Kornimate/medical-research-clean huggingface dataset:
a follow-up study of asymptomatic infections and diagnosed patients with covid-19 in shanghai

Conditions: COVID-19

Summary: this study is to clarify the distribution characteristics, host and clinical characteristics, disease outcome and risk factors, changes of multiple organs such as cardiopulmonary function and changes in social and psychological indicators during long-term follow-up of omicron variant asymptomatic infections and diagnosed patients


Eligibility criteria:
inclusion criteria: * sars-cov-2-rna positive * informed consent signed exclusion criteria: * informed consent rejected
comparison of efficacy and safety between imidafenacin and fesoterodine in patients with overactive bladder

Conditions: Overactive Bladder

Summary: to evaluate the efficacy and safety after 12 weeks oral administration of imidafenacin 0.1mg b.i.d versus fesoterodine 4mg once daily for the urge incontinence and/or increased urinary frequency associated with urgency as may occur in patients with overactive bladder.


Eligibility criteria:
inclusion criteria: * male and female patients with overactive bladder aged 20 years or more * subject who had the continuos symptom for 3 months or more * subject prepare a symptom diary and was deemed eligible for the study by the investigator * 8 times or more of daily mean urination frequency * 2 times or more of daily mean frequency of a sense of urinary urgency or 2 times or more of urge incontinence frequency exclusion criteria: * subjects with clinically significant stress urge incontinence, patients with urinary tract infections or relapsing urinary tract infections who had received treatment more than 4 times in the previous year * subjects with diseases prohibiting anti-cholinergics from administration * subjects who used an indwelling catheter or intermittent self intubation program, patients who had prostatic hyperplasia, prostatic cancer, bladder cancer,bladder stones, interstitial cystitis as complications * subjects who received lower urinary tract surgery within 6 months * subjects with a catheter placed or intermittent catheterization * subjects who were deemed ineligible for the study by the investigator or sub-investigator, pregnant women, nursing women, and women who are planning pregnancy or have not used proper contraceptives during the study period * subjects who are within 1 month after other clinical study was completed * subjects having 100ml or more of residual urine * subjects who had acute urinary retention history * subjects who have been administered prohibited concomitant medications

Keywords: overactive bladder
multicenter study to investigate ser120 nasal spray formulations in patients with nocturia - db4

Conditions: Nocturia

Summary: to investigate the efficacy and safety of ser120 nasal spray formulations in patients with nocturia


Eligibility criteria:
inclusion criteria: * male and female 50 years or older * nocturia of 6 or more months duration averaging greater than 2 nocturic episodes per night exclusion criteria: * chf * diabetis insipidus * renal insufficiency * hepatic insufficiency * incontinence * illnesses requiring systemic steroids * malignancy within the past 5 years * sleep apnea * nephrotic syndrome * unexplained pelvic mass * urinary bladder neurological dysfunction * urinary bladder surgery or radiotherapy * pregnant or breast feeding
proof of concept study of gevokizumab in the treatment of pyoderma gangrenosum

Conditions: Pyoderma Gangrenosum

Summary: the study will evaluate the safety and biologic activity of gevokizumab in subjects in the acute inflammatory phase of pyoderma gangrenosum.


Eligibility criteria:
inclusion criteria: * an established diagnosis of pyoderma gangrenosum * currently experiencing an inflammatory episode of pyoderma gangrenosum * contraceptive measures adequate to prevent pregnancy during the study exclusion criteria: * clinical evidence of acutely infected pyoderma gangrenosum * history of allergic or anaphylactic reactions to monoclonal antibodies * history of recurrent or chronic systemic infections * female subjects who are pregnant, planning to become pregnant, have recently delivered, or are breast-feeding other protocol-defined inclusion/exclusion criteria may apply

Keywords: pyoderma gangrenosum classic pyoderma gangrenosum atypical pyoderma gangrenosum peristomal pyoderma gangrenosum
arterx safety and efficacy study for cardiac indications

Conditions: Vascular Disease

Summary: the study is designed to confirm the acute safety and performance of the arterx® surgical sealant as a hemostatic agent. the study will collect data in support of publications and future product labeling revisions, to provide additional clinical information on use and further details regarding product safety.


