Kornimate/medical-research-clean huggingface dataset:
usability of a website for people with schizophrenia

Conditions: Cognitive Deficits Related to Internet Use

Summary: this study will determine the usability of a website for people with schizophrenia versus other websites designed for the same purpose.

the objective of this study is to test and compare the usability of a website developed as part of a nimh-funded project (see irb #0208128), versus four other online websites in a effort to continue to improve website design elements and maximize usability by those identified with schizophrenia, a disease that produces cognitive impairments. prior usability testing done to evaluate a website developed as part of a nimh-funded project (see irb #0208128) was used to develop a website designed specifically to meet the needs of those with cognitive deficits. generally, the website was well received. however, an implicit component of this project was to make quantitative statements comparing the website developed in this project to other existing websites for individuals with schizophrenia, in order to maintain and improve the usability of the website. as such, it is important to test the usability of this website versus other websites to continue to improve design elements and ease of use for those with serious mental illness.

Eligibility criteria:
inclusion criteria: * diagnosis of schizophrenia exclusion criteria: -

Keywords: website comparison
autologous tac t cells targeting cd19 in r/r large b-cell lymphoma

Conditions: Lymphoma, B-Cell

Summary: phase i/ii study to evaluate tac01-cd19 in subjects with relapsed or refractory b-cell lymphomas. tac technology is a novel way to genetically modify t cells and to redirect these t cells to target cancer antigens by co-opting the natural t cell receptor. the dose finding portion of this study will evaluate the safety and tolerability of increasing dose levels of tac01-cd19 to identify a maximal tolerated dose (mtd) or recommended phase ii dose (rp2d). the dose expansion portion of the study will further evaluate the safety, efficacy and pharmacokinetics of tac01-cd19 at the rp2d.


Eligibility criteria:
inclusion criteria: * histologically confirmed cd19+ large b-cell lymphoma including diffuse large b-cell lymphoma (dlbcl) not otherwise specified (including de novo and transformed lymphoma), primary mediastinal large b-cell lymphoma, high-grade b-cell lymphoma with myc and bcl2 and/or bcl6 rearrangement per who 2016 classification. * relapsed or refractory disease after greater than 2 lines of therapy including anthracycline and anti-cd20 therapy and either having failed autologous stem cell transplant (asct) or being ineligible for asct. * ecog 0-1. * adequate organ function. exclusion criteria: * prior treatment with any of the following: allogeneic bone marrow transplantation, gene therapy, adoptive cell transfer of any kind, including car t cells. * active central nervous system (cns) lymphoma involvement. * history or presence of clinically relevant cns pathology. * active inflammatory neurological disorders, autoimmune disease, or infections.
effects of lmwh in healthy subjects treated with tb-402 and effects of tb-402 in healthy subjects treated with warfarin

Conditions: Healthy

Summary: administration of lmwh in healthy male subjects treated with tb-402 and administration of tb-402 in healthy male subjects treated with warfarin


Eligibility criteria:
inclusion criteria include: * males 18 to 45 years of age * healthy according to medical history, physical exam, ecg, blood pressure and heart rate, and laboratory profile of blood and urine exclusion criteria include: * self or family history of cardiovascular or pulmonary disorder, or coagulation or bleeding disorders or reasonable suspicion of vascular malformations e.g. cerebral haemorrhage, aneurysm or premature stroke * history of important bleeding episodes * previous allergic reaction to immunoglobulin * present or previous history of severe allergy, for example asthma or anaphylactic reactions * fviii:c \<50% at screening * clinically significant out of range values for any coagulation test during screening * received prescribed medication, over the counter medication or herbal medicines within 14 days of receipt of tb-402

Keywords: interaction with lmwh or warfarin
intravesical liposomes for ulcerative cystitis

Conditions: Interstitial Cystitis

Summary: the objective is to instill liposomes reconstituted with sterile water into the bladder as a compassionate use treatment in one patient with ulcerative interstitial cystitis (ic).

