Kornimate/medical-research-clean huggingface dataset:
major complication rate in cancer patients with neutropenic fever potentially eligible for a hospital at home program

Conditions: Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm

Summary: this study investigates the major complication rate in cancer patients potentially eligible for a hospital at home program for management of neutropenic fever. "hospital at home" is a home care program that provides acute, inpatient care in a patient's home in place of a traditional hospital stay. learning more about the characteristics of potentially eligible patients, including reasons for inpatient admission, rates of major complications, and situations or treatments that would be difficult to deliver in an at home setting may help to inform future program development.

primary objective: i. estimate the major complication rate among patients potentially eligible for a hospital at home program for management of neutropenic fever. secondary objectives: i. describe the demographic and clinical characteristics of patients potentially eligible for admission to a hospital at home program for management of neutropenic fever. ii. describe situations or treatments experienced by potentially eligible patients admitted for neutropenic fever that would be difficult to accomplish in a hypothetical hospital at home program (e.g., blood transfusions, echocardiograms, computed tomography \[ct\] scans). outline: patients' medical charts are reviewed.

Eligibility criteria:
inclusion criteria: * admitted to md anderson cancer center through the emergency center with a diagnosis of neutropenic fever between 1/1/2019 and 12/31/2019 * be at low risk for major complications as defined by a multinational association for supportive care in cancer (mascc) score \< 21 exclusion criteria: * reside in a nursing home * homelessness * hospice enrollment * a secondary reason for admission to the hospital or high risk clinical feature not captured in the mascc score that places them at high risk for major complications in a hospital at home program
an observational study of roactemra/actemra (tocilizumab) in patients with rheumatoid arthritis who have an inadequate response to dmards

Conditions: Rheumatoid Arthritis

Summary: this observational study will evaluate in clinical practice the change in disease activity score (das28) in patients with rheumatoid arthritis and an inadequate response to dmards who are initiated on treatment with roactemra/actemra (tocilizumab). data will be collected from eligible patients (on 8 mg/kg or 4 mg/kg intravenously every 4 weeks, with or without methotrexate) for 12 months.


Eligibility criteria:
inclusion criteria: * adult patients, \>/= 18 years of age * moderate to severe active rheumatoid arthritis * inadequate response or intolerance to previous therapy with one or more traditional dmards exclusion criteria: * pregnant or lactating women * active infection * positive for hepatitis b, hepatitis c or hiv infection * concomitant anti-tnf drugs * contraindications to treatment with roactemra/actemra
phase iii study of camrelizumab in combination with chemotherapy in recurrent/metastatic nasopharyngeal carcinoma

Conditions: Nasopharyngeal Carcinoma

Summary: this study is a randomized, placebo-controlled, double-blind, multicenter phase iii clinical study. target population is patients with recurrent/metastatic nasopharyngeal carcinoma who had not received systemic chemotherapy. study objective is to compare the efficacy and safety of camrelizumab in combination with gemcitabine and cisplatin with placebo in combination with gemcitabine and cisplatin in study population in china. camrelizumab is a humanized anti-pd1 igg4 monoclonal antibody.

in this study, eligible subject will be randomized into study arm or control arm to accept study treatment. treatment cycles of chemotherapy will be at most 6 weeks which will be decided by investigators. progression-free survival (pfs) determined by the independent review committee (irc) will be the primary outcome measures.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years and ≤75 years; 2. subjects with histopathological diagnosis of nasopharyngeal carcinoma; 3. primarily metastatic (stage ivb as defined by the international union against cancer and american joint committee on cancer staging system for npc, eighth edition) or recurrent npc that is not amenable for local regional treatment or curative treatment; 4. has not received prior systemic treatment; 5. has a performance status of 0 or 1 on the eastern cooperative oncology group (ecog) performance status 6. subject must have a measurable target lesion based on recist v1.1; exclusion criteria: 1. allergic to monoclonal antibodies, any camrelizumab components, gemcitabine, cisplatin and other platinum drugs; 2. prior therapy as follow: * anti-pd-1 or anti-pd-l1; * received last dose of anticancer therapy (including chemotherapy, radiotherapy, targeted therapy, etc.) within 4 weeks of the first dose of study medication; * concurrent medical condition requiring the use of cortisol (\>10mg/day prednisone or equivalent dose) or other systematic immunosuppressive medications within 14 days before the study treatment. except: inhalation or topical corticosteroids. doses \> 10 mg/day prednisone or equivalent for replacement therapy; * received major operations or serious injuries within 4 weeks of the first dose of study medication; 3. not recovered to ≤ctcae 1 from adverse events (except for hair loss) due to a previously anti-tumor treatment; 4. pregnancy or breast feeding;

