Kornimate/medical-research-clean huggingface dataset:
study of chronic rhinosinusitis symptoms in asthma patients undergoing treatment with reslizumab

Conditions: Chronic Rhinosinusitis (Diagnosis); Asthma; Nasal Polyps

Summary: the primary objective of this research is to monitor chronic rhinosinusitis (crs) symptoms in asthma patients who are undergoing treatment with reslizumab. a secondary objective is to explore whether there are sub-populations that appear to benefit or not benefit from reslizumab in terms of their crs symptoms.

this is a prospective observational study of patients receiving reslizumab to treat their asthma. some asthma patients receiving reslizumab also have crs, which might also be improved by this drug. study measures will be obtained from the medical records of eligible subjects who consent to participate. the study has no specific procedures per se, because all study measures are acquired during the course of standard of care treatment and will be abstracted from those medical records.

Eligibility criteria:
inclusion criteria: * age is 18 years or older * physician diagnosis of poorly controlled moderate to severe asthma despite typical medical therapy with an eosinophilic phenotype (defined by blood eosinophil count of 150 µl or greater within 6 weeks of enrollment) * initiating or undergoing reslizumab therapy (reslizumab - patient information listed in appendix 1 for reference) * physician diagnosis of chronic rhinosinusitis with nasal polyposis * able to understand and willing to provide informed consent * able to complete standard of care english-language questionnaires exclusion criteria: * current smokers * significant uncontrolled medical conditions * ongoing malignancy or history of cancer in remission for less than 12 months * subjects who had received immunosuppressive medications within 3 months of enrollment
prospective evaluation of proteinuria and renal function in diabetic patients with progressive renal disease

Conditions: Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effects of crestor (rosuvastatin) and (lipitor) atorvastatin on urinary protein excretion over 1 year in patients with type 1 or 2 diabetes with moderate proteinuria and hypercholesterolaemia.


Eligibility criteria:
inclusion criteria: * hyperlipidemia * urinary protein * diabetes exclusion criteria: * previous rosuvastatin treatment \< 6 months prior to visit 1 * statin intolerance * severe hypertension

Keywords: hyperlipidemia proteinuria diabetes mellitus
a study to investigate the safety, tolerability, and efficacy of bxc-i17e repeated-dose sc injection in patients with moderate to severe atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the purpose of this study is to assess the safety, tolerability, and efficacy of a multiple sc dose of bxc-i17e in patients with moderate to severe atopic dermatitis (ad)


Eligibility criteria:
inclusion criteria: 1. patients (males or females) aged 18 years or older 2. patients have documented history of moderate to severe ad, that has been present for at least 1 year 3. history of inadequate response to a stable regimen of tcss or tcis as treatment for ad 4. patients must agree to apply stable doses of additive-free, basic bland emollient lotions twice daily for at least 7 days before the baseline visit 5. willingness and ability to comply with clinic visits and study-related procedures 6. patients should be able to read, understand, and be willing to sign the icf exclusion criteria: 1. presence of any of the following laboratory abnormalities * hemoglobin \< 11 g/dl * wbc \< 3.5 × 103/μl * platelet count \< 125 × 103/μl * neutrophils \< 1.75 × 103/μl * ast/alt \> 1.5 × uln * total bilirubin \> uln * creatinine \> uln * creatine phosphokinase \> uln 2. positive test for hepatitis b surface antigen, and/or hepatitis c antibody 3. active dermatologic conditions that may confound the diagnosis of ad 4. prior exposure to any investigational systemic treatment or is currently enrolled in another clinical study 5. significant concomitant illness or history of significant illness such as cardiac, renal, neurological, endocrinological, metabolic or lymphatic disease, or any other illness or condition that would adversely affect the patient's participation in this study 6. treatment with tcs, and/or tci, within 1 week prior to the baseline visit 7. known history of human immunodeficiency virus (hiv) infection 8. pregnant or breastfeeding women
understanding and addressing rejection of personalized breast cancer risk information in women

