Kornimate/medical-research-clean huggingface dataset:
written educational information and phone calls in increasing follow-up care in hispanic women with abnormal pap smears

Conditions: Cervical Cancer

Summary: rationale: written educational materials and counseling by phone may help promote follow-up care in women with abnormal pap smears. purpose: this clinical trial is studying how well written educational information and phone calls work in increasing follow-up care in hispanic women with abnormal pap smears.

objectives: primary * determine the reasons for nonadherence to follow-up in hispanic women with abnormal pap smear findings. * assess the effect of written educational information and phone calls on follow-up rate in these patients. outline: this is a pilot, cross-sectional, controlled, multicenter study. patients are sequentially assigned to 1 of 3 intervention groups. * group 1 (control): patients complete a standardized spanish survey questionnaire, assessing their demographic information, knowledge, attitudes, behaviors, experiences with cervical screening, past medical history, and prior treatment, either in person (for those who kept their colposcopy appointment) or over the telephone (for those who did not keep their colposcopy appointment). additional questions are added for patients who did not keep their colposcopy appointment to test for differences and to learn the reasons for not keeping their appointment. * group 2 (written educational information): patients receive notification of their colposcopy appointment and an educational letter about pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. they complete the standardized spanish survey questionnaire as in group 1. * group 3 (phone call): patients receive notification of their colposcopy appointment and a personal telephone call educating them about pap smears, cervical cancer risk, and the purpose and procedure of colposcopy. they complete the standardized spanish survey questionnaire as in group 1. all patients are asked to agree to submit residual pap smear fluid to the comprehensive cancer center of wake forest university tumor bank, and be included in a tracking system to insure future follow-up communications.

Eligibility criteria:
disease characteristics: * abnormal pap smear findings indicating the need for further treatment at the colposcopy clinic * scheduled for colposcopy at the comprehensive cancer center of wake forest university * no history of invasive cervical cancer patient characteristics: * must be of hispanic background, including any of the following: * hispanic * latino * chicano * mexican american * puerto rican * cuban american prior concurrent therapy: * not specified

Keywords: cervical cancer
a single dose, 2-period, 2-treatment, 2-way crossover bioequivalency study of ropinirole 0.25 mg tablets und fasted conditions

Conditions: Parkinson's Disease; Restless Leg Syndrome

Summary: the objective of this study was to assess the single dose bioequivalence of roxane's ropinirole tablets, 0.25 mg to requip tablets, 0.25 mg (glaxosmithkline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

the objective of this study was to assess the single dose bioequivalence of roxane's ropinirole tablets, 0.25 mg to requip tablets, 0.25 mg (glaxosmithkline) under fasting conditions using a single-dose, randomized, 2-treatment, 2-period, 2-sequence cross-over design.

Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to ropinirole or any other comparable product.
a phase i study of bms-641988 in japanese patients with castration resistant prostate cancer

Conditions: Prostate Cancer

Summary: the purpose of this clinical study is to assess the safety and tolerability of bms-641988 once daily orally in japanese patients with castration resistant prostate cancer


Eligibility criteria:
inclusion criteria: * patients with castration-resistant prostate cancer and serum testosterone ≤50 ng/dl progressive to current therapy who satisfy the inclusion and exclusion criteria
variation in sulphonylurea response in type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the study hypothesis is that people who respond well to sulphonylureas have a different underlying cause for their diabetes than people who respond poorly to this medication. we are using two approaches to study this. in one approach we look at people who have previously responded well or poorly, confirm this by rechallenging them with a sulphonylurea drug, and then looking at how well they produce insulin in response to glucose and an intravenous sulphonylurea called tolbutamide. the second approach identifies people with a certain genetic predisposition to diabetes (due to changes in the tcf7l2 gene) and then looks at how well they respond to sulphonylurea medication.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * age \>35 and \< 70 * age of diabetes diagnosis \>35 and \<70 * white european * pre-su hba1c \<=10% * hba1c (on treatment) \<= 9% * no myocardial infarction or acute coronary syndrome in previous year * no stroke or transient ischaemic attack in previous year * no or stable (background) retinopathy (no unscheduled laser treatment in the last 6 months) * egfr \> 60mls/min * no proteinuria \>30mg/dl on multistix 10sg * no active foot ulceration or infection * liver alt ≤ twice the upper limit of the reference range * contactable by telephone exclusion criteria: * type 1 diabetes * hba1c \>10% prior to commencing su * hba1c\>9% on su treatment * recent mi or stroke within last 12 months * pre-proliferative or proliferative retinopathy * egfr\<60 ml/min * proteinuria \>30mg/dl on multistix 10sg * active foot ulceration or infection * liver alt \> twice the upper limit of the reference range * female planning to conceive within the study period * any other significant medical reason for exclusion as determined by the investigator

