Kornimate/medical-research-clean huggingface dataset:
efficacy and safety of nilotinib (amn107) compared with current treatment options in patients with gist who have failed both imatinib and sunitinib

Conditions: Gastrointestinal Stromal Tumors

Summary: the study evaluated the safety and efficacy of nilotinib versus current treatment in adults with gastrointestinal stromal tumors (gist) who have either progressed or who were intolerant to the first and second line treatments.


Eligibility criteria:
inclusion criteria (core phase): * age ≥18 years * radiological confirmation of disease progression during imatinib and sunitinib therapy or intolerance to imatinib and/or sunitinib * at least one measurable site of disease on ct/mri scan * physically fit even if not able to work * normal organ, electrolyte, and bone marrow function inclusion criteria (extension phase): * patients whose tumors had progressed on the control arm and had crossed over to the nilotinib arm. * the study was stopped due to meeting the primary efficacy endpoint of pfs at the interim analysis. * patients who were still being treated at the close of the core study on the control arm or nilotinib arm (whose tumors have not progressed at the time of the end of the core study). * patients must have had documented, confirmed stable, partial or complete response as defined by the recist criteria at the time of entry into the extension study with the exception of patients who had progressed on the control arm. exclusion criteria (core phase): * previous treatment with nilotinib or any other drug in this class or other targeted therapy * treatment with any cytotoxic and/or investigational cytotoxic drug ≤ 4 weeks prior to study entry * impaired cardiac function * use of coumarin derivatives (i.e. warfarin, acenocoumarol, phenprocoumon) * women who are pregnant or lactating exclusion criteria (extension phase): * use of other anticancer treatments or investigational drugs (with exception of the study drugs) * patients with a history of noncompliance with study drug treatment in the core study protocol. other protocol-defined inclusion/exclusion criteria applied

Keywords: gist adults imatinib resistant sunitinib resistant amn107 nilotinib treatment gastrointestinal stromal tumor (gist)
evaluation of the effect of local propolis application on the healing of pressure ulcers

Conditions: Pressure Sore

Summary: the study was conducted to evaluate the effect of local propolis application in patients with pressure ulcers. a total of 62 patients were included in this randomized controlled experimental study, with 31 patients in the propolis group and 31 in the control group. while the control group received the clinic's standard wound care treatment protocol, the propolis group was administered 30% pure propolis extract in addition to the standard wound care treatment protocol. for data collection, the following tools were used: the introductory characteristics form, which includes patients' socio-demographic and medical information; the propolis application follow-up form; the pressure ulcer healing assessment scale; pain assessment tools including the visual analog scale (vas) for conscious patients and the face pain scale for unconscious patients; katz's index of activities of daily living; and the charlson comorbidity index (cci).


Eligibility criteria:
inclusion criteria: the patient or their caregiver is able to communicate verbally, hospitalized in palliative care or intensive care units for at least one week, has a stage 1, 2, or 3 pressure ulcer according to npuap (13), the wound has not been closed by a physician, agrees to participate in the study, expected to stay in the hospital for at least 21 days. exclusion criteria: the patient or their caregiver is unable to communicate verbally, has a stage 4 or unstageable pressure ulcer according to npuap, the wound has been closed by a physician, does not agree to participate in the study, expected to stay in the hospital for less than 21 days.

Keywords: pressure ulcer propolis application apitherapy
mesh fixation and closure of peritoneum following laparoscopic hernia repair using n-butyl cyanoacrylate

Conditions: Hernia, Inguinal

Summary: fixation of mesh and peritoneal closure during tapp repair using n-butyl cyanoacrylate.

during transabdominal pre peritoneal (tapp) hernia repair a mesh should be fixed at four pre-determined points. number of attempts to fix the mesh with a novel non-penetrating fixation device (liquibandfix8) will be recorded. this novel device uses n-butyl cyanoacrylate and a defined amount of glue can be delivered with this 5mm laparoscopic instrument (liquid anchors). in addition, closure of peritoneum should be accomplished using this device.