Keywords: nasopharyngeal carcinoma pd-1 antibody cisplatin gemcitabine
comparison of low gi and high gi potatoes in relation to satiety (posat)

Conditions: Obesity

Summary: the study is a single-blind, randomised crossover study, investigating how a high glycaemic potato affects satiety in humans compared to a low glycaemic potato. this is done to shed further light on the discussion about whether potatoes with a high glycaemic index increases the risk of overweight and obesity and thus indirectly type 2 diabetes and cardiovascular disease.

the posat study follows a single-blinded randomized crossover design. each subject will have two separate intervention days with at least a six-day washout period in between. on the two intervention days the subjects will be randomized into receiving a breakfast containing isocaloric amounts of either low or high gi potatoes. vas will be measured 5 minutes before the meal, immediately after the meal is consumed and in intervals of 30 minutes thereafter until 2,5 hours after the initial meal. after this the subjects will be served a standardized homogenous ad libitum meal. the amount of food consumed will be registered. the subjects will be asked to fast for 8-10 hours prior to the trial days and abstain from vigorous physical activity and alcohol consumption for 2 days prior to each trial day. the trial will be conducted over a total of 8 days with 5-6 study subjects pr. trial day. the trial days will be spread out over a total of 2 weeks to allow for a 1-week washout period between trial days for each subject.

Eligibility criteria:
inclusion criteria: * healthy men * body mass index (bmi) 18-27 kg/m2 * age 18-40 years * signed informed consent * able to eat 500 grams of potato for breakfast exclusion criteria: * chronic diseases as diabetes, cardiovascular diseases or other chronic metabolic diseases, which could affect the results. * use of daily prescription medicine (mild analgesics and antihistamines are allowed). * use of medicine or dietary supplements that can affect ones appetite one month before the start of the study. * smoking or have been smoking or using any nicotine products (gum or e-cigarette) within the last 3 months. irregular smoking is allowed. * elite athletes defined as doing \>10 hours of strenuous physical activity per week. * participation in other clinical studies \<1 month before or during the study. * inability, physically or psychologically, to comply with the procedures required by the study protocol. judged by the investigators. * any food allergies. * weight change of ±3 kg from screening to the trial has been conducted. * inability to complete the trial within 3 months after screening. * unable to fast 8-10 hours before the trial days.
utility of cd64 and tlr2 assays to diagnose acute pulmonary exacerbations in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: cystic fibrosis (cf) is the most common inherited disease in the western world. on a yearly basis, 56% of cf patients, or nearly 17,000 individuals in the us, suffer from acute pulmonary exacerbations (ape). the purpose of this study is to test a candidate assay for its ability to diagnose ape, the most important disease event in cf. while previous studies have been able to identify biomarkers of cf prognosis and risk stratification, three markers have demonstrated characteristics ideal for ape diagnosis: cd64, tlr2, and gilt. cd64 is a cellular receptor, expressed on numerous cells of the immune system, whose role is to bind antibodies which are attached to infected cells or pathogens. tlr2 plays a major role in early host-microbial interactions. gilt has been shown to be more precise in targeting immune responses against antigens and influences t lymphocyte response. this study looks to identify the differences in the expression of neutrophil cd64 and cd4+ t cell tlr2 and gilt between acute illness and baseline health as a sensitive marker of acute pulmonary exacerbation so that it may facilitate rapid hematologic diagnosis of the condition. the study also looks to compare sensitivity and specificity of the assays above to standard measures, such as health related quality of life scores (cfq-r), loss of lung function, white blood cell counts and crp, for diagnosing acute exacerbations.


