Kornimate/medical-research-clean huggingface dataset:
development and evaluation of e-training and mentoring support program on dementia care for home-care workers

Conditions: Dementia

Summary: this study evaluate the effects of three-month dementia care e-training and mentoring support program on home-care workers using a two-group randomized controlled trial.

home care staff often have insufficient knowledge and skills of caring people with dementia at home. many training courses for home care staff are not developed according to their educational background and workplace needs. an innovative evidence-based online training with peer support program in dementia care was developed and consists of online cloud platform with various training courses and resources, on-the-job mentoring support by senior peers, and social networking in dementia care. they can access to the online cloud platform by computers or smart phones anytime for immediate access to information in dementia care. they can also consult with senior peers for care problems by social network platform and attend monthly dementia care forum. the interventional group attendance staff will accept 3-month e-training care online course, which was supervised by the supervisor and participated in the monthly counseling mentoring support group. the control group will accept the traditional dementedness care traditional classroom teaching course and will not accept any e-training . the curriculum and counseling support group will collect information on the knowledge, attitudes, care abilities, work stress and burnout of the two groups in the pre-test, 3rd and 6th months and learn about their effectiveness.

Eligibility criteria:
inclusion criteria: * qualified as a care worker for the elderly welfare law, and at least three months as a home servant, * literacy * can communicate in mandarin and taiwanese, * caring for community clients with cognitive impairment or dementia * willing to participate in the study and provide informed consent exclusion criteria: * if it does not meet the conditions for receiving the case, it will not be included in the study.

Keywords: home-care worker e-training mentoring support
safety and efficacy study of brimochol™ pf and carbachol pf in subjects with emmetropic phakic and pseudophakic presbyopia

Conditions: Presbyopia

Summary: safety and efficacy study of brimochol™ pf and carbachol pf in subjects with emmetropic phakic and pseudophakic presbyopia

multicenter, double-masked, randomized, safety and efficacy study of brimochol™ pf and carbachol pf topical ophthalmic solution with emmetropic phakic and pseudophakic presbyopia

Eligibility criteria:
inclusion criteria: * male or female in good general health * must have presbyopia exclusion criteria: * history of allergic reaction to the study drug or any of its components * any disease or medical condition that, in the opinion of the investigator, would prevent the subject from participating in the study or might confound study results
identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy (idea sein)

Conditions: Breast Cancer

Summary: biomarkers of resistance to neoadjuvant chemotherapy in locally advanced breast cancer

identification and evaluation of biomarkers of resistance to neoadjuvant chemotherapy and establishment of preclinical models of resistance in locally advanced breast cancer

Eligibility criteria:
inclusion criteria: * proven invasive breast adenocarcinoma (cytology and / or biopsy). * locally advanced stage (tumor size greater than 2 cm). * neoadjuvant chemotherapy indication validated rcp * patient eligible for neoadjuvant chemotherapy. * performance index according to who or less 1. * patient aged 18 years and older. * being affiliated to a social security scheme or an equivalent scheme of social protection * obtaining signed informed consent, and that before any specific prequalification testing. exclusion criteria: * presence of metastatic disease at diagnosis. * breast cancer inflammatory. * rare histologic subtypes (non ductal lobular and not). * other cancer (except basal cell skin carcinoma and cancer of the cervix in situ adequately treated and curative) treated in the previous 5 years. * patient pregnant or nursing or of childbearing age without effective contraception. * breast cancer in men. * legal incapacity or limited legal capacity. medical or psychological conditions allowing the subject to complete the study or to sign the consent (art. l.1121-6, l.1121-7, l.1211-8, l1211-9).
chyle leak after pancreatic surgery

Conditions: Postoperative Chyle Leak

Summary: currently it is unclear whether postoperative chyle leak (cl) after pancreatic surgery requires treatment. thus, the present study aims to compare dietary treatment of cl with drain removal despite of persistent cl.

