Kornimate/medical-research-clean huggingface dataset:
ibuprofen versus mecillinam for uncomplicated cystitis

Conditions: Acute Cystitis (Excl in Pregnancy)

Summary: although uncomplicated cystitis is considered to be a mild condition and mostly self limiting, most patients who see a doctor will be treated with antibiotics. antibiotics are known to give a quick relief of symptoms and shorten the course of the condition by a few days. the aim of this study is to evaluate ibuprofen versus mecillinam in the treatment of uncomplicated cystitis in otherwise healthy, non-pregnant women. our main objective is to see whether symptomatic treatment with ibuprofen is equally efficient as treatment with mecillinam in this group.

the design of the study will be a double blinded randomized controlled trial (rct). half of the patients will receive treatment with mecillinam and the other half will receive treatment with ibuprofen. the study will follow the principles of good clinical practice (gcp). urine cultures will be obtained on day one and after two weeks. the patients will be given a diary where they daily will register symptom load, possible complications or adverse effects and on which day they feel completely cured. we will contact the patients after two weeks to make sure they have followed the study procedures. after four weeks we will perform a final interview with the patient.

Eligibility criteria:
inclusion criteria: * woman between 18 and 60 years of age * dysuria and pollakiuria and/or urinary urgency * ability to give written consent exclusion criteria: * pregnancy/breastfeeding child under one month of age * diabetes * kidney disease * organic aciduria * clinical suspicion of pyelonephritis; fever, reduced general condition, upper back pain * vaginal symptoms such as discharge or irritation * severe abdominal pain * symptoms that have lasted for more than seven days * one or more urinary tract infections within the lasts four weeks * permanent bladder catheter or use of bladder catheter within the last four weeks * use of antibiotics within the last two weeks * participated in a clinical trial within the last four weeks * previously undergone a pyelonephritis * previous allergic reaction to penicillin * previous allergic reaction to ibuprofen, or worsening of asthma when using nonsteroidal antiinflammatory drugs(nsaids) * narrow oesophagus * use of the drug probenecid * severe gastritis or previous ulcer * anticoagulative treatment * ongoing use of steroids * use of immunosuppressant drugs * thrombocytopenia, * chrohn's disease or ulcerative colitis * heart insufficiency * severe psychiatric illness or dementia * severe drug addiction * unable to communicate in norwegian, swedish or danish language
texts for diabetes control among homeless persons

Conditions: Diabetes Mellitus

Summary: this mixed method study includes a randomized controlled trial (rct) and qualitative methods to assess the impact of a sms text strategy in diabetes control among persons who experience homelessness.

diabetes mellitus (dm) is common among persons experiencing homelessness (peh), often inadequately managed, and carries significant costs. sms strategies for dm have not been tested among peh despite the accessibility of mobile phones. this study uses a sms strategy to offer better communication, education, and information management; improve outreach; facilitate care coordination; explore barriers to care; and support behavior changes. this mixed-methods (rct and qualitative) study will be implemented in shelter-clinics in new york city in collaboration with community organizations, allowing for sustainability and scalability. aim 1 will evaluate the efficacy of a 6-month sms program for dm management versus an attention control on changes in hba1c and adherence to dm self-care activities, medications, and appointments at 9 months in adult peh with uncontrolled dm (n=100). outcomes will be measured at 0, 3, 6, \&9 months. aim 2 will assess patients' and providers' attitudes, acceptability, and experience of the program through semi-structured interviews with peh and providers.

