Kornimate/medical-research-clean huggingface dataset:
combined treatment of patients with soft tissue sarcoma including preoperative stereotactic radiation therapy and postoperative conformal radiation therapy

Conditions: Soft Tissue Sarcoma Adult

Summary: combined treatment of soft tissue sarcoma includes 3 steps: 1. step - preoperative stereotactic radiation therapy in hypofractionation mode 2. step - operation 3. step - postoperative conformal radiation therapy in normofractionation mode

combined treatment of soft tissue sarcoma includes 3 steps: 1. at the first step patient undergoes preoperative stereotactic radiation therapy in hypofractionation mode. radiation therapy plan is based on topometric mri and ct scans. radiation therapy plan are performed after mri and ct fusion, contouring of the target and surrounding normal tissues. at first step only tumor and, if necessary, the surrounding normal tissues, which will be removed during surgery, are exposed to radiation. gtv - determined in with the boundaries of the tumor visualised by topometric mri and ct ctv1 - match gtv ctv2 - formed inward (to the tumor center) from gtv by 0.5-1 cm (depending on the proximity of functionally significant normal tissues (neurovascular bundles, bone tissue, skin and subcutaneous fat, etc.) ptv - 3-5 mm indent from ctv1, taking into account the proximity of functionally significant normal tissues and the planned surgery preoperative radiation therapy is carried in 5 fractions with a single dose on ptv - 5 gy, a single dose on ctv2 - 7 gy. 2. second step is surgery in 14-21 days. 3. in 25-35 days after the surgery postoperative conformal radiation therapy is performed according to the standard protocol gtv (tumor bed) - based on the volume of the primary tumor, including the swelling zone (t2-weighted images on preoperative mri) сtv - formed with an indent of 4 cm from gtv (without going beyond the boundaries of the involved compartment), in the transverse direction the indent could be reduced to 2 cm. ptv - formed with an indent of 0.5-1cm from ctv an important condition for planning radiation therapy is to limit the dose absorbed during both stages of radiation therapy in surrounding normal tissues that are not removed during surgery.

Eligibility criteria:
inclusion criteria: * morphologically verified diagnosis of soft tissue sarcoma * first diagnosed tumor process * ability to perform radical surgery * signed informed consent * indications for stereotactic and conformal radiation therapy * no contraindications for radiation and surgical treatment exclusion criteria: * previous radiation treatment * acute infection * pregnancy, lactation * recurrent tumor * refuse to sign informed consent * conditions that can affect the outcome of treatment (immunodeficiency, tuberculosis, etc.) * tumor topography and volume that don't allow to perform stereotactic and conformal radiation therapy.
perioperative pembrolizumab (mk-3475) plus neoadjuvant chemotherapy versus perioperative placebo plus neoadjuvant chemotherapy for cisplatin-eligible muscle-invasive bladder cancer (mibc) (mk-3475-866/keynote-866)

Conditions: Bladder Cancer

Summary: a global study to evaluate peri-operative pembrolizumab with chemotherapy versus placebo to pembrolizumab plus chemotherapy in cisplatin eligible patients.


Eligibility criteria:
inclusion criteria: * have a histologically confirmed diagnosis of urothelial carcinoma (uc) / muscle invasive bladder cancer (mibc) (t2-t4an0m0 or t1-t4an1m0) with predominant (≥50%) urothelial histology. * have clinically non-metastatic bladder cancer (n≤1 m0) determined by imaging (computed tomography (ct) or magnetic resonance imaging (mri)) of the chest/abdomen/pelvis. * be deemed eligible for radical cystectomy (rc) + pelvic lymph node dissection (plnd). * have eastern cooperative oncology group (ecog) performance status of 0 or 1. * have adequate organ function. * male and female participants are eligible to participate if they agree to the contraception use as per study protocol. exclusion criteria: * has a known additional malignancy that is progressing or has required active anti-cancer treatment ≤3 years of study randomization with certain exceptions. * has received any prior systemic treatment for mibc or non-invasive muscle bladder cancer (nmibc - prior treatment for nmibc with intravesical bcg/chemotherapy is permitted) or prior therapy with an anti- programmed cell death 1 (pd-1), anti-programmed cell death ligand 1/ ligand 2 (pd-l1/l2), or anti-cytotoxic t-lymphocyte-associated protein 4 (ctla-4). * has ≥n2 disease or metastatic disease (m1) as identified by imaging. * is cisplatin-ineligible, as defined by meeting any one of the cisplatin ineligibility criteria as per protocol. * has received prior systemic anticancer therapy including investigational agents within 3 years of randomization or any radiotherapy to the bladder. * has undergone partial cystectomy of the bladder to remove any nmibc or mibc. * has received a live or live attenuated vaccine within 30 days before the first dose of study intervention. * has a diagnosis of immunodeficiency or has a known history of human immunodeficiency virus (hiv) infection, hepatitis b infection or known active hepatitis c infection. * has a known psychiatric or substance abuse disorder. * has had an allogenic tissue/solid organ transplant.

