Kornimate/medical-research-clean huggingface dataset:
systemic treatment alone versus systemic treatment plus radiotherapy in oligometastatic renal cell carcinoma

Conditions: Kidney Neoplasm

Summary: to evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

various institutions are attempting to use locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, accompanied by a few metastases. research findings have indicated that high-dose locoregional radiotherapy can suppress disease progression, potentially prolonging the interval for additional systemic therapy; however, whether the addition of locoregional radiotherapy in cases of renal cell carcinoma with oligometastases demonstrates superior oncologic outcome compared to standard systemic therapy alone has yet to be established. therefore, a randomized phase iii study is being conducted to evaluate whether incorporating locoregional radiotherapy in the treatment of oligometastatic renal cell carcinoma, including inductive oligometastases, along with standard systemic therapy, contributes to improved progression-free survival rates for patients.

Eligibility criteria:
inclusion criteria: 1. patients with metastatic renal cell carcinoma classified within the estro/eortc classification system as having ≤ 5 metastases, ≤ 3 metastatic organs, and meeting criteria for new, recurrent, or induced metastases. 2. patients aged 20 to 80 years. 3. patients with individual metastases ≤ 5 cm in longest diameter. 4. patients with primary tumors surgically removed or scheduled for surgery. 5. patients histologically diagnosed with clear cell carcinoma. 6. patients with ecog performance status 0-1. 7. patients with normal major organ function and bone marrow function meeting specific criteria: wbc ≥ 2,000/μl, neutrophils ≥ 1,000/μl, platelets ≥ 50,000/μl. 8. patients who understand the contents of the informed consent form, voluntarily consent to participate in the study, and sign the informed consent form. 9. patients who agree to use contraception from the time of signing the consent form until 1 year after the last standard systemic therapy. 10. breastfeeding women who agree to stop breastfeeding for at least 5 months after the last standard systemic therapy. 11. patients with visible tumors outside the scope of tumor removal surgery (surgical therapy) for metastatic lesions. exclusion criteria: 1. patients with total bilirubin \> 3.6 mg/dl. 2. patients with ast \>160 u/l, alt \> 165 u/l. 3. patients unable to maintain position for partial nephrectomy radiotherapy. 4. patients with a history of radiotherapy to metastatic renal cell carcinoma or surrounding areas. 5. patients with confirmed brain, peritoneal, or pleural metastases. 6. patients diagnosed with another solid tumor and treated within 2 years or with residual lesions. 7. patients who do not consent to participate in the study. 8. pregnant patients.
preoperative portal and splanchnic flow measurement using mri

Conditions: Liver Cirrhoses

Summary: this study aims to assess the alteration of portal and splanchnic flow using mri after liver transplantation in patients with splenomegaly or splenic varix.


Eligibility criteria:
inclusion criteria: * older than 18 years * and signed informed consent * and planned either a) liver transplantation as a recipient; or b) liver transplantation as a donor exclusion criteria: * any absolute/relative contraindication of contrast-enhanced mri

Keywords: mri cirrhosis
comparison of two gelatine solutions

Conditions: Hypovolemia

Summary: the aim of volume replacement is to compensate a reduction in the intravascular volume e.g. during surgery and to counteract hypovolemia in order to maintain hemodynamics and vital functions. to achieve this, different plasma substitutes are available: albumin, dextran, hydroxyethylstarches and gelatine. the aim of this study is to demonstrate that acid-base alterations during elective abdominal surgery can be reduced by the use of a new gelatine solution.


Eligibility criteria:
inclusion: * male or female patients \>= 18 years of age and \<= 90 years of age. women of child bearing potential must test negative on standard pregnancy test. * patients scheduled to undergo elective abdominal surgery (e.g. rectal resection, liver resection, open bowl resection, duodenopancreatectomy reconstitution). * scheduled intraoperative volume requirement of at least 15 ml / kg body weight (broca) gelatine solution * provision of voluntary consent to participate in the study, following a full explanation of the nature and purpose of the study, by signing the informed consent form approved by the institutional ethics committee (iec) prior to all evaluations. exclusion: * patients of asa-class \> iii * known hypersensitivity to gelatine or to any of the constituents of the solution * patients treated with other colloid solutions and / or blood products 24 hours prior to surgery * patients on hemodialysis * patients suffering from decompensated renal function (i.e. serum creatinine \> 3.0 mg/dl) * patients suffering from hypervolemia hyperhydration severe blood coagulation disorders hypernatremia (serum(na+) \> 150 mmol/l) hyperchloremia (serum(cl-) \> 110 mmol/l) * estimated perioperative need for blood products of 3,5 ml / kg body weight (broca) * lactation period * simultaneous participation in another clinical trial * emergencies
dupilumab as an adjunct for subcutaneous grass immunotherapy

