Kornimate/medical-research-clean huggingface dataset:
a study of cs3006 in subjects with locally advanced or metastatic solid tumors

Conditions: Solid Tumor, Adult

Summary: this is a multicenter, open label, dose escalation \& expansion phase i study to evaluate the clinical safety, tolerability, pk, and preliminary efficacy of cs3006.


Eligibility criteria:
inclusion criteria: 1. subjects with histologically or cytologically confirmed advanced or metastatic solid tumor(s) for which no effective standard therapy is available or tolerable. 2. ecog performance status of 0 or 1. 3. life expectancy ≥12 weeks. 4. able to swallow and retain oral medication. 5. subjects must have adequate organ function. 6. use of effective contraception. exclusion criteria: 1. subjects receiving anti-cancer therapy at the time of enrollment. 2. subjects who had prior chemotherapy, targeted therapy, immunotherapy or any other systemic anti-cancer treatment, within 14 days prior to the first dose of cs3006 or who has not recovered from adverse events due to a prior therapy. 3. receipt of any prior therapy with a mek inhibitor. 4. use of any investigational anti-cancer drug within 28 days before the first dose of cs3006. 5. current use of a prohibited medication or use during treatment of cs3006. 6. current use of warfarin. 7. any condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of drugs. 8. history of retinal vein occlusion (rvo) or central serous retinopathy (csr). 9. visible retinal pathology as assessed by ophthalmologic exam. 10. intraocular pressure \> 21mm hg as measured by tomography. 11. glaucoma diagnosed within one month prior to the first dose of cs3006. 12. known brain metastasis or other cns metastasis that is either symptomatic or untreated. 13. primary malignancy of cns. 14. evidence of severe or uncontrolled systemic diseases. 15. subjects with clinically significant cardiovascular disease. 16. qtc interval \>= 450 msecs for male or \>= 470 msecs for female 17. known history of hiv. 18. subjects with active hepatitis b or c infection 19. history of immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to cs3006. for more information regarding trial participation, please contact at cstonera@cstonepharma.com
a clinical study of sph6516 tablets in the treatment of advanced solid tumors.

Conditions: Advanced Solid Tumor

Summary: to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of sph6516 tablets in the treatment of advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. advanced solid tumors; 2. the ecogscore is 0 to 1. 3. expected survival ≥3 months. 4. good organ function before first use of the investigational drug. 5. any toxicity associated with previous antitumor therapy must have returned to ≤ grade 1. 6. voluntarily participate in this clinical trial, understand the research procedures and be able to sign the informed consent in person. exclusion criteria: 1. subjects who have received certain treatment in the prescribed period prior to their first medication; 2. subjects who have undergone major surgery within 6 weeks before the first medication, or who plan to undergo major surgery within 12 weeks after the first medication; 3. subjects who have participated in any other clinical trials and received treatment within 4 weeks prior to the first medication; 4. subjects with third space fluid accumulation that cannot be controlled by drainage or other methods; subjects with factors affecting drug administration and absorption; 5. subjects with allergic constitution or a history of severe allergies; 6. subjects with active hepatitis b virus (hbv) infection, active hepatitis c virus (hcv) infection, or a history of immunodeficiency; 7. subjects with a history or evidence of high risk cardiovascular disease; 8. subjects with severe lung disease; 9. pregnant and lactating female subjects; female subjects of childbearing age or male subjectswith fertile partners who were unwilling to take effective contraceptive measures throughout the entire trial period; 10. subjects with a clear history of neurological or psychiatric disorders; 11. other situations in which the investigator did not consider it appropriate to participate in the study.
treatment of extended spectrum betalactamase producing bacteria causing urinary tract infections in general practice

Conditions: Urinary Tract Infections

Summary: the prevalence of extended spectrum beta-lactamase (esbl) producing bacteria found in urine sample cultures has been increasing over the past decades. the study hypothesis is to assess the clinical and microbiological outcome of pivmecillinam treatment of esbl producing e. coli and k. pneumoni, as well as to observe the clinical and microbiological outcome of the same group of bacteria treated with other antiinfectious agents. samples are gathered in primary care setting.


