Kornimate/medical-research-clean huggingface dataset:
the use of pentoxifylline and vitamin e in the treatment of chronic breast pain

Conditions: Breast Neoplasms

Summary: an estimated 20 - 45 % of women treated with breast conserving treatment experience chronic pain in the treated breast. the aetiology of this is poorly understood. some of these women have signs of chronic radiation mastitis. there is no accepted treatment for this condition. the combination of pentoxifylline and vitamin e has been shown to be effective in reversing radiation fibrosis in this region. many of these patients have had a benefit in pain response in a time period of a few benefits. this study is a phase ii study of these drugs for a 6 month trial period to assess the effect on chronic breast pain in breast cancer patients who are 3 months to 3 years post radiation treatment.


Eligibility criteria:
inclusion criteria: * uicc tnm stage 0 (i.e. in situ disease), 1 or 2 breast cancer patients treated with conservative surgery and adjuvant radiotherapy with chronic breast pain or tenderness, with or without fibrosis, within 3 months to 3 years following completion of radiotherapy * age 18 to 75 years of age * chronic symptoms localised to the breast treated with radiation, i.e. any one or more of the following- pain (not attributable to infection) or tenderness with or without associated oedema, fibrosis, necrosis or ulceration. * breast pain (maximum in the previous 24 hours) measurable on a linear analogue scale with a length of 3cm or greater * prior treatment with radiation to the affected area i.e. in tangential breast fields or boost area * radiation completed at least 3 months and no longer than 3 years prior to study entry * informed consent exclusion criteria: * active cellulitis in the breast * active malignant disease * any medical illness or condition judged likely by the local investigator to preclude safe administration of protocol treatment * contraindication to treatment with pentoxifylline (i.e. previously exhibited intolerance to pentoxifylline or other xanthines such as caffeine, theophylline or theobromine; recent cerebral and/or retinal haemorrhage; ischaemic heart disease; hypotension * pregnant or lactating women
using behavioral science to improve colorectal cancer screening rates with mailed fit kits

Conditions: Colorectal Cancer Screening

Summary: as a part of ucla health's continued goal of improving patient care the investigators are updating our mailing campaign for our fit kit colorectal cancer screening that the investigators administer 2 times per year to include an automated phone call reminder to patients who are overdue for average-risk colorectal cancer screening and enrolled in a mailed fit program. this will help the investigators evaluate if automated phone calls are effective at improving compliance with crc screening, in addition to mailed fit and embedded electronic health record (ehr) portal messages to patients.

ucla health has a biannual mailed fit program designed to capture patients overdue for crc screening who are average-risk for crc. with every campaign, the investigators attempt to improve the return rates for patients receiving the fit kits. for the current campaign, all patients enrolled will receive usual care and the investigators are delivering an automated phone call to half the eligible patients reminding them to return their fit kits and prompting them to request a new kit if needed. the investigators will investigate if this intervention increases the number of patients who complete the mailed fit kit or any type of crc screening over a 6-month follow up period. this quality improvement project will help the investigators improve the processes of care for the patients, and community. if this phone call is successful the investigators will likely expand it to the entire population in future fit kit mailer campaigns. however, if it is not effective this will help the investigators minimize the number of calls/interventions the investigators send to patients and will hopefully allow for more useful outreach to patients in the future.

Eligibility criteria:
inclusion criteria: * overdue for average-risk colorectal cancer screening * active primary care provider at ucla seen within last 3 years exclusion criteria: * inactive mychart status at time of enrollment * died within follow-up period * received fit kit in prior 6 months
glucocorticoid treatment in addison's disease

Conditions: Addison's Disease

Summary: addison's disease is a rare condition which in most cases is caused by autoimmune destruction of the adrenals, leading to deficiency of cortisol, aldosterone and adrenal androgens. unrecognized the disease is life threatening, but with proper treatment patients can live near normal lives. the conventional glucocorticoid replacement therapy renders the cortisol levels unphysiological, which may cause symptoms and long-term complications. glucocorticoid replacement therapy is technically feasible by continuous subcutaneous hydrocortisone infusion (cshi), and can mimic the normal diurnal cortisol rhythm. this study aims to further evaluate cshi treatment in terms of metabolic effects, effects on health-related quality-of-life and sleep in an 8 months randomised open label clinical trial with crossover design.


Eligibility criteria:
inclusion criteria: * patients with verified addison's disease on stable treatment. exclusion criteria: * insulin treated diabetes mellitus, cardiovascular disease,malignant disease, pregnancy. * treatment with glucocorticoids or drugs that interfere with cortisol metabolism (antiepileptics, rifampicin, st. john's wart).