with an incidence of up to 11%, postoperative chyle leak (cl) is a frequent phenomenon after pancreatic surgery, where extensive lymph node dissections are indispensable. postoperative cl is frequently treated with either medium-chain triglyceride diet (mct-diet) or total parenteral nutrition (tpn). ignoring cl and removing the surgical drains irrespective of cl may also be discussed. while dietary restrictions are known to hinder postoperative convalescence and prolong the length of stay at the hospital, recent retrospective data show that leaving cl untreated is not associated with an increased morbidity rate. more precisely, removing the surgical drains irrespective of cl does not result in an increased incidence of ct-guided drainages. however, prospective data on cl after pancreatic surgery do not exist in the literature. accordingly, the present trial aims to compare treatment of cl with dietary restrictions to removing the surgical drains irrespective of cl.

Eligibility criteria:
inclusion criteria: * written informed consent * pancreatic surgery of any kind exclusion criteria: * liver cirrhosis \> child-pugh grade a * history of portal vein thrombosis * portal hypertension dropout criteria: * irresectable tumor (no surgical resection) * biochemical leak or postoperative pancreatic fistula (popf)5 * serous drainage on pod 5 * peritoneal carcinomatosis * portal vein thrombosis * postoperative bile leak * drain volume \>1000ml on pod5

Keywords: pancreatic surgery chylous ascites
long-term observational study of subjects from tanezumab studies who undergo a total knee, hip or shoulder replacement

Conditions: Osteoarthritis

Summary: a4091064 is a multicenter, long-term observational study of subjects from tanezumab interventional studies (regardless of treatment group) who undergo a total knee, hip or shoulder replacement during participation in the study. the study is designed with a total duration of subject follow-up of 24 weeks after the total joint replacement surgery. there will be two methods of data collection utilized in this study: interview by site staff via the telephone and interactive web-response system (or paper if the subject has no access to the internet).

a4091064 is a long-term observational follow up study of subjects from tanezumab interventional studies a4091056, a4091057 or a4091058.

Eligibility criteria:
inclusion criteria: * personally signed and dated informed consent document. * randomized and treated with subcutaneous investigational product in a tanezumab study and has completed the study or been withdrawn from the study. * actual or planned total knee, hip or shoulder replacement surgery during the tanezumab study. * willing and able to comply with scheduled visits and other study procedures. exclusion criteria: - none.
association of dihydropyrimidine dehydrogenase (dpyd) variants with toxicity related to capecitabine

Conditions: Breast Cancer

Summary: the goal of this laboratory research study is to identify possible differences in a gene among patients with breast cancer that cannot be treated by surgery. researchers want to find out if differences in this gene may increase the risk of side effects from capecitabine.

if you agree to take part in this study, 1 blood sample (about 2 tablespoons) will be drawn for use in genetic research. if you are unable to provide a blood sample, researchers will collect leftover tissue samples from your previously collected tumor tissue (from the time of the breast cancer diagnosis). the tumor samples will be used for genetic research. after the blood draw or tissue collection, your participation in this study will be over. the blood samples for the genetic research will be stored at myriad laboratories. before your blood and/or tissue is sent to myriad laboratories for banking, your name and any personal identifying information will be coded to protect your privacy. m. d. anderson will not have oversight of any leftover tissue and/or blood that will be banked by myriad laboratories for additional research. this is an investigational study. up to 210 patients will take part in this study. all will be enrolled at m. d. anderson.

Eligibility criteria:
inclusion criteria: 1. patients must be registered for protocol id 01-580 and only patients who were randomized to receive capecitabine will be included in the study. 2. patients must sign an informed consent for this protocol. exclusion criteria: 1) there are no exclusion criteria.