Keywords: sulphonylurea pharmacogenetics
sleep disorders in pediatric dialysis

Conditions: Chronic Kidney Disease (CKD)

Summary: sleep disorders (sd) are common in adults with chronic kidney disease (ckd) on dialysis with a reported prevalence of 60-80%. to date three studies have reported on sds in children with ckd but these have all been based on questionnaire data alone. the findings were not confirmed with polysomnograms (psg), the gold standard to diagnose sd, or actigraphy, a validated tool to assess the sleep/ wake cycle over a prolonged period in the home. this is highly relevant given the poor sensitivity and specificity of even validated questionnaires alone. the effect of untreated pediatric sd is pervasive. this study will provide the first objective assessment of sds using psgs in children with severe ckd, both on and off dialysis. therefore, we will recognize and when possible treat sd in this severe ckd cohort potentially contributing to their immediate management (eg improved control of hypertension, improved school performance), while improving their quality of life (qol) and helping ensure they achieve their full potential.


Eligibility criteria:
inclusion criteria: * 0 to 18 years * caregivers must be able to read english * patients with either stage 4 chronic kidney disease (ckd) with an estimated gfr of 15-30 ml/min/1.73m2 based on idms schwartz gfr or patients with ckd receiving outpatient hemodialysis (hd) or peritoneal dialysis (pd) for a minimum of 1 month * informed consent exclusion criteria: * caregivers cannot read english * informed consent not given

Keywords: chronic kidney disease (ckd) pediatrics sleep disorders
cab-ror2-adc safety and efficacy study in patients with tnbc or head & neck cancer (ph1) and nsclc or melanoma (ph2)

Conditions: Non Small Cell Lung Cancer; Triple Negative Breast Cancer; Melanoma; Head and Neck Cancer

Summary: the objective of this study is to assess safety and efficacy of cab-ror2-adc in solid tumors

this is a multi-center, open-label, phase 1/2 study designed to evaluate the safety, tolerability, pk, immunogenicity, and antitumor activity of ba3021, a conditionally active biologic (cab) ror2-targeted antibody drug conjugate (cab-ror2-adc) ba3021 in patients with advanced solid tumors. this study will consist of a dose escalation phase and a dose expansion phase with ba3021 in phase 1. phase 2 will study ba3021 alone or in combination with a pd-1 inhibitor.

Eligibility criteria:
inclusion criteria: * patients must have histologically or cytologically confirmed locally advanced unresectable or metastatic solid tumor and have failed all available standard of care (soc) therapy and for whom no curative therapy is available or who are not eligible, intolerant to or refuse standard therapy. * patients must have measurable disease. * for the dose expansion phase: patients with locally advanced unresectable or metastatic, non-small cell lung cancer (nsclc), triple negative breast cancer (tnbc) and soft tissue sarcoma (sts) * age ≥ 18 years. * adequate renal function * adequate liver function * adequate hematological function * have an eastern cooperative oncology group (ecog) performance status of 0 or 1. * life expectancy of at least three months. exclusion criteria: * patients must not have clinically significant cardiac disease. * patients must not have known non-controlled cns metastasis. * patients must not have a history of ≥ grade 3 allergic reactions to mab therapy as wellas known or suspected allergy or intolerance to any agent given during this study. * patients must not have had major surgery within 4 weeks before first ba3021 administration. * patients must not have had prior therapy with a conjugated or unconjugated auristatin derivative/vinca-binding site targeting payload. * patients must not have known human immunodeficiency virus (hiv) infection, active hepatitis b and/or hepatitis c. * patients must not be women who are pregnant or breast feeding.
efficacy of hypno-ear-acupuncture on insomnia in advanced cancer patients

Conditions: Oncology; Insomnia; Symptoms and Signs

Summary: this randomized controlled trial aims to test if a combination of medical hypnosis and ear acupuncture improves sleep quality in patients with advanced cancer during a hospital stay in a palliative care unit. patients submitted to our palliative care unit will receive a medical hypnosis and ear acupuncture on the second day of their stay. sleep quality will be measured using validated patient-reported outcome measures at baseline and after 7 days. additionally, the use of sleep medication will be documented as a secondary outcome. the intervention will be compared to a sham medical hypnosis and ear acupuncture to see if the effect of the true intervention has a unique effect.


