Kornimate/medical-research-clean huggingface dataset:
plexaa for preconditioning: gender affirming mastectomy

Conditions: Nipple Necrosis; Nipple Graft Loss

Summary: the goal of this clinical trial is to evaluate the use of the plexaa preconditioning device (bloom43) in transgender and non-binary patients undergoing gender affirming mastectomy. this study aims to understand a participant's experience of the device, including its usability and acceptability. participants will use the device to precondition their right breast the evening before undergoing surgery (gender affirming mastectomy).


Eligibility criteria:
inclusion criteria: * all transgender or non-binary patients over the age of 18 years (no maximum age limit) * patients undergoing peri-areolar mastectomy or double incision mastectomy with a free nipple graft for gender affirmation exclusion criteria: * patients undergoing surgery for breast cancer * delayed (two-stage) breast reconstruction patients * patients undergoing simple mastectomy or wide local excision of a breast tumour * presence of open breast skin wounds, or infected or inflamed breast skin * presence of a cardiac pacemaker, defibrillator or any other implantable electronic device

Keywords: nipple necrosis nipple graft loss preconditioning
assessment of score system of surgery in necrotizing enterocolitis(nec) patients

Conditions: Necrotizing Enterocolitis; Neonate; Surgery

Summary: necrotizing enterocolitis(nec) is one of the most serious disease in the newborn infants, and two and more grades of nec usually lead to surgery, even death. but, it is difficult to predict when to operate the surgery.

necrotizing enterocolitis(nec) is characterized by vomit, abdominal distention, hypoactive bowel sounds and bloody stools, even shock, disseminated intravascular coagulation(dic) and sepsis. x-ray is shown intestinal wall gas and/or portal vein pneumatosis and pneumoperitoneum. two and more grades of nec in newborn infant is a urgent condition, and whether or not operation is difficult to predict. here, the investigators develop a score system including five parameters(abdominal circumference, base excess, heart rate, severities of respiratory distress, sepsis) in one retrospective cohort, and the score system is used and assessed to predict the need for surgery in another prospective cohort.

Eligibility criteria:
inclusion criteria: * two and more of nec is diagnosed in the newborn infants * on the time of diagnosis for nec both the surgery and non-surgery are reasonable according the surgeon's suggestions exclusion criteria: * pneumoperitoneum * refusing to take part in the study according to parents' decision
netarsudil use after descemetorhexis without endothelial keratoplasty

Conditions: Fuchs' Endothelial Dystrophy; Cataract

Summary: primary aim of the study is to determine whether a rho kinase inhibitor, netarsudil, can speed corneal clearance after dwek. secondary aim of the study is to investigate whether patient factors, such as baseline age, pachymetry, or endothelial cell count influence response to netarsudil.

spontaneous corneal clearance after descemetorhexis without keratoplasty (dwek) has been documented in several previous trials. one of the largest cohorts at massachusetts eye and ear infirmary demonstrated spontaneous corneal clearance in about 82% of cases but mean time to clearance was approximately three months after the procedure. during this time period, patients have significantly reduced central vision. furthermore, some patients fail to have corneal clearance even eight months after dwek and have to undergo descemet membrane endothelial keratoplasty (dmek) to achieve corneal clearance. a recent international case report has documents that the addition of a rho kinase inhibitor, ripasudil, to two eyes that failed to clear by two to three months after dwek resulted in corneal clearance within two weeks after the addition of ripasudil. this finding indicates the possibility that a rho kinase inhibitor can be used to speed corneal clearance after purposeful descemetorhexis. the only fda approved rho kinase inhibitor eye drop currently available is netarsudil, approved in december of 2017 for use in ocular hypertension and primary open angle glaucoma. investigating whether netarsudil can speed corneal clearance after dwek is truly importance as the potential to expand patient eligibility for dwek is significant. both patients that had previously not wanted to wait approximately three months after the procedure for corneal clearance as well as patients with lower mid-peripheral endothelial cell counts may now be eligible for a procedure to treat corneal endothelial dysfunction without a corneal transplant. this would reduce risks for corneal transplant rejection and failure, reduce need for long-term steroid eye drop use, and reduce need for frequent corneal screenings to ensure transplant health. the current study aims to investigate whether the off-label use of netarsudil can improve corneal clearance after dwek in fuchs endothelial dystrophy patients.

