Kornimate/medical-research-clean huggingface dataset:
high-dose folfiri in advanced colorectal cancer patients with wild-type ugt1a1*6 and *28

Conditions: Colorectal Cancer

Summary: this trial aims to evaluate the efficacy, safety of high-dose folfiri regimen in advanced colorectal cancer patients with wild-type ugt1a1\*6 and \*28.

pharmacogenetic testing of uridine diphosphate glucuronosyltransferase 1a1 (ugt1a1) \*6/\*28 is recommended in clinical practice prior to the administration of irinotecan (cpt-11)-based regimens, such as folfiri regimen in patients with advanced colorectal cancer. to avoid severe toxicity of irinotecan, such as severe neutropenia and diarrhea, patients with ugt1a1 \*6/\*28 mutation often start with a reduced dose of irinotecan. however, it remains unclear whether high-dose cpt-based regimen (folfiri) could increase clinical efficacy in crc patients when compared with standard-dose folfiri or folfox-6 regimens. this trial aims to compare the efficacy, safety of high-dose folfiri and standard-dose folfiri or folfox-6 in advanced colorectal cancer patients with ugt1a1\*6 g/g and \*28 ta6/6.

Eligibility criteria:
inclusion criteria: * patients should be histologically diagnosed with advanced colorectal adenocarcinoma or postoperative recurrence * patients should be with ugt1a1\*28 wild-type ta6/6 and ugt1a1\*6 wild-type g/g * patients have measurable lesions * patients are not available for targeted therapy or patients refuse to receive targeted therapy * age should be more than 18 years * performance status should be 0-2 * hemoglobin should be more than 9.0 g/dl; absolute neutrophil count should be more than 1,500/mm3; platelet should be more than 80,000/mm3；total bilirubin should be less than 1.5 times of the upper limit of normal value; alanine aminotransferase and glutamic-oxaloacetic transaminase should less than 2.5 times of the upper limit of normal value (it can be 5 times if liver metastasis); creatinine should be be less than 1.5 times of the upper limit of normal value exclusion criteria: * patients with ugt1a1\*28 wild-type ta6/7, ta7/7 and ugt1a1\*6 wild-type g/a,a/a; * patients with brain metastases; * patients could not tolerate chemotherapy; * patients have secondary primary tumor;

Keywords: irinotecan ugt1a1 advanced colorectal cancer
adherence in chronic adrenal insufficiency

Conditions: Adrenal Insufficiency

Summary: adherence, concerns and satisfaction with information in german patients with adrenal insufficiency as well as the influence of a standardized education program will be assessed by a compared cross-sectional and longitudinal study.

patients with adrenal insufficiency (ai) require a lifelong replacement therapy with glucocorticoids (gc). to avoid over- and under- replacement, an individual daily dose scheme and adequate dose adjustment during stressful events is essential. recent patient surveys revealed nonadherence to treatment, concerns about gc and dissatisfaction with the provided information. the aim of this trial is to evaluate the adherence, concerns and satisfaction with information in german patients with primary and secondary ai (pai/sai) and the influence of a standardized education program. patients with ai on gc therapy will be assessed by questionnaire, including the medication adherence report scale\* (mars), beliefs about medicines questionnaire\* (bmq, adapted for ai) and satisfaction with information about medicines scale\* (sims).\*©professor rob horne. the study includes one cross-sectional-analysis and one longitudinal study (patient survey before and after participation at the standardized education program in germany).

Eligibility criteria:
inclusion criteria: * age \> 18 years * patient's written informed consent * ability to comply with the protocol procedures * patients with chronic adrenal insufficiency under established stable replacement therapy exclusion criteria: * age \< 18 years

Keywords: adrenal insufficiency adrenal crisis adherence standardized patient education
effect of succinylcholine on patients using statins

Conditions: Pain

Summary: based on available mechanistic and clinical information, the investigators propose a nonrandomized study to evaluate the effect of succinylcholine in patients taking statins. the investigators' purpose is to evaluate the effect of succinylcholine on patients taking statins. patients scheduled to undergo elective surgery (other then orthopedic, spinal, vascular or muscle) with planned endotracheal intubation will be approached regarding participation in the trial. design of the study is complex because there is no way to randomize patients to statins or no statins and also no way to take them off the statins prior surgery. so statin use will not be randomized; confounding factors will be accounted for by stratification (every 10 years of age from 40-80 and gender) and statistical adjustment. the investigators propose to test the hypothesis that succinylcholine administration increases plasma myoglobin concentration more in patients who are on statins compared to patients who do not.


