Kornimate/medical-research-clean huggingface dataset:
neoadjuvant chemotherapy plus nephroureterectomy for locally advanced upper tract transitional cell cancer

Conditions: Transitional Cell Carcinoma

Summary: the purpose of this study is to test the effectiveness, safety and side effects of two chemotherapy drugs (gemcitabine and cisplatin) when combined with surgery after chemotherapy for patients with upper urinary tract cancer. the hypothesis is that undergoing chemotherapy prior to surgery will have a beneficial effect on prognosis and may improve overall survival as in patients with bladder cancer, and will allow better tolerance of chemotherapy than if it were given after surgery.

this study will look at improving overall survival of those undergoing nephroureterectomy for upper tract tcc (transitional cell carcinoma, comparing the pathological response of tumors treated with neoadjuvant chemotherapy (gemcitabine and cisplatin) before surgery. there have been reported studies of neoadjuvant chemotherapy in the treatment of upper tract tcc, there have been no studies to date that include the chemotherapy agents gemcitabine and cisplatin that are currently indicated in treating tcc of the bladder in the neoadjuvant and adjuvant setting. these agents have been proven to have a better overall safety profile and tolerability allowing more patients to complete their regimens. secondarily, study will compare disease free overall survival among patients treated with neoadjuvant chemotherapy and surgery versus surgery alone. this study may elucidate the potential benefit of these agents when treating tcc of the upper tracts and may provide a survival advantage in this specific patient population as compared to a historical cohort.

Eligibility criteria:
inclusion criteria: * ecog performance status 0-2 * estimated gfr\>60 * high grade tcc on initial biopsy * clinical stage t1-t3, nx, mx based on the ajcc classification system * tcc confined to the ureter or renal pelvis * grade ii neuropathy or less exclusion criteria: * any other malignancy over the previous five years with a risk of relapse that exceeds 30% * history of previous cystectomy * evidence of metastatic disease * history of pelvic irradiation or prior chemotherapy

Keywords: upper gu tract transitional cell carinoma nephroureterectomy chemotherapy gemcitabine cisplatin
the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer

Summary: the development of anti-angiogenesis drugs has led to renewed enthusiasm in lung cancer treatments. apatinib is a tyrosine kinase inhibitor which selectively inhibits the vascular endothelial growth factor receptor-2 (vegfr-2). etoposide is an oral preparation for lung cancer which is recommended by nccn guideline. the investigators wondered whether these two drugs have synergistic effects when treating advanced non-small cell lung cancer patients who failed to previous at least 2nd line treatments. thus, the aim of this trial is to investigate the efficacy and safety of apatinib combined with etoposide in heavily pretreated advanced non-small cell lung cancer.


Eligibility criteria:
inclusion criteria: * obtain of informed consent. * histologically or cytologically confirmed non-small cell lung cancer. * world health organization (who) performance status (ps) of 0 to 2. * measurable lesions as defined by recist criteria. * second-line or more treatments. * wild type of epidermal-growth-factor receptor (egfr). * life expectancy ≥12 weeks. * organ functions normal, as defined below, within two weeks of randomization: • hb≥90g/l absolute neutrophils count(anc)≥1.5×109/l platelets≥80×109/l serum bilirubin≤2×uln; aspartate transaminase(ast) and alanine transaminase (alt)≤2.5×uln(≤5×uln if liver metastases) creatinine clearance≥45ml/min or cr≤1.25×uln. * females of child-bearing potential must have negative serum pregnancy test. * sexually active males and females (of childbearing potential) willing to practice contraception during the study. exclusion criteria: * small cell lung cancer. * newly diagnosed central nervous system (cns) metastases that have not yet been definitively treated with surgery and/or radiation. * uncontrolled hypertension. * myocardial ischemia or infarction more than stage ii, cardiac insufficiency. * abnormal coagulation (inr\>1.5 or pt\>uln+4, or aptt\>1.5 uln), bleeding tendency or receiving coagulation therapy. * difficulties in taking pills (inability to swallow tablets,gi tract resection, chronic bacillary diarrhea and intestinal obstruction). * hemoptysis, more than 2.5ml daily. * thrombosis in 12 months, including pulmonary thrombosis, stoke, or deep venous thrombosis. * unhealed bone fracture or wound for long time. * received big surgery, had bone fracture or ulcer in 4 weeks. * urine protein≥++, or urine protein in 24 hours≥1.0g. * pregnant or lactating woman.