Eligibility criteria:
inclusion criteria: * documented diagnosis of cf. * age 18 years old or greater. * presentation at baseline health or at the start of treatment for a pulmonary exacerbation of cf. * ability to perform reproducible pulmonary function tests * ability to produce sputum. * willingness to complete a health-related quality of life questionnaire * willingness to comply with study procedure and provide written consent. exclusion criteria: • presence of a condition or abnormality that, in the opinion of the principal investigator (pi), would compromise the safety of the patient or the quality of the data.
recto-anal-repair in the treatment of advanced haemorrhoidal disease

Conditions: Haemorrhoids

Summary: prospective observational study to evaluate the impact of recto-anal-repair (a technique of ultrasound guided haemorrhoidal ligation) in the treatment of stage iii/iv haemorrhoidal disease.


Eligibility criteria:
inclusion criteria: * stage iii or iv hemorrhoidal disease (appendix a) * patient age 18-80 years old * patient fit for general or local anesthesia * no prior surgical treatment for hemorrhoidal disease * no prior surgical treatment for anorectal sepsis * signed informed consent exclusion criteria: * stage i or ii hemorrhoidal disease (appendix a) * patient unfit for surgery * clotting disorders * anal or colorectal malignancy * secondary hemorrhoidal disease * pregnancy * unwilling or unable to sign informed consent
fdg pet and dce-mri in predicting response to treatment in patients with breast cancer

Conditions: Male Breast Cancer; Stage II Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer

Summary: this clinical trial studies fludeoxyglucose f 18 (fdg) positron emission tomography (pet) and dynamic contrast-enhanced (dce)-magnetic resonance imaging (mri) in predicting response to treatment in patients with breast cancer. comparing results of diagnostic procedures done before, during, and after chemotherapy may help doctors predict a patient's response to treatment and help plan the best treatment.

primary objectives: i. to determine whether detailed kinetic analysis of fdg pet and magnetic resonance (mr) imaging studies for measures of tumor metabolism and blood perfusion can predict response and outcome for breast cancer patients undergoing neo-adjuvant therapy. ii. to compare the in vivo tumor biology associated with responsive and resistant tumors as measured by kinetic changes in fdg pet and mr imaging parameters to tumor subtypes analyzed from assay of pre-therapy biopsy and post-therapy surgical tissue. outline: patients undergo fdg pet and dce-mri 1-2 weeks before prior to chemotherapy initiation, between 1-12 weeks after initiation of the first course of chemotherapy, and after the completion of chemotherapy (within 4 weeks prior to surgery).

Eligibility criteria:
inclusion criteria: * pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy * primary tumor 2.0 cm or greater, and/or clinical evidence of axillary disease (palpable n1 or n2 or biopsy proven) * no obvious contraindications for primary chemotherapy * able to lie still for pet and mri scanning * able to understand and willing to sign a written informed consent document and a health insurance portability and accountability act (hipaa) authorization in accordance with institutional guidelines exclusion criteria: * serious systemic illness other than breast cancer * contraindication to mri or history of adverse reaction to gadolinium * evidence of distant disease outside of regional lymph nodes * pregnant * poorly controlled diabetes mellitus (fasting blood glucose \> 200) * prior systemic cancer therapy
combination chemotherapy in treating patients with stage iiib or stage iv non-small cell lung cancer

Conditions: Lung Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. it is not yet known whether three courses of combination chemotherapy are more effective than six courses of combination chemotherapy for non-small cell lung cancer. purpose: randomized phase iii trial to compare the effectiveness of three courses of combination chemotherapy with that of six courses of combination chemotherapy in treating patients who have stage iiib or stage iv non-small cell lung cancer.

