Kornimate/medical-research-clean huggingface dataset:
non-inferiority study of xm02 filgrastim (granix) and filgrastim (neupogen) in combination with plerixafor for autologous stem cell mobilization in patients with multiple myeloma or non-hodgkin lymphoma

Conditions: Multiple Myeloma; Lymphoma, Non-Hodgkin

Summary: this study will compare the results of stem cell mobilization using drugs called filgrastim (neupogen) and plerixafor with the results of stem cell mobilization using drugs called xm02 filgrastim (granix) and plerixafor.

this study will compare the results of stem cell mobilization using drugs called filgrastim (neupogen) and plerixafor with the results of stem cell mobilization using drugs called xm02 filgrastim (granix) and plerixafor. the fda has determined that granix is biosimilar to neupogen, which means that they are similar in terms of quality, safety, and efficacy; however, granix has not been tested in the context of stem cell mobilization to see how its effectiveness compares to that of neupogen

Eligibility criteria:
inclusion criteria: * at least 18 years of age * diagnosis of multiple myeloma or non-hodgkin lymphoma * eligible for autologous transplantation * adequate bone marrow function as defined as: * white blood cell count ≥ 3.0x109/l * absolute neutrophil count ≥ 1.5x109/l * platelet count ≥ 100x109/l * able to understand and willing to sign an irb-approved informed consent document * surgically or biologically sterile or willing to practice acceptable birth control, as follows: * women of childbearing potential must have a negative serum or urine pregnancy test within 7 days of day 1 of study treatment. women of childbearing potential must agree to abstain from sexual activity or use a medically approved contraceptive measure/regimen during and for 3 months after the treatment period. acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (iud), transdermal/implanted or injected contraceptives, and abstinence * males must agree to abstain from sexual activity or agree to utilize a medically approved contraception method during and for 3 months after the treatment period. acceptable methods of birth control include: barriers (condoms), oral contraceptive, intrauterine device (iud), transdermal/implanted or injected contraceptives, and abstinence exclusion criteria: * previous autologous stem cell collection * known hypersensitivity to filgrastim, plerixafor, or e. coli derived products * pregnant or breastfeeding
predicting locally advanced rectal cancer response to nct and ncrt with mri

Conditions: Rectal Cancer; MRI

Summary: this trial was designed to to study whether there is a difference in mri image evaluation between ncrt and nct, and try to build a model to predict the efficacy of neoadjuvant therapy by combining multiple imaging indexes.

this study was designed as a retrospective case-control study. all 116 patients with locally advanced rectal cancer who started neoadjuvant chemoradiotherapy and underwent radical surgery in west of china hospital and completed the required mr examination before and after neoadjuvant treatment were included from march 2016 to december 2019. mri imaging indicators of patients before and after neoadjuvant therapy, including tumor location, longitudinal diameter, circumferential angle, dwi signal, mrtrg and texture feature data, were retrospectively collected to analyze the changes before and after treatment, and compared with patients receiving nct in part1. at the same time, indicators with statistical differences will be included in the construction of models predicting different pathological outcomes after nct and ncrt, and the efficacy of the models was evaluated through c-index values and roc analysis of bootstrap resampling 500 times.

Eligibility criteria:
inclusion criteria: 1. pathological diagnosis of rectal cancer; 2. received neoadjuvant chemoradiotherapy before surgery; 3. before neoadjuvant therapy and before surgery, the patients received thin and high resolution mri examination of the rectum. 4. before neoadjuvant therapy, colonoscopy, rectal contrast-enhanced ultrasound or mri showed that the lower margin of the tumor was within 12cm from the anal margin; 5. pre-neoadjuvant clinical stage ii/iii (ajcc 7th edition); exclusion criteria: 1. simultaneous distant metastatic tumor should be considered at the first diagnosis; 2. patients with distant metastasis were not considered at the initial diagnosis; 3. with other malignant tumors; 4. before neoadjuvant therapy, patients had received other relevant treatments; 5. to undergo palliative surgery or emergency surgery in the course of neoadjuvant therapy;
choice of subjective ocular refraction technique and corneal topography of keratoconus

Conditions: Keratoconus; Alteration of Visual Acuity

Summary: keratoconus is a rare evolving corneal ectasia that alters visual acuity. to improve spectacle-corrected visual acuity, various subjective refraction techniques can be used. the subjective refraction techniques of keratoconus-carrying patients have never been studied. the main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus. the main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.