Eligibility criteria:
inclusion criteria: - all patients were urinary sample taken in a primary care setting shows significant growth of esbl producing e. coli. above age 16. exclusion criteria: - sample from patients in hospital care or living in nursing home facilities. inability to understand and sign information leaflet.

Keywords: extended-spectrum beta-lactamase producing bacteria
efficacy and safety of recombinant human growth hormone on height velocity in subjects with idiopathic short stature

Conditions: Growth Disorder; Idiopathic Short Stature

Summary: this trial is conducted in asia. the aim of this trial is to evaluate the efficacy and safety of recombinant human growth hormone (hgh) in subjects with idiopathic short stature in korea.


Eligibility criteria:
inclusion criteria: * informed consent obtained from subject's parents or legally acceptable representative before any trial-related activities. (trial-related activities are any procedure that would not have been performed during normal management of the subject.) * pre-pubertal status (males aged from 4 to 11 \[both inclusive\], females aged from 4 to 9 \[both inclusive\]): an absence of breast development in females (tanner 1 only) and testicular volume below 4 ml in males * growth hormone level above 10 ng/ml following a stimulation test (test result within 6 months from screening can be used) * height below 3 percentile * bone age below or equal to 12 year * epiphyses confirmed as open in patients at least 10 years or more of age exclusion criteria: * known presence of one or more pituitary hormone deficiencies (acth (adrenocorticotropic hormone), adh (antidiuretic hormone), fsh (follicle-stimulating hormone), lh (luteinising hormone), tsh (thyroid-stimulating hormone)) * known primary hypothyroidism, adrenal insufficiency or hypogonadism (treated or untreated) * specific types of growth failure including, but not limited to, known chromosomal abnormalities associated with growth failure and altered sensitivity to growth hormone * bone age is advanced over chronological age more than 3 years * active malignancy, cns (central nervous system) trauma, active chemotherapy or radiation therapy for neoplasia * prior history of intracranial hypertension * hypertrophic cardiomyopathy
treating nocturnal hypertension and nocturia in african american men

Conditions: High Blood Pressure

Summary: this is a protocol to obtain pilot data to submit a new nih grant on nocturnal hypertension and nocturia. in the diversity supplement to dr. victor's current nih grant (cut your pressure too: the los angeles barbershop blood pressure study) the results show that uncontrolled systolic hypertension is an independent determinant of nocturia in african american men. the investigators now want to pursue this correlation by designing a new nih grant proposal to determine whether replacing short acting with long acting drugs and dosing them at bedtime rather than in the morning will: a. lower systolic blood pressure during sleep b. improve nocturia and result in better sleep quality

aims and significance of pilot data determine: 1. the feasibility of the southern california healthy heart and blood pressure registry as an effective method to recruit african american men to participate in a new research program 2. if participants are willing to comply with the study procedures including wearing an activity monitor, sleep study device, and ambulatory blood pressure monitor 3. the within subject variation for repeated measures of nocturnal blood pressure by ambulatory blood pressure and activity monitoring 4. if nocturnal systolic blood pressure is higher in men with self-reported nocturia ≥2 than in men with 0-1 nocturia 5. if use of long-acting antihypertensive medication as well as nighttime dosing of medication can lower nocturnal systolic blood pressure and reduce nocturia purpose: obtain key pilot data to show feasibility and document the reproducibility of the proposed measurements.

Eligibility criteria:
inclusion criteria: * african american men * age 35 to 59 years-old * able to give informed consent * willing to wear the activity monitor, ambulatory blood pressure monitoring (abpm), and sleep study device * uncontrolled hypertension: both a sleeping average systolic blood pressure of ≥ 125 mm hg and an awake average systolic blood pressure of ≥ 135 mm hg exclusion criteria: * severe sleep apnea (apnea hypopnea index (ahi) of \> 30 on home sleep study) or history of sleep apnea diagnosis and use of continuous positive airway pressure therapy * uncontrolled diabetes mellitus (a random glucose of ≥ 200 mg/dl) * history of diagnosis or symptoms of either prostate disease or overactive bladder (urinary urgency or frequency during the daytime) * chronic kidney disease (glomerular filtration rate of \< 60 ml/min/1.73 m2 based on the mdrd equation) * renal transplant recipient * loop diuretic use * night shift work * on chemotherapy for cancer * orthostatic hypotension o after 2 minutes of standing: a drop in blood pressure of \> 20/10 mm hg, a standing systolic blood pressure of \ 20 beats/minute * other reasons deemed unsafe for study participation by principle investigator
phase 2a study of efficacy and safety of opscf in moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to determine the efficacy and safety of a monoclonal antibody, opscf, in the treatment of adults with moderate to severe atopic dermatitis (eczema). opscf will be compared to a placebo. opscf or placebo will be administered every 2 weeks for 14 weeks, and the efficacy will be assessed two weeks later. after that, subjects may choose to enter an open label extension phase in which all subjects will receive opscf every 4 weeks for 40 additional weeks.