Eligibility criteria:
inclusion criteria: * inguinal hernia, * femoral hernia exclusion criteria: * pregnancy, * not able to understand patient information
optical guided sentinel node biopsy for staging of vulvar cancer

Conditions: Vulva Cancer; Sentinel Lymph Node

Summary: the aim of the study is to evaluate the feasibility of applying the sln mapping technique in combination with fdg-pet/ct imaging in women with vulva cancer tumour size \>4 cm, multifocal tumors and local recurrences.


Eligibility criteria:
inclusion criteria: * patients with vulva cancer, tumor \> 4 cm, multifocal tumor, or local recurrences in vulva exclusion criteria: * previous external irradiation of the vulva or groins * former sentinel node or inguinal lymphadenectomy in the relevant groin * known allergy to icg or iodine * patient is in active treatment for other cancer and/or disseminated disease
sepsis clinical decision support [cds] master enrollment study protocol

Conditions: Severe Sepsis; Severe Sepsis Without Septic Shock

Summary: this protocol will collect real-world data retrospectively from the electronic health record (ehr) as data obtained from the delivery of routine medical care to develop a machine learning (ml)-based clinical decision support (cds) system for severe sepsis prediction and detection.

the purpose of this study is to gather data for the clinical development of the sepsis onset warning system (sows) software as medical device (samd) product to support a de novo fda submission and commercialization in the united states. product development of sows is funded in part with federal funds from the department of health and human services; office of the assistant secretary for preparedness and response; biomedical advanced research and development authority. data will be obtained from passive prospective collection of patient encounter data throughout the duration of the planned study to support the product development life cycle activities associated with developing the sepsis onset warning system (sows) for severe sepsis risk detection. inputs from patient health records in combination with proprietary hematology parameters developed by beckman coulter, such as monocyte distribution width (mdw), will be used. the sows tool will look to use clinical measurements which are commonly and reliably available in the ehr as structured data elements, such as heart rate, temperature, blood pressure, and laboratory results and account for changes in these values over time.

Eligibility criteria:
inclusion criteria: * all races, ages and ethnicities * all patients admitted to the hospital or presenting to the emergency department exclusion criteria: * patients not presenting to a hospital setting (e.g. urgent care, outpatient clinic excluded).
nourishing hair, skin & nails supplement study (derm aid)

Conditions: Hair Loss; Skin Laxity; Cosmetic Acne; Nails; Soft; Skin Aging

Summary: a 90 day eight arm virtual interventional study looking at the impact of various supplement formulations for improves in hair, skin \& nail health via self report, and dermatology assessment via remote dermatologist assessment.

this study is being run entirely on the proofpilot clinical trial platform. participants enroll online, submit selfies, and are shipped dietary various dietary supplements containing a one or more of keratin, astaxanthin, collagen peptides and pro-berry powder in vegan and non-vegan formats. all participants will receive active ingredients but in various fomulations. half the participants will receive the formations for free. the other half will pay a discounted amount for the supplements.

Eligibility criteria:
inclusion criteria: * continental us * ability and willingness to take selfies exclusion criteria: * skin diease * use of retinoids * known allergies * significant facial hair * medically relevant skin disease
adult-onset generalized morphea

Conditions: Generalized Morphea

Summary: this study aimed to describe the demographical and clinical characteristics of a retrospective cohort of adult-onset gm and to investigate whether these findings differ between patients with an isomorphic and a symmetric pattern of lesion distribution.