Eligibility criteria:
inclusion criteria: \>18 years of age, male or female if female, subject is post-menopausal, has no child bearing potential or has a negative serum or urine pregnancy test within 7 days of the index procedure and is practicing abstinence or a highly effective method of contraception for the duration of the study. the subject or guardian must provide written informed consent using a form that is reviewed and approved by the ethics committee. the subject is willing and able to be contacted for 3 months follow-up and attend follow-up visits as needed per protocol. the subject is determined by the surgeon to be at risk for poor hemostasis. exclusion criteria: subject undergoing emergency surgery. subject undergoing minimally invasive surgery. subject has clinically significant medical, psychiatric, or cognitive illness or drug/alcohol abuse that in the opinion of the investigator would affect the subject's safety or compliance with study assessments or follow-up. subject has immune system disorders/immunodeficiency or immunosuppression. subject has participated in another clinical study within 30 days prior to surgery or has received an investigational drug or device within the past 30 days. subject is pregnant, may become pregnant or is currently breast feeding -

Keywords: arterx, surgical sealant
effect of tigulixostat on the pharmacokinetics of theophylline

Conditions: Gout; Hyperuricemia

Summary: a phase 1, open-label, drug-drug interaction study to evaluate the effect of multiple doses of tigulixostat on the pharmacokinetics of single-dose theophylline in healthy adult volunteers.


Eligibility criteria:
inclusion criteria: * male or female, ages 18 to 55, inclusive. * bmi 18.0 - 32.0 kg/m2, inclusive, at screening. * in good general health as determined by medical history, clinical laboratory assessments, vital sign measurements, 12-lead ecg results, and physical examination findings at screening. * females of childbearing potential and males who agree to use contraception. non-pregnant, non-lactating females who must have a negative pregnancy test at screening and check-in. exclusion criteria: * significant history or indications of ill-health, as judged by the investigator. * any surgical or medical condition(s) possibly affecting drug absorption, distribution, metabolism, and excretion. * egfrcr of \<60 (ml/min)/1.73 m2 at screening. * alanine aminotransferase, aspartate aminotransferase, or total bilirubin ≥2 times the upper limit of normal at screening and check-in. * used any prescription or over-the-counter medications (except acetaminophen \[tylenol\] up to 2 g per day), including herbal or nutritional supplements, within 14 days before the first dose of study drug. * consumed grapefruit or grapefruit juice, seville orange or seville orange-containing products (eg, marmalade), or caffeine- or xanthine-containing products within 48 hours before the first dose of study drug. * history of hypersensitivity to theophylline or other xanthines and tigulixostat.
short term safety and efficacy of lubiprostone in adults with cystic fibrosis

Conditions: Constipation; Cystic Fibrosis

Summary: the purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.

cystic fibrosis (cf) affects about 30,000 people in the united states. it is caused by an absent or dysfunctional protein called cf transmembrane conductance regulator (cftr) which functions as a chloride channel. lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (clc-2) and has the potential to be an effective treatment for constipation in adults with cf. it has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on cftr. this project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with cf with constipation. the specific aims are as follows: 1) determine the effectiveness of lubiprostone for constipation in participants with cf, and 2) determine the short term safety of lubiprostone in adults with cf. data will also be collected to generate further information about the effect of lubiprostone on nutritional status.

Eligibility criteria:
inclusion criteria: * men and women of all races * 18 years of age or older at time of enrollment * diagnosis of cystic fibrosis * history of constipation, as defined by the rome iii criteria, or the requirement of chronic scheduled doses of a laxative, or a score ≥1.5 on the patient assessment of constipation symptoms (pac-sym)15 survey administered during the screening visit, or a score of less than 3 on the bristol stool scale (bss) at the screening visit. exclusion criteria: * current gastrointestinal (gi) obstruction * history of gi obstruction requiring hospitalization within six months of enrollment * pregnancy or breastfeeding * hypersensitivity to lubiprostone or any of its components * serum creatinine \>1.8 mg/dl at last annual visit * clinically significant liver disease, defined as aspartate aminotransferase (ast) or alanine aminotransferase (alt) \>3x upper limit of normal * history of frequent hospital admissions for cf exacerbations (≥4 in the last 6 months) * currently registered on a lung transplant waiting list * women of capable of child-bearing who either refuse a pregnancy test, or are incapable or unwilling to use contraception during the protocol, or both. * any other condition, in the opinion of the investigators, that interferes with the ability of the participant to comply with study requirements, confers significant risk to the participant, or limits the ability of the participant to complete the study

Keywords: constipation cystic fibrosis lubiprostone constipation in adults with cystic fibrosis
study of non-small cell lung cancer patients in the us receiving standard-of-care and initiating an approved therapy with risk of pneumonitis/ild

Conditions: Non-Small Cell Lung Cancer

Summary: this is an observational, prospective, multicenter study conducted in the us to gather evidence in the context of lung cancer to complement the development of a digital solution. patients initiating treatment for non-small cell lung cancer (nsclc) will be prospectively followed to characterize risk factors, signs, and symptoms leading to onset, diagnosis, and treatment of pneumonitis/ild should it occur.

this is an observational, prospective, multicenter study conducted in the us to gather evidence in the context of lung cancer to complement the development of a digital solution. data will be collected prospectively from study sites using ecrfs and remotely from patients using a digital health tool.

