Kornimate/medical-research-clean huggingface dataset:
investigating the experiences of individuals with gastric cancer participating in clinical trials

Conditions: Gastric Cancer

Summary: this study is observational, meaning that it does not include any interventions or new treatments. as a result, there may not be an immediate benefit for the patient with gastric cancer. however, the data collected from this trial can contribute to a better understanding of the factors that affect withdrawal and enrolment rates in gastric cancer clinical trials, and may ultimately lead to improved patient outcomes in the future.


Eligibility criteria:
inclusion criteria: * patient is a minimum of 18 years or older * patient has been diagnosed with gastric cancer * patient has been self-identified as planning to enroll in an observational clinical study exclusion criteria: * patient is breastfeeding or pregnant * inability to perform regular electronic reporting * patient does not understand, sign, and return consent form

Keywords: gastric cancer gastric cancer stage
sprint to fitness: effect of outcome expectations on responses to interval exercise training

Conditions: Overweight; Obesity

Summary: the purpose of this study is to research the effects of exercising at high intensities for short periods of time on exercise tolerance and motivation.

the proposed research will investigate whether adding a treatment component that focuses on positive outcome expectations of a high-intensity interval training (hiit) intervention produces greater improvements in psychological and physiological study outcomes. this project will yield empirical evidence that will inform how to help americans meet physical activity guidelines; how to develop exercise programs that are more likely to promote exercise as a habit; and maintenance of health and a healthy body weight.

Eligibility criteria:
inclusion criteria: * body mass index of 25-35 kg/m2 * sedentary (not regularly engaging in exercise more than once per week) * weight stable (have not lost or gained over 10 pounds of body weight in the past 3 months) exclusion criteria: * taking any medications that affect energy expenditure or treat high blood pressure * tobacco use * pregnant or breastfeeding or plan to become pregnant in the next 3 months * have any medical conditions that prevent subject from safely exercising (e.g., orthopedic injuries, cardiovascular, liver, endocrine, or pulmonary diseases) * resting systolic blood pressure ≥ 140 mmhg * resting diastolic blood pressure ≥ 90 mmhg * non-fasting plasma glucose of ≥ 200 mg/dl

Keywords: exercise behavior economics
mepolizumab for eosinophilic fasciitis

Conditions: Eosinophilic Fasciitis

Summary: this is a proof of concept pilot study to investigate the efficacy of mepolizumab in the treatment of eosinophilic fasciitis.

this is an exploratory study designed to generate preliminary data in evaluating the efficacy of mepolizumab (nucala) in the treatment of ef using mean change in the rodnan skin score (mrss) before and after treatment. the study is powered at 90% to detect a 4 point change in the mrss at a 5% significant level with a minimum target accrual of 6 patients.

Eligibility criteria:
inclusion criteria: * male and female patients 18 years or older. * history and physical examination consistent with ef * full thickness skin biopsy characteristic of eosinophilic fascitis and/or mri radiographic findings characteristic of ef * documented peripheral eosinophilia (≥500 microliter) * patients who are willing and capable of cooperating to the extent and degree required by the protocol; and * patients who read and sign an approved informed consent for this study exclusion criteria: * eosinophilic fascitis disease duration \> 5 years * known history of adverse reaction to mepolizumab (nucala) * pregnant females * females actively trying to conceive * vulnerable study population * asthma requiring inhaled cortiosteroids

Keywords: mepolizumab
bepotastine besilate-corticosteroid nasal spray combination compared to placebo, bepotastine besilate nasal spray, and corticosteroid nasal spray in the treatment of patients with seasonal allergic rhinitis

Conditions: Seasonal Allergic Rhinitis

Summary: this is a clinical study to evaluate the safety and efficacy of a bepotastine besilate-corticosteroid combination nasal spray for the treatment of seasonal allergic rhinitis (sar) in an open exposure study with subjects who have a demonstrated history of mountain cedar pollen allergy. the primary study objective is to assess the reduction from baseline in averaged morning (am) and evening (pm) values of reflective total nasal symptom scores for each of 3 nasal sprays (bepotastine besilate-fluticasone propionate combination nasal spray, bepotastine besilate nasal spray, fluticasone propionate nasal spray) compared to placebo nasal spray. for enrolled subjects, the study will involve a 7-10 day run-in screening period dosing with placebo nasal spray and then a 14-day treatment period where subjects will dose twice a day with 1 of the 4 test agent nasal sprays and record reflective and instantaneous scores for both nasal and ocular symptoms prior to each dosing.