Keywords: non-small cell lung cancer apatinib etoposide
effect of training of patients with dysphagia

Conditions: Dysphagia

Summary: effect of training of patients with dysphagia

a randomised controlled study in the effect of training in patients with dysphagia. the patients are randomised for training or for usual care.

Eligibility criteria:
inclusion criteria: * patients diagnosed with dysphaigia * patients living in the participating locations exclusion criteria: * patients who are linguistically or cognitively unable to participate * patients who are unable to collaborate about the training * palliative patients * patients with a probe

Keywords: training effect elderly
study of nicotine patches in patients with sarcoidosis

Conditions: Pulmonary Sarcoidosis

Summary: the purpose of this study is to compare peoples with disease (sarcoidosis) to those without disease. we want to see if people with sarcoidosis have a different immune response to those people without disease. the goal of this study is to see if the nicotine patch is an anti-inflammatory treatment for sarcoidosis.

until recently, there was no good explanation for the fact that smoking cigarettes actually reduces the risk of sarcoidosis. research studies have shown that the nicotine, a common component of cigarette smoke, strongly suppresses the immune system and reduces the type of inflammation that is characteristic of sarcoidosis in the lungs. we propose that nicotine treatment, administered in the form of a skin patch, will reduce the severity of lung disease in patients with sarcoidosis. sarcoidosis patients who volunteer to participate in this study will submit standardized questionnaires relating to their quality of life and the severity of their shortness of breath before and after treatment. we will also compare objective measures of lung function, radiographic parameters, and the severity of lung inflammation. we predict that nicotine treatment will reduce the severity of sarcoidosis symptoms, improve lung function, and resolve lung inflammation. if our hypothesis is proven to be correct in this relatively small group of patients, we will perform additional studies in a larger group of patients and will consider the features of sarcoidosis patients that predict a favorable response to nicotine and other nicotine-like drugs. if nicotine is ultimately found to be an effective treatment for sarcoidosis, it may replace some of the existing treatments which are frequently ineffective and have unacceptable side-effects.

Eligibility criteria:
inclusion criteria: * • symptomatic (active) granulomatous lung disease (radiographic stage ii or iii disease) at least 6 months after the diagnosis. this selects patients that have the chronically active variant of sarcoidosis and will likely require long-term treatment (33). exclusion criteria: * • active smokers, * previous splenectomy, * those requiring high-dose immunosuppression \[i.e., ≥ 0.2 mg/kg/day prednisone (or equivalent) or \> 10 mg/week methotrexate or requires second line cytolytic agents (e.g., cyclophosphamide, azathioprine) or anti-tnf treatments (e.g., thalidomide, anti-tnf antibodies, etc.)\] to control disease activity. * we will also exclude patients at high risk of complications relating to the use of nicotine. this will include patients with a known intolerance of nicotine or those with active cardiac or central nervous system disease who are at higher risk of cardiac arrhythmias or seizures. * we will also exclude patients with extensive pulmonary fibrosis based upon lung biopsy or high resolution ct scan criterion

Keywords: to determine if nicotine treatment reduces lung inflammation
study of the aerin medical vivaer® arc stylus for nasal airway obstruction