Conditions: Allergic Rhinitis

Summary: the primary objective is to assess whether 16 weeks of treatment with dupilumab as an adjunct to timothy grass subcutaneous immunotherapy (scit) improves upon the efficacy of timothy grass scit to reduce provoked allergic rhinitis symptoms, as measured by total nasal symptom score (tnss) after nasal allergen challenge (nac) with timothy grass extract at week 17. the secondary objectives of the study are: * to assess whether 16 weeks of treatment with dupilumab as compared to placebo reduces provoked allergic rhinitis symptoms, as measured by tnss after nasal allergen challenge (nac) with timothy grass extract * to assess whether 16 weeks of treatment with dupilumab as compared to dupilumab + scit reduces provoked allergic rhinitis symptoms, as measured by tnss after nasal allergen challenge (nac) with timothy grass extract * to assess changes in serum timothy-grass-specific immunoglobulin g4 (igg4), serum timothy grass-specific immunoglobulin e (ige), and ratio of serum timothy grass-specific igg4 to ige over 16 weeks of treatment with dupilumab + scit as compared to scit monotherapy * to evaluate the safety and tolerability of 16 weeks of treatment with dupilumab as an adjunct to timothy grass scit


Eligibility criteria:
key inclusion criteria: 1. male and female participants aged 18 to 55 2. history of grass pollen-induced seasonal allergic rhinitis 3. grass pollen allergy confirmed by both: 1. positive skin prick test (spt) with timothy grass extract (mean wheal diameter at least ≥5 mm greater than a negative control) 2. positive serum timothy grass-specific ige (≥0.35ku/l) key exclusion criteria: 1. significant rhinitis, sinusitis, outside of the grass pollen season 2. any contraindications to scit (i.e, severe cardiovascular disease, malignancies, autoimmune disease, use of beta blocker, asthma severe enough to require chronic medication, acute infection) 3. use of systemic corticosteroids within 4 weeks of screening visits or any nac visits 4. abnormal lung function as judged by the investigator 5. a clinical history of asthma requiring chronic medication such as regular inhaled corticosteroids for \>4 weeks per year 6. history of significant recurrent sinusitis, defined as 3 episodes per year for the last 2 years, all of which required antibiotic treatment 7. history of chronic sinusitis (with or without nasal polyps) 8. tobacco smoking (any) within the last year note: other protocol defined inclusion/ exclusion criteria apply
combined retinoic acid,arsenic trioxide and chemo for newly-diagnosed apl

Conditions: Acute Promyelocytic Leukemia

Summary: in this prospective randomized study for patients with newly diagnosed acute promyelocytic leukemia, patients will be randomized (1:1) into two groups which receive retinoic acid and arsenic trioxide based treatment versus retinoic acid and chemotherapy based regimen.