Eligibility criteria:
inclusion criteria: * cataract in both eyes * fuchs endothelial dystrophy in both eyes exclusion criteria: * history of ocular surgery in one eye and not the other * history of significant ocular trauma/burn in one eye and not the other * inability to provide informed consent * inability to undergo eye surgery * inablity to use eye drops reliably

Keywords: dwek, netarsudil
think dry: optimalisation of diagnostic process of urinary incontinence in older people

Conditions: Incontinence, Urge; Incontinence Stress; Incontinence, Daytime Urinary; Incontinence, Nighttime Urinary

Summary: urinary incontinence is an increasing medical and socio-economical problem. 44% of the elderly (\>65 years) women and 28% of the elderly men suffer from unwilling urine loss. moreover, this percentages increase with age. incontinence is a problem with multiple physical, psychological, and financial effects. in addition incontinence has a important impact on the family and healthcare professionals surrounding the elderly. the problem of urinary incontinence is complex and multifactorial. moreover, diagnostic guidelines are inconsistent leading to a high amount of technical interventions to diagnose and to specify the type of incontinence. aim of this study is to create a short form of necessary technical investigations to diagnose and evaluate urinary incontinence.


Eligibility criteria:
inclusion criteria: * \>= 65 years * every type of incontinence: stress, urge, mixed. exclusion criteria: * patients with an indwelling urinary catheter are doing clean intermittent catheterization are excluded from the study protocol * patients with dementia are excluded from the study, based on n-cog evaluation
post market clinical follow-up (pmcf) study of clareon vivity & clareon panoptix

Conditions: Aphakia; Astigmatism; Presbyopia

Summary: the purpose of this post-market clinical follow-up study is to describe the long-term safety and performance of the clareon vivity and vivity toric and clareon panoptix and panoptix toric iols.

subjects will be recruited from a population that has already undergone lens implantation. retrospective data will be collected from the pre-operative and surgical visits and any safety outcomes reported prior to enrollment. prospective data will be collected from time of study enrollment through the year 3 follow-up visit.

Eligibility criteria:
key inclusion criteria: * subject or legally authorized representative must be able to understand and sign an approved informed consent form. * subject must have had bilateral implantation of clareon vivity, clareon vivity toric, clareon panoptix, or clareon panoptix toric iols between 3-6 months prior to enrollment. * subject must have a documented medical history and required pre-operative baseline information available for retrospective data collection. * other protocol-defined inclusion criteria may apply. key exclusion criteria: * subject is currently participating in another investigational drug or device study. * subject has had corneal refractive surgery after clareon vivity, clareon vivity toric, clareon panoptix, or clareon panoptix toric iol implantation. * subject is pregnant at the time of enrollment. * other protocol-defined exclusion criteria may apply.

Keywords: cataract surgery
megestrol acetate against cancer-related critical body weight loss in patients with h&n cancer who receiving ccrt

Conditions: Head and Neck Cancer

Summary: primary objective: to evaluate the population prevalence of critical body weight loss ( more than 5% from baseline) in patients with head and neck cancer. secondary objectives: to evaluate the impact of appetite, and performance status; to evaluate the change of quality of life (qol); to evaluate the incidence of infection and hospitalization; to evaluate the safety profiles

hypothesis testing will be used to determine the patient number in this study. according to a preliminary data at cgmh-lk, the investigators have the untreated patients with population prevalence of critical weight loss that is 0.56, and the investigators assume the study treated population prevalence is 0.4, power set in 0.9, alpha set in 0.05.