Conditions: Nasal Obstruction

Summary: post-market study to continue to evaluate the effectiveness of the vivaer® arc stylus for nasal airway obstruction

prospective, multicenter, non-randomized study of the aerin medical vivaer® arc stylus for nasal airway obstruction to continue to evaluate the effectiveness of the vivaer® arc stylus for treating the nasal valve area to improve symptoms in those diagnosed with nasal airway obstruction.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. willing and able to provide informed consent 3. willing and able to comply with the study protocol 4. seeking treatment for nasal obstruction 5. nose score of ≥ 60 at baseline 6. nasal valve is a primary or significant contributor to the subject's nasal obstruction as determined by the study investigator (based on clinical presentation, physical examination, nasal endoscopy, etc.) and the subject has a positive response to any of the following temporary measures (based on patient history or office exam): * use of external nasal dilator strips (e.g., breathe right strips) * q-tip test (manual intranasal lateralization) * use of nasal stents * cottle maneuver (manual lateral retraction of the cheek) exclusion criteria: 1. prior surgical treatment of the nasal valve 2. rhinoplasty, septoplasty, inferior turbinate reduction or other surgical nasal procedures within the past three (3) months 3. anatomy that requires an adjunctive surgical nasal procedure on the same day or 3 months after the vivaer procedure 4. medical conditions which in the opinion of the treating physician would predispose the subject to poor wound healing or increased surgical risk.

Keywords: nasal valve nasal airway obstruction
evaluation of the scaled (scaling acceptable cds)

Conditions: Traumatic Brain Injury; Venous Thromboembolism

Summary: this project will adapt a currently deployed clinical decision support (cds) system to deliver a vte prevention guideline for adult patients with traumatic brain injury (tbi). we believe this is an ideal pcor use case given pcori's continued effort to combat vte in trauma and our experience previously implementing this guideline. the our overall goal is to successfully scale, evaluate, and maintain an interoperable tbi cds across 7 total institutions.


Eligibility criteria:
inclusion criteria: * age 18 and older * admitted with a tbi exclusion criteria: * patients who die within 24 hours of hospital admission and patients documented as "comfort cares" during the first 72 hours of hospitalization or with mild tbi will be excluded from final analysis.
randomized trial of continuous versus intermittent cefotaxime infusion on icu.

Conditions: Critically Ill

Summary: this study evaluates target attainment after either intermittent intravenous bolus or intravenous continuous infusion of cefotaxime in critically ill patients. critically ill patients will be randomized to intermittent infusion or continuous infusion of cefotaxime.

critically ill patients have other pharmacokinetic/pharmacodynamic profiles than healthy volunteers. suboptimal, both under- and overdosing of antibiotics is an important threat in this patient category. given the time-dependent character of beta-lactam antibiotics continuous dosing as opposed to traditional intermittent dosing is likely to render better target attainment and maintenance and might improve clinical outcome.

Eligibility criteria:
inclusion criteria: * admitted to intensive care * able to give informed consent by themselves or informed consent can be obtained via next of kin * indication for treatment with cefotaxime (as judged by treating physician) in the context of our standard treatment protocol of selective decontamination of the digestive tract (sdd). exclusion criteria: * renal replacement therapy * contra-indication for cefotaxime, including known or suspected allergy to cefotaxime * no indication for an arterial line; an arterial line will not be placed solely for the purpose of this study; thus, only patients with an indication for an arterial line outside this protocol are eligible.
electronic harm reduction treatment for alcohol

Conditions: Alcohol Use Disorder; Harm Reduction; Housing First (eg. Permanent Supportive Housing)

Summary: the goal of this project is to transform a successful, face-to-face harm-reduction treatment (hart-a) into a digital format, creating ehart-a. this new platform is specifically designed for people who have experienced homelessness and an alcohol use disorder (aud), living within the framework of permanent, supportive, housing first (hf) facilities. we hypothesize ehart-a will be more effective than the standard hf services in reducing alcohol-related harm and improving the overall quality of life for participants.