Eligibility criteria:
inclusion criteria: * homeless person age ≥ 21 * diagnosed with type 2 dm * most recent visit hba1c ≥ 8% * english/spanish speaking * connected to study sites' shelter-clinics for care exclusion criteria: * pregnant or within 3 months postpartum * has an uncontrolled severe illness * has had a heart attack or stroke in the previous 6 months * inability to read/respond to texts * inability to provide informed consent * receiving inpatient care for severe substance abuse

Keywords: diabetes homelessness sms text mobile health clinical trial health disparities
the ability of octenilin® to reduce odour of malodorous wound

Conditions: Wound; Wound Heal

Summary: malodours are a common complication of chronic wounds. they are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. wound odour has a big impact on the quality of life of patients. currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. the application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. one suggested antiseptic in a recent published standard is octenilin®. there is ample anecdotal evidence about the efficacy of octenilin® in reducing wound odour. therefore, we propose here to document this ability by evaluating the odour of wounds washed with octenilin® versus standard care (nacl 0.9% solution).

malodours are a common complication of chronic wounds. they are the result of the proliferation of aerobic and anaerobic micro-organisms on the wound surface, where they metabolize healthy tissue which leads to the production of sloughy and even necrotic tissue. wound odour has a big impact on the quality of life of patients. patients describe living with a chronic malodourous wound as devastating particularly in respect to social interaction. the key to addressing the negative consequences of malodorous and/or discharging wounds is an effective wound managements plan based on accurate and holistic assessment of the patient and the wound. currently the standard of care for the management of malodourous wounds are systemic antibiotics, absorbent wound dressings with or without activated carbon and, topical antimicrobials. the application of topical antimicrobials such as antiseptics against wound odour is part of the standard care. one suggested antiseptic in a recent published standard is octenilin®. octenilin® wound cleansing solution is on the swiss market since 2006 and is routinely used in outpatient wound care centers. it exhibits good performance in the reduction of biofilm's pathogens and has excellent moisturizing properties. while there is ample anecdotal evidence about the efficacy of octenilin® in reducing wound odour, we propose here to document this ability by evaluating the odour of wounds washed with octenilin® versus standard care (nacl 0.9% solution).

Eligibility criteria:
inclusion criteria: * a chronic malodourous wound * age over 18 years * proficiency in the french language exclusion criteria: * valid informed consent is not or cannot be given * patients needing dressings with silver * patients needing charcoal dressings * patients under antibiotic treatment

Keywords: odour wound care
prediction of radiotherapy efficacy in patients with triple-negative breast cancer

Conditions: Triple-negative Breast Cancer

Summary: recurrence of triple-negative breast cancer (tnbc) occurs in around 30% of patients within 3 years of treatment. for some tnbc patients, recurrence occurs on average 2.6 years after treatment, while for others recurrence does not occur early. tnbc patients can therefore be divided into two groups: those with early recurrence and those who respond well to treatment. at present, there are no biomarkers to differentiate these two groups. some studies suggest that radiation-induced inflammatory cytokines may stimulate the development of new metastases. gene expression profiling or protein signatures have not been able to define such biomarkers. the aim of this research protocol is to recruit patients to evaluate if the elevation of the cytokines il-1β, il-5 and il-6 in plasma collected during radiotherapy can be used to predict tnbc patients at high risk of recurrence.


Eligibility criteria:
inclusion criteria: women with tnbc breast cancer who meet the following criteria: * women aged 18 and over; * any tumor size (pt stage); * regional lymph node pn0 to pn3; * patient with pathologically confirmed tnbc (estrogen and progesterone receptor negative and her2 negative); * neo- or adjuvant chemotherapy followed by radiotherapy; * no evidence of distant metastasis at time of diagnosis; * primary tumor removed by conservative surgery with negative margins; * patient covered by the french social security system (for french patients). exclusion criteria: * distant metastasis at the time of diagnosis; * pregnant or breast-feeding women; * woman deprived of liberty, under guardianship or trusteeship. * patient unable to give consent * patient unable to speak french * patients unable to undergo regular long-term surveillance.

Keywords: radiotherapy
single and multiple dose evaluation of abt-072 and to evaluate the effect of food on the pharmacokinetics of abt-072

Conditions: Hepatitis C

Summary: to assess the safety, tolerability and pharmacokinetics of the abt-072 tablet formulation administered as a single dose and then administered as multiple doses for 7 days. the effect of food on the safety, tolerability and pharmacokinetics of the abt-072 tablet will also be evaluated.

the study consists of two substudies. substudy 1 is a two-period, single ascending dose (sad) and multiple ascending dose (mad) blinded, randomized, placebo-controlled, non-fasting study. designated groups that participate in period 1 (sad) will also participate in period 2 (mad). substudy 2 is an open-label, randomized two-period, crossover study to examine the effect of food on the pharmacokinetics of abt 072.

