Kornimate/medical-research-clean huggingface dataset:
hydroxychloroquine in cystic fibrosis

Conditions: Cystic Fibrosis

Summary: study levels of inflammatory mediators in induced sputum of patients with cystic fibrosis before and after a 4 week course of oral hydroxychloroquine.

open label study of effect of hydroxychloroquine on inflammation, bacterial burden and exhaled breath condensate ph in patients with cystic fibrosis. patients with cystic fibrosis, 16 years or older and with pulmonary function tests with an fev1 greater than 40% predicted will be eligible for enrollment. enrolled subjects will undergo collection of exhaled breath condensate and sputum induction and collection following nebulized hypertonic saline, before and following a 4 week course of oral hydroxychloroquine at 200 mg a day. inflammatory mediators, neutrophil counts, and bacterial density in sputum and exhaled breath condensate ph will be measure at entry and at the end of 4 weeks of oral drug. there will be no placebo group.

Eligibility criteria:
inclusion criteria: 1. male or female between 16 years and 65 years of age. 2. confirmed diagnosis of cf based on the following criteria: i. positive sweat chloride 60 meq/liter (by pilocarpine iontophoresis) and/or ii. a genotype with two identifiable mutations consistent with cf, and iii. accompanied by one or more clinical features consistent with the cf phenotype 3. fev1 50% predicted value (subjects 16- \<18 years of age) or 40% predicted value (subjects 18 years of age) 4. clinically stable with no evidence of acute upper or lower respiratory tract infection or current pulmonary exacerbation within the 14 days prior to visit 1 (day 0) 5. ability to reproducibly perform spirometry and peak flow measurements 6. ability to understand and sign a written informed consent or assent and comply with the requirements of the study exclusion criteria: 1. use of an investigational agent within the 4-week period prior to visit 1 2. chronic daily use of ibuprofen or other nsaids, or systemic corticosteroids, or any oral diabetic or hypoglycemic agent within the 4 weeks prior to visit 1 or acute usage within 72 hours prior to visit 1 3. history of hypersensitivity to beta-agonists 4. history of hypersensitivity to hydroxychloroquine or chloroquine 5. oxygen saturation \< 92% on room air at visit 1 6. pregnant, breastfeeding, or unwilling to practice birth control during participation in the study 7. history of hemoptysis 30 cc per episode during the 30 days prior to visit 1 8. significant history of hepatic, cardiovascular, renal, neurological, hematologic, or peptic ulcer disease

Keywords: cystic fibrosis induced sputum lung inflammation
pharmacokinetic single dose trial of empagliflozin in children and adolescents with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of the study is to generate pharmacokinetic and pharmacodynamic data to identify the safe-effective dose of empagliflozin in children and adolescents aged 10 to less than 18 years with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: * children and adolescents with type 2 diabetes mellitus * insufficient glycaemic control (hba1c \<=10.5%) despite diet and exercise and/or metformin and/or stable basal or mdi insulin * negative for islet cell antigen and glutamic acid decarboxylase autoantibodies and fasting c-peptide levels \>= 0.85 ng/ml * bmi \> 50th percentile for age and sex exclusion criteria: * uncontrolled hyperglycaemia with a glucose level \> 240 mg/dl (\> 13.3 mmol/l) * history of acute metabolic decompensation such as diabetic ketoacidosis within 3 months before the screening visit with the exception of acute de-compensation at the time of type 2 diabetes diagnosis * treatment with weight reduction medications within 4 weeks before randomisation
the correlation between blood concentration of sintilimab and efficacy and adverse reactions in patients with advanced gastric cancer

Conditions: Gastric Carcinoma; Gastric Neoplasm; Gastric (cardia, Body) Cancer; Gastric Cancer Adenocarcinoma Metastatic

Summary: compared with other anti-tumor drugs, immune checkpoint inhibitors (icis) have their own unique pharmacokinetics (pk) and pharmacodynamics (pd), and affect patient clinical outcomes. however, at present, the data on the pk and pd characteristics of icis in the chinese population are still lacking, thus further clinical trials are needed to verify them. at the same time, a large proportion of patients have no response to icis or the efficacy is poor, and even bring greater side effects, so it is particularly important to find effective biomarkers to predict the efficacy and adverse reactions of patients with icis treatment.the purpose of this study is to explore the correlation between blood concentration of sintilimab and related predictors with efficacy and adverse reactions in patients with advanced gastric cancer so as to provide clinical reference for individualized treatment of patients with gastric cancer.