objectives: i. compare the duration of symptom control, time to disease progression, survival, and quality of life in patients with stage iiib or iv non-small cell lung cancer treated with 3 versus 6 courses of mitomycin, vinblastine, and cisplatin. outline: this is a randomized, multicenter study. patients are stratified by stage of disease (stage iiib vs iv). patients are randomized to 1 of 2 treatment arms: arm i: patients receive cisplatin iv over 4 hours, mitomycin iv, and vinblastine iv on day 1. treatment repeats every 3 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. mitomycin is not administered during course 3. arm ii: patients receive chemotherapy as in arm i. treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity. mitomycin is not administered during courses 3 and 5. quality of life is assessed after completion of 3 courses of chemotherapy for patients in arm i and after completion of 4, 5, and 6 courses for those in arm ii. patients may receive radiotherapy beginning after completion of chemotherapy. projected accrual: a total of 310 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: histologically proven stage iiib or iv non-small cell lung cancer that is not eligible for surgery or radical radiotherapy patient characteristics: age: 18 and over performance status: zubrod-who 0-2 life expectancy: not specified hematopoietic: hemoglobin greater than 10 g/dl wbc greater than 3,000/mm3 platelet count greater than 100,000/mm3 hepatic: liver function tests no greater than 2 times normal (unless due to metastatic disease) renal: creatinine clearance greater than 60 ml/min edta clearance greater than 60 ml/min other: no serious, uncontrolled, concurrent medical illness prior concurrent therapy: biologic therapy: not specified chemotherapy: no prior conventional chemotherapy endocrine therapy: not specified radiotherapy: see disease characteristics surgery: see disease characteristics

Keywords: stage iiib non-small cell lung cancer stage iv non-small cell lung cancer
g-step: gemcitabine based small-cell lung cancer treatment in elderly patients

Conditions: Small Cell Lung Cancer

Summary: the purpose of this study is to describe the activity and toxicity of gemcitabine combined with four different drugs (carboplatin or cisplatin or etoposide or vinorelbine) as first line treatment of elderly patients with extensive small cell lung cancer.

four treatment arms are planned. * gemvin: gemcitabine 1000 mg/m2 and vinorelbine 25 mg/m2 on days 1 \& 8, every 21 days * gemcar: gemcitabine 1000 on days 1 \& 8 and carboplatin auc 3.5 or 4 or 4.5 on day 1, every 21 days * gemcis: gemcitabine 1000 mg/m2 on days 1 \& 8 and cisplatin 50 or 60 or 70 mg/m2 on day 1, every 21 days * gemeto: gemcitabine 1000 mg/m2 on days 1 \& 8 and etoposide 60 or 70 or 80 mg/m2 on days 1,2,3 every 21 days for the study of the gemvin combination a two-stage minimax flexible design will be applied. for the remaining 3 combinations (gemcar, gemcis, gemeto) a phase 1/2 design aimed at looking for optimal dose within a bayesian framework will be applied.

Eligibility criteria:
inclusion criteria: * histologic or cytologic diagnosis of sclc * extensive disease * measurable disease * performance status (ecog) \< o = 2 * age \> o = 70 years. * written informed consent. exclusion criteria: * previous chemotherapy. * previous or concomitant malignancies (with the exception of adequately treated non melanomatous skin cancer or carcinoma in situ of the cervix) * •neutrophils\<2.000/mm3;platelets\<100.000/mm3; hemoglobin \< 10 g/dl * creatinine \> 1.5 time the upper limit * ast, alt \> 2.5 times and/or bilirubin \> 1.5 time the upper limit of normal if liver metastases are absent or ast, alt ³5 times and bilirubin \> 3 times the upper limit of normal if liver metastases are present * symptomatic brain metastases

Keywords: elderly
serotonin/dopamine antagonism of cocaine effect: 1 - 1

Conditions: Cocaine-Related Disorders

Summary: the purpose of this study is to evaluate use of risperidone with cocaine abusers. study measures incorporate an appropriate integration of behavioral and neurobiological indices.


Eligibility criteria:
please contact site for information.