a physician sponsored investigation new drug (in) has been acquired from the fda for compassionate use of this non-approved treatment in one patient from dr. peters' private practice. since this treatment has not been used previously in the us, we propose to evaluate the safety and efficacy of the treatment in this one patient by comparing pre and post treatment symptom changes. prior to treatment (visit 1) baseline measures will be assessed: vital signs,pelvic/bladder pain on a visual analog scale (vas; "0" being none and "10" being severe), concomitant medications, serum pregnancy test and antiphospholipid antibody panel, urine cytology, urinalysis (dipstick), and culture. at visits 2-5 (4 treatment visits) questionnaires will be completed and vital signs, pain vas, post void residual (measured by bladder scan or catheter), unanticipated events, and voiding history (voiding diary) will also be assessed. additionally, cystoscopy will be done prior to the first treatment to view the bladder lining. at each treatment visit, the patients will have a solution of liposomes instilled in the bladder with a catheter, retained for 30 minutes, and be carefully monitored for at least 1 hour after the liposomes are drained. after treatment, visits 6 and 7 (follow up) will include vital signs with vas pain assessment, post void residual (pvr), urinalysis (dipstick), unanticipated events assessment, questionnaire completion and review of voiding diary. visit 8 (study exit) will include the same parameters measured at follow up visits 6 and 7 with the addition of cystoscopy and antiphospholipid antibody panel testing.

Eligibility criteria:
inclusion criteria: * ulcerative ic for at least 6 months documented, * negative urine cytology, * able to independently complete self administered questionnaires and voiding diaries. exclusion criteria: * pregnant or lactating, * history of bleeding diathesis, * on anticoagulant therapy, * active peptic ulcer disease, * obvious neurological impairment, * known allergy to liposomes.
study to evaluate safety and pk/pd of da-3091 in healthy male subjects

Conditions: Diabetes Mellitus

Summary: this phase i clinical study is to evaluate the safety and tolerance of da-3091 and to characterize the pharmacokinetic/pharmacodynamic of da-3091 in healthy male subjects

this is a phase i dose escalation study. to meet the clinical objectives, we are using a two-part approach. in part i, 4 subjects are injected 0.5mg dose of da-3091 or placebo(single/subcutaneous injection). after completion of part i study, we are reporting data about safety to idmc. in part ii, 8 subjects per group are injected 1mg, 2mg, 4mg of da-3091 or placebo through dose escalating protocol. the ratio of da-3091 and placebo is 3:1.

Eligibility criteria:
inclusion criteria: 1. age : 20 \~ 45 years old 2. healthy male 3. body weight : ≥50kg and ideal body weight ± 20% 4. informed consent exclusion criteria: 1. clinically significant medical history 2. acute or chronic pancreatitis 3. clinically significant hypersensitivity of drugs 4. clinically significant cutaneous disorder 5. history of administration of exenatide 6. disorder of blood pressure 7. history of drug abuse

Keywords: sr-exenatide
study of kids itch severity (skis)

Conditions: Chronic Pruritus

Summary: this purpose of this study is to validate two measures of chronic itching in kids: itch severity (itchyquant) and the impact on their quality of life (itchyqol).

there are many diseases that affect children where the primary symptom is pruritus. this study aims to validate an age appropriate pediatric version of the itchyqol, a pruritus-specific quality of life instrument, and the itchyquant, a self-reported itch severity scale, to better understand how pruritus affects the pediatric population. these instruments will comprehensively capture the severity and impact of pruritus in children. the physicians want to explore the opportunity to integrate patient-reported outcome measures (prom) as a patient-reported tool in the ambulatory setting.

Eligibility criteria:
inclusion criteria: * female and male patients between the ages of 4 and 17 (parents and clinicians will be older than 18 years, both male and female) * informed consent/assent signed and dated by the patient/parent * willingness and ability for the patient to commit to all follow-up visits/phone calls for the duration of the study exclusion criteria: * inability to speak or read english * any other disabilities that would prevent them from completing a survey * unwillingness or inability for the patient to commit to all follow-up visits/phone calls for the duration of the study
the association between cervical cancer screening and cancer occurrence

Conditions: Cervical Cancer; Cancer

Summary: to investigate the protective effect of cervical cancer incidence and mortality by screening attending frequency or screening pattern, and to evaluate the possible risk of developing malignancies among women with cervical lesions, inflammation or infection.