Conditions: Breast Cancer Female

Summary: the understanding and addressing rejection of personalized cancer risk information study is a longitudinal study conducted to understand the nature of phenomenon of personalized cancer risk rejection in the context of mammography screening.

the understanding and addressing rejection of personalized cancer risk information study seeks to understand the nature of the phenomenon of personalized cancer risk rejection in the context of mammography screening by 1) identifying demographic and psychological factors associated with risk rejection and 2) identify how risk rejection influences risk-concordant mammography screening behavior. the study will test a priori theory-derived hypotheses about the precursors of risk rejection and the influence of rejection on real-life screening decision making. the breast cancer risk assessment tool (bcrat) will be used to asses participant's breast cancer risk. this model is designed to estimate breast cancer risk in women 35-84, and uses the following predictors: 1) age, 2) age at first menstrual period, 3) age at first live birth, 4) first-degree relatives with breast cancer, 5) previous breast biopsy with atypical hyperplasia, and 6) race/ethnicity. participants will be required to complete the baseline survey in which they receive their bcrat model risk estimate and respond to that risk estimate. they will then complete a 12-month follow-up survey.

Eligibility criteria:
inclusion criteria: 1. female sex 2. age 39-74 (i.e., people who are eligible for routine breast cancer screening and for whom guidelines recommend an informed, risk-based decision) 3. english literacy exclusion criteria: 1. prior diagnosis of 1. breast cancer 2. ductal carcinoma in situ (dcis) 3. lobular carcinoma in situ (lcis) 4. known brca1/2 gene mutation 5. cowan syndrome 6. li-fraumeni syndrome 7. having received previous chest radiation for treatment of hodgkin's lymphoma.

Keywords: risk rejection screening behaviour
the effects of riboflavin/ ultraviolet-a corneal cross-linking on the signs and symptoms of bullous keratopathy

Conditions: Bullous Keratopathy

Summary: recently, riboflavin (0.1%) and ultraviolet-a (uva) collagen cross-linking (c3r) has shown potential to improve the signs and symptoms of bullous keratopathy .the objective of this study is to demonstrate the effects of c3r to treat bullous keratopathy.


Eligibility criteria:
inclusion criteria: * patients with bollous keratopathy exclusion criteria: * corneal scarring or contemporary eye disease affecting va were excluded.
personal activity intelligence (pai) pilot

Conditions: Overweight and Obesity; Diabetes; Hypertension; Dyslipidemias; Cardiovascular Diseases

Summary: pilot study to evaluate the use of the personal activity intelligence (pai) score in a clinical setting.

this is a pilot project to evaluate the feasibility of a larger study to evaluate the effectiveness of personal activity intelligence (pai) score in patients with chronic disease, as an adjunct to lifestyle medical therapy. the pai score is a proprietary formula developed by pai health (ph) to aid physical fitness. a pai score calculation uses biometrics obtained via a device that measures heart rate and steps. for this study, mio slice, a commercial wrist worn device will be utilized to obtain data which will be linked to a smart phone. data from the smart phone app will be accessed by pai health. feedback information will be given to the participants to encourage increased physical activity. the short-term aim of this study is to evaluate the logistics of utilizing pai in the patient setting. the data obtained from this study will be utilized to devise a larger study to evaluate the utility of pai in patients with chronic disease who are receiving lifestyle medical therapy.

Eligibility criteria:
inclusion criteria: * adult patients who are seen by the pi in his lifestyle medicine practice at muntean health care. * participants must own a smart phone and feel comfortable managing apps on their smart phone. * participants must be willing and able to register online with pai health (ph) * participants must be willing to wear a wrist device around the clock, except when charging or bathing for 12 weeks. * participants must have at least one of the following diagnoses: * overweight / obesity * diabetes or prediabetes * hypertension or pre-hypertension * abnormal lipids * cardiovascular disease exclusion criteria: * patients with angina or poor exercise tolerance, based on the evaluation by the pi, will be excluded from the study.
evaluation of brain atrophy in cis patients on avonex

Conditions: Multiple Sclerosis

Summary: the purpose of this study is * to examine if avaonex can delay the development of clinically definite multiple sclerosis. * to investigate if avonex can delay disability progression by slowing brain atrophy.