Keywords: breast cancer dihydropyrimidine dehydrogenase dpyd dpyd variants toxicity capecitabine xeloda
circulating tumor material in colorectal cancer and melanoma

Conditions: Colorectal Cancer and Melanoma

Summary: observational study to allow the collection of blood and medical information to evaluate the role of circulating tumor material in patients with colorectal cancer and melanoma


Eligibility criteria:
inclusion criteria: * the subject must be a patient at the hospital of the university of pennsylvania 1. patients with presumed stage ii, iii, or iv colorectal cancer with planned surgical resection of either the primary tumor or metastatic lesion(s) being evaluated at the hospital of the university of pennsylvania 2. patients with histologically confirmed melanoma stage iib, iic, iiia, iiib, or iiic/iv scheduled for surgical resection being evaluated at the hospital of the university of pennsylvania. * the subject must be able to provide informed consent or have an acceptable surrogate capable of giving consent on the subject's behalf. * the subject must be 18 years of age or older. exclusion criteria: * the subject is not able to provide informed consent.
gemcitabine and epirubicin in treating patients with malignant mesothelioma

Conditions: Malignant Mesothelioma

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining gemcitabine and epirubicin in treating patients who have malignant mesothelioma.

objectives: * determine the antitumor activity of gemcitabine and epirubicin in patients with malignant pleural mesothelioma. * determine the toxicity of this regimen in this patient population. * determine the time to progression and overall survival of patients treated with this regimen. * assess quality of life in patients treated with this regimen. outline: this is a multicenter study. patients receive gemcitabine iv over 30 minutes on days 1 and 8 and epirubicin iv on day 1. treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity. patients achieving complete response (cr) receive 2 additional courses beyond cr. quality of life is assessed at baseline, prior to course 3, at 3 months, and then at 1 year. patients are followed every 3 months for 1 year, every 4 months for 1 year, and then every 6 months for 3 years.

Eligibility criteria:
disease characteristics: * histologically or cytologically confirmed malignant pleural mesothelioma * at least 1 measurable lesion that can be accurately measured in at least one dimension * at least 20 mm (2 cm) in diameter patient characteristics: age: * 18 and over performance status: * ecog 0-2 life expectancy: * at least 12 weeks hematopoietic: * absolute neutrophil count at least 1,500/mm\^3 * platelet count at least 100,000/mm\^3 hepatic: * bilirubin no greater than 1.5 times upper limit of normal (uln) * ast no greater than 3 times uln renal: * creatinine no greater than 1.5 times uln cardiovascular: * lvef at least 50% * no history of congestive heart failure * no new york heart association class iii or iv heart disease other: * no uncontrolled infection * no other severe underlying disease that would preclude study participation * no other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, noninvasive carcinomas, or localized prostate cancer * not pregnant or nursing * negative pregnancy test * fertile patients must use effective contraception during and for 6 months after study participation prior concurrent therapy: chemotherapy: * no more than 1 prior chemotherapy regimen for malignant pleural mesothelioma * no prior gemcitabine or anthracyclines other: * no concurrent cimetidine

Keywords: localized malignant mesothelioma advanced malignant mesothelioma recurrent malignant mesothelioma
vaginal misoprostol versus bilateral uterine artery ligation in decreasing blood loss in trans-abdominal myomectomy

Conditions: Vaginal Misoprostol and Bilateral Uterine Artery Ligation in Decreasing Blood Loss in Trans-abdominal Myomectomy

Summary: the study aims at comparison between the effect of preoperative misoprostol and bilateral uterine artery ligation regarding their effect to decrease blood loss in transabdominal myomectomy.


Eligibility criteria:
inclusion criteria: * women in the reproductive age (20-40 years) diagnosed as having uterine fibroids who are consenting to have trans- abdominal myomectomy in the postmenstrual period diagnosed by: clinical symptoms and signs: * abnormal uterine bleeding (menorrhagia or/and metrorrhagia) * pain (dull aching lower abdominal pain or dysmenorrhea) * pressure symptoms (dyspareunia, dysuria, dyschezia or /and backache) * progressive abdominal enlargement (abdominal swelling) ultrasound (abdominal or transvaginal) to confirm the clinical diagnosis: * maximum diameter of the largest fibroid is greater than 4 cm * maximum number of uterine myomas is not to be more than 5 myomas * uterine fibroid may be subserous or intramural exclusion criteria: * obesity (bmi \>30 kg/m2) * cardiac, endocrine, pulmonary or hematological disease (including anemia; hemoglobin level below 10 gm/dl) * patients known to be allergic to prostaglandin preparations * patients who received preoperative hormonal therapy (gnrh analogue) * patients presented by or with suspected malignant gynecological disease patients diagnosed as having submucous uterine fibroids, cervical or supracervical fibroids, broad ligamentary fibroids and pedunculated fibroids patients with contraindication to general anaesthesia * patients with positive pregnancy test * virgin patients
effects of single doses of gw784568x on allergic rhinitis symptoms in male subjects whilst in an environmental chamber