Eligibility criteria:
inclusion criteria: * scheduled for elective surgery not involving orthopedic procedure, muscle and spinal surgery * asa physical status 1-3 exclusion criteria: * history of liver failure * history of renal failure * history of neuromuscular disease * increased intraocular pressure * recent major burn * multiple trauma * susceptibility to or family history of malignant hyperthermia

Keywords: succinylcholine statins myalgias statins with succinylcholine and pain
pilot evaluation of the filmarray® febrile infant (fi) panel

Conditions: Acute Fever

Summary: the purpose of this study is to collect data to support decisions made by biofire regarding assay development, panel composition, and intended use for the final filmarray fi reagent pouch. the study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.


Eligibility criteria:
inclusion criteria: * under age of 3 * has fever with no obvious focal infection * written informed parental permission exclusion criteria: * parent/legal guardian unable to provide permission * participation determined by a physician to be detrimental to patient health
identifying pards endotypes

Conditions: Respiratory Distress Syndrome; Respiratory Distress Syndrome, Adult

Summary: pediatric acute respiratory distress syndrome (pards) is a severe and diffuse lung injury that is a common cause of admission and mortality in the pediatric intensive care unit (picu). pards can be secondary to many different causes, and there are few therapies that have been shown beneficial in pards. this study seeks to identify important pards subtypes using gene expression profiling of bronchial epithelial cells from control and pards subjects.

enrolled subjects will have nasal brushings collected at days 1, 3, 7, and 14 of intubation with collection of serum at these same time points. brushing rna will be processed by mrna-seq for gene expression analysis and compared to previously published serum biomarkers (interleukin-8, advanced glycosylation end-product specific receptor, and angiopoietin-2) to assess correlation and ability to discriminate pards endotypes. changes in gene expression over time will be assessed to define a pards recovery gene expression signature, and correlation between bronchial and nasal gene expression will be determined.

Eligibility criteria:
inclusion criteria: all potential participants must: 1. be aged zero to 18 years (both control and ards, not age matched) 2. be admitted to the picu with expected duration of hospitalization 7 days or greater. ards patients must: 1. have acute changes in chest x-ray (cxr) 2. have a known or suspected insult within the prior 7 days that is consistent with ards 3. have an oxygenation index (oi) of 4 or greater or and oxygen-sat index (osi) of 5 or greater 1. oi = mean airway pressure x fraction inspired oxygen (fio2) / arterial oxygen partial pressure (pao2) 2. osi = mean airway pressure x fio2 / oxyhemoglobin saturation (spo2) with sat \<= 97%. exclusion criteria: 1. have a baseline oxygen requirement of 2 liters of oxygen or greater at home 2. have disruption of the nasal passages 3. have a history of excessive bleeding or known bleeding disorders 4. be at high risk of bleeding 5. have a do not resuscitate (dnr) or limited resuscitation order

Keywords: endotype pediatric acute respiratory distress syndrome gene expression transcriptomics
efficacy and safety of idp-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects

Conditions: Atopic Dermatitis

Summary: efficacy and safety of idp-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects

a multicenter, randomized, double-blind, vehicle-controlled, study to evaluate the efficacy and safety of idp-124 lotion for the treatment of moderate to severe atopic dermatitis in pediatric and adult subjects

