Kornimate/medical-research-clean huggingface dataset:
enhancing exercise in breast cancer survivors

Conditions: Breast Cancer

Summary: this study will examine whether or not providing early stage breast cancer survivors with tips on making exercise more enjoyable promotes greater levels of moderate to strenuous exercise.


Eligibility criteria:
inclusion criteria: * no health restrictions on performing moderate to strenuous physical activity * must be 18 years or older and able to give legal consent exclusion criteria: * may not be participating in another research study regarding exercise * restrictions on performing physical activity

Keywords: breast cancer survivor exercise physical activity strenuous exercise moderate exercise enjoyable exercise enjoy exercise breast cancer survivor
ctdna assay in patients with resectable pancreatic cancer

Conditions: Pancreas Cancer

Summary: the purpose of this study is to determine the proportion of positive ctdna -freely circulating tumor dna fragments found in the blood plasma- in patients with pancreatic cancer and to better understand the relationship between possible ctdna biomarkers and patient survival. a successful study may provide preliminary evidence that helps improve future patient care through targeted diagnostics, prognosis, and/or treatment.

the objective of this study is to assess the role of serial ctdna analysis as integrative biomarker in patients with resectable or borderline resectable pancreatic cancer undergoing treatment with curative intent. this is a single arm prospective tissue/blood collection from patients undergoing neoadjuvant treatment and surgery as well as surveillance, plan to accrue up to 50 patients. primary objective is to determine the proportion of ctdna positive in patients with resectable pancreatic cancer and to evaluate the progression free survival (pfs) in subjects with ctdna positive versus ctdna negative. patients who consent to the study will participate in pre-study exams and tests to find out if they can take part in the study. this includes, but is not limited to, a doctor's visit with medical history and physical evaluation, blood work, pregnancy test for those capable of becoming pregnant, and imaging tests. the study itself will include the patient's regular treatment for pancreatic cancer which may include 4 to 6 months of chemotherapy, chemo-radiation, surgery to remove pancreatic cancer, 24 weeks of post operative ctdna surveillance and follow up for 2 years. blood will be drawn at regular time points during this study for ctdna detection. the tumor tissue at diagnosis will be collected to develop a personalized and tumor informed pcr test.

Eligibility criteria:
inclusion criteria 1. newly diagnosed exocrine pancreatic cancer with either pathology or radiology imaging suggestive of adenocarcinoma 2. resectable/borderline resectable pancreatic cancer as defined by the nccn guidelines 3. ≥ 18 years old at the time of informed consent 4. ecog performance status 0 or 1 5. patients who are candidates for neoadjuvant chemo/chemoradiotherapy or upfront surgery are eligible for the study. 6. ability to provide written informed consent and hipaa authorization 7. patients must have a life expectancy of at least 6 months exclusion criteria 1. patients with pancreatic malignant tumor histologically confirmed as neuroendocrine or any other type of malignancies 2. positive pregnancy test, pregnant, or breastfeeding 3. any clinically significant and/or uncontrolled cardiac-related abnormality that would compromise patient safety or the outcome of the study 4. locally advanced or metastatic disease
adequacy of the indication of lipid lowering treatment in primary prevention

Conditions: Cardiovascular Diseases

Summary: objective: to evaluate the impact of an intervention addressed to health professionals to improve the adequacy of lipid-lowering prescription in primary prevention of cardiovascular disease and reducing expenditure in this respect. design: a cluster randomized clinical trial, not blind; data were obtained from medical records and other primary care databases. setting: 279 primary health care teams in catalonia (spain), centers managed by catalan health institute (ics) subjects: population from 35 to 74 years, free of cardiovascular disease, who have been started on lipid-lowering therapy during 2 consecutive years of study. intervention: practitioners in the intervention group may have access, whenever they want and through the computerized medical record program, to personalized information on their assigned patients who have started treatment of cardiovascular primary prevention with lipid-lowering. this information is updated monthly for 12 consecutive months.information will be presented in two different and complementary ways to each practitioner: asynchronous information (the patient is not present when the practitioner receives the information) and synchronous information (the patient is present when the practitioner receives the information). variables: 1. primary outcomes are: * variable retira: new lipid-lowering treatments initiated during the year prior to the intervention, seen as inadequate and withdrawn during the intervention period. * variable evita: new lipid-lowering treatments started during the intervention period and considered as inadequate. 2. secondary outcomes are: * variable cost: total cost of the inadequate new lipid-lowering treatments. * variable record: recording of the cardiovascular risk. 2.other variables: * principal: intervention/control group assignment of health professional. * patient variables: demographic and clinical. * professional variables: quality of care indicators. statistical analysis: descriptive analysis, agreggated at health professional level, will be performed and subsequently multilevel analysis techniques will be used to estimate the effect of intervention according to hierarchic data structure and, in particular, patient variables effect.