Eligibility criteria:
inclusion criteria: a. patients who were diagnosed with gastric adenocarcinoma or gastroesophageal junction adenocarcinoma; b. patients who plan to be treated with sintilimab; c.ecog score of 0-2; d. expected survival ≥3 months; e. the patient who have good compliance, follow-up, and can cooperate with relevant treatment and examination; f. agree to participate in the study and sign the informed consent exclusion criteria: a. patients who clinical information and data are incomplete; b. patients who treated with immune checkpoint inhibitors within 6 months
diagnostic value of shear-wave elastography for patellar tendinopathy

Conditions: Patellar Tendinopathy

Summary: to investigate the accuracy of shear-wave elastography (swe) in diagnosing patellar tendinopathy in female volleyball and basketball players. in addition, we want to compare different parts of the patellar tendon and investigated the effects of different knee angles.


Eligibility criteria:
inclusion criteria were: * being a female athlete between the ages of 17-35 playing professional basketball or volleyball and agreeing to participate in the study exclusion criteria were: * to have a history of partial or full-thickness patellar tendon tear, * if they received an injection in or around the patellar tendon within the past 12 months, * undergone patellar tendon graft repair for anterior cruciate ligament, had a ligament or meniscus operation within the past six months, * have a chronic disease (such as diabetes, heart disease, or rheumatic disease), * are actively using oral contraceptives, * have an active infection in the knee or surrounding tissues

Keywords: patellar tendinopathy shear-wave elastography ultrasound
effects of administration of scfa in rheumatoid arthritis inadequate responders

Conditions: Rheumatoid Arthritis

Summary: this study is a pilot, proof of concept study to determine the effects of administering an oral short-chain fatty acid (scfa) supplement to rheumatoid arthritis (ra) patients with inadequate response to methotrexate (mtx). the study will include up to 35 participants to obtain a sample size of at least 25 participants taking the oral supplement. the researchers hypothesize that oral scfa will change the participants' gut microbiome and regulatory immune responses. clinical data to assess for adverse events, stool, urine samples and peripheral blood will be collected at baseline, 1 month, and with an optional 2 month time-point. fecal microbiome will be analyzed. adaptive immune responses will be analyzed from participant blood samples.


Eligibility criteria:
inclusion criteria: 1. diagnosis of ra meeting 2010 acr/eular for ra and/or treating md diagnosis 2. inadequate response to mtx per treating md at maximum tolerated dose. 3. able and willing to provide written informed consent prior to any study specific procedures 4. age 18 years and above at time of enrollment 5. subjects not excluded based on race or ethnicity exclusion criteria: 1. participants who are pregnant or are currently breastfeeding 2. history of sensitivity to study compound or any of their excipients 3. previous intolerance to scfa or related compounds 4. current antibiotic treatment (within 3 months of screening) at discretion of pi 5. current consumption of probiotics (within 3 months of screening) at discretion of pi 6. severe hepatic impairment (eg, ascites and/or clinical signs of coagulopathy) 7. renal failure (egfr \<30 or requiring dialysis) by history 8. history of other autoimmune disease at discretion of pi 9. current immunodeficiency state (e.g., cancer, hiv, others)

Keywords: rheumatoid arthritis short chain fatty acid butyrate microbiome methotrexate
a study to evaluate the efficacy and safety of rosuvastatin in hypercholesterolemia.

Conditions: Hypercholesterolemia

Summary: the objective of this trial is to assess the efficacy of reducing plasma low-density lipoprotein(ldl) cholesterol and safety in two different brand drugs, roty f.c. tablets 10mg and crestor 10mg f.c. tablets in hypercholesterolemia population.


Eligibility criteria:
inclusion criteria: * male or female aged 20 to 85; * ldl - c between 130 mg/dl and 250 mg/dl; * tg \< 400 mg/dl; * who without use of any statin within 2 week prior to the trial; * informed consent given. exclusion criteria: * known hypersensitivity or history of sae with another hmg-coa reductase inhibitor, in particular any history of myopathy; * active liver disease/severe hepatic impairment(child-pugh c,alt2×uln); * treatment with cyclosporin or any disallowed drug; * patients with unstable angina pectoris; * pregnant, lactating women; * patients who have severe medical condition(s) that in the view of the investigator prohibits participation in the trial.
blood pressure guided biofeedback on hemodialysis and the reduction of intradialytic hypotension

