Kornimate/medical-research-clean huggingface dataset:
iressa for egfr mutation negative non-small cell lung cancer (nsclc)

Conditions: Nonsmall Cell Lung Cancer

Summary: the investigators will examine efficacy and toxicity of gefitinib in korean patients with egfr wild tumors diagnosed with direct sequence test.


Eligibility criteria:
inclusion criteria: * pathologically proven nsclc * ineligibile for curative treatment (namely, stage iiib or iv) * history of one to three prior systemic chemotherapy tumors without active egfr mutations (exon 19 deletion, l858r mutation in exon 21) * at least one lesion that was unidimensionally measurable by computed tomography (by recist 1.1) * 18 years old or older * performance status ecog 0-2 * adequate organ function as evidenced by the following: * absolute neutrophil count \> 1.0 x 109/l * platelets \> 75 x 109/l * total bilirubin ≤ 1.5 unl * ast and/or alt \< 5 unl * creatinine clearance ≥ 45ml/min exclusion criteria: * previous egfr tki therapy history * systemic anticancer therapy within the previous 3 weeks * other invasive malignancy within the past 2 years except non-melanoma skin cancer, in situ cervix cancer, or papillary thyroid cancer * other concurrent illness that would preclude study participation (severe heart disease) * other concurrent physical condition (e.g., infectious disease) that would preclude study participation * pregnant or nursing

Keywords: gefitinib egfr mutation negative nsclc
first line treatment trial in multiple myeloma, finnish myeloma group- multiple myeloma 02

Conditions: Multiple Myeloma

Summary: the purpose of this study is to determinate the efficacy and safety of the 3-drug induction treatment (rvd; lenalidomide plus bortezomib plus dexamethasone)followed by randomized autologous stem cell mobilization, autologous stem cell transplantation and lenalidomide maintenance. primary endpoint is the immunophenotypic remission rate.during the randomized mobilization phase two active comparator arms cyclophosphamide (cy)2g/m2 + granulocyte-colony stimulating factor(g-csf) vrs g-csf will be compared regarding efficacy, costs and safety.


Eligibility criteria:
inclusion criteria: * written informed consent * symptomatic, previously untreated international stating system (iss) 1-3 myeloma * measurable disease * who perf status 0-3 * eligible for asct exclusion criteria: * previously treated * peripheral neuropathy gr \>/= 2 * significant hepatic dysfunction * severe cardiac dysfunction * severe renal failure if not in dialysis

Keywords: myeloma, stem cell mobilization, autologous stem cell transplantation induction treatment, maintenance treatment
exercise endurance time on the 2nd day at 2500 m high altitude

Conditions: High Altitude Pulmonary Hypertension

Summary: the impact of a sojourn at 2500 m of high altitude for 26-30 h on constant work-rate exercise test time in patients with precapillary pulmonary hypertension

patients with pulmonary hypertension will perform a constant work-rate exercise test at low altitude (450m) and at high altitude 2500m in a randomized-cross-over sequence protocol. the constant work-rate exercise test time and other measures will be assessed

Eligibility criteria:
inclusion criteria: * informed consent as documented by signature * ph class i (pah) or iv (cteph) diagnosed according to guidelines: mean pulmonary artery pressure \>20 mmhg, pulmonary vascular resistance ≥3 wood units, pulmonary arterial wedge pressure ≤15 mmhg during baseline measures at the diagnostic right-heart catheterization exclusion criteria: * resting partial pressure of oxygen \<8 kilopascal at zurich at 490 m low altitude * exposure to an altitude \>1000 m for ≥3 nights during the last 2 weeks before the study * inability to follow the procedures of the study * other clinically significant concomitant end-stage disease (e.g., renal failure, hepatic dysfunction)
outcomes of early and late administration g-csf for primary prophylaxis in non-hodgkin's lymphoma patients

Conditions: Non-Hodgkin's Lymphoma (NHL); Granulocyte Colony Stimulating Factor; Febrile Neutropenia (FN); Myelosuppression Adult