Eligibility criteria:
inclusion criteria: 1. patient must be 18 years of age or older, at the time of signing the icf (informed consent). 2. have histologically or cytologically documented unresectable stage iii or stage iv nsclc. 3. are initiating treatment with an fda (food and drug administration)-approved immune checkpoint inhibitor (alone or in combination with other agents), antibody drug conjugate, or small molecule egfr inhibitor. 4. minimum life expectancy of 12 weeks at the time of signing the icf. 5. able and willing to provide written signed informed consent. 6. able and willing to use the digital health tool throughout the duration of the study. exclusion criteria: 1. concurrent participation in a research study or a clinical trial. 2. unable to receive soc for the treatment and management of nsclc including clinical or imaging assessments for up to 6 months. 3. judgment by the investigator that the patient is unsuitable to participate in the study and/or the patient is unlikely to comply with study procedures and requirements. 4. confirmed or suspected diagnosis of pneumonitis/ild at the time of signing icf. this does not apply to historical pneumonitis/ild events that have resolved prior to signing icf. 5. more than 2 weeks have passed from the administration of the first dose of qualifying fda-approved treatment.

Keywords: standard-of-care pneumonitis interstitial lung disease (ild)
radiomics of mp-mri assessing nac outcome in breast cancer

Conditions: Breast Cancer; Radiomics; Neoadjuvant Chemotherapy; Multi-parametric MRI

Summary: this is a single-arm, multicentre study that aims to assess whether radiomics combining multiparametric mri and clinical data could be a good predictor of the responses to neoadjuvant chemotherapy in breast cancer.

patients undergo multiparametric mri (including t2wi, dwi and dce-mri) at baseline, after 2 courses of neoadjuvant chemotherapy, and prior to the surgery at least 8 weeks after the treatment procedure. patients undergo biopsy test in one week after the baseline mri scan to detect the biomarkers including er, pr, her-2 and ki-67, which can be used to select the treatment plan referring to the nccn clinical guidelines. after the surgery, responses to neoadjuvant chemotherapy are determined according to the histopathologically examination of the surgically resected specimens. after completion of treatment procedure, patients are followed up for 5 years.

Eligibility criteria:
inclusion criteria: * biopsy-proven invasive breast cancer; * received complete neoadjuvant chemotherapy and no treatment has been done before; * surgery was performed after completion of neoadjuvant chemotherapy, after which pcr was confirmed by postoperative pathological examination; * pretreatment mri data within a month before the start of the treatment was eligible, including t2wi, dwi and dce-mri. exclusion criteria: * not completing neoadjuvant chemoradiotherapy; * not undergoing surgery at our hospital, or pcr was not assessed; * lack of t2wi, or dwi or dce-mri data; * insufficient mri quality to obtain measurements (e.g., owing to motion artifacts); * had unilateral multifocal cancers, and the correlation between the tumor in mr images and postoperative pathological examination was uncertain.
bone health in patients with atopic dermatitis

Conditions: Atopic Dermatitis; Eczema

Summary: this study examines the bone health in children with atopic dermatitis

the goal of this study is to objectively evaluate bone health and contributing factors in children with ad. this will be compared with existing normative data. such an objective prospective study, directly looking at bone health in children has not yet been done. this will be done using bone densitometry (dxa) and high-resolution peripheral quantitative computed tomography (hr-pqct) for the accurate and precise measurement of bone health status. hr-pqct is a cutting-edge technology available at only at a few academic centers in the united states that is used to measure bone strength with minimal doses of radiation. in addition, blood and urine metabolic parameters related to bone health will be analyzed, and data will be correlated with eczema severity. the results from this study will allow us to design large-scale, multi-institutional studies on bone health in this population and ultimately to guide decision making in children who may be at risk specifically regarding treatment recommendations and supportive care. the specific aims of this project are: 1. to determine bone mineral density (bmd) and cortical and trabecular bone strength in children with atopic dermatitis, using dxa and to compare this with normative data. 2. hr-pqct data will be compared with current known data from other diseases 3. to correlate bone mineral density with eczema severity using eczema area and severity index (easi) and scoring atopic dermatitis (scorad) scores. 4. to determine if bone mineral density in children with atopic dermatitis correlates with bone age and bone-health specific serum markers.