Eligibility criteria:
inclusion criteria: * overall healthy subjects, non-childbearing females included. exclusion criteria: * use of any medications (prescription and over-the-counter), vitamins, or herbal supplements within the 2-week period prior to the first dose of study drug administration or within 10 half-lives of the respective medication, whichever is longer. * pregnant or breast-feeding female. * positive test result for hepatitis a virus immunoglobulin m (hav-igm), hepatitis b surface antigen (hbsag), hepatitis c virus antibody (hcv ab), or hiv antibodies (hiv ab). * positive screen for drugs of abuse, alcohol, or cotinine. * clinically significant cardiovascular, respiratory (except mild asthma), renal, gastrointestinal, hematologic, neurologic, thyroid, or any uncontrolled medical illness or psychiatric disorder. * use of tobacco or nicotine-containing products within the 6-month period preceding study drug administration.

Keywords: phase 1 single and multiple ascending dose food effect
first-line treatment of p53 mutation with pd-l1 expression in dlbcl with anti-pd-1 mab and r-chop

Conditions: Diffuse Large B-Cell Lymphoma

Summary: diffuse large b-cell lymphoma (dlbcl) is the most common type of lymphoma。the majority of refractory patients have pd-l1 expression due to p53 mutations, some of which account for about 10% of dlbcl.our department has found that in refractory dlbcl with high pd-l1 expression, cedilizumab monotherapy is also more effective and has reversed chemotherapy resistance.the aim of this study was to determine whether the addition of sindilizumab to the r-chop regimen could improve the objective efficiency of dlbcl patients with p53 mutation with pd-l1 expression and to see if it could prolong patient survival.

this study is a randomized, open, multicenter clinical study to determine whether the addition of sindilizumab to the r-chop regimen could improve the objective efficiency of dlbcl patients with p53 mutation with pd-l1 expression and to see if it could prolong patient survival.in this study, patients with p53 mutation with pd-l1 expressing dlbcl were selected to be randomised 1:1 into 2 groups: group a sindilizumab + r-chop and group b r-chop. sindilizumab was administered on day 10 after chemotherapy to avoid interference from prednisone.at the end of 6 cycles, group a treatment effective maintenance treatment with sindilizumab for 6 months as indicated.each patient's tumour tissue was tested for mutations and ctdna after allocation, and ctdna and peripheral blood free pd-l1 levels were monitored dynamically during and after treatment.

Eligibility criteria:
inclusion criteria: 1. ages≥18 years, ≤ 80 years. 2. patients with primary treatment of dlbcl. 3. histopathologically confirmed diagnosis of diffuse large b-cell lymphoma. 4. at least one measurable lesion according to the 2014 lugano criteria. 5. ecog physical status score of 0, 1 or 2. 6. laboratory tests meet the following criteria unless judged to be due to lymphoma: 1. routine blood tests: (in the absence of growth factor support therapy or blood transfusion within 7 days) haemoglobin ≥ 90 g/l, absolute neutrophil value ≥ 1.5 x 109/l, platelet count ≥ 90 x 109/l. 2. liver biochemistry: serum creatinine ≤ 1.5 x upper limit of normal; total bilirubin ≤ 1.5 x upper limit of normal; glutamate transaminase and glutamic oxalacetic transaminase ≤ 2.5 x upper limit of normal. 3. coagulation: inr and aptt ≤ 2.5 times the upper limit of normal values. 7. consent to use contraception during the trial and for 3 months after its completion. 8. expected survival ≥ 3 months. exclusion criteria: 1. suffering from other untreated malignant tumours. 2. cardiovascular disease that remains unstable under pharmacological control . 3. with severe interstitial lung disease. 4. with cognitive impairment. 5. patients with uncontrolled autoimmune disease. 6. presence of uncontrolled active infection. 7. expected survival time \< 3 months. 8. lactating women and subjects of childbearing age who do not wish to use contraception. 9. with poor adherence or unable to follow up regularly.
transcranial direct current stimulation and robotic therapy in upper limb motor recovery after stroke