Eligibility criteria:
inclusion criteria: * male or female at least 12 years of age with a demonstrated history of mountain cedar pollen allergy exclusion criteria: * no active nasal infection or nasal abnormality that would affect subject safety or symptom assessments
usability study of the commercial auto-injector device and the new auto-injector device (sydney) in patients with high or very high cv risk with hypercholesterolemia not adequately controlled with their lipid-modifying therapy

Conditions: Hypercholesterolaemia

Summary: primary objective: to collect real-use (usability) data assessing the robustness and user interaction of the new alirocumab auto-injector device (which is referred to as sydney), in unsupervised settings. secondary objective: device-related: * to collect real-use (usability) data assessing the robustness and user interaction of sydney and the current alirocumab auto-injector device (which is referred to as ai) in supervised settings. pharmacokinetics: * to compare alirocumab pharmacokinetics (pk) administered using sydney and ai. * to evaluate alirocumab pk administered using sydney. anti-drug antibodies: * to evaluate the development of anti-drug (alirocumab) antibodies (ada). efficacy/pharmacodynamics: * to compare the percent and absolute change in low-density lipoprotein cholesterol (ldl-c) using sydney and ai. * to evaluate the percent and absolute change in ldl-c using sydney. safety: * to evaluate the safety and tolerability of alirocumab using both sydney and ai.

total study duration per participant was expected to be up to 18 weeks, with up to 2 weeks of screening period and 16 weeks of study treatment period.

Eligibility criteria:
inclusion criteria : * participants were in either category a or b (below), and were not adequately controlled with a stable daily dose of atorvastatin (20 mg or 40 mg), or rosuvastatin (10 mg or 20 mg) for at least 4 weeks prior to the screening visit (week -2), with or without other lmt: * a. participants with heterozygous familial hypercholesterolemia (hefh) (diagnosis based on either genotyping or clinical criteria) or * b. non-fh participants at high or very high cardiovascular (cv) risk. high and very high cardiovascular risk participants included participants with coronary heart disease (chd), non-chd cardiovascular disease (cvd), and other risk factors. * participant willing and able to self-inject for the duration of the study. exclusion criteria: * ldl-c \<70 milligrams per deciliter (mg/dl) (\<1.81 millimoles per litre \[mmol/l\]) at the screening visit. * currently taking a daily dose of statin that was not atorvastatin 20 mg or 40 mg, or rosuvastatin 10 mg or 20 mg. * not on a stable dose of lmt (including statin) for at least 4 weeks, prior to the screening visit and from screening to randomization. * having previously used any device for the proprotein convertase subtilisin/kexin type 9 (pcsk9) inhibitor administration, or having participated in any clinical trial for a pcsk9 inhibitor. * fasting serum triglyceride (tg) \>400 mg/dl (\>4.52 mmol/l) at the screening visit. the above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
safety and efficacy results of percutaneous renal stent implantation in ectatic and aneurysmatic coronary arteries

Conditions: Coronary Artery Ectasia

Summary: the aim of this study was to evaluate the efficacy and safety of renal stents implanted in ectatic/aneurysmatic coronary arteries.

in total, 18 patients (renal stent group) who underwent renal stent implantation in ectatic/aneurysmatic coronary arteries requiring percutaneous coronary intervention (pci) and 45 patients who underwent large-sized bare metal coronary stent (bmcs) implantation (bmcs group) at our centre between 2015 and 2020 were included in the study. control coronary angiography (cag) was performed during the follow-up of these patients, and angiography-guided quantitative measurements were performed during pci. the primary endpoints were myocardial infarction and cardiovascular mortality, and the secondary endpoints were restenosis and all-cause mortality.

