Kornimate/medical-research-clean huggingface dataset:
alternate measures of glucose during ogtt testing for cfrd

Conditions: Cystic Fibrosis; Cystic Fibrosis-related Diabetes

Summary: although early detection and treatment of cystic fibrosis-related diabetes (cfrd) can lead to significant clinical improvements and prolong life, rates of screening are poor likely due to the burdensome nature of oral glucose tolerance testing (ogtt). the investigators propose to assess the feasibility and accuracy of two screening tools, continuous glucose monitoring (cgm) and a home ogtt kit (gtt@home). if this pilot study reveals acceptable accuracy of either device, this study will allow for future studies exploring home-based ogtt screening.

the investigators hypothesize that there will be strong agreement between plasma glucose and glucose as measured by either cgm or gtt@home at three different timepoints during an ogtt: fasting, 1-hour, and 2-hours.

Eligibility criteria:
inclusion criteria: * diagnosis of cystic fibrosis * ≥ 10 years of age * fluency in written and spoken english as the gtt@home is currently only available in english exclusion criteria: * hospitalization or treatment with iv antibiotics or supraphysiologic glucocorticoids within 4 weeks * major medical or psychiatric disorders other than cf * use of medications known to impact the accuracy of the dexcom g7 (hydroxyurea, \>2g acetaminophen per day) * history of severe adhesive reactions that may lead to an inability to tolerate cgm wear

Keywords: continuous glucose monitor oral glucose tolerance test
the role of 68ga-psma-11 pet (prostate specific membrane antigen) in surgery guidance in prostate cancer

Conditions: Prostate Cancer

Summary: obtain psma-pet imaging preoperatively and calculate performance for predicting extra-prostatic extension based on whole-mount pathology (gold standard). quantify the frequency of proper treatment changes directed by psma-pet, focusing on appropriate preservation of surrounding structures important for genito-urinary function including: 1) bladder neck, 2) nerve bundles, 3) urethral sphincter (figure 4). directly compare psma-pet performance for predicting extra-prostatic extension to standard-of-care assessments. assess quality of life changes from preoperative baseline.


Eligibility criteria:
inclusion criteria: * 1. men diagnosed with clinically significant prostate cancer who are scheduled or scheduling for prostatectomy 2. prostate pathology results consistent with: 1. \> 3 cores of gleason 3+4 or 2. nccn unfavorable intermediate risk or 3. nccn high-risk or 4. nccn very-high risk 3. scheduled for standard of care mri or has recently completed standard of care mri (within 6 months). willing and able to lie still for approximately 50 minutes in an enclosed space for the pet/ct and mri exclusion criteria: * 1. participation in another investigational trial involving research exposure to ionizing radiation concurrently or within 30 days. 2. does not meet safety criteria for mri scan (e.g. metal implant that could affect prostate imaging). 3. significant acute or chronic medical, neurologic, or illness in the subject that, in the judgment of the principal investigator, could compromise subject safety, limit the ability to complete the study, and/or compromise the objectives of the study.
role of extrarenal 1-alpha-hydroxylase in patients with end stage renal disease

Conditions: End-Stage Renal Disease

Summary: the goal of this study is to evaluate the role of nutritional vitamin d deficiency as a potential contributor to the morbidity witnessed in patients with end-stage renal disease

the goals of this study are to elucidate the function of extrarenal 1 alpha-hydroxylase activity in the setting of renal failure and to evaluate the role of nutritional vitamin d deficiency as a potential contributor to monocyte-associated inflammatory pathways in patients with end-stage renal disease (esrd). this study will consist of patients on chronic maintenance hemodialysis three times per week who have been identified to have nutritional vitamin d deficiency. after consent for study enrollment, patients will undergo a 4 week washout period of all active vitamin d supplementation. after washout is complete, an blood sample will be obtained for baseline 25(oh)d levels and monocyte isolation for analysis by flow cytometry. patients will then be started on cholecalciferol 50,000 iu twice weekly for 8 weeks. 25-vitamin d levels will be monitored midway through the treatment phase of the study and dosing adjusted as further described in detail within the protocol section. an additional blood sample will be drawn post-therapy for repeat 25(oh)d levels and monocyte isolation for flow cytometry analysis.