Keywords: addison's disease glucocorticoid treatment continuous subcutaneous hydrocortisone infusion cshi quality of life sleep
evaluation of novel disposable flexible ureteroscope for the treatment of renal calculi

Conditions: UTI; Stone, Kidney

Summary: this study is designed to provide an evaluation of currently available disposable flexible ureteroscopes in real-world conditions. due to high re-processing costs associated with re-usable flexible ureteroscopes, there has been a demand for urologic device manufacturers to provide single-use flexible ureteroscopes.

patients randomized to the experimental group will receive flexible ureteroscopy with the storz flex-xc1 disposable flexible ureteroscope. data will be collected and stored electronically in redcap. quality assurance steps will include testing of the database, including any potential data calculated by command functions within redcap scope performance survey will be administered with redcap.

Eligibility criteria:
inclusion criteria: * males and females 18-89 undergoing ureteroscopy for laser treatment of renal calculi * willing to sign the informed consent form * able to read, understand, and complete patient questionnaires, pain texts, and medication diary. exclusion criteria: * patients having a concomitant procedure along with ureteroscopy (example: contralateral pcnl) * pregnancy
study evaluating the safety and efficacy of etanercept in patients with idiopathic pulmonary fibrosis

Conditions: Pulmonary Fibrosis

Summary: the objective of the study is to evaluate the safety and efficacy of etanercept in comparison with placebo in a double-blind, parallel, randomized fashion in subjects with idiopathic pulmonary fibrosis (ipf) who failed previous therapy. the treatment period will be up to 1 year. the primary objective is evaluation of safety and efficacy. secondary: the secondary objective is to evaluate quality of life (qol) and pharmacokinetics (pk).


Eligibility criteria:
inclusion criteria: * diagnosis of ipf based on american thoracic society (ats) guidelines exclusion criteria: * subjects with end-stage * previous treatment with etanercept or other tnf antagonists (eg, a tnf monoclonal antibody or a soluble tnf-receptor) * receipt of any investigational drug or biological agent within 4 weeks of screening visit

Keywords: idiopathic pulmonary fibrosis fibrosis, pulmonary pulmonary fibroses fibroses, pulmonary
biomarkers in plasma specimens from patients treated on study calgb-80303

Conditions: Pancreatic Cancer

Summary: rationale: studying plasma samples from patients with pancreatic cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer. purpose: this research trial studies biomarkers in samples from patients with pancreatic cancer treated on study calgb-80303.

objectives: * to determine whether the observed predictive value of plasma vegf-a and vegf-r2 for overall survival (os) in study bo17706 can be replicated in study calgb-80303 using the same immunological multiparameter chip technology (impact) assay. * to determine whether the observed predictive value of plasma vegf-a and vegf-r2 for progression-free survival (pfs), and other circulating biomarkers in study bo17706, can be replicated in study calgb-80303 using the same impact assay. * to explore the relationship between efficacy and other biomarkers measured in the plasma samples. outline: the samples required for this study are stored in the calgb pathology coordinating office at the ohio state university from patients enrolled on protocol calgb-80303. no additional samples are required from patients. the following markers are analyzed in edta plasma samples using the immunological multiparameter chip technology (impact) a roche proprietary multiplex enzyme-linked immunosorbent assay (elisa) platform: vegf-a, vegf-c, vegf-r1, vegf-r2, e-selectin, vegf-r3, il-8, bfgf, pdgf-c, icam-1, and plgf.

Eligibility criteria:
patients must have been registered to calgb-80303 * histologically or cytologically confirmed adenocarcinoma of the pancreas * locally advanced or metastatic disease

Keywords: adenocarcinoma of the pancreas recurrent pancreatic cancer stage iii pancreatic cancer stage iv pancreatic cancer stage iib pancreatic cancer
monitoring health care workers at risk for covid-19 using wearable sensors and smartphone technology

Conditions: Covid19

Summary: this prospective study of health care workers utilizes wearable sensors, surveys and symptom logs, and biospecimens in an effort to improve self-monitoring practices for covid-19 among health care workers and to provide key data for the development of a predictive model for early detection of covid-19 infection.

health care workers work on the front lines of the covid-19 pandemic, so early detection of covid-19 infection is especially important in this population in order to prevent the spread of disease among the health care workforce, their patients, and their families. however, standard symptomatic covid-19 testing is insufficient to protect health care workers and prevent the spread of disease. this study utilizes continuous physiological data from wearable sensors and surveys completed via smartphone technology, in conjunction with biospecimens, in order to assist health care workers in their self-monitoring for covid-19 infection. subjects will wear smart watches and temperature monitoring patches to collect continuous heart rate and temperature data. subjects will also complete baseline and exit surveys, in addition to daily mood and symptom logging surveys. finally, subjects will provide biospecimens - nasal and saliva samples and optional blood samples. using wearable sensor data in conjunction with survey data and biospecimens, this study aims to prevent the spread of covid-19 among health care workers, their patients, and their families, and to eventually develop a predictive model for early detection of covid-19 infection.

