Kornimate/medical-research-clean huggingface dataset:
comparison study of breast computed tomography (ct) with magnetic resonance imaging (mri)

Conditions: Breast Cancer

Summary: lay summary after patients are diagnosed with breast cancer, they undergo breast magnetic resonance (mr) imaging to determine if the cancer is located in more than one place in the breast. breast mr imaging is a good option for this test because it has very high sensitivity (catches almost all breast tumors). however, breast mr is slow: it takes about two minutes to acquire one image, and is very low resolution. the points that make up the breast mr image are around 1 to 3 mm in size. dedicated breast computed tomography (or breast ct), a new way of imaging the breast, has been introduced in the last few years. breast ct is an x-ray exam that uses 3d imaging to show the breast in its real three dimensional shape. combined with the use of special chemicals called iodine contrast enhancement, breast ct can provide images of both the anatomy and the blood flow in the breast. as opposed to breast mr, breast ct is very fast. an image can be taken in 10 seconds, and has very high resolution. the points in the breast ct image are only 0.14 mm in size. the investigators propose to use breast ct instead of breast mr imaging to determine if the patient's breast cancer is located in more than one place. this is the first time anybody has proposed to use breast ct for this, so the investigators aim to test the feasibility of the idea with only 6 patients. since the patients will undergo breast mr as part of the standard of care, the investigators will be able to compare the breast ct images to the current standard, breast mr. this work will lay a foundation for performing this very important test before breast cancer treatment planning with a new, fast, high resolution imaging method, breast ct.

see above

Eligibility criteria:
3.1 eligibility criteria all subjects will be women at least 35 years of age that have been diagnosed with breast cancer and have undergone breast mr imaging for detection of multifocal/multicentric disease. 3.2 ineligibility criteria * subject does not meet any of the inclusion criteria * women with suspected or confirmed pregnancy * women who have had bilateral mastectomy * women who are very frail and unable to cooperate * women who cannot give informed consent * male subjects * women with implants
a study evaluating the role of oral antibiotics in an aim to eradicate carrier state of carbapenem- resistant klebsiella pneumonia (kpc).

Conditions: Klebsiella Pneumoniae Carbapenemase Resistant Associated Bacteremia or Pneumonia

Summary: klebsiella pneumonia, inhabitant of the digestive tract, is a frequent nosocomial pathogen. it is currently the fourth most common cause of pneumonia and fifth most common cause of bacteremia in intensive care patients (1-3). the aim of the present randomized controlled trial is to assess the efficacy of non-absorbable oral antibiotics in the eradication of the kpc carrier state.


Eligibility criteria:
inclusion criteria: * inclusion criteria 1. patient identified as a kpc carrier. 2. patient capable to understand and sign informed consent 3. age \> 18 4. patient capable to receive oral medication exclusion criteria: * exclusion criteria: 1. patient unable to sign informed consent 2. age ≤ 18 3. pregnant/lactating female 4. patient not expected to survive \> 2 weeks. 5. patient unable or not allowed to receive oral medications 6. a known allergy to study drugs.

Keywords: klebsiella , pneumonia, carbapenem-hydrolyzing lactamase, carbapenem-resistant klebsiella (kpc), eradication,
efficacy and safety of donepezil and sodium oligomannate in patients with mild to moderate alzheimer's disease

Conditions: Alzheimer Disease

Summary: alzheimer's disease (ad) is the main cause of dementia. at present, ad is incurable. cholinesterase inhibitors, especially donepezil, are the first choice for mild and moderate ad. sodium oligomannate (gv-971) is a marine-derived oligosaccharide. it is proposed that it can reconstitute the gut microbiota, and inhibit neuroinflammation in the brain as observed in animal models. it reduces aβ deposition in the brain of aβ-transgenic mice. the reduction in both aβ deposition and neuroinflammation may synergistically contribute to the improvement of cognitive impairment and delay the progress of the disease. the state food and drug administration of china (sfda) approved it for the treatment of mild to moderate ad in 2019. due to the different mechanism of cholinesterase inhibitor and gv-971, theoretically, they may synergistically improve cognitive function and delay disease progression. they are also used in patients with ad, but there is a lack of data on their effectiveness and safety. therefore, the purpose of this observational study is to compare the efficacy and safety of donepezil and gv-971 monotherapy and combination therapy in patients with mild and moderate ad, which is of great significance for guiding the treatment of mild and moderate ad.