Eligibility criteria:
the eligibility criteria in the proposal are specified in different part of analyses respectively, which are briefly listed below: part i: * include women covered by national screening program and they did not have previous cervical cancer history before the study initiate date. part ii: * include women ever participated cervical cancer screening and exclude women with previous cervical cancer history before screening attending. part iii: * include women without previous cervical cancer history before the follow-up initiation. part iv: * include women without previous cervical cancer history before the follow-up initiation.

Keywords: pap smear screening
xience skypoint large vessel post approval study

Conditions: Coronary Artery Disease

Summary: spirit xlv pas is a prospective, single arm, multi-center, us and ous post-approval observational study to evaluate the continued safety and effectiveness of the xience skypoint large vessel everolimus eluting coronary stent system (eecss) large vessel (lv) sizes (diameter 4.5 mm and 5.0 mm) during commercial use in a real-world setting.


Eligibility criteria:
inclusion criteria: general inclusion criteria 1. subject must be at least 18 years of age. 2. subject or a legally authorized representative must provide written informed consent per site requirements. 3. subject must have evidence of myocardial ischemia (stemi, nstemi, unstable angina or stable angina) or who have silent ischemia with evidence of ischemia, appropriate for pci treatment with des. subject with stable angina or silent ischemia must have objective sign of ischemia as suggested by one of the following: 1. abnormal stress or imaging stress test 2. abnormal computed tomography-fractional flow reserve (ct-ffr) 3. stenosis by visual estimation ≥ 70% 4. abnormal pressure-derived indexes (ffr, instantaneous wave-free ratio \[ifr\], or relative flow reserve \[rfr\]) 4. subject must agree not to participate in any other clinical study for a period of one year following the index procedure. angiographic inclusion criteria 1. patients who have lesion(s) in a vessel with reference vessel diameter \> 4.25 mm and ≤ 5.25 mm as the target lesion 2. patients who receive at least one skypoint lv stent 1. lesions with rvd ≤ 4.25 mm should be treated as the non-target lesions during the index procedure with commercially available xience family of stents 2. up to three lesions (target and non-target) in two coronary vessels can be treated at the index procedure. exclusion criteria: general exclusion criteria 1. patients who have contraindications of the skypoint lv per the ifu 2. subject has active symptoms and/or a positive test result of covid-19 or other rapidly spreading novel infectious agent within the prior 2 months. angiographic exclusion criteria: 1. patients who require three vessel treatment. 2. if left main coronary artery (lmca) is the intended target vessel, patients who have unprotected left main disease with the syntax score ≥ 23 1. unprotected lm disease with a syntax score ≤ 22 (site-assessment) can be treated as the target lesion but not to exceed 40% of the study population 2. a heart team consensus approach per site's standard of care (soc) to enhance patient protection and optimal clinical practice for the left main treatment is required.

Keywords: abt -cip 10445 coronary artery disease xience large vessel skypoint
effects of glp-1 agonists on gastric volume

Conditions: Diabetes; Gastric Content Aspiration; Glucagon-like Peptide 1; GLP-1

Summary: this study will enroll patients ages 18 and over who have a diagnosis of diabetes, are undergoing an elective surgery under general anesthesia and 1) are taking a glp-1 receptor agonist medication, or 2) not taking a glp-1 receptor agonist medication. the patients will have a gastric ultrasound prior to surgery to measure any retained gastric contents. the primary goal is to assess the effect of subcutaneous injectable glp-1 agonists on preoperative gastric volume in fasted, diabetic surgical patients.


Eligibility criteria:
inclusion criteria * age greater than or equal to 18 years old * diagnosed with diabetes (listed on medical record, hgb a1c greater than or equal to 6.5%, fasting blood glucose greater than or equal to 126mg/dl, and/or on medical treatment for diabetes) * one of the following groups: * taking a glp-1 medication * not taking a glp-1 medication * asa physical classification status 1-3 * scheduled for elective surgery under general anesthesia * appropriately fasted per asa fasting guidelines 201712 exclusion criteria * bmi greater than 40 * previous gastric/esophageal surgery * abnormal gastric anatomy * pregnancy * inability or unwillingness of subject to give informed consent * non-english speaking
long term safety and efficacy study of calcitriol 3 mcg/g ointment in pediatric subjects with plaque psoriasis

Conditions: Psoriasis Vulgaris

Summary: the objective of this study is to evaluate the safety and efficacy of up to 26 weeks of treatment with calcitriol 3 mcg/g ointment when used twice daily, without occlusion, to treat pediatric subjects (2 to 16 years and 11 months of age) with mild to moderate plaque psoriasis.