Eligibility criteria:
inclusion criteria: * acute coronary syndrome patients * 18 year age * ectatic/aneurysmatic coronary arteries exclusion criteria: * patients who underwent elective procedures, * experienced unsuccessful attempts * referred to surgical revascularization
it enhanced peer integrated collaborative care for us trauma care systems

Conditions: PTSD; Physical Injury

Summary: this study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in us trauma care systems. the two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. the collaborative care intervention will be supported by a novel emergency department (ed) health information exchange technology platform.

collaborative care models are an established standard of care for treating combined mental health and chronic medical conditions in acute and primary care medical settings. however, very few interventions exist for the acute injury population transitioning between settings. while peer interventionist programs have been instituted for care delivery in many conditions, they have not yet been comprehensively integrated into acute post-injury interventions. literature reviews support the need for comparative effectiveness trials of health care system interventions targeting high need injured patients with multiple complex mental health and medical comorbidities who are at risk for fragmented post-injury health service utilization. this study evaluates two readily implementable approaches to the delivery of transitional care for injured patients treated emergently in us trauma care systems. the two approaches to be compared are a multidisciplinary team collaborative care intervention that integrates front-line trauma center staff with peer interventionists to trauma surgical team notification of patient emotional distress with recommended mental health consultation. the collaborative care intervention will be supported by a novel emergency department (ed) health information exchange technology platform.

Eligibility criteria:
inclusion criteria: * inpatient/emergency admission for intentional and/or unintentional injury * score of ≥35 on the ptsd checklist * endorsement of ≥ 1 severe posttraumatic concern exclusion criteria: * patients who required immediate psychiatric intervention * patients who are not washington or oregon state residents * patients who are currently incarcerated * patients not speaking spanish or english

Keywords: ptsd physical injury patient concerns emergency department utilization
alpha msh in ocular disease

Conditions: Advanced Dry Macular Degeneration

Summary: the purpose of this study is gain a better understanding of a molecule called alpha melanocyte stimulating hormone (alpha msh) and its potential role in your retinal disease. alpha msh has been shown to have an important role in the regulation of ocular immunity in animal models of inflammatory retinal diseases and retinal dystrophies, and there may be a protective effect of alpha msh. by studying the levels of alpha msh in your eye we may better understand its role in advanced dry macular degeneration. by studying the levels of this molecule we hope to better understand if it may be a good target for future treatment.

a small amount (0.1 ml) of aqueous humor would be removed from the study eye in the clinic setting. this sample will be processed and then sent off for measurement of alpha msh levels.

Eligibility criteria:
inclusion criteria: * 60 years or older * diagnosis of advanced dry macular degeneration with foveal geographic atrophy * limited vision or blindness (20/100 or worse) in that eye * pseudophakia (prior cataract surgery in that eye) exclusion criteria:

Keywords: macular degeneration blindness
a study of participants with lymphoma who take r-chop and enzastaurin compared to participants who take r-chop only

Conditions: Lymphoma

Summary: to compare r-chop plus enzastaurin versus r-chop for progression-free survival (pfs) time measured in participants with intermediate and/or high risk for diffuse large b-cell lymphoma (dlbcl) receiving first-line treatment.


