Kornimate/medical-research-clean huggingface dataset:
membrane target detection for leukemia treatment

Conditions: Hematological Malignancy

Summary: acute myeloid leukemia (aml) accounts for more than 40% of leukemia mortality in the united states. each year around ten thousand people die from the disease, most within a few years of diagnosis. despite advances in our understanding of the disease, few improvements in the therapy of aml have been made. collecting specimens from the blood and bone marrow will increase understanding of the effect of dipeptidyl peptidase-4 (dpp-4) inhibitors on human aml-scp to develop individualized therapies. we also found dpp4 is highly expressed in other hematological malignancies in our mouse model, thus we would like to use human samples to investigate the role of dpp4 in hematological malignancy development and the mechanism underlying, especially to deeply understand the role of ddp4 in leukemia.

specific targets and novel strategies to eliminate aml stem cells are required for aml treatment. collecting specimens from the blood and bone marrow will increase understanding of the effect of dpp4 inhibitors on human aml-scp to develop individualized therapies. we will test the effect of dpp4 inhibitors on human aml-scp in vitro and in vivo and whether the addition of dpp4 inhibitors can prevent aml relapse once the disease is in the remission stage. chronic myeloid leukemia (cml) is a stem cell (sc) neoplasm characterized by the bcr/abl1 oncogene. cml is a steadily developing blood and bone marrow disease that has three stages: chronic, accelerated, and blastic. if it reaches the blastic process, it is known as acute leukemia, which is the same as aml. while the mechanisms of bcr/abl1-induced transformation are well understood, little is known about the effector molecules that contribute to leukemic sc (lsc) malignant expansion and extramedullary spread in cml. furthermore, dpp4 is not only highly expressed in leukemia samples, but also specifically expressed in some of the other hematological malignancies, such as aml, cml, all, cll, lymphomas, or myelomas, and may work as a stem cell marker as well. at this point, we would like to use human blood samples to investigate the role of dpp4 in hematological malignancy to deeply understand the role of dpp4 in leukemia.

Eligibility criteria:
inclusion criteria: * all hematological malignancy patients. * must be 18 years old. exclusion criteria: * participants with impaired decision-making capacities; * pregnant women or fetuses; * children (under 18 in missouri, also dependent on state law); * non-viable neonates or neonates of uncertain viability (neonates=newborns); * non-english-speaking subjects; * prisoners.
effect of laser in treatment of vulval warts

Conditions: Vulval Wart

Summary: vulval warts is a magor problem that affects women .

the causative organism for vulval warts is human papilloma virus there are many treatment modalities that can trat these warts

Eligibility criteria:
inclusion criteria: * women who have vulval warts * age between 18- 40 years exclusion criteria: * warts that were previously treated by surgery or cryotherapy
examination of pregabalin access for treatment of indicated pain disorders: the expand study

Conditions: Fibromyalgia; Painful Diabetic Peripheral Neuropathy

Summary: the investigators hypothesize that fibromyalgia (fm) and painful diabetic peripheral neuropathy (pdpn) patients with access restrictions on pregabalin will lead to higher healthcare resource use and cost compared to patients without such restrictions on pregabalin in a naturalistic setting. the randomization will occur at the physician level and not the patient level.

this trial was terminated prematurely on april 2, 2012, due to the inability to recruit the planned number of subjects. the decision to terminate the trial was not based on any safety or efficacy concerns.

Eligibility criteria:
inclusion criteria: * a physician-confirmed diagnosis of either pdpn or fm, but not both. * initiation of a medication for pdpn or fm is clinically indicated, either as monotherapy or in combination with other treatments, as determined by the treating physician, and agreed to by the patient. * no prior pregabalin use or pregabalin pa requests. exclusion criteria: * age \< 18 years at time of study enrollment. * females or are partners of males currently pregnant/lactating or intending to become pregnant in the next 6 months * physician-confirmed diagnosis of both pdpn and fm.