Eligibility criteria:
inclusion criteria: * age of 50-85 years old , either sex; * met the diagnostic criteria for suspected ad; * mild to moderate ad patients, that is, patients with 11 points ≤mini-mental state examination(mmse) total score ≤26 points * total hachinski ischemic scale (his) score ≤4 points; * memory loss for at least 12 months, with a tendency of progressive deterioration; * brain magnetic resonance imaging（mri） scan suggesting a significant possibility of ad ; * no obvious physical signs during nervous system examination; * stable and reliable caregivers, * elementary school or higher education level * signed an informed consent form exclusion criteria: * previous nervous system diseases (including stroke, optic neuromyelitis, parkinson's disease, epilepsy, etc.); * mental illness according to the diagnostic and statistical manual of mental disorders, 4th edition（dsm-iv), text revision criteria, including schizophrenia and other mental illness, bipolar disorder, and severe depression or paralysis; * unstable or severe heart, lung, liver, kidney, or hematopoietic diseases; * uncorrectable visual and auditory disorders that affected completing neuropsychological tests and scale assessments; * simultaneous use of cholinesterase inhibitors or memantine.
effect of electroacupuncture in patients with sepsis associated brain injury

Conditions: Electroacupuncture; Sepsis; Sepsis-associated Brain Injury

Summary: to investigate the effect of electroacupuncture on patients with sepsis-associated brain injury.


Eligibility criteria:
inclusion criteria: 1. age is between 20 and 80 years. 2. patients meeting the diagnosis of sepsis-associated brain injury. 3. patients who agreed to accept this trial and signed the informed consent form. exclusion criteria: 1. patients with a history of brain injury, stroke, epilepsy, cognitive impairment, or mental illness prior to admission. 2. patients who were also involved in any other interventional study. 3. due to hearing or vision loss, or any other situation that may seriously interfere with study data collection. 4. patients who refused to participate in this study. 5. the pregnancy test was positive or is currently breastfeeding. 6. any other situation that the investigator believed might be detrimental to participant in the study.
efficacy and safety study of r935788 tablets to treat systemic lupus erythematosus

Conditions: Systemic Lupus Erythematosus

Summary: approximately 225 patients meeting study entry requirements will be enrolled and randomized (2:1, active versus placebo superimposed on background treatment) to r788 or placebo. patients will be followed for efficacy and safety parameters for 6 months. the investigator should taper corticosteroids if clinically warranted.

this study is a multi-center, multinational, randomized, double-blind, placebo-controlled phase ii clinical trial. study enrollment will comprise approximately 225 patients meeting study inclusion requirements. the study will be conducted at up to 80 multinational investigational sites. eligible patients will be randomized (2:1) into one of two 6 month treatment groups. one group (approximately 150 patients) will receive r788 150 mg po bid; the other treatment group (approximately 75 patients) will receive placebo.