Eligibility criteria:
inclusion criteria: participants must: 1. have a histologically confirmed diagnosis of dlbcl based on the world health organization classification (harris et al. 1999) at the time of original diagnosis. pathology must be reviewed and confirmed prior to enrollment at the investigational site where the participant is entered. participants with a prior history of an indolent lymphoma or a histological diagnosis of follicular grade 3 lymphoma will not be eligible for enrollment. 2. have received no prior chemotherapy. 3. have an international prognostic index (ipi) score ≥2 at time of original diagnosis. 4. have a performance status of 0, 1, or 2 on the eastern cooperative oncology group (ecog) scale. 5. have adequate organ function as follows: * hepatic: total bilirubin ≤1.5 times the upper limit of normal (x uln); alanine transaminase (alt) and aspartate transaminase (ast) ≤1.5 x uln, (≤5 x uln, if liver involvement). * renal: serum creatinine ≤1.5 x uln. * adequate bone marrow reserve: platelets ≥75 x 10\^9 per liter (l), absolute neutrophil count (anc) ≥1.0 x 10\^9 per l, unless there is bone marrow involvement. exclusion criteria: participants must not: 6. have received treatment within the last 30 days with a drug (not including enzastaurin) that has not received regulatory approval for any indication at the time of study entry. 7. are receiving concurrent administration of any other systemic anticancer therapy. 8. are pregnant or breastfeeding. 9. are unable to swallow tablets. 10. are unable to discontinue use of carbamazepine, phenobarbital, and phenytoin at least 14 days prior to study enrollment.
population pharmacokinetics/pharmacodynamics of carbapenems in febrile neutropenia patients

Conditions: Febrile Neutropenia; Pharmacokinetics; Pharmacodynamic; Carbapenems

Summary: 1. evaluating the differences in the efficacy and safety of meropenem optimal dosing regimen predicted by the ppk/pd model combined with mapb method for patients with malignant hematological myelopathy accompanied by fever, as compared with the current conventional treatment regimen; 2. the visualization software of meropenem individualized medication was developed with the help of java development language, j2ee framework and sql server database.


Eligibility criteria:
inclusion criteria: 1. age ≥18 years old, regardless of gender; 2. patients with malignant hematological diseases with neutropenia and fever are judged as high-risk patients according to the guidelines for clinical application of antibiotics in patients with neutropenia and fever in china (2020 edition); 3. there is infection, and the results of drug sensitivity test show that pathogenic bacteria are sensitive to meropenem or meropenem is used according to experience; 4. the blood concentration of meropenem has reached a steady state; 5. each patient's blood sample points ≥2, and cases with only one blood sample point can also be included in the database; 6. sign the informed consent form. exclusion criteria: 1. patients with non-malignant hematological diseases; 2. non-granular deficiency with fever; 3. those who did not reach steady state when receiving meropenem; 4. there is a history of meropenem drug allergy; 5. the patient lacks treatment compliance based on the patient's history and the judgment of the researcher; 6. the patient has hemophagocytic syndrome; 7. patients undergoing renal replacement therapy; 8. patients with incomplete clinical evaluation data (such as lack of information on renal function and biochemical indicators, and inability to obtain blood samples); 9. the sample contains components that interfere with the determination of drug concentration (such as valproic acid and chloramphenicol); 10. pregnant and lactating women; 11. cases considered by the researcher as unsuitable for inclusion.
dental safety profile of high-dose radioiodine therapy

Conditions: Thyroid Cancer

Summary: we aim to assess the incidence of oral and dental adverse events after high-dose radioiodine therapy for differentiated thyroid cancer.

sialadenitis and xerostomia are the most frequent adverse events of high-dose radioiodine therapy. saliva has vital functions in maintaining periodontal and oral health. therefore, xerostomia not only impairs quality of life permanently, but may also increase the risk of caries and tooth extractions. nevertheless, despite more than 6 decades of radioiodine therapy for thyroid cancer, large studies on long-term oral adverse events are still lacking. in the present study, we investigate the influence of high-dose radioiodine therapy on the long-term oral health.