Eligibility criteria:
inclusion criteria: * adult michigan medicine health care workers age 18 years and older. * health care workers who are involved in direct (in-person) face-to-face patient care or health care workers who are not involved in direct (in-person) face-to-face patient care but work on units where covid-19 patients are/will likely be treated. * possession of a smartphone (apple or android). * ability to understand and demonstrate willingness to remotely sign a written informed consent. exclusion criteria: * unwilling or unable to comply with the study procedures or to allow the study team access to health data.

Keywords: mobile health wearable sensors covid-19
determinants of chronic inflammatory skin disease trajectories

Conditions: Atopic Dermatitis; Psoriasis; Eczema; Lichen; Alopecia Areata

Summary: although it is well known that the clinical expression and course of chronic inflammatory skin diseases are highly variable, there are insufficient epidemiological data on this, and the factors that determine the manifestation, clinical features and course are also largely unknown. there are currently no reliable markers that could predict or delineate patient subgroups to support patient management. the aim of this project is to identify clinical and molecular factors that correlate with disease, disease subtypes and progression through in-depth long-term clinical characterization of patients with chronic inflammatory skin diseases and examination of individual biomaterials.

chronic inflammatory skin diseases such as atopic dermatitis (ad) and psoriasis (pso) are exceptionally heterogeneous diseases. clinical manifestations, disease severity, and individual trigger factors vary widely between patients and over time, presenting a clinical challenge for diagnosis, counseling, and individualization of treatment strategies. with the growing interest in inflammatory skin diseases, the need has been recognized to better investigate their natural history and associations with environmental and lifestyle factors, and to conduct research to identify the clinical and, where appropriate, molecular features underlying heterogeneity. initial small pilot studies suggested disease subtypes that differ molecularly and/or clinically; however, molecular profiles in particular are subject to variation over time and not necessarily. to confirm and extend such preliminary observations, a larger cohort of patients will be studied with careful longitudinal clinical characterization as well as repeatedly obtained specimens, in order to gain deeper insights into disease dynamics. in particular, we will search for clinical and molecular factors that correlate with disease progression and subtypes, and investigate variability in the regulation of molecular mechanisms over time and at resolution and flare-ups.

Eligibility criteria:
inclusion criteria: * dermatologist-diagnosed inflammatory skin disease * informed consent exclusion criteria: * subject and/or the legal guardians are not able to give written informed consent * pregnant and breastfeeding women * concurrent participation in a clinical trial * use of systemic immunosuppressive therapy or phototherapy during the last 4 weeks or receipt of biologics therapy (e.g. dupilumab, tralokinumab) within the last 3 months * treatment of the target skin areas with topical corticosteroids, calcineurin inhibitors or emollients 24 hours before sample collection

Keywords: inflammatory skin diseases
study of post menopausal osteoporosis (pmo) among gynecology outpatients in pakistan

Conditions: Postmenopausal Osteoporosis

Summary: this observational study will provide an opportunity to document local patterns of susceptibility, patient profile, and usefulness of screening in postmenopausal patients coming to gynecology outpatient clinics in pakistan. this will also capture the initial management of pmo in diagnosed patients. the information gathered will serve as a foundation for developing national guidelines on screening and management of pmo in pakistan.


Eligibility criteria:
inclusion criteria: * postmenopausal women * age 50 years or greater exclusion criteria: * previously diagnosed osteoporosis, or receiving treatment for osteoporosis
a development study to evaluate a nasal mask for the treatment of obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: this investigation is designed to evaluate the comfort, ease of use and performance of a trial nasal mask for the treatment of obstructive sleep apnea (osa) in the home environment.

the investigation is a prospective, non-randomized, non-blinded study. up to 45 osa patients who currently use a nasal or nasal pillows mask will be recruited this study will involve a baseline (visit one) data gathering with the participant's pap therapy and their usual mask. this will be followed by the participants being fitted with the trial nasal mask for use in-home (visit two). the participant then will come in to return the mask (visit three) and give feedback on their experience using the mask in home in the form of a structured interview during visit three. the maximum amount of time the participants will be exposed to the trial mask in-home will be 14 ± 5 days from visit two. the mask and cpap (if used from the loan research pool) will be returned to the institution at the conclusion of the trial and participant will return to their usual mask and therapy device for the treatment of obstructive sleep apnea. neither the investigators nor the participants will be blinded to the study.