Eligibility criteria:
inclusion criteria: * end-stage renal disease undergoing maintenance hemodialysis at kumc outpatient hemodialysis unit * dialysis vintage of at least 6 months duration * nutritional vitamin d deficiency, defined as 25(oh)d \<25 ng/ml * age 21 to 88 years exclusion criteria: * active infection * recent hospitalization for acute illness (within last 1 month) * refusal to study participation * poorly controlled secondary hyperparathyroidism (ipth\>500) * history of chronic inflammatory disease process, such as inflammatory bowel, rheumatoid arthritis, lupus, etc. * cinacalcet therapy * previous allergy to ergocalciferol * history of parathyroidectomy * current treatment with immunosuppressant medications * noncompliance with prescribed hemodialysis regimen (i.e. skipping treatments, ending sessions early) * functional renal transplant within the last five years

Keywords: endstage renal disease vitamin d monocyte function
esomeprazole/vonoprazan combined with high-dose amoxicillin dual therapy for primary eradication of helicobacter pylori infection

Conditions: Helicobacter Pylori Infection

Summary: this study intends to collect the clinical data of patients with helicobacter pylori infection, and to observe and count the high-dose double therapy and the traditional quadruple / triple therapy ( i.e., esomeprazole + amoxicillin double high-dose double therapy and esomeprazole + amoxicillin + clarithromycin + colloidal bismuth tartrate traditional quadruple therapy or vonoprazan + amoxicillin double high-dose double therapy and vonoprazan + amoxicillin + clarithromycin triple therapy ). the eradication rate of helicobacter pylori was compared between the two different regimens respectively, and the efficacy, safety and compliance of different regimens were compared. it provides a new reference for clinical treatment of helicobacter pylori, and has great clinical value and significance for simplifying the anti-helicobacter-pylori treatment plan, increasing patient compliance, and exploring efficient anti-helicobacter-pylori therapy suitable for the chinese population.


Eligibility criteria:
inclusion criteria: 1. patients aged 14-90 years, no requirement for gender; 2. patients diagnosed as h. pylori infection by at least one of the following tests: carbon-13/14 urea breath test (13c/14c-ubt) or immuno-histochemical staining of biopsy specimens; 3. patients with no use of antibiotics, bismuth or chinese traditional medicines with antibacterial effects in the previous 4 weeks of 13c/14c-ubt, and no h2 receptor antagonists, ppis, p-cab or other drugs affecting h .pylori activity within the previous 2 weeks of 13c/14c-ubt; 4. patients without history of receiving h. pylori eradication therapy. exclusion criteria: 1. patients with serious diseases or clinical conditions that may interfere with the evaluation of the results of the study, such as severe heart, liver, lung, and renal insufficiency, low immunity, and so on; 2. patients with allergy to penicillin or any research-program-related drugs; 3. patients with mental illness and communication disorders; 4. patients in pregnancy or lactation; 5. patients with severe gastrointestinal diseases, such as gastrointestinal tumors, gastrointestinal bleeding, other organic diseases, etc.; 6. patients who were participating in other clinical trials; 7. patients who were considered inappropriate for enrollment after evaluation by the researchers.
gut microbiota, scfas and glucolipid metabolism in pregnant women with abnormal fetal size and their newborns

Conditions: Fetal Growth Restriction; Gut Microbiota; Fetal Macrosomia; Glucolipid Metabolism