Keywords: programmed cell death-1 (pd1, pd-1) programmed death-ligand 1 (pdl1, pd-l1) pembrolizumab (mk-3475) chemotherapy
control of hyperglycemia after cardiac surgery: chycs trial

Conditions: Hyperglycemia

Summary: the investigators aim to study the impact of a strategy of a intensive glycemic control in patients undergoing cardiac surgery.

patients undergoing heart surgery at the heart institute (incor) will be randomized and in accordance with a list of random numbers, generated by a computer program, are allocated in one of the treatment groups (conventional or intensive) when the blood glucose value recorded is greater than 200 mg/dl on two consecutive measures in an interval of 30 minutes.conventional group (gcon): patients randomized to the conventional group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (nacl 0.9%) in continuous infusion pump for maintenance of blood glucose between 140 mg/dl and 180 mg/dl. group intensive (gint): patients randomized to the intensive group will receive insulin infusion in a dilution of 100 units of regular insulin in 100 ml of physiological solution (nacl 0.9%) in continuous infusion pump for maintenance of blood glucose between 90 mg/dl and 110 mg/dl. the insulin dose adjustment will be based on measurements of arterial blood glucose undiluted, held at intervals of one to 4 hours with the use of a monitoring system of glucose and beta-blood ketone (freestyle precision pro, abbott). the dosage is adjusted according to an algorithm by a team of intensive care nurses, trained for this purpose and assisted by a study physician not involved in the clinical care of patients. on admission, all patients will receive intravenous glucose solution continuously (200 to 300 g in 24 hours). as soon as possible, the patient will be nurtured according to the routine of surgical icu for nutrition in the postoperative period of cardiac surgery patient.

Eligibility criteria:
inclusion criteria: * patients undergoing heart surgery; * age greater than 18 years; * sign the informed consent form; * capillary blood glucose greater than 200mg/dl icu admission exclusion criteria: * admitted for surgical repair of congenital heart defects; * dialytic chronic renal failure; * participation in other research protocol; * diagnosis of hiv/aids; * pregnant.
use of nesiritide (bnp) in kidney function in patients with congestive heart failure (chf) and kidney failure

Conditions: Cardiorenal Syndrome

Summary: the objective of this study is to determine the safety and effectiveness of intrarenal administration of brain natriuretic peptide (bnp) in improving renal function as measured by glomerular filtration rate (gfr) and sodium excretion in patients hospitalized with acute congestive heart failure (chf) and deterioration of kidney function (cardiorenal syndrome).


Eligibility criteria:
inclusion criteria * age 18 years and older * clinical diagnosis of class iii-iv chf requiring hospitalization * current acute chf decompensation * systolic bp \> 90 mmhg * stable cardiac rhythm * estimated creatinine clearance by the cockcroft-gault equation of less than or equal to 60 ml/min. * worsening renal function after greater than or equal to 24 hours of standard therapy as defined by a plasma creatinine concentration greater than their admission of 0.3 mg/dl and a 10% increase from hospital admission creatinine or creatinine which remains at 0.3 mg/dl and 10% increase from baseline draw done within 4 weeks of hospitalization * ability to provide informed consent exclusion criteria * patients needing emergency coronary revascularization or those who may have rapidly changing cardiac function (i.e., patients with acute myocardial infarction or shock) * peritoneal or hemodialysis within 90 days or anticipation that dialysis or ultrafiltration of any form will be required during the study period * systolic blood pressure \< 90 mmhg or cardiogenic shock * requirement of pressors for maintenance of blood pressure * intra-aortic blood pump use * history of significant uncorrected renal artery stenosis as defined by \>50% stenosis * severe aortic or mitral stenosis or significant lv outflow tract obstruction * pregnant or nursing women * prisoners * contraindication to nesiritide * contraindication to heparin * cause of acute renal dysfunction can be reasonably ascribed to factors other than heart failure or its treatment * inability to have nsaid dose held for up to 30 hours, if being treated with these medications * ongoing treatment with calcineurin inhibitors (cyclosporine or tacrolimus) * administration of radiocontrast medium within 7 days of enrollment or anticipated use of such agents during the study (other than the minimal contrast required to place the renal infusion catheter) * known bleeding diathesis * known condition that would increase the likelihood of vascular perforation or trauma, dissection such as marfan's syndrome, cystic medial necrosis, abdominal or thoracoabdominal aortic dissection, mycotic aneurysm, abdominal aneurysm, thoracoabdominal aneurysm, renal artery aneurysm, thoracic aneurysm involving the visceral region of the aorta, and severe calcification in the area of the renal arteries * solitary kidney or solitary functioning kidney * iodine allergy
the cre8™ btk post market clinical follow-up study