the study is carried out based on sanz risk stratification of newly-diagnosed apl patients into low-, intermediate- and high-risk groups, and all of them will receive atra and ato as induction therapy (atra 25 mg/m2 per day orally + ato 0.16mg/kg intravenously daily). anthracycline is added to both high-risk groups or intermediate-risk group with hyperleukocytosis developed during induction therapy but not in low-risk groups. after achieving cr, patients enter into consolidation therapy. low-risk patients receive either 2 courses of atra plus ato (experimental group) or 2 courses of atra plus anthracycline chemotherapy (control group). intermediate-risk patients receive either 3 courses of atra plus ato (experimental group) or 2 courses of atra plus anthracycline chemotherapy (control group). patients of high-risk disease receive 2 courses of atra plus ato and anthracycline and 1 course of atra plus ato treatment (experimental group) or 2 courses of atra plus anthracycline and cytarabine and 1 course of atra plus mid-dose cytarabine (control group). after consolidation therapy, patients with molecular complete remission (mcr) enter into maintenance therapy. low- and intermediate-risk patients receive 3 cycles of atra and ato sequential treatment, while those of high-risk receive 5 cycles of atra, ato and methotrexate (mtx) treatment. for low- and intermediate-risk patients who fail to achieve mcr after consolidation therapy, 3 courses of consolidation therapy of high-risk group will be given with cross-over (i.e. patients in experimental group received the therapy of control group, and patients in control group received the therapy of experimental group). if patients still fail to achieve mcr, together with high-risk group who fail to achieve mcr after consolidation therapy will be withdrawn from the study and proceed to salvage treatment.

Eligibility criteria:
inclusion criteria: * newly-diagnosed patients with acute promyelocytic leukemia via cytogenetics and molecular assay * age: 18-65 * hepatic/renal function: bil≤35μmol/l，ast/alt less than 2xnormal range, cr 150μmol/l * normal cardial function * ecog：0-4 * informed consent exclusion criteria: * qtc interval \>450ms * pregnant or breast feeding patients * patients with drug addiction or mental illness * patients documented of cns infiltration at diagnosis * patients with severe heart disease (acute myocardial infarction or heart failure) * patients with concurrent active malignancy, tuberculosis or hiv infection * patients with contraindication or allergy to anthracyclines or other agent in the protocol * patients enrolled in other clinical trials * patients not apply to the study protocol

Keywords: acute promyelocytic leukemia atra arsenic
a study of taspoglutide versus pioglitazone in patients with type 2 diabetes

Conditions: Diabetes Mellitus Type 2

Summary: this double-blind, double-dummy 3 arm study will evaluate the efficacy, safety and tolerability of taspoglutide versus pioglitazone in patients with type 2 diabetes mellitus inadequately controlled with sulfonylurea monotherapy or sulfonylurea plus metformin combination therapy. after an initial screening period, patients will be randomized to one of 3 groups, to receive a)taspoglutide 10mg sc weekly, b)taspoglutide 20mg sc weekly after 4 weeks of taspoglutide 10mg sc weekly or c)pioglitazone 45mg/day po after 4 weeks of pioglitazone 30mg/day po.the anticipated time on study treatment is 24 months, and the target sample size is 500+ individuals.


Eligibility criteria:
inclusion criteria: * adult patients, 18-75 years of age; * type 2 diabetes mellitus; * treated with stable sulfonylurea monotherapy or metformin + sulfonylurea for \>=12 weeks prior to screening; * hba1c \>=7.0% and \<=10% at screening; * stable weight +/-5% for \>=12 weeks prior to screening. exclusion criteria: * type 1 diabetes, diabetes resulting from pancreatic injury, or secondary forms of diabetes; * clinically significant diabetic complications; * clinically symptomatic gastrointestinal disease; * \>3 episodes of severe hypoglycemia within 6 months before screening.
phase ii study of sch66336, a farnesyltransferase inhibitor in chronic myelogenous leukemia (cml)

Conditions: Myelogenous Leukemia, Chronic

Summary: the goal of this research is to see if giving the drug sch66336 by mouth can improve the disease in patients with chronic or accelerated phase cml. the safety of this treatment will also be studied.

objectives for this study are two-fold: 1. to determine the efficacy of sch66336 in patients with chronic phase and accelerated phase cml in relation to response rate, duration of response, and survival. 2. to assess the toxicity of sch66366 in these patients.

Eligibility criteria:
* diagnosis of philadelphia chromosome (ph) -positive cml in chronic or accelerated phase; * failure to respond to or intolerance to imatinib mesylate (gleevec); * age \>/= 16 years; * life expectancy of \>/= 2 months; * performance status 2 or better (zubrod); * adequate renal and hepatic functions (creatinine and bilirubin \</= 2 mg/dl); * adequate cardiac function; * not candidates for or have refused allogeneic transplantation; * patients should not be receiving azoles (ketoconazole, itraconazole, fluconazole), macrolides, hiv protease inhibitors, cyclosporin or anti-seizure drugs (phenobarbital, phenytoin, carbamazepine), rifampin or isoniazid.