Summary: the goal of this clinical trial is to primary objectives: 1. to compare the incidence of febrile neutropenia in patients with non-hodgkin's lymphoma who received early or late granulocyte colony-stimulating factor (g-csf) during standard chemotherapy in a multicenter study 2. to determine the incidence of leukopenia and neutropenia in patients with non-hodgkin's lymphoma who received early or late g-csf during standard chemotherapy in a multicenter study secondary objectives: 1. to determine changes in white blood cell, hemoglobin, and platelet levels in patients with non-hodgkin's lymphoma who received early or late g-csf during standard chemotherapy. 2. to determine the quality of life of patients with non-hodgkin's lymphoma who undergoing standard chemotherapy and with neutropenia researchers will compare the outcome between patients received either early g-csf (within 72 hours) or late g-csf (after 72 hours). all patients will be followed up to monitor for febrile neutropenia events, other hematological parameters and quality of life.

this study aims to analyze the impact of the timing of granulocyte colony-stimulating factor (g-csf) administration on the prevention of febrile neutropenia (fn) in non-hodgkin's lymphoma patients undergoing standard chemotherapy. g-csf is a growth factor that stimulates the production of white blood cell in order to fighting infection. when non-hodgkin's lymphoma patients receive chemotherapy for eradicating cancer cells. they also have collateral damage those white blood cells and other hematopoietic cell lines. all patients received standard chemotherapy regimens once every four weeks. the study will compare the efficacy of early g-csf administration, or late administration, after each course of chemotherapy. the primary endpoint is the incidence of fn in each chemotherapy course. at the end of each chemotherapy course, patients received either early g-csf (within 72 hours) or late g-csf (after 72 hours). all patients will be followed up to monitor for fn events. secondary endpoints include the incidence of myelosuppression and quality of life, assessed during outpatient and emergency department visits.

Eligibility criteria:
inclusion criteria: * aged 18 years or old * confirmed lymphoma undergoing standard chemotherapy * signed an approval informed consent * has a good understanding of thai * available for follow-up after chemotherapy exclusion criteria: * pregnancy or lactation * serious concomitant diseases and discontinuous treatment such as cardiovascular, liver, or kidney diseases * contraindication to chemotherapy or g-csf administration * antibiotic use within 1 week prior to enrollment

Keywords: non-hodgkin&#39;s lymphoma febrile neutropenia granulocyte colony stimulating factor myelosuppression
mi-thos® transcatheter mitral valve replacement(first-in-man study)

Conditions: Mitral Valve Regurgitation

Summary: to evaluate the effectiveness and safety of the mi-thos® transcatheter mitral valve replacement system in the treatment of patients with moderate or greater mitral regurgitation who are at high risk for conventional surgery, or who are not candidates for conventional surgery.

the mi-thos® study is a single-arm, prospective, safety and performance clinical study.

Eligibility criteria:
inclusion criteria: * severe mitral regurgitation ≥ 3+; * patients with an sts score \>8 or who have been evaluated by a cardiothoracic surgeon as high risk for conventional surgery or who cannot tolerate conventional open-heart surgery; * age ≥ 65 years old; * life expectancy \> 12 months; * patients sign an informed consent form. exclusion criteria: * previous cardiac mitral valve surgery; * active infections requiring antibiotic therapy; * clinically significant untreated coronary artery disease (cad); * pulmonary hypertension （pulmonary systolic pressure \> 70 mmhg）; * patients with severe right heart failure; * left ventricular ejection fraction \<25%; * diagnosis of hypertrophic cardiomyopathy, restrictive cardiomyopathy, constrictive pericarditis; * dialysis patient; * patients with severe coagulopathy; * patients with contraindications to anticoagulant drugs; * patients with stroke or transient ischemic within 30 days; * echocardiography found any intracardiac mass, left ventricle or atrial thrombus; * patients who require surgery or interventional therapy for other valvular lesions; * patients with severe macrovascular disease requiring surgical treatment; * patients with more than 70% of carotid stenosis; * to be allergic to contrast agents, nickel-titanium memory alloys or bovine-derived products; * patients with severe neurological disorders affecting cognitive ability; * life expectancy \< 12 months; * patients with severe thoracic deformities.
correlation between fluorodeoxyglucose (fdg) and flt uptake and gene-expression oncotype assay in patients with breast cancer