Conditions: Stroke

Summary: the objective of the study is to evaluate the effectiveness of transcranial direct current stimulation (tdcs) integrated with wrist robot-assisted treatment. in detail, the anodal stimulation on the impaired hemisphere will be used associated with a robotic treatment.

as for transcranial direct current stimulation a hdc kit (ates/eb neuro, firenze, italy) will be used as device. it is a new device generation of stimulator able to provide an effective stimulation pattern. as robotic device the inmotion wrist robot (interactive motion technologies inc., watertown, ma, usa) will be used. it is an end-effector robotic device able to assist as needed the wrist movements.

Eligibility criteria:
inclusion criteria: 1. persons affected by first supratentorial stroke, whose onset time is 25±7 days; 2. upper limb hemiparesis; 3. cognitive and speech abilities sufficient to understand instructions and to provide informed consent; 4. absence of intense pain due to passive wrist mobilization assessed by vas \< 3 (range 0-10); 5. ability to provide written informed consent. exclusion criteria: 1. previous epilepsy seizures; 2. severe electroencephalographic anomalies; 3. previous neurosurgery interventions involving metallic elements placement; 4. ongoing anticonvulsant drugs treatment 5. inability to keep sitting posture; 6. severe sensory deficits; 7. general clinical complication preventing delivery of rehabilitation treatment.
the effect of abpm on sleep disturbance

Conditions: Blood Pressure Monitoring, Ambulatory

Summary: ambulatory blood pressure monitoring (abpm) is an ideal tool for the diagnosis and evaluation of hypertension.however, abpm frequently measures the tightening feeling and buzzing sound of the blood pressure cuff during nighttime, which can cause the patient to wake up easily during sleep, which will affect the sleep of the patient. moreover, improper awakening of the patient from sleep can significantly increase the patient's blood pressure and affect the accuracy of abpm monitoring. the effect of abpm on sleep disturbance (embed) study is designed to examine whether abpm affects sleep, as well as the relationship and influencing factors of sleep and abpm results, and screening for people who are susceptible to abpm testing.

participants who accept abpm in the second affiliated hospital of zhejiang university school of medicine, will be recruited for embed enrollment. participants will be asked to provide basic background information and to fill out the stop-bang evaluation form. anxiety, depression, insomnia, sleep questionnaire and pain assessment scale for cuff inflation are used to assess characteristics of participants and their sleep quality. before abpm starts, office blood pressure of participants will be measured. participants will undergo abpm under standardized guidance. at the end of abpm, participants will be asked to fill in sleep questionnaire and pain assessment scale for cuff inflation again. embed proposes to study whether abpm affects sleep, as well as the relationship and influencing factors of sleep and abpm results, and screening for people who are susceptible to abpm testing. a better understanding of interaction between abpm and sleep will help us further evaluate the accuracy of abpm and more precisely control diurnal hypertension in the future.

Eligibility criteria:
inclusion criteria: 1. signed written informed consent 2. age 18-80 years 3. capable of understanding the test and cooperating with the questionnaire. exclusion criteria: 1. history of psychosis, including schizophrenia, bipolar disorder, depression, anxiety, obsessive-compulsive disorder, phobia, somatoform disorder, stress-related disorders 2. history of insomnia, currently with medication 3. history of obstructive sleep apnea (osa) 4. history of other sleep disorders, including narcolepsy/hypersomnias, circadian rhythm sleep disorder, parasomnias, sleep-related dyskinesia 5. history of heart failure, that is new york heart association (nyha) class ⅲ-ⅳ 6. history of atrial fibrillation and frequent atrial or ventricular extrasystoles 7. ongoing substance or alcohol abuse 8. currently receiving sedative hypnotic medication within 1 week 9. pregnant women 10. ongoing involvement in night-shift work (22:00-6:00) within 1 week 11. ongoing need of care of families at home that wake during the night within 1 week 12. incomprehensible or unwilling to fill in informed consent or questionnaire