Eligibility criteria:
inclusion criteria: * patient who is confirmed the diagnosis of head and neck cancer and will receive concurrent chemoradiotherapy (ccrt). * patient who is capable to understand and complete questionnaires * patient who is convenient to receive body weight measurement * life expectancy of at least 12 weeks * age over 20 years old at registration * voluntarily signed the written informed consent form exclusion criteria: * special populations that needs unique risk/benefit considerations. (ex. pregnant or nursing women or mental disorder patients, et al.) * any significant co-morbid medical condition that out of medication control. (ex. heart/renal/hepatic failure or poorly controlled diabetes, et al.) * any evidence of mechanical obstruction of the alimentary track, malabsorption, or intractable vomiting. * any thromboembolism event, e.g. cerebral or peripheral vascular disease * judged ineligible by physicians for participation in the study due to any safety concern.

Keywords: phase ii study critical body weight loss concurrent chemoradiotherapy megestrol acetate head and neck cancer
remission of icd by switching dopamine agonist to levodopa/carbidopa

Conditions: Impulse Control Disorder

Summary: the purpose of this study is to see whether the icds(impulse control disorder) are improved and neuropsychiatric traits related to icd are changed or not when switching dopamine agonist to levodopa/carbidopa in patients with parkinson's disease who have been treated with dopaminergic medications.

* primary objective to evaluate the improvement of mmidi(modified version of minnesota impulsive disorders interview,korean version) score from the baseline to 12 weeks or locf(last observation carried forward) * secondary objective i) to evaluate the improvement of neuropsychiatric profiles from the baseline to 12 weeks or locf ii) to evaluate the improvement of updrs(unified parkinson's disease rating scale)score from the baseline to 12 weeks or locf

Eligibility criteria:
inclusion criteria: * patient with a diagnosis of idiopathic pd according to united kingdom parkinson's disease brain bank criteria * mmidi ≥ 3 score with icd * patients must be on an anti-parkinson treatment at least 6 months before screening. * for this protocol, dopamine agonists should be included in his/her anti-parkinson treatment. * 30years ≤ patients \< 80years of age, male or female * patients must give written informed consent before any assessment is performed exclusion criteria: * requirement of treatment with serious cognitive disorder, behavioral disorder, or mental illness currently or in the future * for the patients ≤ 65years: k-mmse(korean version of mini-mental state exam) ≤24, or for the patients ≥ 66years: k-mmse ≤ 20, or the patients have dementia(incl. early dementia) even though k-mmse score is more than 20 * requirement of treatment more than 6times per day due to the severe motor fluctuation. * severe dyskinesia * dbs(deep brain stimulation)or any other surgical treatment * history of melanoma or not-diagnostic skin trouble/skin lesions * narrow angle glaucoma * clinically serious surgical or medical condition * malignant tumor * use of other investigational drugs at the time of enrollment within 4weeks * pregnant, nursing or lactating women * women of child-bearing potential * history of hypersensitivity or allergy to levodopa/carbidopa * any serious disease according to the investigator's discretion
monitoring the response of port wine stain birthmarks to laser therapy with wide-field functional imaging technologies

Conditions: PORT WINE STAIN

Summary: the researcher develop non-invasive imaging modalities for assessment of port wine stain during laser therapy treatment of port wine stain. the imaging modalities will be used to guide immediate retreatment of regions of persistent perfusion during the procedure.

the researcher can use imaging system operates by projecting low-power near-infrared structured light patterns on to the tissue of interest in a non-contact, reflection geometry and then capturing the reflectance with a camera.the system can image the depth-resolved optical properties of in-vivo tissues, allowing rapid, non-invasive visualization of sub-surface structures of port wine stain.