Keywords: prior authorization fibromyalgia painful diabetic peripheral neuropathy policy real world data
combining topical imiquimod 5% cream with a pulsed dye laser to treat port wine stain birthmarks

Conditions: Port Wine Stain

Summary: port wine stains are red birthmarks that without treatment persist for a lifetime. they are frequently found on the face and can be conspicuous and disfiguring, negatively impacting social interactions for these patients. treating port wine stains is difficult. the standard of care is to use laser treatment, but over 80% of patients fail to completely clear despite multiple treatments. the growth of additional blood vessels (angiogenesis) following the laser treatment is likely an important factor in why these lesions persist despite therapy.

imiquimod is a topical cream that affects the immune response and has been noted to inhibit blood vessel formation. it has been used to successfully treat other vascular growths such as hemangiomas. the research can use imiquimod cream 5% cream apply to port wine stains after laser therapy to improve lightening of port wine stains. the imiquimod 5% cream cream apply to port wine stains everyday for 8 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of port wine stain birthmark * male and female subjects of any age who are in good health. * fitzpatrick skin type i-vi exclusion criteria: * pregnant or lactating * history of cutaneous photosensitivity * history of hypersensitivity to imiquimod 5% cream or any of its components * history of photodermatoses

Keywords: birthmarks
spectamel: screening patients with melanoma tumors for efficient clinical trial access

Conditions: Melanoma

Summary: spectamel is a standardized, quality-assured molecular screening platform for tumor characterization and storage of human biological material (hbm) for the purpose of integrating new biomarkers into clinical trials and optimizing access of patients to therapeutic biomarker-driven clinical trials. hbm and clinical/pathological data are collected from consenting patients.


Eligibility criteria:
inclusion criteria: * pathologically confirmed melanoma of any stage (the steering committee will decide on which stage to include at any particular time point during this trial, this will be communicated appropriately to all participating sites) * mandatory availability of adequate human biological material (hbm): ffpe tissue sample from the primary tumor, recurrent tumor, metastasis, obtained at the time of primary surgery/biopsy; minimal amount requested is detailed in the hbm guidelines; if feasible, inclusion of samples taken at any recurrence diagnosed during follow-up is strongly encouraged but optional; * age ≥ 18 years; * at least three months life-expectancy; * written informed consent according to ich/gcp and national/local regulations; * absence of any active malignancy, except pt1-2 prostatic cancer gleason score \< 6, or carcinoma in situ of the cervix, in the 5 years before study entry; * absence of exclusion criteria like active hepatitis b/c or hiv, second malignancies, no severe organ dysfunction or other comorbidities that may prevent inclusion into clinical trials. * central confirmation of human biological material (hbm) adequacy for step 2: * centrally performed confirmation of tumor tissue adequacy in terms of quality/ quantity for central screening. exclusion criteria: * active hepatitis b/c or hiv * second malignancies * severe organ dysfunction or other comorbidities
efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris

Conditions: Unstable Angina

Summary: this parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris.

this parallel, double blind, randomized, controlled, multi-center study will evaluate the efficacy and safety of salvianolate injection in elderly patients with unstable angina pectoris. patients will treated with or without salvianolate injection on the basis of conventional therapy for 14 days. the primary measures of effectiveness include the change from baseline to the end of treatment in the angina scores.(angina score table :sum of 4 items), the variation of ekg (level of the s-t segment)., additional measures of effectiveness include the change from baseline to the end of the treatment in the seattle angina questionnaire(saq),euroqol-5 dimensions(eq-5d) will be performed throughout the study. patients who complete the double-blind portion of the study will be followed up 28 days. effectiveness will be assessed at 7 days, 14 days and 28 days. safety evaluations (incidence of adverse events,, physical examinations, laboratory tests) will be performed at at 7 days, 14 days and 28 days of the study.

Eligibility criteria:
inclusion criteria 1. patient in line with 1979 who diagnostic criteria for ua 2. ages eligible for study: 60-85years (adult,senior) 3. traditional chinese medicine for chd treatment should be stopped at least 1 week;take chd drugs standardly 4. participates give written informed consent exclusion criteria 1. nste-acs caused by non atherosclerotic disease 2. angina pectoris caused by violent activities, fever, tachycardia, high adrenergic state, mental stress, lack of sleep, eating too full, left ventricular load increased (hypertension, aortic stenosis) 3. angina pectoris caused byanemia, methemoglobinemia and hypoxemia 4. abnormal thyroid function 5. poorly controlled hypertension (systolic pressure ≥160mmhg or diastolic blood pressure ≥100mmhg) 6. severe cardiopulmonary dysfunction 7. severe arrhythmia (atrial fibrillation, atrial flutter, paroxysmal ventricular tachycardia, sinus bradycardia (heart rate \< 55),complete left bundle branch block 8. combined liver and kidney and hematopoietic system and other serious diseases, liver function (alt, ast) 3 times higher than the upper limit of normal renal function, creatinine clearance rate (crcl) less than 30 ml/min/1.73m2 9. recent 4 weeks underwent surgery and bleeding tendency 10. poor compliance 11. at the same time in other clinical researches 12. allergic constitution
endoscopic characterization of colorectal neoplasia with the different published classifications

