Kornimate/medical-research-clean huggingface dataset:
fibrin melanoma axillary node study in patients with melanoma

Conditions: Melanoma

Summary: primary objective: * to determine whether the use of a fibrin sealant applied to axillary soft tissues following node dissection can result in earlier drain removal. secondary objectives: * to determine the postoperative morbidity rate using fibrin sealant following axillary node dissection. * to assess patient-valuation of outcome by performing a cost-benefit analysis using a willingness-to-pay model. * to determine if serum levels, lymphatic fluids level, or cutaneous expression of vascular endothelial growth factor-d (vegf-d), vascular endothelial growth factor-c (vegf-c) or their receptor, vascular endothelial growth factor receptor-3 (vegfr-3) correlates with nodal tumor burden or development of lymphedema in patients with melanoma.

patients in this study are scheduled to have axillary node dissection as part of their surgery for treatment of their melanoma. within 2 weeks before entry into the study, patients will have a complete physical exam and medical history. these patients will be randomly assigned (as in the toss of a coin) to one of two groups. patients in one group will receive tisseel applied externally to the dissected axillary area. patients in the other group will receive no fibrin sealant. for patients who are admitted to the hospital, the surgical site will be monitored by the surgeon for evidence of wound complications in the first 24 hours after surgery. at the time of discharge from the hospital, patients will be instructed in drain care and how to measure the drainage each day until the drain is removed. the contents of the drain will be collected from patients during the first day after surgery, during the first return follow-up visit to m.d. anderson cancer center, and during drain removal (unless these latter 2 dates are the same). follow-up wound exams will be performed by the local primary physician or in the m.d. anderson melanoma clinic between 1-4 weeks and 6 weeks after surgery. participation will be over at the 6-week follow-up. this is an investigational study. the sealant is fda approved, though its use in this study is experimental. about 115 patients will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. part i - inclusion criteria, patients that consent to participate. 2. patients with melanoma who have undergone axillary dissection within the last six months as part of their surgical treatment will be considered for the study. exclusion criteria: 1. part ii - exclusion criteria, patients with known hypersensitivity to bovine proteins. 2. patient has undergone prior radiation therapy to the operative site. 3. patient is pregnant or lactating. 4. patient is steroid dependent within prior 6 months. 5. patient has used aspirin or other anti-platelet drug (excluding celebrex) within seven days of operation. 6. patient has pre-existing lymphedema. 7. patient has other pre-existing medical conditions with evidence of organ dysfunction as determined by principal investigator.

Keywords: axillary node dissection fibrin sealant tisseel melanoma seroma
examining the long-term safety of insulin aspart when used as a part of the treatment for type 1 diabetes

Conditions: Diabetes; Diabetes Mellitus, Type 1

Summary: this trial is conducted in europe and asia. the aim of this clinical trial is to investigate the long-term safety of insulin aspart in the management of type 1 diabetes. an extension to the ana/dcd/065 trial


Eligibility criteria:
inclusion criteria: * signed informed consent obtained before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject) * the subject must have completed the ana/dcd/065 trial exclusion criteria: * impaired hepatic function * impaired renal function * total daily insulin requirements of more than 1.4 u/kg * cardiac problems * uncontrolled hypertension * known or suspected allergy to trial product or related products * current hypoglycaemic unawareness as judged by the investigator * known or suspect abuse of alcohol or narcotics * women breastfeeding or having the intention of becoming pregnant, or if judged not to be using adequate contraceptive measures (adequate measures are intrauterine device (iud), oral contraception and barrier methods) * any condition that the investigator and/or sponsor feels would interfere with trial participation or evaluation of results
a study to evaluate pegsitacianine, an intraoperative fluorescence imaging agent for the detection of lung malignancies

Conditions: Lung Cancer

Summary: this phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. all patients will receive a single dose of pegsitacianine prior to standard of care surgery.

this single-arm trial will enroll patients with biopsy confirmed or a high clinical suspicion of a lung malignancy based on mri, ct and/or pet imaging. a total of up to 40 patients will be enrolled in this trial. the sponsor reserves the right to perform an interim analysis following early enrollment (i.e., n ≤ 10 subjects) to determine the feasibility and benefit of pegsitacianine as an adjunct to standard of care surgical resection of lung malignancies. the surgeon will begin by attempting to perform their soc tumor resection. if the tumor is unable to be located under standard white light conditions, an appropriate fda-cleared near-infrared imaging device may be used to aid in the location of the primary tumor. localization of the primary tumor, when unable to be located using white light imaging, in conjunction with pathology confirmed presence of disease will be considered a clinically significant event. following any standard of care procedures conducted under white light only, the near infrared camera will be used to evaluate areas of residual fluorescence that may be resected if suscpicious for metastatic spread or residual margins. the fluorescence status of each specimen will then be correlated to the final pathology for each, and performance metrics of pegsitacianine will be tabulated.