Eligibility criteria:
inclusion criteria: * all minors, birth to 18 years of age or older with port wine stain birthmark * ability to understand and carry out subject instructions * sign photograph release form exclusion criteria: * inability to understand and/or carry out instructions * pregnant women * do not sign photograph release form

Keywords: birthmark
evaluation of a smartphone based diagnostic tool to assess neonatal jaundice in a mexican population

Conditions: Jaundice, Neonatal

Summary: this corss-sectional study aims to test the performance and accuracy of the picterus jp screening device in newborns with different skin types.

a descriptive cross-sectional study among 174 newborns was carried out at hospital materno-infantil de irapuato in mexico during july and august 2018. the picterus calibration card will be placed on the chest of the newborn with the hole in the card placed over the infant's sternum. a validated smartphone with picterus jp will be used to collect digital images..

Eligibility criteria:
inclusion criteria: * healthy newborns with or without signs of jaundice * gestational age \>35 weeks * age 0-14 days * birth weight \> 1500 g. * parents acceptance of their children to participate in the study. * newborn needing a blood test exclusion criteria: * newborns showing signs or with diagnosis of inborn diseases * newborn transferred to pediatric ward for any treatment * newborns who had received phototherapy.
safety and efficacy trial of mtx101 2mg for the acute treatment of migraine in adults

Conditions: Migraine

Summary: the goal of this clinical trial is to learn if drug mtx101 works to treat acute migraine attacks in adults. it will also learn about the safety of the drug mtx101. the main questions it aims to answer are: does the drug mtx101 lower headache pain for participants and the need to use a rescue medication? what side effects, if any, do participants have when taking the drug mtx101? researchers will compare the drug mtx101 to a placebo (a look-alike substance that contains no drug) to see if the drug mtx101 works to treat acute migraine attacks. participants will: take the drug mtx101 or a placebo to treat 1 migraine attack with each treatment. visit the clinic twice and have one phone call over a 4 week period for checkups and tests. keep a diary of their symptoms and the number of times they use a rescue medication.

subjects enrolled in the study will be randomized to receive investigational product (mtx101 2mg or placebo), to be taken as soon as they have a migraine headache that reaches moderate to severe intensity. subjects will take a single dose of either active or placebo to treat one migraine headache. rescue medication should not be taken until at least 2 hours post study medication dose. the subject will have a telephone check up within 72 to 120 hours after treatment of the first migraine headache. the subject will treat a 2nd moderate to severe migraine at least 48 hours after the first treated migraine headache. the subject will return to the clinic for re-evaluation within a 4 week period from the start of the study.

Eligibility criteria:
key inclusion criteria: 1. male or female aged 18 to 65 years at the time of consent. 2. onset of migraine headache before age 50. 3. history of episodic migraine headache starting at least 1-year ago with or without aura. 4. has a minimum of 4 monthly migraine days and not more than 10 migraine days per month. 5. able to distinguish pain related to migraine attacks from tension-type and cluster headache attacks. 6. able to understand and provide signed informed consent. 7. willing and able to comply with all scheduled visits, treatment plan, and other study procedures. key exclusion criteria: 1. no more than a total of 15 headache days per month. 2. use of more than 2 migraine preventive medications. 3. current diagnosis of glaucoma. 4. use of opioids or barbiturates more than 4 days/month, triptans or ergots 10 or more days/month, or simple analgesics (e.g., aspirin, nsaids, acetaminophen) 15 or more days/month in the 3 months prior to visit 1. 5. current diagnosis of any post-traumatic headaches, medication overuse headaches, new daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), painful cranial neuropathy or daily headaches. 6. vaccination within less than 7 days from the screening or plans to get a vaccine during the study or within a week after final study dose.

Keywords: acute treatment of migraine nervous system diseases central nervous system diseases brain diseases headache migraine with or without aura
correlation of sozo bis measures with cardiomems pa pressure

Conditions: NYHA Class III Heart Failure

Summary: this study aims to establish the degree to which change in the ratio of ecf to tbw measured using the sozo bis device correlates with change in end-expiratory end-diastolic pap measured using the cardiomems hf system (st. jude medical).

this is a prospective, single-arm, observational, non-randomized clinical study that will enroll patients with heart failure who have had a cardiomems™ device implanted to monitor their diastolic pulmonary artery pressure. the study will recruit and enroll thirty participants. participants will be monitored daily at home for a period of 30 days. each day, the patient's diastolic pulmonary artery pressure will be measured by cardiomems™ and the impedimed's bis technology. participant's weight will also be taken each day.