Conditions: Breast Cancer

Summary: in the current study fdg (fluorodeoxyglucose) uptake, flt uptake (f18-fluoro-3'-deoxythymidine) and their ratios will be correlated with the risk score results of the oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor.

several publications have addressed the role of pet imaging for biological characterization of breast cancer. a modest but significant correlation was reported between tumor grading and fdg uptake. few studies reported a positive correlation between suv and the ki-67 labeling index of malignant breast tumors. others have correlated p53 expression in breast cancer and fdg uptake. f18-fluoro-3'-deoxythymidine (flt) has been developed as a pet marker for cellular proliferation has been developed for imaging cell proliferation and findings correlate strongly with the ki-67 labeling index in breast cancer. a 10-minute flt-pet scan acquired two weeks after the end of the first course of chemotherapy, has been shown in two recent studies to be useful for predicting longer-term efficacy of chemotherapy regimens for women with breast cancer. in the current study fdg and flt uptake and their ratios will be correlated with the risk score results of the oncotype gene-expression assay in patients with clinically negative nodal disease planned for surgical removal of the tumor. it is our hypothesis that since high uptake of these tracers implies aggressive behavior and rapid tumor growth, it might well be that patients with high risk score on oncotype will have high uptake of the pet tracers and those with low risk score will show low-intensity uptake values. if this will be the case, it might well be that in patients with non-conclusive oncotype results (intermediate score) fdg and flt uptake measurement will allow further dichotomy to 1. patients with intermediate score on oncotype and high uptake of the pet tracers, suggestive of aggressive behavior and 2. patients with intermediate score on oncotype and low uptake of the pet tracers suggesting a less aggressive behavior.

Eligibility criteria:
inclusion criteria: * newly diagnosed patients with breast cancer * clinically nodal negative * prior to surgery and/or treatment * age over 18 years exclusion criteria: * age under 18 * pregnancy * previous therapy for breast cancer * clinical or histological evidence of nodal involvement or other proven metastatic sites

Keywords: breast cancer lymph nodes gene-expression oncotype age over 18 newly diagnosed breast cancer prior to surgery or treatment. no evidence of clinical nodal disease
covid-19 surveillance based on smart wearable device

Conditions: COVID-19

Summary: this is a prospective, multi-center cohort study. 200 subjects with covid-19will be included . wearable device's physiological parameters and clinical data will be continually collected , the investigators aim to explore whether using smart wearable devices is useful to early alerting deterioration of covid-19.