Eligibility criteria:
inclusion criteria: * male or female 2 to 16 years and 11 months of age * clinical diagnosis of stable mild to moderate plaque psoriasis exclusion criteria: * other forms of psoriasis * hypercalcemia * past history of kidney stones * vitamin d deficiency * other concomitant dermatological disease
inhaled tobramycin in bpd

Conditions: Bronchopulmonary Dysplasia

Summary: this study is an open-label, phase 1, sequential dose escalation trial seeking to establish preliminary tolerability, efficacy, and pharmacokinetic data for up to 4 different doses of inhaled tobramycin administered to very preterm infants with bpd who are receiving invasive mechanical ventilation and have a pathogenic gram-negative organism detected by tracheal aspirate culture.


Eligibility criteria:
inclusion criteria: 1. male or female infants born \<32 weeks' gestation 2. diagnosed with bpd (use of supplemental oxygen or respiratory support at 36 weeks postmenstrual age ) 3. postmenstrual age ≥36 weeks at study enrollment 4. treatment with invasive mechanical ventilation at enrollment without planned tracheal extubation within 7 days after enrollment 5. tracheal aspirate culture positive for one of the following pathogenic gnr bacteria within 7 days prior to enrollment: pseudomonas aeruginosa, klebsiella species, enterobacter species, stenotrophomonas maltophilia, escherichia coli, acinetobacter baumannii, or serratia marcescens 6. parental/guardian permission (informed consent). exclusion criteria: 1. serum creatinine \>0.4mg/dl within 14 days prior to enrollment 2. congenital or acquired disease of the kidney or renal collecting system that adversely affects renal function 3. congenital or acquired hepatobiliary disease that adversely affects liver function 4. treatment with a systemic antibiotic within 7 days prior to enrollment 5. treatment with a nephrotoxic medication, excluding diuretics, within 48 hours prior to enrollment 6. treatment with a neuromuscular blocker within 48 hours prior to enrollment 7. known intolerance to aminoglycoside antibiotics 8. current treatment with high frequency or other oscillating mechanical ventilation 9. presence of a cancer diagnosis 10. maternal family history of early onset hearing loss defined as the need for an assistive hearing device prescribed before 30 years of age 11. endotracheal tube leak \>20%. 12. any prior use of an investigational drug \[as part of an fda approved investigational new drug (ind) protocol\]. 13. a subject who, in the judgement of the investigator, is not an appropriate candidate for this research study.
efficacy of well-being promotion program for management of emotional and behavioural problems among adolescents

Conditions: Well-being, Emotional and Behavioral Problems, Adolescents

Summary: the objectives of the study are given as under; 1. to examine the efficacy of the well-being promotion program in enhancing subjective well-being, positive affect, life satisfaction and reducing emotional /behavioral problems , negative affect among adolescents with emotional and behavioral problems. 2. to examine the differences in terms of subjective well-being, emotional / behavioral problems , positive / negative affect and life satisfaction between the treatment and control group after intervention. 3. to examine the differences in terms of subjective well-being, emotional / behavioral problems, positive / negative affect and life satisfaction in the intervention group at (t1) before and at (t2) after intervention.

in this study, adolescents within age range ( 14-19years) will participates in the study because this study focus on the emotional and behavioral problems and their low level of well-being and life satisfaction among adolescents. adolescence is a developmental period in which dramatically emotional changes occur which may be the result of biological changes such as secretions of hormones. chances of psychological distress are increased due to emotional changes. depression and anxiety are most common psychopathology in adolescents (ma \& fang, 2019). child turns out to be independent, gradually deals with the external world and starts taking his/her decisions such as selection of subjects, peer pressure and so on. thus , it is important to focus on mental health and management of emotional and behavioral problems.