Eligibility criteria:
inclusion criteria: * subject has clinically confirmed diagnosis of active ad * subject has at least a 6-month history of ad * subject is willing to use effective birth control exclusion criteria: * subject is a female who is breastfeeding, pregnant, or who is planning to become pregnant during the study. * subject has any clinically significant medical condition that would put the subject at undue risk or interfere with interpretation of study results. * subject has used dupilumab within 26 weeks prior to day 1 * subject has used tralokinumab within 12 weeks prior to day 1

Keywords: eczema monoclonal antibody
evaluation of fractalkine and its receptor in peri-implantitis

Conditions: Peri-implantitis

Summary: in this study, mechanical debridement group, er:yag laser group and diode laser group will be compared in terms of reducing peri-implant sulcus depth in the treatment of peri-implantitis.


Eligibility criteria:
inclusion criteria: * probing depth of 4-6 mm, bone loss of at least 2 mm on x-ray and presence of inflammatory symptoms in soft tissue * no systemic disease that may affect the outcome of the treatment * patients with healthy periodontium or patients with completed periodontal treatment * individuals at least 6 months after prosthesis loading on the implant * individuals who do not require further surgery for the treatment of peri-implantitis * implants with at least 2 mm keratised gingiva * individuals aged 40-60 years exclusion criteria: * individuals undergoing radiation therapy * individuals who smoke and drink alcohol * individuals in pregnancy or lactation * individuals who have received antibiotic treatment in the last three months * individuals with parafunctional habits

Keywords: er:yag laser debridment peri-implantitis
comparison effectiveness of distractions on pain and fear of children

Conditions: Peripheral Intravenous Cannulation

Summary: distraction is a non-pharmacological technique that moves focus away from anxiety, discomfort or unpleasant stimulation to more stimulating or friendly stimulation. distraction is one of the most effective, simplest and inexpensive non-pharmacological pain management methods (hockenberry \& wilson, 2018). the benefits of using non-pharmacological methods include decreased pain, distress, and fear reported by the parent, child, and/or observer (wente, 2013). there are two main types of distraction techniques: active and passive (mutlu \& balcı, 2015; wohlheiter \& dahlquist, 2013). objectives: to evaluate the roles of the tick-b, listening music, and watching cartoon, in relieving pain and fear of school-age children during pivc. to compare the effect of tick-b with the effects of the listening music, and watching cartoon, on reducing pain and fear during pivc in children. to compare the effects of three distraction groups with the control group in relieving pain and fear during pivc.

peripheral intravenous cannulation (pivc) is an invasive technique. in this technique, a catheter is entrenched through the skin of the recipient into the lumen of a peripheral blood vein. it is the second most painful procedure performed in hospitals. peripheral intravenous cannulation (picv) is a common painful procedure for children, and nearly all ill children have experience with pivc, and up to 80% of patients receive a peripheral venous cannula in a hospital. therefore, the use of effective methods in pain and anxiety relief is very important during injection procedures in children. in order to relieve pain and fear in children undergoing picv. psychological and physical approaches for coping with children's pain are favored, as well as pharmacological methods. application of topical anesthetic creams is the most commonly used pharmacological solution to reduce pain associated with the medical procedure, or refrigerant preparations, however, only reduce the perception of pain in children during procedures. these approaches are not resolved anxiety, a core factor of noncooperation, which encumbers the efficiency of the needle procedure. for this cause, non-pharmacological approaches are generally recognized as alternative techniques, which may be used separately or in addition to pharmacological approaches, to provide sufficient pain and fear relief and to offer children a sense of control over the situation.