Keywords: ambulatory blood pressure monitoring sleep
measurement of care safety culture in french icu, correlation with the characteristics of morbi-mortality reviews

Conditions: Emergency

Summary: the tools to measure safety culture (cs) have recently become available. no study has focused on the measure in france, apart from pilot studies. intensive services are particularly at risk of serious adverse events occurred (saes). patients who are hospitalized are in fact fragile and precarious clinical condition requires rapid decision taken often. diagnostic or therapeutic strategies have report "risk-benefit" narrow. they may well be complicated by eig.safety of care is a priority in the field of health in general, and especially in intensive care. cs measure in this context seems particularly relevant. the main objective is to describe the cs intensive care units in france. the study will explore the development of the cs level for the units investigated. this study will also describe the main features of rmm practiced in intensive care units in france.


Eligibility criteria:
inclusion criteria: * practicing resuscitation activity (this practice is medical or surgical, pediatric or adult, in public or private sector) * volunteer to participate in the study (agreement of the head of the unit) * for which at least 2 matching / references for the study were identified: * a medical officer, * caregiver responsible (health framework). exclusion criteria: * measurement safety culture done in a period of significant change during a period where the staff and activities of the respondent unit of work is relatively stable. * the responses of professionals to the questionnaire can be influenced by internal factors in their work unit (recent accident occurred, change of close supervision, personnel changes ...) and by factors external to their unit work (establishment certification period, arrival of a new director, recent media coverage of medical accidents ...).
structuring of diabetes care in primary health care

Conditions: Diabetes Mellitus, Type 2

Summary: the aim of this study is to evaluate the effectiveness of reorganization in primary health care teams and individualized glycemic targets for type 2 diabetes.

the prevalence of diabetes is increasing in parallel with the obesity epidemic. diabetes is, therefore, a costly disease for individuals and healthcare system, generating expenses in its management and its complications. also, it has significant social cost related to reduction of productivity. this study will evaluate the effectiveness of a multimodal intervention for primary health care (phc) teams to increase the nurse clinical role and implement individualized glycemic targets and care plan for type 2 diabetes through a pragmatic cluster-randomized clinical trial, with 1:1 allocation of health units in porto alegre, brazil. two study arms will be evaluated: 1) intervention group: will receive a set of proposed actions (redistribution of diabetes care between nurses and physicians, use of the individualized glycemic target calculator and implementation of care recommendations); 2) control group: usual follow-up in phc.

Eligibility criteria:
health care unit: inclusion criteria * health unit has registered at least 50 users diagnosed with type 2 diabetes exclusion criteria: * health units that do not have a doctor and a nurse available on the same shift or do not have at least one doctor and a nurse willing to participate in the study. individuals: inclusion criteria * individuals with type 2 diabetes for at least one year * in person diabetes consultation in the last six months exclusion criteria: * expected survival \< one year
office hysteroscopy and endometrial snip improve intrauterine insemination outcome

Conditions: Infertility

Summary: endometrial injury had been studied before prior to intracytoplasmic sperm injection (icsi) cycles , in cases of repeated implantation failure. it is found that it will improve the implantation rate.

the investigators can combine office hysteroscopy to diagnose hidden endometrial pathology, with hysteroscopically guided endometrial snip from the fundus of the uterus, trying to improve the pregnancy rate.

Eligibility criteria:
inclusion criteria: * 18- 38 years old * at least one patent tube * unexplained infertility, anovulation, mild to moderate male factor infertility * previous failed iui exclusion criteria: * indicated for icsi

Keywords: office hysteroscopy, intrauterine insemination endometrial scrap