Conditions: Colorectal Neoplasia

Summary: endoscopic characterization is now essential in front of a colorectal lesion to predict its histology and choose the best therapeutic strategy. different classifications have been proposed to predict histology depending on the endoscopic aspect. thus, the aspect of the shape of the lesion is described in the paris classification, the aspect of the mucosal pattern in kudo's classification and the vascular pattern in sano's one. recently, classifications combining several color and mucosal and vascular pattern criteria have been described as the nice classification or even more recently the japanese jnet classification. however, although the interest in combining the paris, sano and kudo criteria has recently shown its interest, there was not yet an overall classification covering all the published criteria. we have created a synthetic classification called conecct grouping the different criteria for an initial educational purpose. we have demonstrated that this tool allows interns and gastroenterologists to progress in the histological prediction of colorectal lesions presented in the form of photo files. nevertheless, comparative data of the performances of those different classifications to predict the histology and the concordance intra and inter-observer have never been published. to validate this conecct classification, we created this comparative study evaluating the endoscopic characterization performances of these different classifications in terms of histological prediction and intra- and interobserver concordance in a group of gastroenterologists with varying levels of expertise in front of colorectal lesions presented in the form of photographic records.


Eligibility criteria:
inclusion criteria: * the participants were gastroenterologist doctors (experts, general or internal). * lesions presented were resected endoscopically after completion of a picture file. * pathology available for presented lesions. * participants signed informed consent and voluntarily participated in the characterization of these 206 lesions. exclusion criteria: * none
fox bionet project: ecv-003

Conditions: Parkinson Disease

Summary: the goal of this study is to optimize pre-analytical cerebrospinal fluid (csf) extracellular vesicle isolation protocols for increasing the detection of lrrk2 activity in human csf

specific aims to accomplish this objective are: primary objectives: * to evaluate a series of extracellular vesicle isolation methods for their ability to enrich for lrrk2 and increase the detection of lrrk2 in csf samples. * to compare the measurements of lrrk2, p1292 lrrk2, rabs and prabs from the ecvs isolated using each method. * to assess the inter-lab reliability of each method secondary objectives * to assess the ability of the network of sites to efficiently conduct a study involving biosample collection for pd research. efficiency will be assessed using measures of the time taken to meet specific milestones within the study * to assess the ability of the network to collect high quality biospecimens adhering to agreed-upon protocols. * to gauge the willingness of participants to participate in subsequent fox bionet studies

Eligibility criteria:
inclusion criteria: parkinson's disease patients: * a diagnosis of parkinson's disease in the opinion of the enrolling investigator * disease duration: any * male or female age 18 years or older at time of pd diagnosis. healthy controls: •male or female age 18 years or older at screening. exclusion criteria: parkinson's disease patients: * inability to provide informed consent * current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. * condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. * participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans. healthy controls: * inability to provide informed consent * current treatment with anticoagulants (e.g., coumadin, heparin) that might preclude safe completion of the lumbar puncture. * condition that precludes the safe performance of routine lumbar puncture, such as prohibitive lumbar spinal disease, bleeding diathesis, or clinically significant coagulopathy or thrombocytopenia. * participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans. * currently pregnant (female participants)

Keywords: parkinson's disease biomarker lrrk2 csf
prospective validation of "cholecystectomy first" strategy for gallstone migration

Conditions: Choledocholithiasis; Gallstone Migration; Cholecystitis; Gallstone Pancreatitis; Cholangitis

Summary: initial cholecystectomy with intraoperative cholangiogram, followed if required by ercp, has been implemented at the investigators institution as the standard management strategy for patients at intermediate risk of common bile duct stone migration, following a randomized controlled trial previously published by the same investigators team. the aim of this study is to prospectively analyze the outcomes of this strategy.

a previous randomized controlled trial comparing initial cholecystectomy with intraoperative cholangiogram (ioc) versus common bile duct (cbd) assessment and subsequent cholecystectomy for patients admitted in the emergency room with an acute gallstone-related condition and with an intermediate risk of common bile duct stone was performed by the investigators. this study had been registered on clinicaltrials.gov as well and had shown that a strategy with initial cholecystectomy significantly decreased the length of hospital stay and the number of cbd investigations procedures. initial cholecystectomy with ioc is now the standard management strategy for these patients in the investigators hospital. the goal of this study is to perform a prospective validation of this strategy and to analyze if the results obtained in the previously mentioned randomized controlled trial are confirmed on a larger patients cohort. this study will be observational, since the intervention (initial cholecystectomy) is not assigned by the investigators, but is already a standard treatment strategy at our institution.