* multiple sclerosis (ms) is a chronic inflammatory disorder characterized by focal areas of demyelination in the central nervous system (cns). mri findings suggest that we should look at gray matter atrophy as a marker of the disease process in ms. * avonex is a proven effective disease-modifying treatment, which reduces total brain and gm atrophy and should be considered first-line therapy in patients with rrms and cis. * the original set study is an open-label observational study of high risk subjects after cis for development of cdms that will enroll 220 patients who have started avonex immediately after their first clinical attack in czech republic, and are followed with clinical and mri examinations for 4 years at 0, 6, 12, 24, 36 and 48 months. the clinical and mri acquisition examinations of this study are conducted in czech republic.

Eligibility criteria:
inclusion criteria: * mri findings must reveal at least 2 hyperintense lesions on t2-wi or flair images at first clinical onset * csf examination should confirm oligoclonal bands (examination must be done in an internationally approved lab and the csf taken before the treatment of attack starts) * age 18 - 55 years * effective contraception in female patients of childbearing potential * kurtzke edss ≤ 3.5 at baseline * willingness to accept the plan of the study and compliance with the study * time from the beginning of first symptoms of cis to baseline visit should not exceed 4 months (baseline mri and baseline visit will be organized first 28 days after last steroid administration) * cis attack is treated by at least 3g of methylprednisolone without taper * in case of severe attack 1 g of cyclophosphamide does not disqualify the patient from the study if first mri and csf examination was done before treatment administered * no active major organ disease especially of hepatic or thyroid origin exclusion criteria: * the clinical diagnosis of ms is definite (the second attack occurs before the baseline visit) * age less than 18 or more than 55 * non-effective contraception method or pregnancy planning * active major organ disease, especially hepatic or endocrinologic * cooperation of the subject cannot be ensured * kurtzke edss higher than 3.5 at baseline

Keywords: multiple sclerosis avonex brain atrophy mri interferon-beta 1a ifn beta 1-a clinically isolated syndrome cis
the young adult clinic (yac) study

Conditions: Insomnia; Chronic Pain; Insomnia Due to Medical Condition

Summary: the overarching aim of the young adult clinic (yac) study is to evaluate the doze app, a digital, transdiagnostic behavioral sleep medicine and self-management approach in young adult patients (ages 18-25) with chronic pain.

sleep, activity, and pain interactions have the potential to impact almost all important protective and regulatory processes in the body. long-term sleep disruption is associated with increased pain sensitivity, prolonged pain duration, and development of chronic pain. degree of pain relief can directly impact the quality and disruption of sleep, mood, behavior, social participation, and has a devastating impact on health related quality of life (hrql). transdiagnostic behavioral sleep medicine and self-management is a behavioral modification approach and is currently a frontline therapy like cognitive behavioral therapy for insomnia (cbti) in adults with sleep disorders. however, it is still in early stages of development for adolescent and young adult populations, and less so for youth with co-morbid mental and physical health conditions and chronic pain. primary aim: assess the feasibility of implementing the doze app. secondary aim: 1. to examine the variance in effectiveness outcomes, including sleep health, pain, and overall health related quality of life (hrql). 2. to determine the required sample size for a future definitive trial.

Eligibility criteria:
inclusion criteria: * young adult patients aged 18 - 25 years old, who have * non-malignant chronic pain lasting more than 3 months, with * clinically assessed as having a sleep disorder * english speaking with * access to a mobile phone or a computer with internet access. exclusion criteria: * patients who require urgent cbt treatment as per their health care provider * patients who have received cbt in the past 3 months * patients participating in other psychological treatments and/or drug trials during the study * patients who have other significant medical conditions- life threatening (e.g. cancer), neurological conditions (e.g. epilepsy) * patients who have other significant psychiatric conditions-severe depression or active suicide intent * situations resulting in forced sleep disruption or derangement of sleep schedule such as night shift work \> 2 nights per week in the past 3months * pregnancy or breastfeeding. * inability to communicate with health care providers or the research personnel * inability to fill out self-report questionnaires, study materials, or follow instructions.