keratoconus is a rare evolving corneal ectasia that alters visual acuity. to improve spectacle-corrected visual acuity, various subjective refraction techniques can be used. the jackson cylinder cross method, the astigmatic dial technique and the stenopeic slit are three validated subjective refraction techniques for measuring astigmatism. the subjective refraction techniques of keratoconus-carrying patients have never been studied. the main hypothesis is that the most suitable subjective ocular refraction method varies with the corneal topography of the keratoconus. the investigators collect several characteristics of corneal topography of the keratoconus : the average value of the keratometry of the 3 central mm called km ; the value of the point corresponding to the maximum keratometry (called kmax), the distance between the center and the point of kmax, (called d_kmax) ; the corneal surface variance index called isv ; the belin/ambrósio enhanced ectasia display (called bad-d). the main objective is to define the most appropriate refractive technique(s) based on corneal topographies in order to provide keratoconus-affected patients with the best spectacle-corrected visual acuity.

Eligibility criteria:
inclusion criteria: * adult persons * patients with keratoconus * patients with alteration of visual acuity * ability to give informed consent to participate in the study * affiliation to a social security scheme exclusion criteria: * keratoconus grafted with cornea or with intracorneal rings. * central corneal opacities. * presence of other eye diseases affecting visual acuity. * patients under guardianship, curatorship or justice protection. * pregnant or breastfeeding women. * refusal to participate in the study.

Keywords: keratoconus corneal topography eyeglasses ocular refraction jackson cross cylinder astigmatic dial technique stenopeic slit
treatment of late abortion: evacuatio uteri or conservative treatment

Conditions: Abortion, Spontaneous; Abortion, Induced

Summary: a randomize trial: expectation or evacuatio uteri for the treatment after late abortion

a randomize trial adressing 200 women consecutively recruited from clinical practice at rigshospitalet.expectation: administration of 800 microgram cytotec half an hour after delivery. surgery: evacuation of the uterus

Eligibility criteria:
inclusion criteria: abortion at gestational age (ultrasound) 14+0 - 20+0 exclusion criteria: allergy to cytotec

Keywords: late abortion
a "window trial" on curcumin for invasive breast cancer primary tumors

Conditions: Breast Cancer

Summary: the purpose of this study is to determine whether oral administration of curcumin causes biological changes in primary tumors of breast cancer patients.

the purpose of this study is to determine whether oral administration of curcuma longa extract causes biological changes related to apoptosis (dna fragmentation) and cell proliferation (ki67) in primary tumors of breast cancer patients.

Eligibility criteria:
inclusion criteria: 1. histologically confirmed invasive breast cancer (stages i, ii, or iii) with primary tumor(s) ≥ 1.0 cm on mammogram, ultrasound, mri, or physical exam 2. 18 years of age or older 3. subject must understand risks and benefits of the protocol and be able to give informed consent 4. women of childbearing potential (wocbp) must agree to use an approved form of birth control and to have a negative pregnancy test result within 14 days of registration. wocbp is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy) or who is not postmenopausal. menopause is defined clinically as 12 consecutive months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes approved forms of birth control: * combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation (oral, intra-vaginal, or transdermal) * progestogen only hormonal contraception associated with inhibition of ovulation (oral, injectable, or implantable) * intrauterine device, intrauterine hormone-releasing system * bilateral tubal occlusion/ligation * vasectomized partner * barrier contraception * sexual abstinence 5. eastern cooperative oncology group (ecog) performance status of 0 or 1 6. adequate hematologic and end organ function 7. ability and capacity to comply with the study and follow-up procedures 8. subjects must be scheduled for surgery at musc no less than 5 days from the planned start of day 1 and no more than 56 days from the planned start of day 1 9. at least 6 sections of unstained slides should be obtained. if sufficient slides or tissue is unavailable, the patient will be excluded from the trial exclusion criteria: 1. subjects undergoing neoadjuvant chemotherapy or neoadjuvant endocrine therapy 2. subjects with end-stage kidney disease and/or grade ii liver dysfunction 3. subjects who are pregnant or are lactating. 4. subjects with bile duct obstruction, gallstones, predisposition to kidney stones(39), or gastrointestinal disorders such as stomach ulcers and hyperacidity disorders(40) 5. subjects taking anti-coagulants or platelet inhibitors 6. subjects taking drugs metabolized by cyp3a4, cyp1a2, and cyp2a6 enzymes 7. subjects taking drugs that interact with p-glycoprotein (p-gp) 8. subjects taking any of the medications listed under other herb-drug interactions according to the memorial sloan kettering cancer center in section 5.
open trial of miglitol in type 1 diabetic patients with insulin treatment

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is evaluate the clinical efficacy and safety of miglitol in patients with type1 diabetes mellitus treated with insulin.