Eligibility criteria:
inclusion criteria: * age of onset ≥ 18 years * patients with generalized morphea as defined by criteria established by laxer and zulian (4 or more morpheaform plaques larger than 3 centimeters that show tendency to confluence and involve at least 2 different anatomic sites) * availability of good-quality clinical photographs * patient who, after being informed, has not expressed his or her opposition to the re-use of his or her data for the purposes of this research exclusion criteria: * patients with linear morphea who met criteria for generalized morphea * patient's opposition to participate

Keywords: morphea generalized morphea localized scleroderma
low-level light therapy for overactive bladder and urinary incontinence

Conditions: Overactive Bladder; Urinary Incontinence

Summary: this study aims to evaluate the effectiveness of a self-therapeutic approach of skin adhesive low-level light therapy (lllt) in females with overactive bladder (oab) and urinary incontinence (ui)

study design: this was a prospective, randomized, double-blind, placebo-controlled, multi-centered trial carried out at two university hospitals. this clinical trial was approved by the korea food and drug administration and the institutional review boards of the two hospitals. study process: all patients gave informed written consent after being informed of the details of the study. participants were randomized into either the lllt or placebo control groups at the third visit. all participants underwent demographic and history taking, a physical examination, bladder examination and laboratory tests. all participants were educated on how to use the device by demonstration and a picture-guided user manual. during the second visit, the participants conducted a self-evaluation of frequency of urgency urinary incontinence episode using the oabss scale and underwent urine examination (pre-treatment measurement). the third visit occurred 7 days from the date of the second visit, and a clinical primary nurse described how to use the medical equipment and devices when they were at home. all subjects filled out self-reported diary and filled out udi-6 and iiq-7 questionnaires in each visit. subjects carried out the self-treatment in the same way at home 3 times a day for 12 weeks and then visited the hospital at week 4 and 12 to undergo examination and filled out oabss, udi-6 and iiq-7 questionnaires (post-treatment measurement). statistical analysis: all data are summarized as means ± standard deviation or as numbers with proportions. a p \ 20% reduction in the frequency of urgency urinary incontinence episodes after treatment. the statistical analysis was conducted using the self-reported micturition diary after the 12 week visit as the primary endpoint. the investigator used an independent t-test or wilcoxon rank sum test depending on the normality of the data to evaluate differences in each group between frequency of urgency urinary incontinence episodes measured after the 12 week visit and baseline values. to test for normality, the investigator performed shapiro-wilk's test. the examination of the ratio difference in nominal variable was carried out using chi-square test or fisher's exact test. a per-protocol (pp) and intent to treat (itt) analyses were used in our clinical trial to assess efficacy and safety. a last observation carried forward (locf) method was used for itt analysis missing data.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of overactive bladder or urinary incontinence exclusion criteria: * history of taking medication for urgency urinary incontinence,

Keywords: overactive bladder urinary incontinence low-level light therapy
the promotion plan of moxibustion on ulcerate colitis

Conditions: Ulcerative Colitis

Summary: to evaluate the efficacy of moxibustion in the treatment of ulcerative colitis, thus the scientific foundation for rational use of moxibustion in clinical usage, in order to find admission of the acupuncture and moxibustion and even medicine field, accomplish popularization and application.

a total of 128 patients with uc were randomly divided into the following 2 groups: a) herb-partition moxibustion (treatment group) and b) sham herb-partition moxibustion (control group). all patients in the trial will be treated with moxibustion 3 times a week, once a day for 30 minutes, for a total of 12 weeks. after treating the treatment had ended and the 52nd week of follow-up to observe the clinical therapy effect of moxibustion in uc patients. tissue morphology and molecular biology tests will be conducted to observe the regulation in the intestinal mucosa of uc patients. all these steps will be done in order to provide clinical usage for the effects of herb-partition moxibustion in the treatment of uc.

Eligibility criteria:
inclusion criteria: * meet the diagnosis of uc * patients do not receive any medicine, or if they are receiving medicine, it should be aminosalicylates and/or prednisone (dose ≤15mg and have taken at least 1 month); * patients should have not received antibiotic, biologicals within 3 months prior to entering the study; * signing a written informed consent. exclusion criteria: * patients with cardiac, encephalic, hepatic, nephric, hematopoietic system, psychotic or any other serious diseases; * pregnancy or lactation; * genetic family history of nervous system disease
minimally invasive treatment methods for pilonidal disease

Conditions: Pilonidal Sinus

Summary: patients with pilonidal sinus disease will be randomised to two groups (crystallised phenol and platelet rich plasma). sinus healing time, patient satisfaction, complications and recurrence rates will be compared.

patients with pilonidal sinus disease will be treated by either crystallised phenol or platelet rich plasma application. treatment results, healing time, postprocedural complications, patient satisfaction and recurrences will be compared.