Eligibility criteria:
inclusion criteria: * biopsy confirmed diagnosis, or a high clinical suspicion of a lung malignancy based on mri, ct and/or pet imaging exclusion criteria: * known hypersensitivity or allergy to indocyanine green (icg), polymethylmethacrylate (pmma; found in dental and bone cements) or polyethylene glycol (peg) * tumor locations the surgeon deems unfeasible to image intraoperatively * excessive and/or generalized disease deemed inoperable by the surgeon * life expectancy less than 12 weeks
low fat diet for fatigue in ms

Conditions: Multiple Sclerosis

Summary: a randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with ms and fatigue for management of their fatigue. the hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.


Eligibility criteria:
for participants with ms: inclusion criteria: * age 18-70 * diagnosis of ms by 2010 mcdonald criteria * edss ≤ 7.5 * experiencing moderate to severe fatigue (mfis ≥ 38) exclusion criteria: * current cardiopulmonary disease requiring treatment * diabetes * pregnancy or breast-feeding * ms exacerbation within 30 days of screening visit * iv steroids within 30 days of screening visit * dietary fat content of \<30% as assessed by food frequency questionnaire (ffq) at screening visit * fish oil or flax seed oil supplementation within 30 days of screening visit

Keywords: diet, low-fat
change in serum biomarkers after endovascular treatment for acute anterior circulation large vessel occlusion

Conditions: Ischemic Stroke

Summary: acute ischaemic stroke (ais) results in high rates of neurological morbidity and mortality, especially in patients with large vessel occlusion (lvo). endovascular therapy (evt) has been approved as the most effective treatment for patients with lvo , but about half patients undergoing evt did not achieve good outcome. the mechanisms of poor prognosis are complex. how to accurately identify serological biomarkers related to patients' clinical prognosis is an important research topic nowadays.


Eligibility criteria:
inclusion criteria: 1. age: 18-80 years; 2. patients with acute anterior circulation large vessel occlusion within 24 hours of onset who will receive endovascular treatment; 3. pre-stroke mrs: 0-1; 4. baseline nihss: ≥6; 5. signed informed consent. exclusion criteria: 1. the presence of contraindications to internal jugular vein cannulation; 2. receiving intravenous thrombolysis; 3. haemorrhagic stroke (cerebral haemorrhage or subarachnoid haemorrhage); 4. coagulation disorders, systemic bleeding tendency, thrombocytopenia (\<100×109/l); 5. severe cardiac, hepatic or renal insufficiency (alt or ast elevated more than 2 times the upper limit of normal value, or serum creatinine elevated more than 1.5 times the upper limit of normal value or in need of dialysis) or other serious medical diseases; 6. severe uncontrolled hypertension (systolic blood pressure greater than 200 mmhg or diastolic blood pressure greater than 110 mmhg); 7. pregnant or lactating women; 8. other conditions who are not suitable for this trial by investigator.
controlled trial: 5-day course of telithromycin versus doxycycline for the treatment of mild to moderate scrub typhus

Conditions: Scrub Typhus

Summary: new antibiotics are required that have antibacterial activity against doxycyline resistant o. tsutsugamushi, that can be safely used in pregnant women and children, that have a low possibility of inducing resistance and that do not induce cross resistant to other antibiotics. telithromycin has been reported to be effective on rickettsia, batonella and coxiella burnetii. therefore, telithromycin may be considered as a substitute antibiotic that can be used safely in pregnant women and children for rickettsiosis or orientia infection. our study was designed to prove the clinical usefulness of telithromycin by comparing it with doxycycline for treating mild or moderate scrub typhus.

randomization and treatment assignment. after submitting a written, informed consent, the patients with an temperature of higher than 37.5°c and who met the eligibility criteria were randomly allocated to receive one of two oral regimens in accordance with a protocol that was determined by the last digit of a resident registration number (the patients with an odd number were treated by a5-daycourseofdaily 200-mg doses of doxycycline,and the patients with an even number were treated by a 5-day course of daily 800-mg doses of telithromycin). therapy was started immediately after acomprehensive clinical examinationand the collection of specimens for laboratory tests.