Eligibility criteria:
inclusion criteria: * histologically confirmed cancer * rcsq total score \<25mm * ability to read and understand the questionnaires * ability to give informed consent exclusion criteria: * pregnancy * language barrier (non german) * inability to give informed consent * hypacusis * radiographical verified brain metastases * diagnosed psychosis

Keywords: ear acupuncture medical hypnosis
radical surgery followed by immunotherapy using precision t cells specific to multiple common tumor-associated antigen for the treatment of hepatocellular carcinoma

Conditions: Liver Cancer

Summary: objectives: the purpose of this study is to evaluate the safety and efficacy of radical surgery combined with dendritic cell-precision multiple antigen t cells in reducing the recurrence and metastasis of liver cancer methods: this study designs a novel therapy using dendritic cell-precision multiple antigen t cells. 60 postoperative patients of hepatocellular carcinoma will be enrolled. they are randomly divided into postoperative routine therapy group and dendritic cell-precision multiple antigen t cells combined with postoperative routine therapy group. dendritic cell-precision multiple antigen t cells treatments will be performed every 3 weeks with a total of three periods. the mail clinical indicators are progression-free-survival and overall survival.

a total of 60 patients may be enrolled over a period of 1-2 years.

Eligibility criteria:
inclusion criteria: 1. age 18\~65 years old, male or female 2. signed informed consent 3. diagnosis of hepatocellular carcinoma (hcc), radical surgery was performed 4. the recurrence of hcc was not found after the operation and no other immunotherapy was carried out 5. the eastern cooperative oncology group (ecog) score ≤2 6. child-pugh score of liver function ≤ 9 7. routine blood meets the requirements exclusion criteria: 1. expected overall survival \< 3 months 2. radical surgery was not performed or recurrence was found after operation 3. liver function is childs pugh c 4. had received other immunotherapy 5. other serious diseases:the heart,lung, kidney,digestive, nervous, mental disorders, immune regulatory diseases, metabolic diseases, infectious diseases, etc. 6. unable or unwilling to provide informed consent, or fail to comply with the test requirements

Keywords: recurrence metastasis liver cancer
acalabrutinib study with best supportive care versus best supportive care in subjects hospitalized with covid-19.

Conditions: COVID-19

Summary: calavi us will investigate the safety, efficacy and pharmacokinetics of acalabrutinib together with best supportive care in the treatment of covid-19.


Eligibility criteria:
inclusion criteria: 1. ability to understand the purpose and risks of the study and provide signed and dated informed consent or have a legal representative provide consent and authorization to use protected health information (in accordance with national and local patient privacy regulations) 2. men and women ≥18 years of age at the time of signing the informed consent form 3. confirmed infection with sars-cov-2 confirmed per world health organization criteria (including positive rt-pcr nucleic acid test) 4. covid-19 pneumonia (documented radiographically) requiring hospitalization and oxygen saturation \<94% on room air or requires supplemental oxygen 5. able to swallow pills 6. willing to follow contraception guidelines exclusion criteria: 1. respiratory failure at the time of screening due to covid-19 pneumonia that impedes the ability to swallow pills, or in the opinion of the treating physician, the subject is likely to require mechanical ventilation within the immediate 24 hours and therefore unable to swallow pills. 2. known medical resuscitation within 14 days of randomization 3. pregnant or breast feeding 4. suspected uncontrolled active bacterial, fungal, viral, or other infection (besides infection with sars-cov-2) 5. alanine aminotransferase (alt), and/or aspartate aminotransferase (ast) and/or bilirubin ≥ 3x upper limit of normal (uln) and/or severe hepatic impairment detected during the screening period (per local lab) exception: ast and/or alt ≤5 × uln if considered due to underlying covid-19 disease, but cannot be associated with concurrent elevated bilirubin (≤2 × uln). 6. uncontrolled or untreated symptomatic arrhythmias, myocardial infarction within the last 6 weeks, or congestive heart failure (nyha grade 3 or 4). exception: subjects with controlled, asymptomatic atrial fibrillation during screening are allowed to enroll 7. treatment with a strong cytochrome p450 (cyp)3a inhibitor (within 7 days before first dose of study drug) or inducer (within 14 days before first dose of study drug).

Keywords: 2019 novel coronavirus disease acalabrutinib btk inhibitor
effects of aerobic training in end stage renal disease patients

Conditions: Kidney Failure, Chronic

Summary: the investigators raised the hypothesis that exercise training would be associated with improvement in exercise tolerance and vo2 kinetics in hemodialysis patients.

end-stage renal disease (esrd) is associated with several hemodynamic and peripheral muscle abnormalities which could slow the kinetics of o2 uptake(vo2)and diminished tolerance to incremental exercise. although previous studies have shown that aerobic training is able to accelerate vo2 kinetics in several disease populations, little is known if these positive findings are also applicable to hemodialysis patients.