Eligibility criteria:
inclusion criteria: * inclusion criteria only those participants who meet the category of moderate level of emotional and behavioural problems through strength and difficulty questionnaire (sdq; urdu version) (samad et al., 2005) will be selected for the study. exclusion criteria: * exclusion criteria those participants who meet high levels of emotional and behavioural problems through strength and difficulty questionnaire (sdq; urdu version) (samad et al., 2005) will not be selected for the study.
european sickle cell disease cohort - hydroxyurea

Conditions: Sickle Cell Disease

Summary: in the context of the risk management plan (rmp), as requested from addmedica by the emea, to collect information about long-term safety of siklos® (hydroxycarbamide) when used in patients with sickle cell disease.


Eligibility criteria:
inclusion criteria: * male or female ambulatory patients, aged 2 years and more (children, adolescents or adults) * with symptomatic sickle cell syndrome * treated with siklos® * having been informed of the study by the initiating physician and consenting to participate to the cohort.
immune response to pneumococcal polysaccharide vaccine (23-valent) predicts asthma status and outcomes in late adolescents with asthma

Conditions: Asthma

Summary: advisory committee for immunization practices (acip) from the centers for disease control (cdc) recommends that children (6-18 years) and adults (≥19 years old) with chronic lung condition such as asthma or cigarette smoking be vaccinated with pneumococcal vaccine (ppsv23). the purpose of this study is to increase awareness of vaccination to late adolescents with asthma and smokers (social aspect of study), and to recommend vaccination (which is the clinical aspect). individuals who agree to receiving vaccine will be enrolled in research to determine whether late adolescents with and without asthma (smokers) have distinctive pneumococcal vaccine response patterns and whether such patterns are associated with subsequent variance in asthma outcomes.


Eligibility criteria:
inclusion criteria: * reside in olmsted county, minnesota (defined by olmsted county address in medical record within one year prior to last follow-up date as of data abstraction) * receive medical care from mayo clinic clinical practice * signed research authorization for using medical record for research exclusion criteria: * diagnosis of an immunodeficiency (primary and secondary) * previous or current diagnosis of a rheumatological disorders (rheumatoid arthritis, lupus, sjögren, and vasculitis), cancer (chronic lymphocytic leukemia, non-hodgkin lymphoma, and b-cell malignancy), diabetes, active infection (pneumonia, otitis media, hiv, and ebv), other chronic diseases (multiple sclerosis, etc), renal disease such nephritic syndrome, and protein losing enteropathy * current or previous use (within the last 6 months) of systemic corticosteroids, and other immunosuppressive agents (cyclosporin, methotrexate, and mycophenolic acid) * vaccination of ppsv-23 (receiving childhood pneumococcal vaccination during infancy is eligible for this study) * pregnancy enrollment will be delayed 2 weeks for those subjects that can be included but have upper respiratory infection or viral illness to allow for natural resolution.
cost-effectiveness study of peg-rhg-csf in prophylactic treatment of neutropenia after chemotherapy in lymphoma

Conditions: Lymphoma, Non-Hodgkin; Granulocyte Colony-Stimulating Factor; Cost-Benefit Analysis

Summary: this is a pharmacoeconomic research to explore the cost-effectiveness of peg-rhg-csf and rhg-csf in prophylactic treatment of neutropenia in lymphoma patients. it should provide more scientific basis for clinical decision-making.


Eligibility criteria:
inclusion criteria: * 18-65 years * histologically confirmed de novo non hodgkin's lymphoma (except highly aggressive lymphoma such as lymphoblastic lymphoma and burkitt lymphoma) * plan to be given 6-8 cycles of cyclophosphamide, doxorubicin, vincristine, and prednisone (chop) ± rituximab (r) * kps ≥70 * plan continuous peg-rhg-csf or rhg-csf adiministration after at least 3 cycles of treatment for neutropenia prophylactic treatment * absolute neutrophil count≥1.5×109/l，platelet count ≥100× 109/l，hemoglobin≥90g/l，while blood cell count≥3.0×109/l，without bleeding signs * adquate liver and renal function as protocol discribed * no serious cardiovascular disease as protocol discribed * under good mental conditions and informed consented * potential benefit for subjects based on investigators' decision exclusion criteria: * history of hematopoetic stem cell transplantationor organ transplantation * uncontrollable infection * allergic to study drugs or ingredients * accepted any other investigational drug or participated another interventional study within 30 days during screening period * other uncontrollable conditions judged by the investigator * breast-feeding , pregnant or plan to be pregnant during study observation period