Keywords: insomnia pain
fish oil for cognitive function, sleep quality, and bone density

Conditions: Cognitive Decline; Sleep; Bone Mineral Density

Summary: the precision nutritional management for diabetes trial (pnmd; nct03708887) is a randomized clinical trial in 415 diabetic patients investigating whether taking daily dietary supplements of omega-3 fatty acids (1.5 or 3 grams) improves glucose and lipid homeostasis in chinese diabetic patients. this ancillary study is being conducted among pnmd participants and will examine whether fish oil supplements affect a) cognitive function, b) sleep quality, and c) bone mineral density. cognitive function, sleep quality, and bone mineral density will be evaluated at baseline and post-intervention. the mini-mental state exams (mmse) will be conducted to evaluate the cognitive function of participants. the pittsburgh sleep quality index (psqi) will be calculated through questionnaires to evaluate sleep quality. the dual-emission x-ray absorptiometry (dxa) will be assessed to measure the bone density.


Eligibility criteria:
inclusion criteria: 1) diagnosed type 2 diabetes according to who diagnostic criteria or those on the use of diabetic medications; 2) between 40 and 75 years old (postmenopausal women); 3) have never used n-3 pufa supplements before or have stopped using them for more than six months. exclusion criteria: 1) type 1 diabetes; 2) coronary heart disease, stroke, cancer, hepatic or kidney disease; 3) pregnancy or lactation; 4) allergy to fish; 5) have participated in other clinical trials in the last three months.

Keywords: fish oil omega-3 fatty acids cognitive function sleep quality bone density
articulated laparoscopic instruments clinical study

Conditions: Gastric Cancer

Summary: recently, with the development of minimally invasive surgery and the development of instruments, laparoscopic and robotic surgery are increasing, and laparoscopic and robotic surgery are evolving. the association between the new surgical instruments used in each upper gastrointestinal surgery and the results has been traditionally analyzed through the learning curve, and in addition, the study aims to collect and analyze the utilization of the instrument and surgical results prospectively through surgical video analysis.

prior to surgery, all patients subject to the study are explained and informed of the prior consent form of prior consent is delivered. during surgery, video recording is performed to check the type of surgical instrument, the time of use, and the event that occurred during surgery. after surgery, the morbidity after surgery will be monitored and recorded. additional morbidity will be recorded one to three months after surgery.

Eligibility criteria:
inclusion criteria: patients with gastric cancer shcedulled for gastrectomy exclusion criteria: vulnerable subject (illiterate, pregnant)

Keywords: articulated laparoscopic instruments gastrointestinal surgery complication
maxillofacial rehabilitation using motor imagery vs sham after orthognathic surgery

Conditions: Maxillofacial Abnormalities

Summary: dento-maxillary dysmorphoses are defined as an anomaly in the relative growth of the maxilla and/or mandible. they lead to functional disorders (i.e., disturbances in chewing or oral communication) and aesthetic issues with psychological repercussions on self-esteem, affecting the quality of life of these patients. the multidisciplinary treatment involves orthodontics (duration = 18-24 months), orthognathic surgery involving the maxillary and/or mandibular bone (at 12 months), immediately followed by physiotherapy (duration = 3 months). one main goal after surgery is the recovery of month opening to restore an appropriate orofacial function. motor imagery (mental rehearsal of a movement without actually moving) is effectively used in athletes and in rehabilitation mainly neurological but so far has not been investigated in maxillofacial rehabilitation. considering that the effectiveness of rehabilitation is increased when physical and mental practices are combined, this leads to propose this study aiming to investigate whether the addition of motor imagery of the maxillofacial region to maxillofacial physiotherapy (based on a practice of physical therapeutic exercises) modifies the recovery of maximum mouth opening, other ranges of motion, jaw function, and quality of life in patients after orthognathic surgery compared to the addition of a control cognitive task \[watching a non-emotional content film or filling out a crossword or sudoku grid\] to maxillofacial physiotherapy.