Keywords: cocaine abuse, cocaine addiction
the feasibility and application of intraoperative ultrasound to evaluate femoral head shaping

Conditions: Femoroacetabular Impingement

Summary: to assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.

ultrasound can provide a multi-directional scan of the femoral head and neck junction, and the range of evaluation is larger than that of the intraoperative c-arm. the study was to assess the feasibility of using intraoperative ultrasound to evaluate the femoral head formation; to evaluate the forming of the femoral head and the improvement of the forming effect using the intraoperative ultrasound combined with c-arm.

Eligibility criteria:
inclusion criteria: * patients with hip pain; * cam type (alpha angle \> 50°) impingement and glenoid labrum laceration exclusion criteria: * previous hip surgery; * patients with subosseous cystic degeneration of synovitis
effect of intensivist communication on surrogate prognosis interpretation

Conditions: Critical Illness

Summary: this study evaluates the effect of physician communication styles on the interpretation of prognosis by family members of chronically-ill patients. participants were randomized to view one of four videos how depicting different physicians disclose prognosis when physicians expect an icu patient to die.

intensivist-surrogate discordance about prognosis is common in the intensive care unit. minimizing discordance and empowering families to make informed decisions about participants' loved one's care is important, but it is unclear how best to communicate prognostic information to vulnerable surrogates when a patient is expected to die. participants are randomized to view one of 4 intensivist communication styles in response to the question "what do you think is most likely to happen?": 1) a direct response (control), 2) an indirect response comparing the patient's condition to other patients, 3) an indirect response describing physiology, or 4) redirection to a discussion of patient values and goals. the participant will then be asked a series of questions to measure participants' interpretation of what the intensivist says.

Eligibility criteria:
inclusion criteria: * spouse/partner, sibling, or adult child of a patient with chronic obstructive pulmonary disease (copd) on home oxygen * over age 18 exclusion criteria: * ever working in healthcare as a nurse, advanced practice provider, or physician
effects of sodium-glucose co-transporter-2( sglt-2 ) inhibition on sympathetic nervous system activity in humans

Conditions: Metabolic Syndrome; Type 2 Diabetes Mellitus; Obesity

Summary: this study is designed to investigate whether the sodium-glucose co-transporter-2 (sglt-2) inhibitor empagliflozin reduces sympathetic nervous system (sns) activity in humans.

this is a randomised, double-blind, placebo controlled, cross-over study. participants will be randomly assigned to receive either empagliflozin 10mg/daily or placebo and will later receive the alternate treatment. comprehensive testing will occur after each 4 week treatment phase and will include assessment of muscle sympathetic nerve activity, cardiac and renal noradrenaline spillover to assess organ specific sns activity.

Eligibility criteria:
inclusion criteria: * age: 25 -65 years * (body mass index) bmi≥30kg/m2 * currently weight stable (+/- 3% in previous 6-12 months and not on any specific exercise or dietary program) * metabolic syndrome (defined as having: obesity (bmi ≥30kg/m2 ) plus any two of the following four factors: elevated triglycerides (triglyceride≥ 1.7mmol/l), reduced hdl (high - density lipoprotein) cholesterol (\<1.0mmol/l in males, \<1.3mmol/l in females), elevated clinic systolic (blood pressure) bp ≥130 or diastolic bp ≥85mmhg, fasting glucose ≥5.6mmol/l or type 2 diabetes. * office bp for screening purposes ≤160/90mmhg * drug naïve for at least 6 weeks prior to baseline assessment exclusion criteria: * grade 2-3 hypertension (systolic office bp \>160, diastolic office bp \>100 mmhg) * secondary causes of hypertension * ckd (chronic kidney disease) stage 4-5 {(estimated glomerular filtration) egfr\<30ml/min} * heart failure nyha (new york heart association) class ii-iv * recent cv (cardiovascular) event (acute myocardial infarction, acute coronary syndrome, stroke or transient ischaemic attack within the previous six months) * unstable psychiatric condition * medication such as corticosteroids, several antidepressants and antipsychotics * female participants of childbearing potential must have a negative pregnancy test prior to treatment

Keywords: metabolic syndrome central sympathetic nervous system sodium-glucose co-transporter-2 (sglt2) blood pressure