Conditions: Rhinitis, Allergic, Perennial

Summary: this study was designed to look at safety aspects and effects of intranasal doses of gw784568x on allergic rhinitis symptoms to develop this drug for its use in people who suffer with allergic rhinitis

a randomised, placebo-controlled, 4-period, incomplete block, crossover study of 7 days dosing of intranasal gw784568x (100mcg, 200mcg and 400mcg od), fluticasone propionate (200mcg od) and placebo (blinded for gw784568x vs placebo) to evaluate the efficacy and safety using an environmental chamber in male subjects with allergic rhinitis

Eligibility criteria:
inclusion criteria: * healthy with exception of seasonal rhinitis. may also have mild asthma. * weight greater than or equal to 50kg * non-smoker for at least 12 months exclusion criteria: * history of frequent nosebleeds * have participated in another trial in the last 30 days. * have donated blood in the previous 3 months * have used prescription or non prescription drugs within last 7 days * have history of alcohol/drug abuse within last 12 months * have positive hepatitis b or c test within 3 months of screening * subject tested positive for hiv

Keywords: environmental challenge chamber gw784568x intranasal
nurse assisted post-discharge intervention in decompensated cirrhosis

Conditions: Liver Cirrhosis

Summary: in a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis compared with standard follow-up will be investigated.

since 1970 the mortality from cirrhosis has increased with 26.7 %, with a 50% mortality rate within 2 years of diagnosis. grave complications result in functional impairment and reduced quality of life. 20-37 % of patients with liver cirrhosis are readmitted less than 30 days after a hospitalization for decompensation. these patients have a higher 90-day mortality rate than those who avoid readmission. re-admissions have great personal-, societal- and economic consequences. in a randomized controlled trial, the effects of a nurse-driven post-discharge intervention for patients with liver cirrhosis, compared with standard follow-up will be investigated. the intervention, based on concepts from family nursing, will comprise three home-visits within eight weeks after discharge including therapeutic conversations focusing on strengthening participants' family relationships and social networks, disease education and help to initiate contact to municipal offers. after 12 weeks the participants will be followed-up by telephone.

Eligibility criteria:
inclusion criteria: * patients diagnosed with liver cirrhosis and one or more complications hereto during admission to the gastro unit, ahh. complications include, but are not limited to: hepatic encephalopathy, infection, ascites, edema, kidney failure, upper or lower gi bleeding. * patients must read and understand danish. * adults \>18 years. exclusion criteria: * when the diagnosis of liver cirrhosis is questioned with reasonable doubt or the diagnosis of liver cirrhosis is disproved by histology or relevant imaging. * patients with comorbidity as the primary diagnosis and where an independent rehabilitation or post-discharge program is offered, for example hip fracture, chronic obstructive pulmonary disease etc. * patients diagnosed with an active and invasive malignant disease. * residency outside the catchment area of amager hvidovre hospital.
crossover rct of tamer lenses in myopia control

Conditions: Myopia; Progressive

Summary: this study is a prospective, randomized, crossover clinical trial with a planned proposed enrollment of 120 chinese male and female subjects aged 6-12 years without systemic or ocular diseases to follow up their cycloplegic equivalent spherical lens power and other relevant indices in order to determine the role of tamer lenses in myopia control as compared to singlie vision lenses.