Eligibility criteria:
inclusion criteria: * having pilonidal sinus disease * accepting to be involved in the study exclusion criteria: * below the age of 18 * having connective tissue disorders * diabetes mellitus * severe anemia
intraoperative bleeding during endoscopic sinus surgery

Conditions: Blood Loss

Summary: the purpose of this study is to compare the blood loss during sinus surgery looking at two different types of anesthesia: either intravenous anesthesia with propofol or inhalational anesthesia with sevoflurane.


Eligibility criteria:
inclusion criteria: * male or female patients who are 18 years of age or older, * asa grade 1 (normal otherwise healthy patient), * asa grade 2 (patient with mild systemic disease), * patients who have chronic sinusitis with or without nasal polyps. exclusion criteria: * pregnancy, * abnormal coagulation panel * preoperative use of nsaids or asa medications within 7 days, * end-stage renal disease, * allergy to any of the used medications, * maximal body mass index over 35
acupoint therapy device for dry eye

Conditions: Dry Eye

Summary: to built a dry eye acupoint therapeutic instrument by stimulating acupoints with low impulse current .and the safety of the dry eye acupoint treatment device will be tested and the initial validation will be verified.


Eligibility criteria:
inclusion criteria: 1. patients who meet the diagnostic criteria for dry eye: the diagnostic and classification criteria refer to the consensus of chinese dry eye experts: definition and classification (2020); 2. this study included patients with dry eyes can be treated as usual or are using artificial tears, also can be never accepted artificial tears treatment; 3. this research project, informed consent and signed informed consent form, participants are willing to accept treatment. those who met the above criteria could be included in the study. exclusion criteria: 1. patients with other eye diseases, acute inflammation or allergy of the eye or skin around the eye: such as blepharitis, lacrimal duct obstruction, congenital absence or dysplasia of lacrimal gland, anterior ganglia inflammation, such as trachoma, chemical burn and other corneal and conjunctival lesions, extensive scar of the eyelid conjunctival, long-term use of anti-glaucoma eye drops for glaucoma; 2. those who have undergone external or internal eye surgery in the past 6 months； 3. patients who have undergone tear punctum embolization or submandibular gland transplantation; 4. wearing contact lenses within the past 3 months； （5）history of ocular trauma; （6）active fundus lesions in the past 3 months； （7）people who are allergic to artificial tears; （8）suffering from diseases that affect tear secretion, such as facial paralysis, diabetes, and hyperthyroidism; (9)patients with serious life-threatening primary diseases such as cardiovascular, cerebrovascular, liver, kidney, and hematopoietic system diseases, as well as mental illness; (10)attending other clinical trials.

Keywords: acupuncture treatment dry eye acupoint therapeutic instrument safety validity
exercise test and cardiac injury

Conditions: Cardiovascular Disease

Summary: strenuous exercise in apparent healthy individuals increases plasma (high sensitive) troponin levels. the underlying mechanism is not yet elucidated, but could be explained by changes due to a mismatch in oxygen demand and supply that mimic those of ischemia and reperfusion injury. if the mechanism underlying the troponin release during exercise is similar to that of ischemia reperfusion injury (iri), than it should be susceptible to remote ischemic preconditioning (ripc) as ripc is a well validated technique to reduce iri. to test this hypothesis healthy volunteers underwent a strenuous exercise test with or without preceding ripc.