Eligibility criteria:
inclusion criteria: * admission through emergency department for an acute gallstone-related condition (cholecystitis, gallstone pancreatitis, ascending cholangitis, suspicion of gallstone migration, choledocholithiasis) exclusion criteria: * severe sepsis or septic shock * contra-indication to surgery * previous surgery interfering with common bile duct assessment procedures (roux-en-y gastric bypass, etc.) * previous cholecystectomy
safety study of eteplirsen to treat advanced stage duchenne muscular dystrophy

Conditions: Muscular Dystrophy, Duchenne

Summary: the primary objective of this study is to explore safety and tolerability of eteplirsen in participants with advanced stage duchenne muscular dystrophy (dmd) who are amenable to exon 51 skipping.

this is an open-label, multi-center study to explore the safety and tolerability of eteplirsen injection in participants with advanced stage dmd with confirmed genetic mutations amenable to treatment by exon 51 skipping. participants will be evaluated for inclusion during a screening/baseline period of up to 4 weeks. eligible participants will receive once weekly intravenous (iv) infusions of 30 mg/kg eteplirsen for 96 weeks, followed by a safety extension (not to exceed 48 weeks). safety will be regularly assessed throughout the study via the collection of adverse events (aes), laboratory tests, electrocardiograms (ecgs), echocardiograms (echos), vital signs, and physical examinations.

Eligibility criteria:
inclusion criteria: * male 7 - 21 years of age * diagnosis of dmd with a mutation that is amenable to exon 51 skipping, confirmed by a genetic report * stable dose of oral corticosteroids for at least 24 weeks or has not received corticosteroids for at least 24 weeks * non-ambulatory, or incapable of walking ≥300 meters on the 6-minute walk test (6mwt). * score of ≤4 on the brooke score for arms and shoulders. * stable cardiac and pulmonary function * use of contraceptives for sexually active males throughout the study * willing to provide consent and comply with the study exclusion criteria: * use of any pharmacologic treatment (other than corticosteroids) within 12 weeks that may have an effect on muscle strength or function (e.g., growth hormone, anabolic steroids). * previous treatment with smt c1100/bmn 195 at any time. * previous treatment with drisapersen (pro051) within the last 6 months. * participation in any other dmd interventional clinical study within 12 weeks * major change in physiotherapy regimen within the past 3 months * major surgery within 3 months * presence of other clinically significant illness * use of an aminoglycoside antibiotic within 12 weeks or the need for this antibiotic or statin during study * forced vital capacity % predicted \[fvc % predicted\] \<40%, or requiring daytime ventilation. * require antiarrhythmic and/or antidiuretic therapy for heart failure. * have a left ventricular ejection fraction (lvef) of \<40%. * prior or ongoing medical condition that could adversely affect the safety of the patient, make it unlikely that the course of treatment would be completed, or impair the assessment of study results.

Keywords: dmd exon 51 dystrophin dystrophy eteplirsen duchenne
need for the assessment and consultation team (act) following anesthetic care

Conditions: Cardiovascular Diseases; Respiratory Diseases; Neurologic Diseases

Summary: the goal of this study was to identify the etiology of events and demographics of patients that experience complications requiring activation of the rapid response team (rrt) during the first 24 h following anesthetic care.


Eligibility criteria:
inclusion criteria: * any study subject that experienced an act following anesthetic administration during care at any nationwide children's hospital facility. exclusion criteria: * any study subject that has not experienced an act following anesthetic administration during care at any nationwide children's hospital facility.

Keywords: assessment and consultation team (act) rapid response team (rrt) perioperative complications respiratory insufficiency asa status
efficacy and safety of idp-120 gel in the treatment of acne vulgaris

Conditions: Acne Vulgaris

Summary: efficacy and safety of idp-120 gel in the treatment of acne vulgaris

a phase 2, multi-center, randomized, double-blind, vehicle- controlled, parallel-group, clinical study comparing the efficacy and safety of idp-120 gel in the treatment of acne vulgaris

Eligibility criteria:
key inclusion criteria: * male or female at least 9 years of age and older; * written and verbal informed consent must be obtained. subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit) * pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit. * subjects must be willing to comply with study instructions and return to the clinic for required visits. subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing. * if a cleanser, moisturizer or sunscreen is needed during the study, subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. if the subject wears makeup they must agree to use non-comedogenic makeup. key exclusion criteria: * use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study. * any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis. * any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive. * subjects with a facial beard or mustache that could interfere with the study assessments.