Eligibility criteria:
inclusion criteria: * histologically confirmed differentiated thyroid cancer * status after total thyroidectomy * status after subsequent high-dose radioiodine treatment * regular follow-up by a board-certified dentist * a minimum follow-up of 1 year after radioiodine therapy. exclusion criteria: * anaplastic thyroid cancer

Keywords: radioiodine, thyroid cancer, sialadenitis, xerostomia
the impact of exercise on hand function, daily activities performance and quality of life of sle' patients

Conditions: Systemic Lupus Erythematosus; Arthralgia

Summary: a total of 240 consecutive sle patients fulfilling the slicc classification criteria was evaluated. sixty two patients who met the inclusion criteria were randomly assigned to the exercise group (n=32) or the control group (n=30). patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. performance of daily activities was evaluated with the dash and haq questionnaires, grip and pinch strength with the jamar dynamometer and pinch gauge tools respectively, dexterity with the purdue pegboard test and the quality of life with the lupusqol questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. sle activity and cumulative organ damage were evaluated with the sle disease activity index 2000 (sledai-2k) and slicc/acr-di, respectively.

a total of 240 consecutive sle patients fulfilling the slicc classification criteria was evaluated. sixty two patients who met the inclusion criteria \[age\>18, upper limb arthralgias, and dash (disabilities of the arm, shoulder, and hand) questionnaire score\>10)\] were randomly assigned to the exercise group (n=32) or the control group (n=30). patients in the exercise group performed a program of strengthening, stretching and resistance upper limbs exercises, of 30 minutes duration daily, for 12 weeks. performance of daily activities was evaluated with the dash and haq questionnaires, grip and pinch strength with the jamar dynamometer and pinch gauge tools respectively, dexterity with the purdue pegboard test and the quality of life with the lupusqol questionnaire at 0, 6, 12 (end of the exercise program) and 24 weeks for both groups. sle activity and cumulative organ damage were evaluated with the sle disease activity index 2000 (sledai-2k) and slicc/acr-di, respectively.

Eligibility criteria:
inclusion criteria: * sle patients fulfilling the slicc classification criteria * upper limb arthralgias * dash score\>10 * stable drug regimen≥3 months exclusion criteria: * hand fracture or surgery in last 6 months * physiotherapy program in last month

Keywords: exercise hand function quality of life
comprehensive reverse shoulder data collection

Conditions: Arthropathy of Shoulder Region; Grossly Deficient Rotator Cuff; Osteoarthritis of the Shoulder; Rheumatoid Arthritis Without Humeral Metaphyseal Defects; Post-Traumatic Arthitis

Summary: this study is a multicenter, prospective, non-randomized, non-controlled clinical outcome study. the primary objective of this study is to evaluate improvement of pain score at one year for the biomet comprehensive reverse shoulder. the secondary objective is collection of long term clinical outcomes.

the biomet comprehensive reverse shoulder was developed to provide an additional surgical option for patients anatomically and structurally suited to receive a reverse shoulder arthroplasty. the aim of the biomet comprehensive reverse shoulder is to increase shoulder function while reducing pain. this is a multi-center study. having several clinical sites will allow for multiple investigators to contribute to the results of the study. 175 implants will be included into the study. all potential study subjects will be required to participate in the informed consent process.

Eligibility criteria:
inclusion criteria: * biomet® comprehensive™ reverse shoulder products are indicated for use in patients whose shoulder joint has a grossly deficient rotator cuff with severe arthropathy and/or previously failed shoulder joint replacement with a grossly deficient rotator cuff. * the patient must be anatomically and structurally suited to receive the implants and a functional deltoid muscle is necessary. * the comprehensive® reverse shoulder is indicated for primary, fracture, or revision total shoulder replacement for the relief of pain and significant disability due to gross rotator cuff deficiency. exclusion criteria: * absolute contraindications include infection, sepsis, and osteomyelitis. * uncooperative patient or patient with neurologic disorders who is incapable or unwilling to follow directions. * osteoporosis. * metabolic disorders which may impair bone formation. * osteomalacia. * distant foci of infections which may spread to the implant site. * rapid joint destruction, marked bone loss or bone resorption apparent on roentgenogram.

Keywords: reverse shoulder arthroplasty medical device performance safety shoulder prosthesis glenoid erosion