Conditions: Hypotension

Summary: it is very common for hemodialysis patients to have problems with low blood pressure while on hemodialysis. low blood pressure on dialysis is not a good thing and it is associated with an increased risk of death and hospitalizations. it might be possible to minimize or even prevent these low blood pressure episodes with a software that can be added to the dialysis machine which detects the patient's changes in blood pressure and automatically slows down how much fluid is being removed from the person. the investigators hypothesize that a blood pressure guided biofeedback system (called biologics rr) will result in a 30% reduction in the number of hypotensive episodes on hemodialysis.

this is a randomized cross over trial in which 30 chronic hemodialysis patients with a history of intradialytic hypotension, idh will be randomized to receive either standard hemodialysis or hemodialysis with blood pressure guided biofeedback (biologics rr comfort, b braun). after the initial period of 8 weeks patients will cross over to the other group for the final 8 weeks of the study. the primary outcome is the reduction in the number of idh episodes associated with patient symptoms or nursing symptoms.

Eligibility criteria:
inclusion criteria: * chronic hemodialysis patients * history of 3 of the last 12 runs with documented hypotension with symptoms or nursing interventions exclusion criteria: * \<19 years * hemodiafiltration * expected switch in modality within next 6 months

Keywords: idh, intradialytic hypotension, hypotension on hemodialysis, hemodialysis, blood pressure guided biofeedback
12-hour time limited feeding in critical care

Conditions: Critical Illness

Summary: this study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients. * investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding. * investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar.

investigators will test a 12-hour time-restricted feeding (trf12) protocol in critically ill adults and compare this to a standard-of-care, 24-hour continuous feeding (cont24) schedule. time-restricted feeding (trf) is form of intermittent fasting involving eating within a consistent, shortened period each day, following by fasting for at least 12 hours daily. trf may improve glycemic control, blood pressure, and circadian rhythms in metabolism relative to feeding over a longer period. in critically ill patients, most facilities feed enterally over 24-hours which may exacerbate sleep disturbances and post-intensive care syndrome. in addition to safety and feasibility measures, this 10-day trial will gather preliminary data regarding how these feeding protocols each affect glycemic control, sleep, and long-term effects of critical care, such as delirium.

Eligibility criteria:
inclusion criteria: * adults (≥18 years of age) * with critical illness (hospitalized in an intensive care unit with a status of "icu") * who have received orders for continuous enteral nutrition exclusion criteria: * "comfort measures only" status * have orders to receive trickle feedings (feeding rate ≤10ml/hr) * recent surgical procedure on the gi tract (within previous 5 days at time of recruitment) or admission for gi bleed * receiving continuous sedation * expected to undergo a procedure requiring removal of study devices in the three days following enrollment * history of malabsorptive bariatric surgery * admitted for a burn injury * known intolerance to feeding rates \>100ml/hr * current diagnosis of pancreatitis, ileus or gastroparesis (only if using a gastrostomy tube) * requiring intermittent or continuous renal replacement therapy * pregnant or lactating * on an intermittent feeding schedule * nutritional needs would require a rate higher than 120ml/hr on trf12 protocol * lack of clearance by primary physician

Keywords: time-restricted feeding enteral feeding critical illness intermittent fasting
health literacy for children with atopic dermatitis and their caregivers

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the university of missouri dermatology clinic.

the purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the university of missouri dermatology clinic. caregivers of children with atopic dermatitis will be randomized to one of two instruction/education procedures. the goal is to determine if improved retention of information by caregivers/parents of children with atopic dermatitis is associated with better patient outcomes.

Eligibility criteria:
inclusion criteria: * new clinical diagnosis of pediatric atopic dermatitis, or existing atopic dermatitis but new patient to mu dermatology * age 7 or under exclusion criteria: * age 8 or above

Keywords: pediatric atopic dermatitis easi realm-sf nurse instruction health literacy
mri to assess the effects of dysautonomia and chronic nausea on brain transmitters