Eligibility criteria:
inclusion criteria: * race: chinese children and adolescents. * age 6-12 years, gender unrestricted. * cycloplegic refraction ser: -0.75ds\~-5.0ds in both eyes. * best corrected visual acuity of both eyes reaches 0.8 (0.00 logmar). * cylinder power and astigmatism are no more than 1.5d. * during the study period, willing to wear glasses provided by the researcher only and without additional interventions. * willing to be randomly assigned. * able to sign an informed consent form with the accompaniment and understanding of parents or guardians. exclusion criteria: * allergic or intolerant to medications used for cycloplegia. * received any nearsightedness treatment such as atropine, rigid gas permeable contact lens, bifocal/progressive lens, red light therapy, or acupuncture within half a year before the study. * diagnosed with any eye disease other than nearsightedness, including strabismus, corneal diseases, conjunctival or eyelid damage or other conditions (such as keratoconus, herpes simplex keratitis, etc.). * history of eye surgery (including strabismus correction surgery). * eye or systemic diseases that might be associated with nearsightedness or its progression, such as marfan syndrome, retinopathy of prematurity, diabetes, etc. * anatomical or dermatological factors that may interfere with the wearing of spectacle frames. * other reasons that the researcher deems inappropriate for the participant to be included in the study, such as excessively high expectations for the effectiveness of defocus lenses, or plans to use other nearsightedness intervention strategies simultaneously with the study.
novel mri and biomarkers in golimumab-treated patients with axial spondyloarthritis

Conditions: Axial Spondyloarthritis

Summary: the study investigates different criteria for remission based on mri and circulating biomarkers for inflammation, cartilage, connective tissue and bone turnover in patients with axial spondyloarthritis treated with golimumab. furthermore, the study also investigates factors that affect disease activity, function and participation by use of different questionnaires.


Eligibility criteria:
inclusion criteria: * axial spondyloarthritis according to the assessment of spondyloarthritis international society (asas) classification criteria for axial spondyloarthritis * sacroiliitis on conventional x-rays or magnetic resonance imaging (mri). * disease activity assessed by bath ankylosing spondylitis disease activity index (basdai) \>40 mm despite treatment with non-steroidal anti-inflammatory drugs (nsaid). * clinical indication for tumor necrosis factor (tnf) inhibitor treatment by the treating physician. exclusion criteria: * no contraindications for tnf inhibitor * no contraindications for mri * no contraindications in participation in a study
efficacy and tolerance of potassium hydroxide (10% and 15%) in molluscum contagiosum

Conditions: Molluscum Contagiosum

Summary: background: molluscum contagiosum is a non-serious children viral infection. because of its natural history, being highly contagious and the aesthetic and psychotherapeutic effects of its treatment, the investigators intend to test the use of different concentrations of potassium hydroxide solution in the primary care setting. methods: a double blind, randomized clinical trial, in three groups of topic treatment is designed. the intended treatment consists on a daily application of potassium hydroxide in aqueous solution at 10% and 15% concentration, versus a placebo administered to the control group. 4 follow-up visits (15, 30, 45 and 60 days) are planned to evaluate treatment effectiveness and tolerance. the main target of the trial is to determine the healing rate, defined as lesion disappearance in the affected zones after the topic application of the treatment. secondary targets are the main characteristics and evolution of the affected zone (surface, number of lesions, size and density) description, tolerance evaluation (hyperpigmentation, itching, burning, pain), recurrence rate estimation and natural evolution of lesions in the control group.


Eligibility criteria:
inclusion criteria: * who are diagnosed with a molluscum contagiosum (mc) infection (clinical diagnosis). * who are between the ages of two and six. * whose parents or guardians have provided written informed consent for participation. exclusion criteria: * immunocompromised patient (congenital or acquired). * patient has received other topical treatment within the last month. * patient has lesions on face, neck or genital area. * patient who, in the view of the attending physician, will not comply with treatment and/or scheduled visits.

Keywords: potassium hydroxide. molluscum contagiosum