Keywords: philadelphia chromosome positive cml myelogenous leukemia, chronic, chronic phase myelogenous leukemia, chronic, accelerated phase
virtual reality visual field testing as an alternative in childhood eye disease

Conditions: Visual Field Defect, Peripheral

Summary: the purpose of this study is to test a new way of measuring the peripheral vision (called a visual field test) using a device which can be worn as goggles rather than being a large instrument the patient must sit at. this new visual field test (called visuall) is an fda-approved virtual reality system which has been used in adults and children. this study will compare the performance of the visuall to the standard testing for peripheral vision, which is called the humphrey visual field (hvf) test. the study will recruit both healthy children, as well children and young adults who have eye conditions which require visual field testing as part of their standard care. the test will be performed on a day when the child or young adult already has a scheduled eye appointment as standard care. the test does not touch the eyes or require any eye drops to be given, and there is no known risk associated with the test itself. there may be a risk of loss of confidentiality. participating in this study will require approximately 30 minutes, has no extra cost associated with it, and will be compensated by a parking pass for the day of the visit. there are no direct benefits for participants. selected participants will be also be given training and then loaned a home visuall system to allow home visual field testing. if your child is selected, additional information would be provided.


Eligibility criteria:
inclusion criteria: * patients must be at least four (4) years old * cognitively normal (no developmental delay or syndrome) * be able to tolerate wearing the virtual reality goggles for at least 10 minutes * be able to provide informed consent of a parent/guardian (and assent if 12 years or older) * do not have any ocular diseases that could interfere with the visual field testing exclusion criteria: * developmental delay * inability to obtain consent * inability to understand english

Keywords: virtual reality visual field glaucoma neuro-ophthalmology
clinical factors associated with position sense in patients with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: sensory impairment is an important problem for patients with multiple sclerosis (ms). although there is no complete loss of sensation in patients, 80% of patients have a significant sensory impairment. the sensory system plays an important role in providing the feedback required to perform motor tasks. cutaneous sensation, especially in the sole of the foot, is very important in maintaining balance and gait. there are studies showing decreased foot sole sensation in ms patients. another sensation that is important during motor tasks is the proprioceptive sensation. the aim of this study is to examine the relationship between the sensation of foot sole and joint position, clinical features, attention, fatigue, body awareness and physical activity level in patients with ms.

patients with ms between 0-5,5 score according to the extended disability status scale (edss) and healthy individuals of similar age and sex to patients will be included in the study. the sensation of foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level will be evaluated. the investigators will use t-tests to compare for quantitative variables and chi-square for the categorical variables between groups. in addition, the investigators will examine the correlations between the sensation of the foot sole, joint position sensation, attention, fatigue, body awareness, and physical activity level using pearson bivariate correlations.

Eligibility criteria:
inclusion criteria: * 18-65 years of age * having a diagnosis of "multiple sclerosis" * relapse free in the last 3 mounts * ambulatory status (expanded disability status scale score ≤ 6 ) * no diagnosis of depression exclusion criteria: * any cardiovascular, orthopedic, visual, and hearing problems that may affect the results of the research

Keywords: multiple sclerosis sensation fatigue physical activity
phase 2 dose-response study evaluating the safety and efficacy of ncx 470 vs latanoprost in subjects with open-angle glaucoma or ocular hypertension

Conditions: Glaucoma, Open-Angle; Hypertension, Ocular

Summary: the objective of this clinical study is to evaluate the safety and efficacy of ncx 470 ophthalmic solution in lowering intraocular pressure (iop) in patients with ocular hypertension or open-angle glaucoma. three different concentrations of ncx 470 ophthalmic solution (0.021%, 0.042%, and 0.065%) will be compared to latanoprost 0.005% ophthalmic solution.