Conditions: Peripheral Arterial Disease

Summary: cre8™ btk is a ce marked drug eluting stent, integrally coated with i-carbofilm, loaded with formulated sirolimus for the treatment of infrapopliteal peripheral artery disease. the aim of this post-market retrospective study protocol p32102 is to collect clinical data of patient treated with cre8™ btk stent in routine clinical practice. in order to obtain long-term follow-up data, the data collection will be limited to patients that have been treated with the cre8™ btk stent at least 12 months prior to the study start.

the objective of this post-market observational study is to collect retrospective clinical data on the implantable medical device cre8™ btk in an unselected population, in the current clinical practice treated within the intended use. data will be collected via medical chart review in anonymous form to assess the safety and efficacy of the device. the cre8™ btk stent is made of cobalt-chromium alloy (l605) and it is coated with icarbofilm™, a thin carbon film with a high density turbostratic structure substantially identical with that of the pyrolytic carbon used for mechanical cardiac valve discs. coating the substrate with icarbofilm™ provides it with the bio- and haemocompatible characteristics of pyrolytic carbon, without affecting the physical and structural properties of the substrate itself. the outer surface of the stent has dedicated grooves, fully coated with icarbofilm™, for containing the pharmaceutical formulation amphilimus™, which is composed of the drug sirolimus and a mixture of long-chain fatty acid. the specific drug dosage is 0.9 μg/mm2 corresponding to a minimum dose of 50 μg on the smaller stent (2.25x8mm) and a maximum dose of 395 μg on the larger stents (4.0x38mm and 3.5x46mm). two radiopaque platinum markers, positioned at each end of the stent, allow to correctly position it over the lesion to be treated.

Eligibility criteria:
inclusion criteria: * patient has been implanted with at least one cre8™ btk device according to the indications described in the instructions for use (ifu), * study device implantation date is at least one year (12 months) prior to the starting date of the retrospective anonymous data collection. exclusion criteria: * patients treated less than 12 months prior to study start
response of brain metastases after gamma-knife radiosurgery using dynamic susceptibility-weighted contrast-enhanced perfusion magnetic resonance imaging

Conditions: Brain Metastases

Summary: this study is designed to evaluate whether advanced magnetic resonance imaging (mri) techniques such as dynamic susceptibility-weighted contrast-enhanced perfusion mri may be used to predict treatment response of brain metastasis after radiosurgery.


Eligibility criteria:
inclusion criteria: * patient must have newly diagnosed brain metastases visible on brain mri. a biopsy of the lesion is not required as long as the patient has a biopsy-proven malignancy elsewhere and a clinician deems the lesion to be metastatic. * at least one brain metastasis must be ≥ 1cm to allow adequate quantitative imaging measurement for dsc-pmr. * patient must be clinically eligible for and elect to be treated with gk alone without wbrt. * patient must be ≥ 18 years of age. * patient must have karnofsky performance status (kps) of at least 60 * patient may be part of other clinical trials (as long as no other local treatments beyond gk such as wbrt or other local therapy are indicated to the brain) or imaging studies. * patient or legally authorized representative must be able to understand and willing to sign a written informed consent document. exclusion criteria: * patient must not have any medical contraindications to mri (e.g., unsafe foreign metallic implants, incompatible pacemaker, inability to lie still for long periods, severe to end-stage kidney disease or on hemodialysis). * patient must not be pregnant or breastfeeding. * patient must not have an estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2. * patient must not have melanoma. * patient must not have hemorrhagic lesions.
neuromodulation and language acquisition (stage ib)

Conditions: Healthy

Summary: the purpose of this study is to determine whether rivastigmine or pramipexol are effective in boosting semantic language acquisition in healthy subjects.

our prior work shows that d-amphetamine and the dopamine precursor levodopa markedly improve word learning success in healthy subjects. in this randomized, placebo-controlled, double-blind clinical trial, we probe whether a selective d2/d3 dopamine agonist (pramipexole) or cholinergic neuromodulation (rivastigmine), after a titration period of five days, will yield a learning enhancement comparable to using levodopa in healthy subjects. the expected scientific results will strengthen the basis for transferring neuromodulatory interventions from the laboratory to stroke patients with language dysfunctions.