this is a prospective cohort study. 200 subjects aged 18～75y with asymptomatic, mild, general-type covid-19 will be recruited. the physiological parameters of wearable devices, including heart rate, sleep, blood oxygen saturation, electrocardiogram and exercise records, will be continuously collected from the day of admission / isolation to 14 days after discharge or out of quarantine. the department of respiratory and critical care of peking university first hospital is responsible for this research. all clinical data of patients during hospitalization will be collected including demographic characteristics, onset time, visit time, hospitalization time, symptoms, physical examination, laboratory examination, imaging characteristics, disease severity, treatment and outcome. primary outcome is the deterioration of disease, the correlation analysis between the change of wearable device physiological parameters and the deterioration of disease determined by the traditional disease evaluation system will be used to find it whether can early alert deterioration of covid-19. the study protocol has been approved by the peking university first hospital institutional review board (irb) (2020-055). any protocol modifications will be submitted for the irb review and approval.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years(both 18 and 75), either gender; 2. at the time of enrollment, patients with novel coronavirus infection meeting the criteria of the new coronavirus pneumonia diagnosis and treatment program (seventh edition) 3. able to engage in daily activities; 4. willing to participate in this research and willing to follow the research program, with the ability to sign informed consent; 5. having mobile communication equipment which can install app of wearable device. exclusion criteria: 1. wear time of wearable devices \<50% during the whole study period 2. wearable devices have faults, missing signals or errors throughout the study period, resulting in the proportion of analyzable information \<50% 3. patients with incomplete outpatient and inpatient information and missing core information such as hospitalization / discharge time, symptoms, laboratory examination, disease progress record, etc. 4. patients with serious underlying diseases (including serious mental diseases, mental disorders, nervous system diseases, malignant tumors, chronic liver diseases, heart failure, autoimmune diseases, chronic kidney diseases), or life expectancy less than 6 months 5. unable to take care of themselves in daily life, unable to cooperate with medical history and data collection 6. participating in other clinical trials; 7. pregnant women, women in puerperium

Keywords: covid-19 surveillance smart wearable device
single-application terbinafine hydrochloride (1%) topical liquid solution versus a single-application butenafine hydrochloride (1%) topical liquid solution for the treatment of tinea pedis

Conditions: Tinea Pedis

Summary: tinea pedis or athlete's foot is the most common fungal infection worldwide, caused by infection of the feet with dermatophytes such as trichophyton rubrum, trichophyton interdigitale (formerly trichophyton mentagrophytes), and epidermophyton floccosum. diagnosis of tinea pedia involves clinical symptoms as well as microscopic examination. topical therapies are usually applied once or twice daily for as long as 4 weeks, posing a challenge to compliance. the current study aims to test a formulation of the single-dose 1% terbinafine hydrochloride, as well as a single-dose 1% butenafine hydrochloride, versus a vehicle control in adult filipino patients with athlete's foot. this study will benefit the filipino community by helping us determine which anti-fungal cream is most effective for athlete's foot.


Eligibility criteria:
inclusion criteria: * male or nonpregnant females aged 18-60 years old. * clinical diagnosis of tinea pedis (total sign/symptom score \>2), lesions between the toes, with possible extension to the lateral surfaces and soles of the feet confirmed by a positive microscopy prior to dosing. * willing to sign the informed consent. exclusion criteria: * females who are pregnant (confirmed by a pregnancy test), suspect themselves to be pregnant (even if pregnancy test is negative), breast-feeding, or planning a pregnancy. * signs of systemic or other superficial fungal disease (e.g.onychomycosis), clinically relevant abnormal findings upon physical examination of the foot or previous treatment with a disallowed medication (such as corticosteroids). * presence of non-healing wounds and/or bacterial infection on the feet. * secondary bacterial infection due to tinea pedis * presence of pigmentation, extensive scarring, or pigmented lesions in the treatment areas, which could interfere with the rating of efficacy parameters. * history of hypersensitivity to any component of the test products. * current imuunosuppression. specifically, these include ￼patients with co-morbidities such as diabetes, hiv, chronic diseases requiring maintenance medications, acute febrile/infectious illnesses (i.e. dengue, pneumonia, etc) * use within 3 months prior to baseline of: 1.) chemotherapy, or 2.) radiation therapy
repair vs non-repair of the pronator quadratus muscle in distal radius fractures. rct.

Conditions: Radius Fractures; Colles' Fracture; Rupture of Muscle; Arm Injuries

Summary: the purpose of this study is to determine the functional outcome of repairing the pronator quadratus (pq) muscle in subjects operated for a distal radius fracture (drf) with volar locked plating.

fractures of the distal radius are common in the elderly. a frequent treatment of an unstable drf is surgery with volar plating using the modified henry's approach. in some cases the fracture mechanism has injured the pq muscle and subsequent reconstruction of the muscle can be difficult. when the pq muscle is not injured the plate is fixated through a radial and distal release of the pq muscle and resuture/repair of the pq muscle is attempted by most surgeons. the clinical relevance of repairing the pq muscle has not previously been investigated in a randomised clinical trial and we hypothesise that there is no difference in functional outcome whether the pq muscle is repaired or not.