Eligibility criteria:
inclusion criteria: * male or female at least 2 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) * nonimmunocompromized male or female who failed to respond adequately to other topical prescription treatment for ad or for whom those treatments are not advisable * 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 exclusion criteria: * females who are pregnant, breast feeding, or who wish to become pregnant during the study period * active cutaneous bacterial or viral infection in any treatment area at baseline (eg, clinically infected ad) * sunburn, extensive scarring, or pigmented lesion(s) in any treatment area at baseline, which would interfere with evaluations * history of confounding skin conditions, eg, psoriasis, rosacea, erythroderma, or ichthyosis (other than ichthyosis vulgaris) * history or presence of: * basal cell carcinoma of skin effectively treated more than 2 years ago * carcinoma of cervix effectively treated more than 5 years ago * immunological deficiencies or diseases, hiv, or serious recurrent infection * clinically significant severe renal insufficiency or severe hepatic disorders * current or recent serious infection
decreasing propofol injection pain by pre-treatment with lidocaine in pediatric procedural sedation

Conditions: Pain

Summary: this is a double blind, randomized, controlled study. the sedationist performing the sedation procedure will inject the appropriate amount of either a 1% lidocaine solution or a placebo before the administration of propofol. a research staff will observe the patient simultaneously with the induction of propofol to determine the patient's pain level, as measured by the face, legs, activity, cry, consolability (flacc) scale. the purpose of this study is to determine the efficacy of premedication with 1% lidocaine in decreasing the burning sensation caused by intravenous propofol.

propofol is a short-acting, intravenously administered anesthetic. it has become a popular choice for procedural sedation in both children and adults. despite its many advantages, propofol is associated with a burning sensation during injection. propofol pain begins within the first few seconds after administration and often lasts approximately 10-20 seconds until the patient is asleep. lidocaine is often used in an attempt to reduce propofol injection pain, but neither its delivery mode nor concentration has been standardized. the purpose of this study is to determine the efficacy of premedication with 1% lidocaine in decreasing the burning sensation caused by intravenous propofol. this is a double blind, randomized, controlled study. the sedationist performing the sedation procedure will inject the appropriate amount of either a 1% lidocaine solution or a placebo before the administration of propofol. a research staff will observe the patient simultaneously with the induction of propofol to determine the patient's pain level, as measured by the flacc scale.

Eligibility criteria:
inclusion criteria: * age 2 months to 17 years * patient already scheduled for procedural sedation with propofol * sedation procedure to be performed by a sedationist from children's respiratory and critical care specialists exclusion criteria: * patients who are not receiving deep sedation with propofol * patients with allergy or other contraindication to lidocaine administration * patients with central venous catheters as propofol does not burn when given centrally * patients being premedicated with an analgesic other than nitrous oxide or 1% lidocaine * patients weighing less than 5 kg to prevent any risk of inadvertent lidocaine overdose.

Keywords: propofol lidocaine intravenous propofol
microbial colonization of oral probiotics

Conditions: Microbial Colonization

Summary: the aim of this study is to evaluate the colonization efficacy of probiotic lozenges and powders containing specific prebiotics in healthy adults

this is a double-blind, randomized controlled colonization pilot study with no cross over to evaluate the colonization efficacy of lozenges and powders containing two different commercially available probiotic bacteria (s. salivarius k12 ) or s. salivarius m18 with or without 2 different prebiotic sugars or their combinations. participants will be randomly assigned to one of the 12 groups consuming probiotic lozenge or powder containing streptococcus salivarius k12 or s. salivarius m18 with or without prebiotics (e.g. sugars that may promote probiotic activity) over a seven day period. saliva samples will be collected at predetermined time points pre and post intervention. colonisation efficacy will be determined by enumerating the probiotic in the saliva samples using standard microbiological techniques.

Eligibility criteria:
inclusion criteria: 1. male or female 18y - 80y age 2. in general good health 18 - 80 years of age. 3. practice good oral hygiene. exclusion criteria: 1. have a history of autoimmune disease or are immunocompromised. 2. are on concurrent antibiotic therapy or regular antibiotic use within last 1 week 3. history of allergy (e.g. dairy).