Eligibility criteria:
inclusion criteria: 1. age 18 years or older. 2. nyha class iii hf. 3. patient has undergone implantation of cardiomems hf system (st. jude medical). 4. patient is characterized by at least one of the following: * cardiomems implanted within the previous 90 days * received treatment with intravenous diuretics within the previous 30 days * received dose escalation of oral diuretics at least twice within the previous 30 days 5. patient is able to sit upright for bis measurements. 6. patient provides written informed consent and authorization to use and disclose health information. exclusion criteria: 1. patient is enrolled in a concurrent interventional study of an experimental treatment that may confound the results of this study, in the investigator's opinion. 2. patient has a clinical condition that would not allow them to complete the study. 3. patient is pregnant or lactating. 4. patient has nephrotic syndrome or nephrosis. 5. patient has estimated glomerular filtration rate (egfr) \< 20 ml/min/1.73m2 or end-stage renal disease requiring chronic dialysis. 6. patient has been diagnosed with lymphedema. 7. patient has chronic liver failure or cirrhosis. 8. patient has a moderate or large pleural effusion as seen on chest x-ray. 9. patient has been diagnosed with thrombophlebitis or deep vein thrombosis in arms or legs in the past 90 days. 10. patient has an implanted cardiac rhythm management device (pacemaker or implantable cardioverter defibrillator). 11. patient has an amputation of a limb.

Keywords: bioimpedance spectroscopy
a phase i-c study of recombinant gm-csf herpes simplex virus to treatⅳ m1c

Conditions: Melanoma

Summary: recombinant human gm-csf herpes simplex virus injection (orienx010) is a genetically engineered from chinese patients oral separation of wild type 1 herpes simplex virus (hsv) as the carrier insert gm-csf gene therapy drug.after gene recombination technology successively removing icp34.5, icp47 and insert the deactivation icp6 gene, and at the site of the original icp34.5 insert guided by ie promoter of hcmv human gm-csf gene.the drug after tumor site local injections of dosing, on the one hand, because of the soluble tumor characteristics of herpes simplex virus, reconstructing it after hsv-1 virus carrier at the injection site specific "soluble tumor" kill tumor cells;viral vector expressed in tumor site, on the other hand, to produce high concentrations of gm-csf enhance the antitumor immune function, play "beside the destruction effect", have inhibition effect on the distant metastases.

subjects were tested drugs within 8 x 107 pfu/ml tumor injection treatment, the injection quantity according to tumor lesion size, injection amount shall not exceed 10 ml each time, injection frequency for every 2 weeks, 4 times per cycle treatment, treatment 2 cycles. completed at the end of the second cycle after curative effect evaluation, such as the researchers determine continue to medicine can bring benefit to the subjects, can continue to offer benefits to the subjects' potential drug until disease progression, smaller, not tolerance toxicity or participants to withdraw consent.

Eligibility criteria:
inclusion criteria: * by histological and/or cytology diagnosis ⅳ m1c malignant melanoma patients with liver metastasis, the lack of an effective method for the conventional or the failure of conventional therapy or recurrence * general physical status score (ecog) 0-2 points * lifetime is expected to more than 4 months * always anti-tumor treatment (including/radiation therapy, immune therapy, targeted therapy, endocrine therapy, etc.) to end more than 4 weeks (using the nitroso urea class and mitomycin chemotherapy drug withdrawal over 6 weeks), and always treat the adverse reaction of restored or stability exclusion criteria: * in the group treated with other experimental drugs within 4 weeks before, but in the intervening clinical research (except such as epidemiological studies) * in group of four weeks before received the treatment of herpes simplex virus, such as acyclovir, ganciclovir, respectively.there is galloway, vidarabine, etc * in group of four weeks before too much surgery * screening stage hsv - 1 antibody igg and igm are negative