Eligibility criteria:
inclusion criteria: * children 5 to 17 years of age with a diagnosis of moderate to severe atopic dermatitis as made by a dermatologist * duration of atopic dermatitis symptoms for a minimum of 6 months * ability to cooperate with dxa and hr-pqct procedure exclusion criteria: * those without a confirmed diagnosis of moderate to severe atopic dermatitis * presence of concurrent disease that may also affect bone health, including rickets or other vitamin d deficiency, thyroid disease, renal disease, paget's disease, osteogenesis imperfecta, inflammatory bowel disease, and other chronic inflammatory diseases * current use of medications that may affect bone health, including bisphosphonate, forteo, tymlos, denosumab, thiazide, heparin, medroxyprogesterone acetate, cyclosporine, and oral tacrolimus. however, medications that are used for atopic dermatitis treatment are allowed * pregnant or breast feeding females * inability to cooperate with the blood draw

Keywords: bone health
cytogam administration in abdominal organ transplant recipients at high risk for cytomegalovirus infection

Conditions: Cytomegalovirus Disease

Summary: the purpose of the study is to assess the incidence and severity of late cytomegalovirus (cmv) disease, defined as cmv syndrome or tissue invasive disease occurring between 100 and 200 days and after 200 days post-transplant in patients treated with valganciclovir per package insert guidelines for prophylaxis against cmv infection for 200 days post-transplant versus valganciclovir per package insert guidelines for 100 days post-transplant with cytogam 100 mg/kg administered at 90 days, 120 days, and 180 days post-transplant.


Eligibility criteria:
inclusion criteria: 1. male and female patients ≥ 18 years of age. 2. male or female patients who cmv seronegative receiving a kidney, pancreas or liver from a seropositive donor. 3. female patients of child bearing potential must have a negative urine or serum pregnancy test within the past 48 hours prior to receiving transplant or study inclusion. 4. the patient has given written informed consent to participate in the study. exclusion criteria: 1. solid organ transplant recipient is cmv seropositive at the time of transplant. 2. recipient or donor is known to be seropositive for human immunodeficiency virus (hiv). 3. patient has uncontrolled concomitant infection or any other unstable medical condition that could interfere with the study objectives. 4. patients with thrombocytopenia (\<25,000/mm3 ), with an absolute neutrophil count of \< 1,000/mm3); and/or leucopoenia (\< 2,000/mm3), or anemia (hemoglobin \< 6 g/dl) prior to study inclusion. 5. patient is taking or has been taking an investigational drug in the 30 days prior to transplant. 6. patient has a known hypersensitivity to valganciclovir, tacrolimus, mycophenolate mofetil, rabbit anti-thymocyte globulin, cmv hyperimmune globulin, basiliximab or corticosteroids. 7. patients with severe diarrhea or other gastrointestinal disorders that might interfere with their ability to absorb oral medication. 8. patient is pregnant or lactating, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by positive human chorionic gonadotropin (hcg) laboratory test. 9. patient has any form of substance abuse, psychiatric disorder or a condition that, in the opinion of the investigator, may invalidate communication with the investigator. 10. inability to cooperate or communicate with the investigator.

Keywords: cmv cytomegalovirus transplant
bupivacaine versus lidocaine infiltration for postoperative pain in thyroid surgery

Conditions: Postoperative Pain; Thyroid Diseases; Anesthesia, Local

Summary: the purpose of this study is to compare the efficacy of bupivicaine and lidocaine for postoperative pain control in thyroid surgery.

patients planned for total thyroidectomy will be recruited for participation. after being informed about the study and potential risks, all patients giving written informed consent will be screened for eligibility for study entry. patients that meet inclusion and exclusion criteria will be randomized via block randomization in a double blind fashion and a 1:1 ratio to surgical incision infiltration with bupivacaine (0.5% with 1:200 000 epinephrine) or lidocaine (2% with 1:100 000 epinephrine).

Eligibility criteria:
inclusion criteria: * diagnosis of thyroid disease (malignant tumors t1-t3/nx-n1a, benign tumors) * planned for thyroid surgery with midline neck incision (total thyroidectomy, completion thyroidectomy, with or without central neck dissection) * will be admitted for at least 12h postoperatively exclusion criteria: * thyroid cancer staged as t4 (invasion, anaplastic) or requiring sternotomy * thyroid cancer staged as n1b (cervical, retropharyngeal, superior mediastinal nodal involvement) * previous ipsilateral thyroid surgery to operation side * previous total thyroidectomy or completion thyroidectomy * history of neck radiation therapy * neck dissection beyond central neck (levels 1-5) * goiter extending beyond sternal notch (intrathoracic) or requiring sternotomy * surgery requiring extension of incision beyond 8 cm * history of diabetes mellitus * history of renal or liver disease * history of narcotic abuse * history of chronic pain medications use in past 6 months for any condition * history of coagulation defect * allergy to bupivacaine or lidocaine

Keywords: thyroidectomy bupivacaine lidocaine