Summary: abnormal fetal size includes fetal growth restriction and fetal macrosomia. onset is closely related to maternal nutrition metabolism. the specific correlation and mechanism is unclear, and there are no effective measures for early diagnosis and treatment. previous study found that maternal gut microbiota participates in the material metabolism throughout the pregnancy. insulin sensitivity in pregnant women, and intrauterine environment under abnormal blood glucose and lipid metabolism are important for the gut microbiota of newborns and even they grow up. however, changes in gut microbiota are the cause of the disease or the outcome is not yet clear. short chain fatty acids (scfas) are produced from soluble dietary fibers in the diet by colon bacteriolysis. studies have found that gut microbiota can regulate insulin sensitivity and glucose and lipid metabolism disorders through scfas. therefore, this research group uses the gut microbiota as a new idea to studythe relationship of gut microbiota characteristics and level's change of scfas with glucolipid metabolism and insulin sensitivity in pregnant women with abnormal fetal size and their newborns through 16s-rrna high-throughput sequencing, pyrosequencing, and gas chromatography-mass spectrometry, so we can reveal the role of gut microbiota in the pathogenesis of abnormal fetal size and explore targeted rational dietary adjustment and scfas reconstruction of gut microbiota to improve maternal and neonatal pregnancy outcomes.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * term pregnancy with the gestational age of 37-40 weeks exclusion criteria: * maternal systemic diseases (hypertension disorders, immunological diseases) or pregnant complications (polyhydramnios, oligohydramnios, diabetes mellitus, intrahepatic cholestasis of pregnancy) * delivery before 37 weeks or after 40 weeks * neonates had major congenital malformations (congenital anal atresia, congenital biliary atresia, congenital heart disease)
experience with topical acne treatment

Conditions: Acne

Summary: acne is a chronic condition that typically requires the use of multiple medications.1 medication adherence is especially challenging for patients with chronic diseases and often decreases over time, especially for those using topical medications.1 nonadherence can result in multiple negative effects including treatment failure, increased healthcare costs, and decreased quality of life. primary nonadherence refers to problems acquiring and starting treatment. challenges to this form of nonadherence include a lack of knowledge, misunderstanding of usage, poor communication with provider, increased cost, and fear of side effects.2 secondary nonadherence refers to when the patient does not use the medication as prescribed. hurdles to secondary nonadherence include delayed results, increased complexity of treatment plan, adverse effects, busy lifestyle, and inconvenience.2


Eligibility criteria:
inclusion criteria: 1. adult patients ≥18 years of age 2. patients with a current diagnosis of acne 3. patients who live in the us, 4. patients have sufficient command of the english language exclusion criteria: 1. patients less than the age of 18 2. patients without a current diagnosis of acne 3. patients who do not live in the us 4. patients without a sufficient command of the english language
the urinary incontinence treatment study

Conditions: Urinary Incontinence; Sarcopenia

Summary: investigators plan a prospective cohort study with an adaptive design based on physical function status. the design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. investigators aim to recruit similar numbers of women in each group. if investigators find unequal numbers, they will adapt recruit strategies based on a woman's functional status.

investigators plan a prospective cohort study with an adaptive design based on physical function status. the design will involve tracking the number of women recruited with physical function impairment and those without any functional impairment. investigators aim to recruit similar numbers of women in each group. if they find unequal numbers, they will adapt recruit strategies based on a woman's functional status. investigators will compare changes in outcome measures within and between groups after 6 and 12 weeks of pelvic floor muscle exercises (pfme). the change in pelvic floor strength/efficiency will be assessed by repeating the pelvic floor perfect assessment and will be compared between groups. changes in ui symptoms, symptom severity, and impact of ui symptoms on quality of life will be determined using standardized measures described above. data analysis will define associations between changes in perfect measures and the change in ui episodes (based on 3-day voiding diary), severity, and type (based on quid-7), and impact on quality of life (pfiq-7) within and between groups. objective measurement of lower-extremity strength will inform the relationship between lower-extremity strength, pelvic floor strength, and ui symptoms at baseline and the 6-week visit.