Eligibility criteria:
inclusion criteria: * patients must give written informed consent to participate in this study by signing an irb/ec-approved informed consent form (icf) prior to admission to this study. * males and females, 18 years of age or older, with active sle diagnosed at least 6 months prior to day 1 dosing. active sle is defined as having fulfilled the acr criteria for sle. * patients of childbearing potential must be fully informed of the potential for r788 to adversely affect the fetus and, if sexually active, must agree to use an effective method of birth control during the study (oral contraceptive, mechanical barrier, long acting hormonal agent). * the patient must otherwise be in good health as determined by the investigator on the basis of medical history, physical examination, and laboratory screening tests during the screening period. * in the investigator's opinion, the patient has the ability to understand the nature of the study and any anticipated risks of participation, communicate satisfactorily with the investigator, and participate in and comply with the requirements of the entire protocol. exclusion criteria: * the patient has a history of, or a concurrent, clinically significant illness, medical condition or laboratory abnormality that, in the investigator's opinion, could affect the conduct of the study. * clinically significant or uncontrolled medical disease in any organ system, other than due to sle. * background immunosuppressive therapy that has not remained stable ≤ 4 weeks prior to baseline. * severe active or unstable renal disease. * active severe neuropsychiatric sle. * female patients must not be breastfeeding and must have a negative urine pregnancy test per the schedule of study activities. * the patient has a history of substance abuse, drug addiction, or alcoholism.

Keywords: sle lupus
special investigation for abrysvo in pregnant women and infants

Conditions: Respiratory Tract Infection

Summary: this post-marketing study is a multicenter cohort study in pregnant women vaccinated with abrysvo (rsv vaccine）designed to confirm the safety in pregnant women and their infants under actual clinical practice in japan.


Eligibility criteria:
inclusion criteria: 1. pregnant women who have been vaccinated with abrysvo for the first time after abrysvo is launched. pregnant women who have previously participated in the clinical trials of abrysvo will be excluded. 2. vaccinated participants who have provided written consent regarding their participation in the study and entry of symptoms to epro with the use of their devices (smartphones, tablets pc, etc.) (or paper-pro if there is any compelling reason) upon understanding the explanatory document. for a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent. 3. pregnant women who have provided written consent to the participation of their infants in the study. for a minor vaccinated participant, the parent(s) or legally acceptable representatives shall provide written consent. exclusion criteria: * there are no exclusion criteria for this study.

Keywords: respiratory tract infection rsv vaccine maternal infant post marketing study
single and multiple dose evaluation of qbkpn ssi in healthy volunteers

Conditions: Healthy

Summary: the purpose of this dose-escalation study is to assess the safety and pharmacodynamics of single and multiple doses of qbkpn ssi, administered subcutaneously to healthy adult volunteers


Eligibility criteria:
inclusion criteria: * healthy, non-smoking (at least for 6 months prior to first study drug administration) males or females, 18 to 65 years of age, inclusive at the time of informed consent. * body mass index (bmi) that is within 18.5 - 30.0 kg/m2, inclusive. * healthy, according to the medical history, ecg, vital signs, laboratory results and physical examination * systolic blood pressure between 95-140 mmhg, inclusive, and diastolic blood pressure between 55-90 mmhg, inclusive, and heart rate between 50-100 bpm, inclusive, unless deemed otherwise by the pi/sub-investigator. * qtc interval ≤ 450 milliseconds for males and females, unless deemed otherwise not clinically significant by the principal investigator/sub-investigator. * availability to volunteer for the entire study duration and willing to adhere to all protocol requirements. * agree not to have a tattoo or body piercing until the end of the study. * agree to practice effective methods of contraception exclusion criteria: * known history or presence of any clinically significant hepatic, renal/genitourinary, gastrointestinal, cardiovascular, cerebrovascular, pulmonary, endocrine, immunological, musculoskeletal, neurological, psychiatric, dermatological or hematological disease or condition unless determined as not clinically significant by the pi/sub-investigator. * a known history or positive test result for human immunodeficiency virus (hiv), chronic hepatitis b surface antigen, or hepatitis c. * a positive test result for drugs of abuse (marijuana, amphetamines, barbiturates, cocaine, opiates, phencyclidine and benzodiazepines), alcohol test and cotinine. positive pregnancy test for female subjects. * known history or presence of (1) alcohol abuse or dependence within one year prior to first study drug administration; (2) drug abuse or dependence; (3) known or suspected hypersensitivity to any component of the product (4) food allergies and/or presence of any dietary restrictions; or (5) severe allergic reactions (e.g. anaphylactic reactions, angioedema). * recent history (within 8 weeks prior to screening) of travel to or emigration from any country with high incidence for tuberculosis. * a positive tuberculin skin (ppd) test result
fibrinogen concentrate in isolated traumatic brain injury