Conditions: Dysautonomia

Summary: the purpose of this research study is to better understand what causes dysautonomia and how this affects blood pressure and pulse. dysautonomia is a condition of the autonomic nervous system. it is associated with fluctuations in blood pressure and pulse and may cause symptoms of nausea and belly pain, fatigue, excessive thirst, lightheadedness, dizziness, feelings of anxiety or panic, and fainting. a common example of dysautonomia is postural orthostatic tachycardia syndrome or pots. sometimes symptoms worsen when people move from lying down to standing, called orthostatic intolerance. we would like to learn more about the link between orthostatic intolerance and nausea. while medications currently used to treat orthostatic intolerance and nausea have proven to be effective in some patients, this may not be the best treatment for everyone as long term use could pose certain risks including high blood pressure. in order to provide a more focused and safer treatment for patients suffering from nausea and orthostatic intolerance, we have looked at how the blood pressure, pulse, and certain blood tests change during a tilt table test. this test helps to create the same circumstances that patients with orthostatic intolerance experience when they stand. to better understand if some of these problems are associated with the brain, we will study mri in patients with dysautonomia compared to children without dysautonomia. this information may allow us to use alternative and safer treatments in the future.


Eligibility criteria:
inclusion criteria: * subjects who have completed tilt autonomic testing * subjects from 9 - 18 years of age exclusion criteria: * subjects who have a metabolic, mechanical, or mucosal inflammatory cause which has been defined to explain their gastrointestinal symptoms * patients with cardiac or cardiovascular disease, malignancy, psychiatric illness, neurodevelopmental delay, or other co-morbid conditions * patients with with pacemakers, implanted devices, or any other mri contraindications will be excluded from this study.

Keywords: dysautonomia postural orthostatic tachycardic hypotension neurocardiogenic vasovagal syncope
comparison of unilateral ci vs. bimodal stimulation in prosodic perception

Conditions: Cochlear Hearing Loss

Summary: an observational study to determine and assess perception of prosodic information in adults who use bimodal stimulation (cochlear implant plus hearing aid) when using both devices vs. cochlear implant alone.

people with severe to profound hearing loss often do not get satisfactory benefit from their hearing aids. a cochlear implant (ci) is a prosthetic device for the inner ear which can directly stimulate the auditory nerve, bypassing damaged inner ear hair cells and thus provide audible sensations to profoundly deaf patients. currently, one ci is funded by nhs england for adult patients and the eligibility criteria for implantation has been relaxed in recent years. as a result, there are now an increasing number of unilateral ci users who possess low-frequency residual hearing in their non-implanted ear. for many patients this residual hearing may still be usefully amplified by a ha. this configuration, consisting of a ci and a contralateral ha, is known as bimodal stimulation. the peps-c receptive test battery has been previously used to assess prosody perception in hearing loss. the current project will use selected tests from the peps-c prosodic test battery to assess intonation, emotion and phrase stress perception ability in adults with bimodal stimulation using both devices together and ci alone.

Eligibility criteria:
inclusion criteria: * adult * has unilateral cochlear implant * consistent use of hearing aid * obtains some benefit in speech discrimination from hearing aid (\> 20% ab words) * post-lingually deafened * fluent english exclusion criteria: * longstanding significant asymmetry (\> 20 db hl 4 frequency average) in hearing where the unimplanted ear is the worse ear * inconsistent hearing aid use * significant conductive hearing loss (\> 20 db hl 4 frequency average) * using electro-acoustic stimulation cochlear implant * aetiology of hearing loss likely associated with auditory neuropathy * significantly abnormal appearance of cochlea or cochlear nerve
a clinical trial to investigate the long-term safety and tolerability, efficacy, pharmacodynamics, pharmacokinetics, and immunogenicity of argx-117 in adults with multifocal motor neuropathy

Conditions: Multifocal Motor Neuropathy (MMN)

Summary: this trial is an extension of the antecedent trial argx-117-2002. it is a multicenter trial that has been designed to evaluate the long-term safety and tolerability, efficacy, immunogenicity, pharmacokinetics (pk), and pharmacodynamics (pd) of argx-117 intravenously (iv) in adults with multifocal motor neuropathy (mmn). the trial will include a double-blinded rollover treatment period (dtp), an open-label treatment period (otp), and a safety follow-up period.


Eligibility criteria:
inclusion criteria: * capable of providing signed informed consent and complying with protocol requirements. participants must be able to read and write. * must have completed the double-blinded treatment period of the argx-117-2002 trial and considered to be eligible for treatment with argx-117. exclusion criteria: * clinically significant uncontrolled active or chronic bacterial, viral, or fungal infection. * clinical evidence of other significant serious diseases, have had a recent major surgery, or who have any other condition, in the opinion of the investigator, that could confound the results of the trial or put the participant at undue risk. * currently participating in another interventional clinical study. * pregnant or lactating or intend to become pregnant during the trial or within 15 months after last dose of the study drug.