Eligibility criteria:
inclusion criteria: * women, age 70 years or older * diagnosis of urinary incontinence (defined by the quid assessment as having subscale score for stress ≥4, and/or urge score ≥ 6) * willing and able to be compliant with pelvic floor muscle exercise intervention (standard of care) for 12 weeks and to log compliance * willing and able to undergo an extensive physical function evaluation exclusion criteria: * prior surgical intervention for urinary incontinence within the past 12 months * hysterectomy within 12 months * diagnosis of: * pelvic organ prolapse beyond the hymenal ring * urogenital fistula * neurogenic overactive bladder (associated with a diagnosis of multiple -sclerosis or stroke within past 12 months) * incomplete bladder emptying/urinary retention with pvr \>150 ml (measured by bladder scan) * requires assisted device (4 point cane, walker) for ambulation all /most of the time or wheelchair bound * having significant cognitive impairment or dementia * unsafe to exercise (severe cardiopulmonary disease) * unable/unwilling to provide informed consent * determined otherwise ineligible by the principal investigator
a registry study of covid-19 serologic and virologic testing to accelerate recovery and transition

Conditions: Covid19; SARS-CoV Infection

Summary: the co-primary objectives of this study are to: 1. determine and compare the covid-19 antibody positivity rate in health care workers and patients without a known covid-19 infection 2. determine if pcr negativity for covid-19 early in quarantine predicts negativity at day 14 in quarantining individuals

this is a prospective cohort study designed to identify the prevalence of igg antibodies to sars cov-2 as well as to assess risk factors for igg positivity. it will compare rates of positivity and risk factors among healthcare workers and non-healthcare workers and assess the ability of pcr negativity at day 3 or 4, 5, 7, or 10 to predict negativity on day 14 in individuals quarantining after a covid exposure. in addition to having a standard of care clinical antibody test, both healthcare workers, quarantining individuals, and patients will be asked to fill out a survey to assess risk factors for covid infection and provide a research blood sample. quarantining individuals will also have standard of care pcr testing on days 3 or 4, 5, 7, 10, and 14 of the quarantine period. collected blood samples will be used to assess for the presence of neutralizing antibodies and measure antibodies with a research test. an annual blood specimen and survey will be collected from each study participant for up to 2 years total after study entry.

Eligibility criteria:
inclusion criteria: * individuals (health-care workers and patients) undergoing standard of care assessment of sars-cov-2 serology testing * individuals with a covid-19 exposure requiring quarantine who are asymptomatic and who will receive standard of care sars-cov-2 pcr testing. * able to understand and sign the informed consent and research authorization from. exclusion criteria: * prisoners * patients with psychiatric illness that would limit compliance * patients with social situations that would limit compliance

Keywords: prevalance risk-factor population kentucky antibody sars cov-2 seroconversion physical distancing pcr quarantine
balloon-stent kissing technique versus jailed wire technique for the coronary bifurcation lesions

Conditions: Coronary Artery Disease

Summary: to compare the immediate and long-term clinical outcomes between balloon-stent kissing technique (bskt) and jailed wire technique (jwt) for the interventional treatment of coronary bifurcation lesions.

coronary bifurcation lesions account for 15-20% of percutaneous coronary interventions (pcis)\[1-2\]. they have lower success rate after operation, higher re-stricture ratio by radiography and frequent complications, which result in adverse clinical outcomes as compared to non-bifurcation lesions\[3-5\]. secure and efficient treatment strategies for pci and bifurcation lesions are research hotspots for cardiovascular surgeons. single-side stand strategy (main-support implantation stand or side-support implantation stand when necessary) is currently preferred for bifurcation lesions\[2,6\]. however, as main-support implantation stand could lead to plaque transposition, bifurcation ridge excursion and side a sandwich, the side openings could become narrower or even blocked\[7\]. in 2011, our centre initiated the use of balloon-stent kissing technique (bskt)\[8\] to protect the side branch, which has higher success rate after operation, lower block ratio of side branch and lower incidence of perioperative adverse events, which led to immediate clinical effect. this study compared bskt versus jailed wire technique (jwt) in the interventional treatment of coronary bifurcation lesions to further clarify bskt's efficacy and advantages.

Eligibility criteria:
inclusion criteria: * 1. patients with chd; 2. coronary arteriography revealed true bifurcation lesion exclusion criteria: * 1. severe carcified lesion; 2. left main lesion; 3. severe heart failure(nyha grade 4)
the evaluation of the efficacy of tci66207 on the skin.