Conditions: Traumatic Brain Injury; Hemorrhage

Summary: fibrinogen is a unique precursor of fibrin and cannot be compensated for by other coagulation factors. if plasma fibrinogen concentrations are insufficient, hemostatic clots cannot be formed with the appropriate firmness. in severe traumatic brain injury(tbi) patients, plasma fibrinogen concentrations decrease earlier and more frequently than other coagulation factors,predicting massive bleeding and death. the purpose of this study is to try early injection of fibrinogen concentrate in severe isolated traumatic brain injury and investigation the effect of it on post bleeding and complications.


Eligibility criteria:
inclusion criteria: * patients with severe isolated traumatic brain injury. exclusion criteria: * severe abdomen or extremities trauma. * severe bleeding from abdomen or extremities. * congenital coagulopathy (hemophilia, protein s and c deficiency, factor 5 leiden deficiency and ...). * warfarin, heparin, enoxaparin, dabigatran and other anticoagulation drugs consumption.
cognitive and speech disorders in children with congenital heart defects

Conditions: Cognition Disorder

Summary: the study is aimed to found out expressive speech disorders as a sign of neurocognitive development delay in children with congenital heart defects before and after surgery

the study will investigate the influence of congenital heart disease, operation and other health factors on neurocognitive and speech status of 5-7 years old children

Eligibility criteria:
inclusion criteria: * children with congenital heart disease that required total correction using cardiopulmonary bypass exclusion criteria: * patients with heart disease requiring palliative or endovascular correction, as well as children with chromosomal and genetic diseases (determined by karyotyping)

Keywords: cognitive disoders heart disease
efficacy and safety of narrow focus (f1) versus wide focus (f3) of shock wave lithotripsy (swl) for renal calculi

Conditions: Renal Stone; Treatment Side Effects

Summary: this study aims to compare the narrow focus (f1) versus the wide focus (f3) in terms of the efficacy of shock wave lithotripsy (swl) in the management of renal calculi 1-2 cm and their injurious effect on the kidney.

recently, some shock wave lithotripsy (swl) devices have been announced in the market with a different focus points. one early experimental study found that stone disintegration is better with small focusing points than larger focusing points. nevertheless, these findings, in terms of the efficacy of stone disintegration, need to be validated in-vivo. furthermore, the effect of focal size on renal injury during swl need to be studied as well. therefore, the objectives of this study are to compare the effect of using the narrow focus of 2mm (f1) versus the wide focus of 8 mm (f3) on the stone free rate (sfr) following swl for renal stones 1-2cm and estimating renal injury effect of f1 vs. f3 by urinary renal injury markers such as neutrophil gelatinase-associated lipocalin (ngal) for assessment of proximal and distal renal tubules injury \& kidney injury molecule-1 (kim-1) for assessment of proximal renal tubules injury). the swl device: lithotripter type: piezo lith3000 plus ( from richard wolf, germany.

Eligibility criteria:
inclusion criteria: 1. adult patients (\>18years old) with 1-2 cm single renal stone. 2. normal functioning kidney. exclusion criteria: 1. pregnancy. 2. bleeding diatheses. 3. radiolucent stones. 4. radio-opaque stones with hounsfield unit (hu) \> 1200 5. patients with a pacemaker. 6. active urinary tract infection (uti). 7. severe skeletal malformations. 8. morbid obesity with body mass index (bmi) ≥40 kg/m2. 9. renal artery aneurysm at the same site of the stone. 10. anatomical obstruction distal to the stone. 11. patients with renal impairment with serum creatinine \> 1.2 mg/dl.
improved practice outcomes and value excellence in colposcopy

Conditions: High Grade Cervical Intraepithelial Neoplasia

Summary: the study will observe and quantify shifts in colposcopy practice and outcome improvements in u.s. community-based cervical screening colposcopy examinations after the introduction of the dysis colposcope with advanced cervical scan. the study will collect colposcopy data across multiple sites in two arms; a prospective arm, with dysis being used for the examination and a retrospective arm, with data retrieved from patient charts.