Keywords: streptococcus salivarius k12 probiotic microbial colonization oral probiotic lozenges powder prebiotic streptococcus salivarius m18
plan for testing fingerstick bloods on magellan systems

Conditions: Lead Poisoning

Summary: this study is to supplement our internal data that demonstrates the continued performance of capillary blood samples on magellan's lead testing systems: leadcare ii, leadcare ultra (which have been cleared previously by fda), and pediastat, which is an upgraded leadcare ii instrument in development.


Eligibility criteria:
inclusion criteria: * healthy subjects who consent to a capillary blood collection exclusion criteria: * patients are not currently taking chelating agents, e.g., penicillamine, succimer
the effects of stromal vascular fraction and mesenchymal stem cells as intra-articular injection in knee joint osteoarthritis

Conditions: Osteoarthritis

Summary: osteoarthritis of the knee is one of the most common causes of disability among elderly. as the disease progresses the cartilage become frustrated, surrounding bone react to become thicker and inflammation occurs in subchondral bone seen in t2-weighted mri as increase in signal density. patients are treated initially by pain management. in patients who don't response to first line treatment invasive treatment like total knee replacement is done. the investigators designed this clinical study with the aim of evaluating therapeutic effects of intra-articular injection of bone marrow mesenchymal stem cells (msc) and stromal vascular fraction (svf) in patients with severe knee osteoarthritis

this is single center, randomized, triple blind phase ii clinical study. patients will be divided into two groups of case and control. all subjects will undergo bone marrow aspiration. mesenchymal stem cells will be isolated from bone marrow and stromal vascular fraction fram lipoaspirate, cultured and transplanted back to the knee joint. patients of case group will receive cell injection 1 and 4 months after bone marrow aspiration. placebo will be administered in this group 6 months after the first injection. patients of control group will receive placebo 1 and 4 months after bone marrow aspiration. they all receive cell injection 6 months after first placebo injection. follow up visit will occur at 2 and 6 weeks, and 3 and 6 months after the first injection. radiological exams will be performed before and 6 months after the first injection by mri. clinical quantitative assessment will measure joint function by the womac index and pain by the visual analogue scale

Eligibility criteria:
inclusion criteria: * osteoarthritis diagnosed by mri exclusion criteria: * pregnancy or lactating * positive tests for hiv, hepatitis c virus (hcv), hepatitis c virus (hbv) * active neurologic disorder * end organ damage * uncontrolled endocrine disorder

Keywords: joint diseases musculoskeletal diseases arthritis
parathyroid allo-transplantation with a new technique

Conditions: Parathyroid Allo-transplantation

Summary: parathyroid allo-transplantation (pa-t) is a valuable alternative in the treatment of permanent hypoparathyroidism. however, it is a difficult process that requires a number of trained staff and advanced laboratory equipment which bring high costs. in this study, we have identified a new pa-t technique.

hypoparathyroidism is a clinical problem which is associated with hypocalcemia, hyperphosphatemia, low parathyroid hormone levels and often manifests itself as a complication of thyroid surgery . direct injury, ischemia or unintended excision of parathyroid tissue are the most common mechanisms that cause temporary or permanent hypoparathyroidism. temporary hypoparathyroidism (\ 6 months) (3-5). due to the rapid increase in thyroid cancer cases in recent years, total thyroidectomy and neck dissection is performed more frequently than before that yields increase in frequency of permanent hypoparathyroidism. as a current standard treatment, oral or intravenous calcium preparations and active vitamin-d3 are used in the treatment of hypocalcemia which was developed due to permanent hypoparathyroidism (ph). however, this approach is a symptomatic treatment, must continue a lifetime, the cost is high and is only intended to correct hypocalcemia. besides, it has no beneficial effect on metabolic problems due to ph. for these reasons, less costly and effective treatments have been searched over 30 years and parathyroid allo-transplantation (pa-t) was introduced as a treatment alternative. nonetheless, it did not meet the expectations completely. the main problem in pa-t is the development of immune and inflammatory response against graft tissue which shortens its life and impairs the efficacy of the treatment. various kinds of treatment methods such as immunosuppression, microencapsulation and cultivation were tried to overcome this problem. despite these treatment options, convincing results have not yet been achieved . in literature, pa-t cases are often presented as case reports, only a few clinical series are available . in this study, we aimed to present the results of our new pa-t technique that is performed on 10 patients who were diagnosed as permanent hypocalcemia following thyroid surgery and had no benefit from standard medical therapy