Eligibility criteria:
inclusion criteria: * school-aged 6-12 years old. * children who require pivc. exclusion criteria: 1. respiratory chronic diseases, 2. physical impairment, 3. disability contributing to difficult communication, 4. children of unsatisfied parents, 5. children with neurodevelopment delay, 6. cognitive impairment, hearing impairment or a visual impairment, 7. taking an analgesic within 6 hours, or for those with a syncope history.
mojito study (mashed or just integral pill of ticagrelor ? )

Conditions: Acute Coronary Syndrome; Adverse Reaction to Antiplatelet Agent

Summary: the aim of the mashed or just integral pill of ticagrelor (mojito) study is to evaluate the superiority of ticagrelor 180 mg ld mashed pill versus ticagrelor 180 mg ld integral pill both orally administrated in decreasing residual platelet reactivity 1 hour after the administration among 70 patients with stemi (st segment elevation myocardial infarction) undergoing ppci (primary percutaneous coronary intervention) with bivalirudin monotherapy.


Eligibility criteria:
inclusion criteria: * patients presenting within 12 hours from the onset of symptoms with stemi * informed, written consent exclusion criteria: * age \ 75 years * active bleeding; bleeding diathesis; coagulopathy * increased risk of bradycardiac events * history of gastrointestinal or genitourinary bleeding \<2 months * major surgery in the last 6 weeks * history of intracranial bleeding or structural abnormalities * suspected aortic dissection * any other condition that may put the patient at risk or influence study results or investigator's opinion (severe hemodynamic instability, known malignancies or other comorbid conditions with life expectancy \<1 year) * administration in the week before the index event of clopidogrel, ticlopidine, prasugrel, ticagrelor, thrombolytics, bivalirudin, low-molecular weight heparin or fondaparinux . * concomitant oral or iv therapy with strong cyp3a inhibitors or strong cyp3a inducers, cyp3a with narrow therapeutic windows * known relevant hematological deviations: hb \<10 g/dl, thrombi. \<100x10\^9/l * use of coumadin derivatives within the last 7 days * chronic therapy with ticagrelor, prasugrel, clopidogrel or ticlopidine * known severe liver disease, severe renal failure * known allergy to the study medications * pregnancy

Keywords: ticagrelor antiplatelet acute coronary syndrome
evaluation of anti-inflammatory treatment in dry eye patients

Conditions: Dry Eye Disease

Summary: the purpose of this study was to determine if difluprednate ophthalmic emulsion is effective in reducing the ocular symptoms of dry eye disease, as measured by a global visual analog scale (vas) discomfort score.

following run-in, patients qualifying for treatment were randomized 1:1 to receive durezol (experimental group) or vehicle (control group) for 5 weeks.

Eligibility criteria:
inclusion criteria: normal subjects: * no known history of dry eye disease. * non-contact lens wearer. * no current use of artificial tears or any other dry eye treatment. or dry eye patients: * at least a 6 month history of dry eye. * non-contact lens wearer. * uses artificial tears. * experiences persistent ocular discomfort. * other protocol-defined inclusion criteria may apply. exclusion criteria: * the presence of any acute infectious or non-infectious ocular conditions in either eye within 1 month of visit 1. * severe sjogren's syndrome. * lid function abnormalities. * use of steroids, tetracycline, doxycycline, etc., within 30 days of visit 1. * history of corneal surgery including refractive surgeries. * history of glaucoma or ocular hypertension * other protocol-defined exclusion criteria may apply.