Eligibility criteria:
inclusion criteria: * type1 diabetes * criteria of postprandial glucose and hba1c are met exclusion criteria: * type2 diabetes * patients with antidiabetic drugs * the other exclusion criteria are met

Keywords: alpha-glucosidase inhibitor,insulin
new prognostic index for neoadjuvant chemotherapy outcome in patients with advanced high-grade serous ovarian cancer

Conditions: Ovarian Cancer; Neoadjuvant Chemotherapy; Prognostic Cancer Model

Summary: a validated prognostic index for the outcome of advanced high-grade serous ovarian cancer (hgsoc) patients undergoing neoadjuvant chemotherapy (nact) is still lacking. to address this need, we developed an ovarian neoadjuvant chemotherapy prognostic index (oncpi) to improve predictive accuracy. we analyzed the clinicopathological characteristics of advanced hgsoc patients receiving platinum-based nact. blood inflammatory composite markers were calculated and binary-transformed using optimal cutoffs. omental hematoxylin and eosin (h\&e) stained slides were selected for the assessment of chemotherapy response score (crs). logistic regression analysis and cox proportional hazards regression model were utilized to develop a prognostic index.

1. the clinicopathological data of patients newly diagnosed with high-grade serous ovarian cancer in sun yat-sen memorial hospital were collected and screened. 2. statistical analysis of hematological indicators that may be related to inflammation before platinum-based therapy in patients who met the inclusion criteria, including but not limited to: absolute white blood cell count, absolute neutrophil count, absolute lymphocyte count, absolute monocyte count, platelet count, hemoglobin and fibrinogen were calculated. nlr, mlr, plr, flr and sii were calculated, and the correlation between the above indicators and tumor grade, stage, platinum-based drug sensitivity and prognosis was analyzed. 3. crs scoring was performed using h\&e sections of omentum obtained during ids surgery. 4. logistic regression and cox regression were used to analyze the independent risk factors affecting the sensitivity of neoadjuvant platinum-based chemotherapy and the prognosis of patients. 5. k-m analysis and roc curve were used to analyze the predictive value of nlr combined with crs oncpi index for the response of high-grade serous ovarian cancer to platinum therapy.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of hgsoc by two experienced pathologists; 2. clinical stage iii-iv according to the 2018 international federation of gynecology and obstetrics (figo) guideline; 3. eastern cooperative oncology group (ecgo) performance status of 0 to 1; 4. no prior anti-cancer therapy; 5. received ≥ 3 cycles of platinum-based nact followed by ids; 6. complete pretreatment blood test results and clinical and imaging data. exclusion criteria: 1. other pathological types; 2. without nact or ids; 3. incomplete pretreatment data; 4. lost to follow-up.

Keywords: high-grade serous ovarian cancer neoadjuvant chemotherapy prognostic index
the effect of the cosmetic cream nmbm on leg ulcers - a pilot study

Conditions: Ulcer; Venous Ulcer; Skin Ulcer; Leg Ulcer

Summary: ulcers of the lower extremities, caused by chronic venous insufficiency and cellulitis are common in patients older than 65 years and cause a significant morbidity. natural matrix bio polymer membrane (nmbm) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. the aim of this study is to test whether of natural matrix bio polymer membrane (nmbm) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

ulcers of the lower extremities, particularly in patients older than 65 years, are common among the population. studies estimate the prevalence of current chronic leg ulcers at approximately 1%. the most common cause (approximately 80%) is thought to be chronic venous insufficiency disease. recurrent cellulitis is an additional common cause. the ulcers cause a significant morbidity and negative impact on the patients' quality of life. the care of chronic vascular ulcers places a significant burden on the patient and the health care system. additionally, these nonhealing ulcers place the patient at much higher risk for lower extremity amputation. natural matrix bio polymer membrane (nmbm) is a novel topical cosmetic cream containing a mix of natural waxes, sugars and lipids. the aim of this study is to test whether of natural matrix bio polymer membrane (nmbm) is effective as an adjunctive therapy to the treatment of venous stasis and post-erysipelas leg ulcers.

Eligibility criteria:
inclusion criteria: 1. signed and dated written institutional review board (irb) or independent ethics committee (iec) approved informed consent obtained from the subject in accordance with the local regulations; 2. male or female subjects, ≥18 to ≤90 years of age 3. patient with venous or predominantly venous leg ulcer (ankle-brachial index \> 0.8) 4. chronic venous insufficiency or post-erysipelas ulcer 5. ulcer size between 5 and 170 sq cm, inclusive 6. ulcer present for at least one month 7. ankle-brachial index \>0.7 exclusion criteria: 1. suffers from diabetes mellitus with hba1c ≥ 8% 2. albumin less than 2. 2. patients with the following abnormal laboratory test levels hemoglobin \<10.5 g/dl platelet count \<100 x 109/l serum albumin level \< 2.5 g/dl 3. suffers from clinically significant arterial disease 34. has a known allergy to any of the compounds that are part of this protocol 45. has evidence of the ulcer and / or infection extending to the underlying muscle, tendon or bone 56. has used any investigational drug(s) within 30 days preceding randomization 67. is unable to manage self-treatment 78. is pregnant, nursing mother or a woman of child bearing potential who is not using an adequate form of contraception (or abstinence) 8. 9. suffers from a condition which in the opinion of the investigator would compromise the safety of the subject and / or the quality of the data 9. 10. unwilling or unable to comply with study requirements.