each site will contribute data to both arms; the study will collect data on demographics, disease yield, number of biopsies and treatment decisions. study subjects will receive standard of care procedures and management. prospective data will be collected at colposcopy examinations performed using the dysis digital colposcope on consecutive patients that have been referred for colposcopy after a positive screening test. retrospective data on colposcopy examinations performed using a standard colposcope will be collected from patient medical records, to capture standard practice to-date as a control for comparisons. the retrospective data will be collected from consecutive examinations performed by the providers participating in the prospective arm and for the preceding year.

Eligibility criteria:
inclusion criteria: 1. females 21 years or older 2. able to give informed consent 3. referred for colposcopy with a screening test result that indicates the need for a colposcopy, based on guidelines and practice: * hsil, asc-h, lsil cytology * 2x asc-us cytology (25 or above) * 2x/3x lsil/asc-us cytology (21-24) * asc-us pap and hrhpv cotest/reflex * hpv 16/18 primary screening (≥25) * asc-us pap after hrhpv * hrhpv x2 (≥30) * hpv16 or 16 after negative cytology/hrhpv (≥30) * follow-up of cin2/3 biopsy (younger women) * hrhpv and/or ≥asc-us pap post-excision exclusion criteria: 1. previous hysterectomy, previous/current chemotherapy, radiation treatment for cervical neoplasia or other concurrent cancer 2. pregnancy 3. known human immunodeficiency virus (hiv) infection or acquired immune deficiency syndrome (aids) 4. referred for vulva/vaginal disease

Keywords: colposcopy cin cervical neoplasia cervical dysplasia cervical cancer cin2+
rct of low-dose clomiphene vs. high dose gonadotropin protocol for ivf poor responders

Conditions: Infertility

Summary: the purpose of this study is compare two commonly-used medication protocols ( low-dose clomiphene citrate and high dose gonadotropin protocols) for the treatment of patients with diminished ovarian reserve (decreased number of eggs remaining in the ovary) undergoing ivf. this research is being done because we do not know if these two medication protocols are equally likely to help a woman become pregnant.

the objective of this protocol is to prospectively evaluate whether a clomid-based, low dose gonadotropin protocol (225 iu) would be non-inferior in terms of mature oocyte yield (eggs that are ready to be fertilized) as compared to a high-dose protocol. patients meeting the criteria for poor ovarian response will be consented and randomized to either a stimulation protocol involving pretreatment with a 0.1mg estradiol patch in the luteal phase starting 10 days after the lh surge (the hormone released by the brain to cause ovulation to occur, which is detectable in urine) followed by oral clomiphene citrate 100mg on days 2-6 of the menstrual cycle and 225 international units of gonadotropins starting on day 5, or to the control group involving the same pretreatment with 0.1mg luteal estradiol patches starting 10 days after the lh surge, with high dose gonadotropins (600iu) alone, starting on day 2 of the cycle. after randomization, patients will undergo routine ivf procedures, monitoring, blood draws, cancellation criteria, oocyte retrieval, and embryo transfer as non-study participants.

Eligibility criteria:
inclusion criteria: * patients age 18-42 undergoing ivf * afc \<7 (see definition above) and amh (see definition above) \<0.5 and/or prior poor ivf response exclusion criteria: * bmi (body mass index) \>30 * pgd (preimplantation genetic diagnosis, in which embryos are biopsied to rule out chromosomal abnormalities) * age \>42 * fragile x carriers (a condition associated with premature ovarian aging) * tese (testicular sperm extraction) * asherman's syndrome (uterine scarring which can affect implantation and pregnancy) * untreated hydrosalpinx (accumulated fluid in the fallopian tube which may be toxic to embryos) * \>6 prior attempted cycles

Keywords: ivf poor responder low ovarian reserve art ovarian stimulation ivf protocols