Eligibility criteria:
inclusion criteria: * ahi ≥ 5 from diagnostic psg night * aged 22 and over (fda defined as adult) * either prescribed apap, cpap or bi-level pap for osa * existing nasal or nasal pillows mask users (preferable 70%:30% split) * fluent in spoken and written english exclusion criteria: * inability to give informed consent * patient intolerant to cpap therapy * anatomical or physiological conditions making pap therapy inappropriate * current diagnosis of respiratory disease or co2 retention * pregnant or think they may be pregnant
pilot study in the cholesterol absorption reduction after consumption of low-fat, drinkable fermented milk enriched with plant sterols

Conditions: Mildly Hypercholesterolemic Subjects

Summary: the objective of this study is to compare efficacy of a plant sterol enriched yogurt given at different moments of the day in lowering blood cholesterol of hypercholesterolemic.


Eligibility criteria:
inclusion criteria: * male and post-menopausal female aged 40-80 years; * bmi between 22 and 32 kg/m2, * non-smoker, stabilized ldl-c over 3.0 mmol/l, * not taking any medication known to affect lipid metabolism for at least the previous 3 month period, * agree to follow the dietary recommendations in the context of their hypercholesterolemia, * have to give written consent to take part in the study exclusion criteria: * thyroid disease, diabetes mellitus, kidney disease or liver disease, hypertension (95\ 140 mmhg and/or 45\ 90 mmhg), * previous history of symptomatic vascular disease, tg level \> 2,8 g/l, * history of metabolic or gastrointestinal disease with the exception of appendicectomy, * consumption of large amounts of alcohol, * having undergone general anesthesia in the month prior to pre-selection, * receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters, * having serious or acute disease likely to influence study results or involved in life time, * presenting allergy or hypersensitivity to milk proteins, or refusing to consume them, * refusing to stop his/her consumption of enriched plant sterol trade products during the study, * in a situation which in the investigator's opinion could interfere with optimal participation in the present study or could constitute a special risk for the subject, * for female subjects: likely to change her hormonal substitutive treatment, * currently in an exclusion period following participation in another clinical trial.

Keywords: plant sterol - hypercholesterolemia - dairy - meal
enhanced consent and preparedness for surgery trial

Conditions: Stress Urinary Incontinence; Urge Incontinence; Pelvic Organ Prolapse

Summary: to develop an audiovisual decision aid (avda) to improve the informed consent process. the investigators aim to examine the impact of a comprehensible avda that is written below the 8th grade reading level. the avda would be used for surgical consent compared to traditional verbal consent. additionally, the investigators plan to determine whether this effect varies across the measured levels of health literacy of our patients.

to address the limitations of consent, interventions have been developed to improve the quality of information provided to patients including written pamphlets, videos, and websites. such interventions have been called decision aids. decision aids may promote informed consent through greater knowledge and consistency of personal values or attitudes with an enacted choice. providing adequate information increases satisfaction, more rapid symptom resolution, reduced emotional distress, reduced use of analgesia, and possibly shorter hospital admissions. cochrane reviews have established that audiovisual decision aids enhance informed surgical consent, yet little data exists about the benefits of such aids in female pelvic medicine and reconstructive surgery (fpmrs)4.

Eligibility criteria:
inclusion criteria: * patients electing for surgical intervention of pelvic organ prolapse, stress urinary incontinence, urgency urinary incontinence by treating physicians in the female pelvic medicine \& reconstructive surgery. exclusion criteria: * patients ≤ 18 years old * non-english speaking patients * patients with video or audio impairments who are unable to view the avda
description of lymphatic damage in encephalic venous thrombosis and strictures in mri a reverse-recovery sequence: a pilot study

Conditions: Description of Local Modifications of Lymph Nodes or Bundles With the FABIR Sequence in MRI

Summary: inclusion (j0): * information * verification of inclusion and non-inclusion criteria * collection of consent * mri examination with injection of contrast product as part of the treatment comprising the sequences: t1 tfe 1.0 iso 3d flair injected injected elliptical venous angiography 0.4mm iso or less 3d swip multiecho 3d t1 injected fabir iso without injection (added as part of care in case of suspected ash or meningitis) flair 1.0 without injection (added as part of care for suspected ash or meningitis) t2 bffe xd (added by search) fabir iso injected (added by research) 3d pd t1 0.55 msde iso injected (added by research) clinical information (srm on inclusion, on discharge and at 3 months and recurrence within the year) will be collected from the patient's medical file


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * performing an mri injected as part of care for one of the following reasons: * suspicion of pathology likely to be associated with narrowing or obstruction of one or more venous sinuses (cerebral thrombophlebitis, tissue damage with venous extension, idiopathic hic * venous narrowing or obstruction proven by one of the above pathologies, requiring as part of routine care an injected mri (search for impact, monitoring, pre-therapeutic assessment or prognosis) * express consent to participate in the study * affiliate or beneficiary of a social security scheme exclusion criteria: * absolute contraindication to mri * patient benefiting from a legal protection measure * pregnant or breastfeeding woman