Eligibility criteria:
inclusion criteria: * patients over 18 years. * patients with an unstable drf ao type 23 a2, a3, c1, c2 or c3 elected for surgery with volar plating. unstable is defined as one of the following: 1) more than 10 degrees dorsal angulation of radius' joint surface in lateral plane measured from an orthogonal axis through radius. 2) ulnar variance more than 2 mm. 3) fracture line involving joint surface with more than 2 mm dislocation. 4) incongruence of the drj. * patients that can undergo the surgery in plexus brachialis block (so the operation can be performed in the outpatient department). * patients with the ability to read and understand danish. exclusion criteria: * patients with an open fracture. * patients with a neurologic disorder affecting the fractured upper extremity. * patients with a history of fracture to the same wrist. * patients with dementia, substance abuse or severe psychiatric disorder. * patients who do not agree to be randomised. * patients unable to continue follow-up.

Keywords: pronator quadratus distal radius fracture repair volar plating prwe
dehydrated human amnion chorion membrane (dhacm) vs. control in the treatment of partial thickness burns.

Conditions: Treatment of Partial Thickness Burns

Summary: multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of dehydrated human amnion chorion membrane (dhacm) plus control as compared to control alone for the treatment of second degree burns (partial thickness burns) as assessed by time to healing and scarring

multicenter, prospective, randomized, controlled feasibility trial to determine the safety and effectiveness of dehydrated human amnion chorion membrane (dhacm) plus control as compared to control alone for the treatment of second degree burns as assessed by time to healing and scarring

Eligibility criteria:
inclusion criteria: ll patients enrolled must meet all the following criteria: 1. patient with burn injury that meets all of the following requirements: 1. occurred within the last 48 hours 2. wound is thermal in nature 3. partial-thickness burn (burn extends through the epidermis and may penetrate into the dermis) 4. total body surface area (tbsa) of burn(s) is 2-20% for all subjects 5. burn area(s) located on smooth, flat surface 6. 2 burn areas, each with a minimum size of 16cm2 (burn areas may be two separate burns or within one large burn, see section 9.4.2) 2. age ≥ 12 months and ≤ 70 years exclusion criteria: subjects meeting any of the following criteria will be excluded: 1. burns meeting any of the following criteria: 1. mechanism of injury was electrical, radiation, chemical or frostbite 2. wound is larger than 200 cm2 3. clinically infected burn (as judged by the investigator) 4. previous or planned treatment of the burn area(s) with any of the following: * biological skin substitutes (including apligraf®, dermagraft®, etc.) 2. patient criteria that will make patient ineligible for enrollment: 1. ventilator dependence 2. active malignant disease or patient is less than 1 year disease-free 3. use of immunosuppressive agents, radiation or chemotherapy within the past 30 days 4. auto-immune disorders including systemic lupus erythematosus (sle), fibromyalgia, acquired immunodeficiency syndrome (aids) or human immunodeficiency virus (hiv) 5. presence of any condition (including current drug or alcohol abuse, medical or psychiatric condition) that is likely to impair understanding of or compliance with the study protocol in the judgment of the investigator 6. presence of any condition that is likely to compromise healing in the judgment of the investigator 7. pregnancy at enrollment or within last 6 months, women who are breastfeeding, or women of childbearing potential who are planning to become pregnant during the time of the study or are unwilling/unable to use acceptable methods of contraception (birth control pills, barriers, or abstinence) 8. patient has been on any investigational drug(s) or therapeutic device(s) in the last 30 days or any previous enrollment in this study 3. allergy or known sensitivity to any of the following: 1. aminoglycosides such as gentamicin sulfate and/or streptomycin sulfate 2. silver -