the intervention on the percent of patients at expert recommended goals for glycemic, lipid, and blood pressure control. we are also performing a qualitative analysis to describe provider and patient attitudes toward the interventions.

Eligibility criteria:
inclusion criteria: * icd9 code for diabetes * primary care visit in the past 18 months * english or spanish as primary language exclusion criteria: * age more than 75 * no working address

Keywords: diabetes registry computer self management
the complete study

Conditions: Coronary Artery Disease

Summary: the complete study is a single-centre, investigator-initiated study of patients with an indication for invasive coronary angiography with ccta performed during the diagnostic evaluation. after identifying the presence of a coronary stenosis, defined as an epicardial lesion \>50% stenosis on ccta, patients eligible for the study will be invited to participate. the main aim of this trial is to assess the accuracy of coronary ct angiography to quantify total atheroma volume with intravascular ultrasound as reference. patients will be divided into 2 sub-groups: cohort 1: patients with stable coronary artery disease or stabilized acute coronary syndromes with a clinical indication for invasive coronary angiography. cohort 2: patients previously revascularized with a metallic stent with a clinical indication for invasive coronary angiography. in both cohorts, patients should have undergone coronary ct angiography as part of the standard of care. patients included in the study will be managed according to the standard of care for the assessment of coronary artery disease. clinical follow-up will be collected until 3 years follow-up.


Eligibility criteria:
inclusion criteria: 1. epicardial stenosis more than 50% by visual assessment. exclusion criteria: 1. stemi. 2. hemodynamic instability. 3. rapid atrial fibrillation, flutter or arrhythmia (hr \> 80 bpm). 4. insufficient ccta image quality. 5. age \<18 years. 6. chronic obstructive pulmonary disease. 7. contraindication to adenosine. 8. nyha class iii or iv, or last known left ventricular ejection fraction \<30%. 9. uncontrolled or recurrent ventricular tachycardia. 10. history of recent stroke (≤90 days). 11. prior myocardial infarction. 12. history of ischemic stroke (\>90 days) with modified rankin score ≥ 2. 13. history of any hemorrhagic stroke. 14. previous coronary artery bypass surgery. 15. active liver disease or hepatic dysfunction, defined as ast or alt \> 3 times the uln. 16. severe renal dysfunction, defined as an egfr \<30 ml/min/1.73 m2. 17. bmi \>35 kg/m2. 18. nitrate intolerance 19. contra-indication to heart rate lowering drugs. 20. unable to provide written informed consent.

Keywords: ffrct
the modified ketogenic diet for the treatment of pharmacoresistant epilepsy in adults

Conditions: Epilepsy

Summary: the modified ketogenic diet for the treatment of pharmacoresistant epilepsy in adults: an observational cohort study

epilepsy is a common neurological condition. unfortunately, just over 30% of patients with epilepsy (pwe) do not become seizure free with anti-epileptic drugs. some patients may be suitable for epilepsy surgery. alternative established treatments include vagal nerve stimulation and the ketogenic diet in children. the evidence base for the use of ketogenic diet in adults is limited. there are a few prospective studies and no randomised control trial to date. this study is a prospective observational cohort study for adult patients with drug resistant epilepsy who are not suitable for resective epilepsy surgery. the intervention is a modified ketogenic diet. the carbohydrate load will be between 20-30gm per day. blood ketones and blood sugars will be monitored. the primary outcome measure is seizure frequency at 12 months. there are a number of secondary outcome measures including tolerability, seizure severity, quality of life, lipid profiles and health care utilisation.

Eligibility criteria:
the study will have no formal inclusion/exclusion criteria as it is purely observational and it will be the clinical team's decision as to whether or not people are seen by the dietary clinic based on established dietary clinic protocols.
the effect of intraoperative goal directed restricted fluid therapy on extravascular lung water

Conditions: Surgery

Summary: the aim of this study is to compare the use of goal directed fluid therapy guided by stroke volume variation plus a restricted fluid management approach to standard fluid management in patients undergoing major abdominal operations.

perioperative fluid management has an important impact on patient outcome. under-resuscitation leads to hypoperfusion and over-resuscitation leads to tissue oedema. intraoperative goal directed fluid therapy (gdt) has been reported to improve patient outcome in high risk surgical patients. gdt aims to optimize oxygen delivery through various strategies. the main three gdt strategies are: 1. stroke volume optimization with fluids 2. stroke volume variation (svv) and pulse pressure variation (ppv) optimization with fluids. 3. oxygen delivery index with fluids and inotropes although gdt was recommended by professional societies in europe and united kingdom, these recommendations were recently challenged in many randomized controlled trials and meta-analysis.the effect of gdt on intraoperative fluid requirements was previously reported, however; its effect on extravascular lung water is not well studied. electrical cardiometry is a recent non-invasive technology for cardiac output measurement. electrical cardiometry drive co measurement from thoracic electrical bioimpedance. good correlation was reported between co measurements derived from electrical cardiometry and continuous thermodilution monitoring system. although many protocols for gdt have been reported in major abdominal operations, till now there is no consensus about the optimum protocol nor the optimum goals to achieve during fluid management. major abdominal operations are characterized by major fluid shifts. moreover, patients undergoing these operations are prone to impaired organ functions due to tissue oedema. traditional standard care in major abdominal operations usually includes 6 ml/kg/h balanced crystalloids (to restore insensible losses and maintenance requirements) in addition to replacement of blood losses. we hypothesize that the use of a more restricted fluid approach (2ml/kg/h) + gdt guided by cardiometry will improve fluid management and decrease extra-vascular lung water. the aim of this study is to compare the use of goal directed fluid therapy guided by stroke volume variation plus a restricted fluid management approach to standard fluid management in patients undergoing major abdominal operations.

Eligibility criteria:
inclusion criteria: * patients scheduled for major abdominal operations exclusion criteria: * patients with arrhythmias, pulmonary hypertension or impaired cardiac contractility. * patients with impaired liver or kidney function. * patients with bmi above 40.