Keywords: chronic venous leg ulcers venous ulcer stasis ulcer varicose ulcer
spesolimab post-marketing surveillance in korean patients with flares with generalized pustular psoriasis

Conditions: Generalized Pustular Psoriasis

Summary: the primary and secondary objectives are to respectively monitor the safety and effectiveness of spesolimab iv in korean patients with flares with generalized pustular psoriasis (gpp) in a routine medical practice.


Eligibility criteria:
inclusion criteria: * patients starting spesolimab iv for the first time in accordance with the approved label in korea (complete enumeration for the first 2 years after product launch) * patients with generalized pustular psoriasis (gpp) flare * age \>/=19 years at enrolment * patients who have signed the data release consent form exclusion criteria: * patients with severe or life-threatening hypersensitivity to spesolimab or to any of the excipients * patients with clinically important active infections (e.g. active tuberculosis)
a proteomic analysis for understanding the link between migraine and cardiovascular disease

Conditions: Coronary Artery Disease; Migraine; Cardiovascular Diseases

Summary: this is a multicenter, prospective observational study. will be collecting data from 90 consecutive patients (aged 25- 60 years ) with and without migraine admitted at our hospital. primary aim of the study will be to assess the correlation between migraine and proteomic profiling of plasma and their possible correlation with known cardio and cerebrovascular disease and cardiovascular (cv) risk factors.

ninety consecutive patients hospitalized for noncoronary artery disease will follow their clinical course. they will be classified into symptomatic for migraine with aura (n=45) and migraine free (n=45) and will be enrolled in the study. patients will be screened for migraine characteristics and a comprehensive clinical analysis, including sex-related cardiovascular risk factors, will be collected. to achieve the study objective, blood will be drawn to do targeted proteomic evaluation of proteins relevant to cardiovascular disease (cvd), inflammation, immune response, and neurological disorders, in order to compare the profile of migraine patients with that obtained in patients without migraine.

Eligibility criteria:
inclusion criteria: * age \>25 years and \> 60 years * signed patient informed consent form (icf) * non-coronary disease exclusion criteria: * age \ 60 years * acute myocardial infarction (mi) * chronic kidney disease: glomerular filtration rate (gfr) \< 30 ml/min * severe mitral or aortic valvular disease * acute heart failure * reduced left ventricular (lv) function (ejection fraction \< 35%) * atrial fibrillation
a clinical trial of oral suberoylanilide hydroxamic acid (saha) in patients with advanced multiple myeloma (0683-004)

Conditions: Multiple Myeloma

Summary: the purposes of this study are: * to determine the maximum tolerated dose (mtd) of saha administered every 12 hours for 14 consecutive days followed by 7 days of rest during the first two cycles (i.e., first 6 weeks) in patients with advanced multiple myeloma; * to assess the safety and overall response rate to saha in patients with advanced multiple myeloma.


Eligibility criteria:
inclusion criteria: * adult patients with refractory or relapsed multiple myeloma, ecog performance status 0-2 (ecog) * adequate bone marrow reserve * adequate hepatic and renal function * ability to swallow capsules * 3 weeks or more from prior chemotherapy and have recovered from prior toxicities exclusion criteria: * patients who plan to go for bone marrow transplant within 4 weeks of start of treatment * patients with prior treatment with other investigational agents with a similar anti-tumor mechanism * patients with other active/uncontrolled clinically significant illnesses * pregnant or nursing female patients
the clinical study of botulinum toxin type a injection in the treatment of wilson disease

Conditions: Wilson Disease

Summary: in order to expand the treatment of wilson disease and improve the quality of life of patients with wilson's disease, the clinical effect of botulinum toxin type a injection on wilson's disease was discussed.


Eligibility criteria:
inclusion criteria：1.conform to the diagnosis of "2012 european liver study guidelines for diagnosis and treatment of hepatolenticular degeneration". 2. aged from 15 to 65 years. exclusion criteria:non-wilson's disease

Keywords: botulinum toxin type a wilson disease