Eligibility criteria:
inclusion criteria: we conducted a multicenter prospective study of patients with possible scrub typhus. adult patients (aged ≥18 years) who have had fever (temperature: ≥37.5°c) together with eschar or a maculopapular skin rash and ≥2 of the following symptoms: headache, malaise, myalgia, coughing, nausea, and abdominal discomfort, were enrolled after obtaining an informed consent from the patients or their guardians (10). each patient was admitted between september, 2005 to december, 2005 to chosun university hospital or one of its two community branch hospitals (jangheung hospital and chumdan hospital), which are all located in southwest korea. exclusion criteria: * the exclusion criteria were an inability to take oral medications, pregnancy, hypersensitivity to the trial drugs, previous drug therapy with potential antirickettsial activity (e.g., rifampicin, chloramphenicol, macrolides, fluoroquinolones or tetracyclines) within 48 h prior to admission, severe scrub typhus (shock requiring vasopressor therapy for \>1 h, a stuporous or comatose level of consciousness, respiratory failure requiring mechanical ventilation or renal failure requiring immediate dialysis)

Keywords: scrub typhus telithromycin doxycycline
high-dose etoposide could discriminate patients with refractory/relapsed lymphoma benefit from apbsct

Conditions: Lymphoma

Summary: patients with refractory /relapsed lymphoma received high-dose etoposide for hematopoietic stem cell (hsc) mobilization.all patients received high-dose etoposide 20-25 mg/kg/d intravenously for two consecutive days followed by rhg-csf10ug/kg/day subcutaneously at 48 hours after chemotherapy; rhg-csf was continued until the end of harvesting for hscs/hpcs. peripheral blood counts were performed daily for all patients following the initiating of rhg-csf. leukapheresis was performed when peripheral blood white blood count exceeded 4×109/l with blood cell the harvested cells reached at least 2\*108/kg for mononuclear cells and/or 2\*106/kg for cd34+ cells with once to twice leukapheresis. the final product was kept frozen in liquid nitrogen.auto-pbsct


Eligibility criteria:
inclusion criteria: * relapsed/refractory lymphoma ,siut apbsct exclusion criteria: * bone marrow without involvement by lymphoma cells

Keywords: high-dose etoposide,autologous peripheral blood stem cell transplantation
safety and efficacy of etanercept in patients with psoriasis

Conditions: Psoriasis

Summary: the purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional dmards.


Eligibility criteria:
inclusion criteria: * has plaque psoriasis and has shown an unsatisfactory response to traditional dmards * 18 to 75 years old * has pga of 3 or more at day 0 * has bsa of 3% or more at day 0 * has psoriasis severe enough to be eligible to systemic therapy * willing to use an effective method of contraception for at least 30 days before day 0 and until at least 1 month after the last drug administration; * capable of giving informed consent * with normal or non clinically significant chest x-ray within 6 months prior to day 0 * with negative purified protein derivative (ppd) or quantiferon tb gold test within 90 days prior to day 0 * female patients of childbearing potential have a negative serum pregnancy test * patient is able to start etanercept per the approved product monograph exclusion criteria: * has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to day 0 or during the study period * has presence of erythrodermic, pustular or guttate psoriasis * has had significant infections within the 30 days prior to day 0 * has received investigational drugs within the four weeks prior to screening or during the study period * has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, puva therapy or methotrexate within the four weeks prior to day 0 or during the study period * received systemic antibiotics within the four weeks prior to day 0 * has been treated with ultraviolet light therapy (uvb, nbuvb) within the two weeks prior to day 0 or during the study period * has used infliximab within 14 days of day 0 or during the study period * has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to day 0 or during the study period * has had an allergic reaction to infliximab * has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient * uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, nyha class iii or iv heart failure, history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris * uncontrolled hypertension, oxygen-dependent severe pulmonary disease * has a known sero-positivity for hiv virus or history of any other immunosuppressive disease * has active or chronic hepatitis b or c * has any mycobacterial disease, patient with a chest x-ray suggestive of tuberculosis or patient taking anti-tuberculosis medication * has a known hypersensitivity to etanercept or one of its components * has received a live attenuated vaccine within the 12 weeks prior to day 0 or plans to receive one during the study * current pregnancy or lactation
phase iii confirmatory study of de-089 ophthalmic solution in patients with dry eye

Conditions: Dry Eye

Summary: to investigate that the efficacy of 3% de-089 ophthalmic solution (one drop at a time, 6 times daily, 4 weeks topical administration), in comparison to 0.1% sodium hyaluronate ophthalmic solution (0.1% ha) (one drop at a time, 6 times daily, 4 weeks topical administration), is at least non-inferior in the change in fluorescein staining score, and is superior in the change in rose bengal score, in a multicenter, double-masked, parallel-group comparison study. safety profile will likewise be compared.