Eligibility criteria:
inclusion criteria: * patients who have permanent hypocalcemia * patients who accept to participate to study exclusion criteria: -patients who don't accept to participate to study

Keywords: parathyroid permanent hypocalcemia transplantation
bioequivalence studies of dasatinib 100 mg

Conditions: Myeloma Multiple

Summary: a bioequivalence study of dasatinib will be carried out in 46 healthy subjects, in fed condition, following the complete replicated design, randomized, comparative of 2 sequences, 2 study formulations, in a single dose of 100 mg of dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose

a bioequivalence study of dasatinib in 46 healthy subjects, in fed condition, complete replicated design, comparative of 2 sequences, 2 formulations, single dose of 100 mg of dasatinib tablets / coated tablets, 4 periods. , with a washout time of 7 days between each dose

Eligibility criteria:
inclusion criteria: * men of legal age between 18 to 50 years. * have been clinically diagnosed as healthy by the trial doctor. * subjects with clinical laboratory results within normal ranges and/or suitable by medical selection. * non-smoking subjects for the last 3 months. * have signed the informed consent. * body mass index between 18-30 kg/m2 * subject with complete contact information (cell phone and/or contact landline, address, email). * subject who has a family member or guardian with a contact telephone number. * subject to the availability of time to comply with scheduled visits and activities. exclusion criteria: * subject with a diagnosis of renal, cardiac, hepatic, immunological, dermatological, endocrine, gastrointestinal, neurological or psychiatric disease. * subjects diagnosed with positive covid 19 * subject diagnosed with hematological disorders, such as anemia and/or polycythemia. * subjects with a history of gastric surgeries. * permanent or temporary use during the last 15 days of any type of medication, both on their own initiative and by medical prescription. except female patients who are planning regularly with the same contraceptive method in the last 6 months prior to the start of this trial. * smoker in the last 3 months, regardless of the number of cigarettes. * consumption of xanthines from coffee, tea or chocolate during the previous 48 hours * drinker of alcohol in more than 16 grams every week equivalent to 1 beer or 2 glasses of wine during the last 15 days. * consumption of drugs of abuse or psychoactive substances reported as a positive test. * known hypersensitivity to the active substance or to the excipients of the test product. * medical history of angioedema or anaphylaxis. * subject diagnosed with human immunodeficiency virus infection, hepatitis b or positive hepatitis c. * have participated in clinical studies in the 4 months prior to the start of this trial. * have donated blood in the 30 days prior to the start of the trial.

Keywords: dasatinib , fed condition, bioequivalence
catheter ablation of ventricular arrhythmia reduces skin sympathetic activity

Conditions: Ventricular Tachycardia

Summary: this study is being done to determine whether there is an increase in sympathetic nerve activity before the onset of ventricular arrhythmias or irregular heartbeat rhythm. in addition, this study is looking at the relationship between sympathetic nerve activity and how patients with ventricular arrhythmias respond to catheter ablation treatment.


Eligibility criteria:
inclusion criteria: * patients who have non-sustained or sustained va (va ≥ 30s or receiving appropriate icd therapies) are presented to the clinic or admitted to the hospital within 7 days of episodes. * the causes of va are associated with structural heart diseases including ischemic or nonischemic cardiomyopathy (idiopathic cardiomyopathy, hypertrophic cardiomyopathy, cardiac sarcoidosis or amyloidosis, and arrhythmogentic right ventricular dysplasia). * subjects are 18 years of age and older. exclusion criteria: * female patients who is pregnant or of childbearing potential and not on a reliable form of birth control. * allergic to skin patch electrodes. * vulnerable populations (fetuses, neonates, pregnant women, prisoners, institutionalized individuals).