Eligibility criteria:
inclusion criteria: * diagnosis of open-angle glaucoma or ocular hypertension in both eyes * qualifying iop at 3 time points throughout the day at 2 visits following washout of iop-lowering medication, if applicable * qualifying best-corrected visual acuity (bcva) using the early treatment of diabetic retinopathy study (etdrs) protocol in each eye * ability to provide informed consent and follow study instructions exclusion criteria: * pigmentary or pseudoexfoliative glaucoma * narrow anterior chamber angles or disqualifying corneal thickness in either eye * clinically significant ocular disease in either eye * previous complicated surgery or certain types of glaucoma surgery in either eye * incisional ocular surgery or severe trauma in either eye within the past 6 months * uncontrolled systemic disease
functional neuroimaging in fibromyalgia patients receiving tdcs

Conditions: Fibromyalgia; Chronic Pain

Summary: the purpose of this study is to evaluate effectiveness and cerebral neuronal ability to adaptation in patients with fibromyalgia who receive pregabalin and transcranial direct current stimulation.

fibromyalgia syndrome occurs in around 2% of the population (predominantly women), and is characterized by its poor response to conventional therapies. therapeutic approaches modulating inhibitory pathways, including pharmacologic options as pregabalin, and non pharmacological ones as transcranial direct current stimulation (tdcs) have been proven to be of limited utility independently. aiming to evaluate a better understanding of the pathophysiogenic mechanisms and the effect of these treatments on neuroplasticity, this study was designed evaluating neurophysiologic, neurochemical and clinical parameters. neurophysiologic parameters and functions to be assessed will include pain threshold, motor evoked potential, silent period, intracortical facilitation and inhibition assessed by transcranial magnetic stimulation (tms) and optic functional neuroimaging. neurochemical measurements considered will be neurotrophins (bdnf) and inflammatory mediators (tnf, il1, il6, il10 and cortisol). clinical characteristics will be assessed using validated scales capable to detect functional capacity, quality of life (whocohl), catastrophism, sleep disruptions (pittsburgh) and depressive symptoms (beck depression inventory). considering the above described hypothesis, the present randomized clinical trial with blinded patients and evaluators is proposed. it pretends to analyze short-, mid- and long-term neurobiological mechanisms triggered by the selected interventions.

Eligibility criteria:
inclusion criteria: * - diagnosis of fibromyalgia according to the american college of rheumatology criteria exclusion criteria: * psychiatric or neurologic disorder that unable patient to consent and follow study protocol. * de-compensated systemic disease. * chronic inflammatory disease (e.g. systemic lupus erythematous, rheumatoid arthritis).

Keywords: fibromyalgia transcranial direct current stimulation tdcs pregabalin functional neuroimaging near infrared spectroscopy nirs chronic pain transcranial magnetic stimulation tms
analysis of the reliability and validity of the chinese version of cc-qol

Conditions: Chronic Cough

Summary: at present, there is no research scale designed for the quality of life of children with chronic cough in china, most of them use the cough scale designed for adults to evaluate the quality of life of children. in china, more and more attention has been paid to evaluate and improve the quality of life of children with chronic cough, but cough specific quality of life measurement tools for adults and parents are mostly used, and the chinese translation version of cqlq and lcq is still the main method. there is still no cough specific quality of life measurement tool for children with chronic cough in china. cc-qol, a specific scale for chronic cough in children, has not been promoted, and no relevant verification of the applicability, validity and reliability of the chinese version has been found. therefore, this study aims to verify and compare the applicability, reliability and validity of cc-qol chinese version in china through questionnaire survey and follow-up of children with chronic cough.

descriptive score: cc-qol, cet,vas, peds-qol,scas and verbal category score (vcd); descriptive score: descriptive score; descriptive score: descriptive score; descriptive score: descriptive score; to evaluate the reliability and validity of cc-qol in evaluating children's quality of life in china, compare and analyze leicester cough questionnaire(lcq) and child chronic cough-specific quality of life measure cc-qol was used to evaluate the quality of life in children with chronic cough.

Eligibility criteria:
inclusion criteria: * 1.age 7-14； * 2.disease duration \> 4 weeks； * 3.spontaneous cough as the main or only clinical symptom。 exclusion criteria: * chest x-ray was unremarkable, excluding cystic fibrosis, typical asthma or dyspnea, and other underlying diseases.

Keywords: reliability validity cc-qol