Eligibility criteria:
inclusion criteria: * volunteer after orthognathic surgery of the mandible alone or concurrently with the maxilla. * consent to participate to the study after receiving clear, loyal and appropriate information. * aged ≥ 18 years. * health care beneficiary exclusion criteria: * patient who has undergone maxillary surgery alone (e.g., lefort i) or genioplasty. indeed, both of these surgeries typically have a favorable and rapid recovery without the need for maxillofacial physiotherapy. * patient unable to imagine a maximum mouth opening movement (i.e., score = 1, no mental image / no sensations) on the 5-point likert scale used during the administration of the tongue month imagery questionnaire (tmiq). * ongoing participation in another research that aim to evaluate an intervention likely to improve the neurological or functional recovery introducing an experimental bias. * patients not undergoing rehabilitation in the study centers. * patients under guardians, curators, or legal protection. * pregnant or lactating patients.

Keywords: motor imagery maxillofacial physiotherapy orthognathic surgery
double-masked study of netarsudil (ar-13324) ophthalmic solution in subjects with glaucoma or ocular hypertension

Conditions: Open-angle Glaucoma; Ocular Hypertension

Summary: to evaluate ocular hypotensive efficacy and safety of netarsudil (ar-13324) ophthalmic solution compared to timolol maleate ophthalmic solution.


Eligibility criteria:
inclusion criteria: 1. 18 years of age or older 2. diagnosis of open angle glaucoma or ocular hypertension in both eyes 3. post-washout intraocular pressure \>20mmhg and \<30mmhg in 1 or both eyes at 2 qualification visits 4. corrected visual acuity equivalent to 20/200 5. able to give informed consent and follow study instructions exclusion criteria: 1. clinically significant ocular disease 2. pseudoexfoliation or pigment dispersion component glaucoma, history of angle closure or narrow angles 3. unmedicated intraocular pressure ≥30mmhg 4. use of more than 2 ocular hypotensive medications within 30 days of screening 5. known hypersensitivity to any component of the formulation 6. previous glaucoma surgery or refractive surgery 7. ocular trauma within 6 months prior to screening 8. any ocular surgery or non-refractive laser treatment within 3 months prior to screening 9. recent or current ocular infection or inflammation in either eye 10. used ocular medication in either eye of any kind within 30 days of screening 11. mean central corneal thickness \>620µm at screening 12. any abnormality preventing reliable applanation tonometry of either eye 13. clinically significant abnormalities in lab tests at screening 14. known hypersensitivity or contraindication to beta-adrenoceptor antagonists 15. clinically significant systemic disease 16. participation in any investigational study within 60 days prior to screening 17. used any systemic medication that could have a substantial effect in intraocular pressure within 30 days prior to screening 18. women who are pregnant, nursing, planning a pregnancy or not using a medically acceptable form of birth control
a phase iii study of an otic formulation in acute otitis media with tympanostomy tubes

Conditions: Acute Otitis Media

Summary: the purpose of this study is to determine if an otic formulation is safe and effective in treating middle ear infections in patients with ear tubes.


Eligibility criteria:
inclusion criteria: * 6 months to 12 years old * ear tubes in one or both ears * ear drainage visible by the parent / guardian * ear drainage less than 21 days * ear tube may not be silver oxide, silver salt, t-type tube or long-shafted tube * patient may not have non-tube otorrhea * patient may not have had otic surgery other than tube placement in the last year * patient may not be a menarchal female * diabetic patients are not eligible * patient may not have any disease or condition that would negatively affect the conduct of the study * patient may not require any other systemic antimicrobial therapy during the study * patient must meet certain medication washouts to be eligible * analgesic use (other than acetaminophen) is not allowed * patient may not be pre-disposed to neurosensory hearing loss * other protocol-defined inclusion criteria may apply exclusion criteria: * age related * other protocol-defined exclusion criteria may apply

Keywords: acute otitis media tympanostomy tubes