Eligibility criteria:
inclusion criteria: the sample included end stage renal disease patients undergoing hemodialysis, three times per week totaling 12h weekly, for at least 6 months in the nephrology unit at the university hospital of the federal university of juiz de fora, state of minas gerais, brazil. no patient had been involved in any kind of exercise training in the preceding 6 months exclusion criteria: * unstable angina; * uncontrolled arrhythmia; * uncompensated heart failure; * uncontrolled hypertension (systolic blood pressure ≥ 200 mmhg and/or diastolic blood pressure ≥ 120 mmhg); * diabetes mellitus; * severe respiratory diseases; * acute infection; * severe renal osteodystrophy; * neurological or musculoskeletal disturbances

Keywords: exercise tolerance physical endurance
a physician-based trial to increase colorectal cancer screening in chinese

Conditions: Colorectal Cancer

Summary: the objective of this study is to test whether a culturally-tailored in-office based intervention have impact on increasing chinese physician's recommendation of colorectal cancer (crc) screening to their nonadherent chinese patients. special aims are to: 1. evaluate the efficacy of a culturally-tailored physician intervention on increasing non-adherent chinese american's patients' crc screening rate. 2. identify factors that mediate or moderate the intervention effects. for example, patients who hold an eastern cultural view or are less acculturated will be more likely to benefit from the intervention than patients who hold a western view or who are more acculturated.

this study is a randomized controlled trial aiming to test the effect of the culturally-tailored in-office based intervention on physicians. a total of 24 chinese physicians in the washington dc and philadelphia areas and a total of 24 eligible chinese patients from each physician will be recruited for this study. physicians and their patients are randomized into two groups: a and b. physician in the intervention group (a) will receive mailed printed materials including a crc physician guide, patient brochure, flip chart and a poster and two sessions of in-office training aimed to reinforce learning of the topic covered by the mailed materials and provide physicians with hands-on experience in using communication skills with standardized patients. physicians in the control group (b) will receive nothing until the end of the study. patients will be followed 12-month later after their completion of the baseline survey and their self-reported crc screening status will be verified by chart audit.

Eligibility criteria:
inclusion criteria: for physicians 1. are chinese american, 2. practice primary care, 3. have a least 75 chinese patients aged 50 and older in their practice, 4. can communicate with patients in chinese (mandarin, cantonese, etc.) for patients 1. visiting the participating physician at least once in the past 2 years, 2. are chinese americans, 3. are 50 years and older, 4. never had any crc screening or are overdue for screening. exclusion criteria: for patients: 1. have a colorectal polyp, crc cancer, or a family history of crc (first degree relative), and 2. had updated crc screening (fobt within one year, colonoscopy within 10 years, sigmoidoscopy within 5 years and double-contrast barium enema within 5 years).

Keywords: colorectal cancer screening chinese americans patients nonadherent with crc screening
bladder cancer chemoradiation using intensity modulated radiation therapy

Conditions: Bladder Cancer

Summary: while the gold standard of treatment in invasive bladder cancer is surgical removal of the bladder, it is well accepted that a reasonable alternative is an organ preserving approach. bladder preservation can be achieved in patients with radiotherapy alone or together with concurrent chemotherapy. this clinical trial will assess the potential of intensity modulated radiation therapy (imrt) delivered using helical tomotherapy to reduce radiation-induced gastrointestinal toxicity and increase the accuracy of bladder cancer irradiation.

patients opting for bladder conservation in ottawa are currently treated using intra-arterial cisplatin and concurrent radiotherapy using 3d-conformal radiotherapy. it has been recently reported that while combination chemotherapy with local therapy (surgery or radiation) does modestly increase survival, greater toxicity results. as a precursor to the integration of gemcitabine in the standard chemotherapy regimen at our centre, the current clinical trial is designed to determine if a novel approach to the delivery of intensity modulated radiotherapy (imrt), namely helical tomotherapy, will decrease the toxicity of standard chemoradiation. chemoradiation will be administered as follows: 3 courses intra-arterial cisplatin 90mg/m2 every 3 weeks and radical radiation delivered as imrt for a total dose of 60 gy in 30 daily fractions of 2 gy per day m-f starting day 15.

Eligibility criteria:
inclusion criteria: 1. a pathological diagnosis of pure or predominantly transitional cell bladder carcinoma 2. adequate hematology and biochemistry parameters 3. invasive or treatment refractory non-invasive transitional cell bladder carcinoma or operable patients who prefer bladder preservation or inoperable patients. 4. no metastases on ct scan of chest exclusion criteria: 1. patient with contraindication to radical radiotherapy including inflammatory bowel disease or significant irritative bladder symptoms 2. contraindication to internal iliac arterial catheterization 3. prior pelvic radiotherapy for other malignancies 4. prior cytotoxic chemotherapy excepting intravesical agents

Keywords: bladder, cancer, chemoradiation, imrt, tomotherapy