Eligibility criteria:
inclusion criteria: * those who show: * keratoconjunctival disorder confirmed with vital dye staining * abnormal schirmer score results exclusion criteria: * eye disease that needs therapy other than that for dry eye * those who need to wear contact lenses during the clinical study
the effect of the left smartwatch app as sleep positional therapy for nocturnal gastroesophageal reflux symptoms.

Conditions: Gastroesophageal Reflux; Heartburn

Summary: the main objectives of the study are (1) to investigate if sleep positional therapy, using the left smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with gastroesophageal reflux disease symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.

gastroesophageal reflux disease (gerd) is one of the most common gastro-intestinal disorders and approximately 50-80% of the gerd patients experience nocturnal gastroesophageal reflux symptoms. symptoms at night have a negative impact on sleep quality, daytime functioning and quality of life. when sleeping in left lateral decubitus position, the stomach is positioned below the esophagus, resulting in less reflux compared to sleeping in right lateral decubitus position. sleep positional therapy, using an electronic wearable device which gently vibrates in an annoying way when turning in the sleep to the disadvantageous right lateral decubitus position, stimulates subjects to avoid sleeping in the right lateral decubitus position and effectively alleviates nocturnal gastroesophageal reflux symptoms. this prospective single center interventional pilot study will aim to (1) investigate if sleep positional therapy, using the left smartwatch app reduces nocturnal gastroesophageal reflux symptoms in patients with gerd symptomatology at night and (2) stimulates patients to avoid sleeping in the right lateral sleep position.

Eligibility criteria:
inclusion criteria: * written informed consent. * both male and female patients will be included. * age 18 years or older. * symptoms of heartburn and/or acid regurgitation during at least three nights a week. * a total reflux symptom score ≥8 (measured through the gerdq questionnaire score). * able to wear the apple watch on the left wrist. exclusion criteria: * complete ppis non-responders. * nightshift workers * surgery of the esophagus or stomach. * regular use of sleep medication (benzodiazepines) or medication which affect gastrointestinal motility (e.g. prokinetics or opioids) that cannot be stopped during the duration of the trial. * severe and clinically unstable concomitant disease (e.g. liver, cardiovascular or lung disease, neurological or psychiatric disorders, cancer or aids and other endocrine disorders) * patients with obstructive sleep apnea or esophageal motility disorders. * pregnant or lactating women.

Keywords: sleep positional therapy
efficacy and safety of paclitaxel for injection (albumin-bound) for first-line chemotherapy of ovarian cancer

Conditions: Ovarian Cancer

Summary: preliminary evaluation of the efficacy and safety of paclitaxel for injection (albumin-bound) in combination with carboplatin for first-line chemotherapy of ovarian cancer.


Eligibility criteria:
inclusion criteria: * age: 18 to 75 years; * histologically confirmed epithelial ovarian cancer, fallopian tube cancer and primary peritoneal cancer; * patients with stage ic-iv according to the international federation of obstetrics and gynecology (figo) and who underwent an ideal tumor reduction procedure within 6 weeks prior to enrollment; * lesion is measurable according to recist 1.1 criteria or patient's ca125 is evaluable according to gcig criteria; * ecog performance status of 0-2; * expected survival ≥ 3 months; * bone marrow function: neutrophils ≥ 1.5×109/l, platelets ≥ 100×109/l, hemoglobin ≥ 90 g/l; * hepatic and renal function: serum creatinine ≤ 1.5×uln; ast and alt ≤ 1.5×uln or ≤ 5×uln in the presence of hepatic metastasis; total bilirubin ≤ 1.5×uln, or ≤ 2.5×uln in patients with gilbert's syndrome; * must agree to use effective contraception during the trial; women of childbearing potential must have a negative serum or urine pregnancy test; non-lactating patients. exclusion criteria: * ovarian low-grade malignant tumor patients; * patients who have received abdominal or pelvic radiotherapy; * patients with central nervous system disease or brain metastases; * other malignancies have occurred within the last 5 years, except for cervical carcinoma in situ, non-melanoma skin cancers that have been cured; * prior grade ≥ 2 sensory or motor neuropathy; * uncontrolled serious medical conditions that, in the opinion of the investigator, would affect the ability of the subject to receive the study regimen, such as concomitant serious medical conditions, including severe heart disease, cerebrovascular disease, uncontrolled diabetes mellitus, uncontrolled hypertension, uncontrolled infection, active peptic ulcer, etc.; * known to be hypersensitive, highly sensitive, or intolerant to study-related medications or their excipients; * receive other study drug chemotherapy within 30 days of the first dose of chemotherapy; * patients not suitable for participation in this study judged by investigator.