Conditions: Skin Diseases

Summary: the purpose of this study is to explore the evaluation of the efficacy of tci66207 deep-sea live-face bacteria on the skin.


Eligibility criteria:
inclusion criteria: 1. healthy volunteers aged above 20 years old 2. subject has dull skin. exclusion criteria: 1. .subject with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history). 2. subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder. 3. female who is pregnant or nursing or planning to become pregnant during the course of the study. 4. received facial laser therapy, chemical peeling or uv overexposure in the past 4 weeks. 5. subjects who have large spots (area \>3 square centimeter) or abnormal acne.
abx plus cisplatin versus gemcitabine plus cisplatin in triple negative breast cancer (tnbc)

Conditions: Breast Cancer

Summary: abx plus cisplatin versus gemcitabine plus cisplatin in triple negative breast cancer (tnbc)

a phase iii, multicenter, randomized study of abx plus cisplatin (ap) versus gemcitabine plus cisplatin (gp) as first-line treatment in patients with advanced triple-negative breast cancer

Eligibility criteria:
inclusion criteria: 1. females with age between 18 and 70 years old 2. histological proven unresectable recurrent or advanced breast cancer, including de novo stage iv disease. 3. triple-negative for estrogen receptor (er), progestogen receptor (pr), and human epithelial receptor-2 (her2) by immunohistochemistry (er \<1%, pr \<1% and her2 negative). a negative her2 gene amplification should be verified by fish test for those patients with her2 (2+). for those with her2 (1+), fish test might be considered by the investigator. 4. no prior chemotherapy for metastatic breast cancer is permitted. prior administration of chemotherapy in the adjuvant/neoadjuvant setting is acceptable if completed 6 months before the enrollment. 5. at least one measurable disease according to the response evaluation criteria in solid tumor (recist 1.1) 6. performance status no more than 1 7. all patients enrolled are required to have adequate hematologic, hepatic, and renal function 8. life expectancy longer than 12 weeks 9. no serious medical history of heart, lung, liver and kidney 10. be able to understand the study procedures and sign informed consent. exclusion criteria: 1. pregnant or lactating women (female patients of child-bearing potential must have a negative serum pregnancy test within 14 days before the first day of drug dosing, or, if positive, a pregnancy should be ruled out by ultrasound) 2. women of child-bearing potential, unwilling to use adequate contraceptive protection during the process of the study 3. treatment with radiotherapy at the axial skeleton within 4 weeks before the first treatment or has not recovered from all toxicities of previous radiotherapy 4. treatment with an investigational product within 4 weeks before the first treatment 5. patients with symptomatic central nervous system metastases are not permitted, except for those with stable and asymptomatic brain metastases who have completed cranial irradiation, and have at least one measurable lesion outside the brain. radiotherapy should be completed within 4 weeks prior to the registration 6. other active malignancies (including other hematologic malignancies) or other malignancies within the last 5 years, except for cured nonmelanoma skin cancer or cervical intraepithelial neoplasia. 7. patients having a history of clinically significant cardiovascular, hepatic, respiratory or renal diseases, clinically significant hematological and endocrinal abnormalities, clinically significant neurological or psychiatric conditions 8. uncontrolled serious infection

Keywords: triple negative breast cancer fine line chemotherapy
effectiveness of group based schema therapy in the treatment of personality disorders

Conditions: Personality Disorder, Borderline; Avoidant Personality Disorder

Summary: this study intends to compare the effectiveness of schema therapy with standard psychiatric outpatient care for patients with borderline or avoidant personality disorder.


Eligibility criteria:
inclusion criteria: * avoidant or borderline personality disorders exclusion criteria: * do not speak scandinavian languages * antisocial personality disorder * narcissistic personality disorder * affective bipolar disorder i * schizophrenia * mental impairment/organic brain disorder * substance dependence * planned pregnancy * serious somatic illness * anorexia nervosa