Eligibility criteria:
inclusion criteria: * being at least 21 years of age * speak english fluently * currently a registered client at one of the housing first sites * currently drinking (has used alcohol in the past 2 weeks) * meeting criteria for "current" (e.g., past-year) aud according to the diagnostic and statistical manual of mental health disorders, fifth edition (determined as scoring \>= 2 on the scid-5-cv) exclusion criteria: * enrollment in any related treatment studies (including studies by this research team) * refusal or inability to consent * constituting a risk to the safety and security of residents or staff

Keywords: telehealth alcohol-related harm community based participatory research lived experience of chronic homelessness
aprepitant for the prevention of chemotherapy induced nausea and vomiting (cinv) associated with highly emetogenic chemotherapy (0869-801)(completed)

Conditions: Nausea; Vomiting

Summary: a multicenter trial to assess the safety and efficacy of an investigational drug in the prevention of chemotherapy-induced nausea and vomiting (cinv) in patients with confirmed solid tumors who will be treated with a chemotherapy regimen that includes cisplatin. the study will evaluate the investigational drug for the treatment of cinv during the first cycle of treatment with cisplatin.


Eligibility criteria:
inclusion criteria: * patient is greater than 18 years of age. * patient is scheduled to receive his/her first course of cisplatin chemotherapy for a solid tumor. * patient has a prognosis (life expectancy) greater than or equal to 3 months.
vicor study-high frequency chest wall oscillations (hfcwo) in patients with acute respiratory failure and hypersecretion

Conditions: Acute Respiratory Failure; Acute-on-chronic Respiratory Failure; Airway Clearance Impairment

Summary: the study aims to evaluates if the treatment with hfcwo via the vest® airway clearance system, in addition to standard care in critically ill patients admitted in the respiratory intensive care unit for acute respiratory failure or acute on chronic respiratory failure and unable to manage secretions, could primarily prevent the need for bronchoscopy, and secondarily shorten duration of non invasive respiratory therapy, shorten length of stay and reduce mortality.


Eligibility criteria:
inclusion criteria: * diagnosis of acute respiratory failure (arf) or acute on chronic respiratory failure (including patients having home oxygen therapy, hfnc, niv) both hypercapnic arf (paco2 \> 45 mmhg; pao2/fio2 \<300) or hypoxaemic (paco2 \<45 mmhg; pao2/fio2 \<300); * informed consent from patient or legal tutor; * accessory respiratory muscles use; * respiratory rate above 25 apm; * use of non invasive respiratory therapy (nirt) niv+/-hfnc or hfnc alone since ricu admission * kelly neurological index ≤ 3 * excessive airway mucus secretion (clinical evaluation asking the patient to cough) and inability to efficiently remove secretions (evaluated with the cough peak flow (cpf) measurement. a cpf under 270 lpm is highly suggestive of inadequate cough which prevent the patient from adequately manage and remove airway secretions. * cough score \< 3: in the case of inability to perform cpf measurement due to poor patient collaboration, cough adequacy will be evaluated by a respiratory physiotherapy with a semiquantitative score ("cough score") based on the measurement of sputum volume produced after coughing three times (1 point: less than 2 ml, 2 points: 2-6 ml, 3 points: more than 6 ml). exclusion criteria: * patient unwillingness or incapability to provide informed consent * need for subcontinuous niv(more than 20 hours per day) * kelly neurological index \>3 * cardiac arrest * severe haemodynamic instability (more than two amines required); * acute coronary syndrome; * psychomotor agitation unresponsive to analgo-sedation (rass\> 1) * contraindications to hfcwo use: acute pneumothorax (even if chest drainage is not required ); severe chest wall deformities (pectus excavatum, pectus carinatum or pectus arcuatum); severe obesity (bmi \>40 kg/m2); pregnancy; thoracic or abdominal surgery in the six previous weeks * nasal swab positivity to sars-cov-2 * need for endotracheal intubation or urgent bronchoscopy for excessive airway mucus

Keywords: acute respiratory failure nirt hfcwo airway hypersecretion non invasive ventilation high flow nasal cannulae
an open-label, single-dose, intravenous administration study of ono-2745/cns 7056 in subjects with chronic hepatic impairment