Eligibility criteria:
inclusion criteria: * healthy subjects * 20-35 years old * right handedness * left language dominance (as assessed by functional transcranial doppler ultrasonography \[ftcd\]) exclusion criteria: * neurological/psychiatric/metabolic/cardiac disorders * asthma * known allergic reactions to one of the experimental drugs * other drugs affecting the central nervous system * leisure drug ingestion during the past 4 weeks (urine test) * smoking cessation during the past 2 weeks * \> 6 cups of coffee or energy drinks per day * \> 10 cigarettes per day * \> 50 grams of alcohol per day

Keywords: language acquisition plasticity stroke recovery associative learning
fmri of the brainstem in migraine sufferers and controls. does iron deposition correlate with progression of disease?

Conditions: Episodic Migraine; Chronic Daily Migraine

Summary: this is a 2 visit research study for patients with or without a diagnosis of migraine. participants will be administered informed consent, have a medical history taken and a physical examination performed, and complete 3 questionnaires at the first visit. the participants will have a functional mri performed after completion of visit 1. study stipends will be given for each completed research visit. the purpose of this study is to potentially identify risk factors and/or biomarkers (which are differences in the brain structures)by comparing the brain mri scans of migraine sufferers to brain scans of control persons to attempt to identify migraine progression using the functional mri scans.

at visit 1, patients in 3 diagnostic arms,(consisting of subjects with episodic migraine, chronic daily migraine or non-migraineurs/controls), of 11 subjects each, will be consented and then have a physical exam, medical history and current medication use documented. each of these enrolled subjects will have a prime md assessment administered, and will complete the midas and asc-12 questionnaires. at visit 2 these same subjects will have an fmri performed. subjects will be greater than age 18, have the appropriate diagnoses, be able to be consented and not be pregnant or have an inability to have the fmri performed (have implanted metal devices, have severe claustrophobia).

Eligibility criteria:
inclusion criteria: * adult episodic, chronic or non-migraine sufferers able to consent exclusion criteria: * contraindication to mri such as severe claustrophobia and implanted devices such as neurostimulators, pacemakers, aneurysm clips, etc * pregnancy

Keywords: fmri scans episodic migraine sufferers chronic migraine sufferers non migraine sufferers (controls)
sublingual buprenorphine through telemedicine vs in-person care as usual

Conditions: Opioid Use Disorder

Summary: this study will compare in-person induction and maintenance dosing of sublingual buprenorphine to induction and maintenance dosing of sublingual buprenorphine through comprehensive telehealth sessions and telehealth medication for opioid use disorder (moud).

the study is a 12-week, randomized, active-control, open-label, early phase ii effectiveness trial of telemedicine treatment using sublingual buprenorphine as compared to in person clinic treatment with sublingual buprenorphine for outpatients seeking treatment for opioid use disorder (oud). this telehealth protocol serves as a model of the integration of evidence-based practices in medication for opioid use disorder (moud) and could be used by non addiction specialists at scale. the primary outcome will be time to dropout. participants will have daily study visits (either in person or remote) during the initial buprenorphine induction week and then twice per week during the maintenance phase (either in person or remote) over the 12-week trial. remote visits will be conducted using the hipaa-compliant technology, facetime and/or webex.

Eligibility criteria:
inclusion criteria: * meet dsm-5 criteria for oud * voluntarily seeking buprenorphine treatment for oud * able to provide informed consent and comply with study procedures exclusion criteria: * meeting dsm-5 criteria for substance use disorder other than opioid as the primary diagnosis that would compromise safety of participation in the trial as determined by the study physician, such as an alcohol or sedative hypnotic use disorder that requires detoxification * having a comorbid psychiatric diagnosis that might interfere with participation or make participation hazardous, such as a psychotic disorder including schizophrenia or schizoaffective disorder * concurrent methadone, buprenorphine, or vivitrol maintenance treatment * known history of allergy, intolerance, or hypersensitivity to candidate medication (buprenorphine) * pregnancy, lactation, or failure to use adequate contraceptive methods in female patients * unstable medical conditions, such as severe hepatic, renal, or cardiovascular disease, which might make participation * current or recent history history of significant violent or suicidal behavior or risk for suicide or homicide * legally mandated to substance use disorder treatment.
assessment of contrast enhancement boost for the direct identification of pulmonary emboli in thoracic ct angiography

Conditions: Pulmonary Embolism

Summary: pulmonary embolism is a common cardiovascular disease and thoracic ct angiography is currently considered the gold standard for its non-invasive diagnosis. however, the diagnostic performance of ct angiography can be hampered by an insufficient enhancement of pulmonary arteries. contrast enhancement boost (ce boost) is a post-processing technique using an iodine density map to artificially improve pulmonary artery enhancement. this retrospective study compares standard ct-angiography images with ce boost images to assess the potential improvement of diagnostic performance for the detection of pulmonary embolism.


Eligibility criteria:
inclusion criteria: * patient who underwent thoracic ct angiography for suspicion of pulmonary embolism in our institution between march and june 2018 exclusion criteria: * none

Keywords: pulmonary embolism