Keywords: dry eye ocular discomfort
acute effects of cookies containing 2.5 g spirulina on postprandial glycemic and insulin responses

Conditions: Potential Abnormality of Glucose Tolerance; Appetitive Behavior; Blood Pressure

Summary: this study investigated the effects of cookies containing 2.5 g spirulina on postprandial glycemic and insulin responses.

this study examined the short-term effects of cookies containing 0 and 2.5 g spirulina on postprandial glycemic and insulin responses, arterial blood pressure and subjective appetite

Eligibility criteria:
inclusion criteria: * healthy * non-smoking * men and women * body mass index between 18 and 24.9 kg/m2 exclusion criteria: * severe chronic disease (e.g. cardiovascular diseases, diabetes mellitus, kidney or liver conditions, endrocrine conditions) * gastrointestinal diseases * pregnancy * lactation * competitive sports * alcohol abuse * drug dependency

Keywords: blood glucose responses spirulina blood glucose concentrations glycemic index
urine proteome of surgical patients and healthy volunteers

Conditions: Renal Cell Cancer

Summary: the purpose of this study is to define early urinary biomarkers for diagnosis and prognosis of renal cell carcinoma (rcc) with subsequent development of reliable, cost-effective, screening techniques.


Eligibility criteria:
inclusion criteria: * 18 years and older * planned procedure with presumptive diagnosis of rcc, bladder or prostate cancer or control patient undergoing non-urological surgery or normal healthy volunteer or post surgical patient with a diagnosis of rcc and under surveillance for reoccurrence of rcc or treatment of metastatic rcc * signed, informed consent exclusion criteria: * patients on dialysis

Keywords: surgery, renal cell cancer
a study to evaluate the efficacy of cytal® burn matrix in the management of partial-thickness burns to the hand

Conditions: Partial Thickness Burn of Hand

Summary: this is a randomized controlled trial (rct) aimed at determining if use of cytal® burn matrix in the management of partial-thickness burns to the hand shows improved wound healing times when compared to ez-derm porcine xenograft.

a single site, two arm, parallel-design randomized trial comparing cytal® burn matrix to ez-derm® porcine xenograft, for patients with partial-thickness burns to the hand. up to 60 patients from a single center will be recruited and randomized (using a 1:1 randomization scheme) to receive either cytal® burn matrix or ez-derm®. scar formation, number of wounds requiring autografting, wound infections, rate of healing, hand function and impact of treatment will be compared between study arms. additionally, a cost analysis and review of individual and group changes in narcotic prescription patterns and employment status will be evaluated. the protocol defined patient follow-up is 6 months. an independent biostatistician will review all participant data for power and futility analysis. in addition, a clinical events committee will adjudicate adverse events (aes) and serious adverse events (saes)

Eligibility criteria:
inclusion criteria: 1. male and female, 18 to 75 years of age. 2. negative pregnancy test required. 3. presence of partial thickness burns to one or both hands. 4. thermal burn etiology. exclusion criteria: 1. allergy or hypersensitivity to materials in porcine-based study products or personal preference. 2. friction, chemical, or electric burn etiology. 3. immunosuppression. 4. presence of a local and/or systemic infection. 5. received prior treatment to the study site within 60 days of screening. 6. concurrent participation in another clinical trial.

Keywords: acell hand burn acell cytal burn matrix® extracellular matrix urinary bladder matrix wound partial-thickness burn management
observational, prospective, single-center study: should body mass index (bmi) be added to the scoring criteria of hepatic critically ill patients in intensive care unit??

Conditions: ICU Stay & Mortality

Summary: the purpose of the study is to evaluate the hypothesis of poor clinical outcomes in critically ill patients that are having abnormal bmi.

all demographic data will be obtained including the patients' age, sex, body mass index (bmi) \& categorized into; bmi \< 18.5kg/m2 = underweight, bmi between 18.5-24.9kg/m2 = normal weight, while bmi between 25-29.9kg/m2 = overweight \& obese = bmi ≥ 30kg/m2, associated co-morbidities (diabetes mellitus, hypertension, chronic renal failure, cancer\& chronic liver disease), the cause of admission to icu, sequential organ failure assessment (sofa), nutritional risk screening (nrs) on admission \& discharge, prior cardiac arrest, previous icu admission within 6months, nosocomial infection, organ failure e.g. cardiovascular, respiratory, renal \& organic support requirement e.g. hemodynamic support, mechanical ventilation, renal replacement therapy (rrt).

Eligibility criteria:
inclusion criteria: * patients who are admitted to the intensive care unit of national hepatology \& tropical medicine research institute (nhtmri) for medical \& surgical indications during the period from february 2018 to december 2020. exclusion criteria: * patients will be excluded if they have stayed in icu ≤24 hours and underweight (bmi\<18.5).