Conditions: Hepatic Impairment; Healthy

Summary: to evaluate and compare the pharmacokinetics and safety of ono-2745/cns 7056 in subjects with the hepatic impairment and matched healthy subjects.

in part one, 8 subjects with moderate hepatic impairment (child pugh scale b) and 8 matched healthy subjects will be enrolled. in part 2, 8 subjects with mild hepatic impairment (child-pugh scale a) and 8 matched healthy subjects will be enrolled. in part 3, 3 subjects with severe hepatic impairment (child-pugh scale c) will be enrolled. parts 2 and 3 will only be initiated if the criteria per protocol is met in part one. the pharmacokinetics and safety profiles will be compared between hepatic impaired subjects and healthy subjects.

Eligibility criteria:
inclusion criteria: * males or females between 18 and 65 years of age * negative test for the selected drugs of abuse at screening hepatic impaired subjects: * stable hepatic function and medication regimen for at least 28 days prior to check-in * degree of hepatic impairment will be determined by the child-pugh scale exclusion criteria: * clinical manifestation of any disease (except hepatic impaired subjects) * history of significant hypersensitivity, intolerance, or allergy to any drug compound, including food, or other substance

Keywords: adult healthy subjects will be matched with individual subjects by age (± 5 years, gender, and bmi (± 15%)
sirolimus and cyclophosphamide in metastatic or unresectable myxoid liposarcoma and chondrosarcoma

Conditions: Conventional Chondrosarcoma; Myxoid Liposarcoma; Mesenchymal Chondrosarcoma; Dedifferentiated Chondrosarcoma

Summary: chondrosarcoma and liposarcoma consists of different subtypes with a wide range of patient survival. current treatment options consist of wide surgical resection, however for patients with a local recurrence or metastatic disease the outcome is poor. new treatment options being evaluated and mouse models show in vivo that mammilian target of rapamycin (mtor) inhibition can prevent tumour growth. mtor is an kinase that is present in two complexes and thereby activates multiple pathways. aberrant mtor signalling is known to be involved in cancer cell survival. several clinical studies for patients with bone or soft tissue sarcoma treated with mtor inhibitors have been conducted and they show promising results. from these studies the investigators can conclude that the combination of an mtor inhibitor with cyclophosphamide shows promising results in chondrosarcoma. with the lack of other treatment options for unresectable and metastatic chondrosarcoma or myxoid liposarcoma the eurosarc consortium (www.eurosarc.eu) decided to treat these patients in a standardised way according to a common protocol with the combination of sirolimus and cyclophosphamide using the growth modulation index for evaluation in the current clinical study protocol.


Eligibility criteria:
inclusion criteria: * pathologically proven conventional chondrosarcoma * or pathologically proven myxoid liposarcoma with pik3ca mutation or phosphatase and tensin homolog (pten) loss * or pathologically proven mesenchymal or dedifferentiated chondrosarcoma * patient is 18 years and up * documented radiographic progression of disease according to recist 1.1 criteria in last 6 months * written signed informed consent * adequate bone marrow function (hb ≥ 6.0 mmol/l, absolute neutrophil count ≥ 1.5 x 109/l, platelets ≥ 80 x 109/l) * availability of archival tumor material for central review or be able to perform a 3 core fresh biopsy * ability to adhere to the study visits and all protocol requirements exclusion criteria: * previously treated with an mtor inhibitor * known to be allergic to cyclophosphamide * life expectancy of less than 3 months * no measurable lesions according to recist 1.1 * eastern cooperative oncology group (ecog) performance status \>2 * major surgery less than 4 weeks prior to start of treatment * known human immunodeficiency virus (hiv) positivity * a decreased renal function with calculated glomerular filtration rate (gfr) \< 30ml/min * systemic anti-cancer therapy within 28 days prior to the first dose of study drug , or radiotherapy to a target lesion within 21 days prior to the first dose of study drug * pregnant or lactating women * other invasive malignancies diagnosed within the last 5 years, except non-melanoma skin cancer and localised cured prostate and cervical cancer