Eligibility criteria:
inclusion criteria: * age: 18-45 year * willing to sign informed consent * healthy exclusion criteria: * hypertension (systolic blood pressure \>140 mmhg or diastolic blood pressure \> 90 mmhg) * any cardiovascular abnormality in past medical history, physical examination or ecg, including qtc interval * drug abuse * alcohol abuse (\> 3 units/day) * smoking during the last 2 years * bmi \>30 kg/m2 * inability to perform bicycle test * the presence of an absolute or relative contra-indication for exercise (table 2 in protocol) * the presence of diabetes (fasting glucose \> 6.9 mmol/l, non-fasting glucose \>11.0 mmol/l; if non-fasting glucose is \> 6.9 mmol/l, blood glucose measurement will be repeated in fasting condition and should then not exceed 6.9 mmol/l) * total cholesterol in blood 6.6 mmol/l or higher

Keywords: exercise induced (high sensitive) troponin release ischemia reperfusion injury remote ischemic preconditioning
nipple areola complex conservation

Conditions: Breast Cancer

Summary: 96 patients were offered a nipple sparing mastectomy.

96 patients were operated on 109 breasts between jul 2003 and may 2006 because of breast cancer, recurrence was observed.

Eligibility criteria:
inclusion criteria: * breast cancer exclusion criteria: * inflammatory breast cancer * clinical skin or nipple involvement

Keywords: nipple sparing mastectomy nac conservation
bergen psychosis project 2 - the best intro study

Conditions: Schizophrenia; Psychotic Disorders

Summary: in the bergen psychosis project 2 the antipsychotic drugs aripiprazole, amisulpride, and olanzapine will be compared head-to-head in patients with schizophrenia and related psychoses and followed for 12 months. the study is independent of the pharmaceutical industry, and in accordance with a pragmatic design a clinically relevant sample will be included with as few exclusion criteria as possible. the patients will be assessed repeatedly with regards to symptoms, side effects, and cognitive functioning, as well as laboratory parameters. the study hypothesis is that clinically meaningful differences among the drugs will be disclosed in a pragmatic design.


Eligibility criteria:
inclusion criteria: a:the observational cohort * patients 16 years old or older * active psychosis as determined by a score of 4 or more on one or more of the items delusions, hallucinatory behavior, grandiosity, suspiciousness/ persecution, or unusual thought content in the positive and negative syndrome scale (panss). * or icd-10 diagnosis corresponding to psychotic disorders or other mental disorders with psychotic features (f10-f19: .5 (psychotic disorder); f20-f29, f30.2, f31.2, f31.5, f32.3, f33.3). from which eligible patients are recruited to the b:the pragmatic, randomized, controlled trial (the best intro study) * patients 18 years and older * schizophrenia spectrum and delusional disorder * symptoms of psychosis as determined by a score of 4 or more on one or more of the items delusions, hallucinatory behavior, grandiosity, suspiciousness/ persecution, or unusual thought content in the positive and negative syndrome scale (panss). exclusion criteria: * inability to understand spoken norwegian. * patients with organic psychosis due to limbic encephalitis detected by antibodies in serum obtains at inclusion (such as nmdar, vgkc and paraneoplastic antibodies performed at the neuroimmunology laboratory, department of neurology, haukeland university hospital) pregnant or breast feeding women. * aripiprazole: hypersensitivity to the active substance or to any of the excipients * amisulpride: hypersensitivity to the active ingredient or to other ingredients of the medicinal product; concomitant prolactin-dependent tumours e.g. pituitary gland prolactinomas and breast cancer; phaeochromocytoma; lactation, combination with the following medications which could induce torsade de pointes: class ia antiarrhythmic agents such as quinidine, disopyramide, procainamide. class iii antiarrhythmic agents such as amiodarone, sotalol. other medications such as bepridil, cisapride, sultopride, thioridazine, methadone, iv erythromycin, iv vincamine, halofantrine, pentamidine, sparfloxacin. combinations with levodopa. * olanzapine: hypersensitivity to the active substance or to any of the excipients. patients with known risk of narrow-angle glaucoma.

Keywords: antipsychotic drugs randomized controlled trial treatment effectiveness translational research