Eligibility criteria:
inclusion criteria: * population from 35 to 74 years * free of cardiovascular disease * start on lipid-lowering therapy during 2 consecutive years of study exclusion criteria: * previous treatment with lipid-lowering * history of cardiovascular disease

Keywords: primary care lipid-lowering therapy prescription adequacy primary prevention cardiovascular diseases electronic medical records clinical practice guideline
drug resistance mechanism of enterobacteriaceae and its strategies

Conditions: Carbapenem-Resistant Enterobacteriaceae Infection

Summary: the first aim of this study is to explore the drug resistance mechanism of enterobacteriaceae bacteria and to evaluate the treatment effect of ceftazidime-avibactam (caz-avi) in combination with aztreonam (atm) against metallo-β-lactamases (mbl) producing enterobacterales in vivo. the investigators then use crispr/cas9 technology to remove enterobacteriaceae bacteria resistance and virulence genes

clinical information of subjects, including diseases, departments, medication history, days of hospitalization, and treatment outcomes will be collected; bacterial species names will be identified and drugs sensitivity will be detected; for patients with bloodstream infection of mbl-producing enterobacterales, ceftazidime-avibactam (caz-avi) was administered at the dose of 2.5 g every 8 hours and aztreonam (atm) at the dose of 2 g every 8 hours. the primary outcome measure was 30-day all-cause mortality, while secondary outcomes were clinical failure at day 14 and length of stay (los) after bloodstream infection diagnosis. cox regression analysis, including a propensity score (ps) for receiving caz-avi plus atm, was conducted to assess the primary and secondary outcomes. the crispr/cas9 gene curation technology was used to eliminate the drug resistance and virulence factors of enterobacteriaceae in the mouse intestinal colonization model.

Eligibility criteria:
inclusion criteria: * subjects clinically suspected of infection caused by enterobacterales * subjects with bloodstream infection by mbl-producing enterobacterales exclusion criteria: * infections caused by viruses, fungi, atypical pathogens, and other non-enterobacteriaceae bacteria * subjects who are unwilling to enter the research group

Keywords: carbapenem resistance enterobacteriaceae crispr/cas9
evaluation of immune memory to twinrix or comparator by challenge dose administration 4 years after primary vaccination

Conditions: Hepatitis A; Hepatitis B

Summary: only subjects who participated in the primary study will be invited to participate in the extension phase and the challenge dose phase of this study.


Eligibility criteria:
inclusion criteria: * subjects who the investigator believes that they can and will comply with the requirements of the protocol. * a male or female who completed the primary vaccination phase of the hab-160 study (nct 00603252). * written informed consent obtained from the subject. * if the subject is female, she must be of non-childbearing potential; or, if of childbearing potential, she must be abstinent or have used adequate contraceptive precautions for 30 days prior to vaccination, have a negative pregnancy test and must agree to continue such precautions for two months after the vaccination. exclusion criteria: the following criteria should be checked at the time of study entry. if any apply, the subject must not be included in the study: * use of any investigational or non-registered product (drug or vaccine) other than the study vaccines within 30 days preceding the challenge dose, or planned use during the study period. * history of any hepatitis a or hepatitis b vaccination or infection since the primary vaccination study. * history of allergic disease or reactions likely to be exacerbated by any component of the vaccine. * acute disease at the time of enrolment. * pregnant or lactating female.

Keywords: immune memory combined hepatitis a and b vaccine > 41 years old
women's refusal to participate in a randomized trial involving first-trimester screening for pre-eclampsia: factors associated with refusal and reasons for acceptance and refusal

Conditions: Pregnancy Related

Summary: the main objective is to assess whether there are factors associated with women's refusal to participate in a randomized clinical trial involving first-trimester screening for pre-eclampsia. the secondary objective is to qualitatively evaluate the reasons for acceptance and refusal to participate.

1. determine the acceptance/refusal rate among all women identified, eligible and offered rct. 2. comparison of demographic characteristics between the two groups * group 1: women accepting to participate in rct * group 2: women refusing to participate in rct 3. assessment of motivations for acceptance (based on questionnaire given to women who agree to participate) 4. evaluation of reasons for refusal to participate - obstacles (based on the questionnaire given to women who refuse to participate).

Eligibility criteria:
inclusion criteria : inclusion criteria are the same as for the ranspre trial. any pregnant woman is eligible if: * monofetal pregnancy * between 11 and 14 weeks * legal age * health insurance coverage exclusion criteria : inclusion criteria are the same as for the ranspre trial. a history of pre-eclampsia in a previous pregnancy and a contraindication to aspirin are non-inclusion criteria.

Keywords: refusal clinical trial factors reasons pregnancy pre-eclampsia
vicryl plus and monocryl plus in breast surgery

Conditions: Breast Cancer Surgery

Summary: this is a randomised pilot study comparing conventional sutures (vicryl and monocryl) with antiseptic coated equivalents (vicryl plus andf monocryl plus) in elective breast surgery.


Eligibility criteria:
inclusion criteria: * all patients over 18 years old who attend the cardiff and vale nhs trust for elective breast cancer surgery exclusion criteria: * patients unable to give consent or comply with follow up * patients undergoing surgery for benign disease * patients with inflammatory cancers or skin ulceration * patients having neo-adjuvant chemotherapy or radiotherapy * patients with known allergy to triclosan antiseptic * patients with immune deficiency diseases

Keywords: surgical site infection wound complications suture antiseptic wound closure
break wave(tm) extracorporeal lithotripter first-in-human study

Conditions: Renal Calculi; Urinary Calculi

Summary: this is a prospective, open-label, multi-center, single-arm (non-randomized) study to assess the safety and effectiveness of breaking stones in the upper urinary tract using the sonomotion break wave technology. up to 30 subjects will be included. the procedure will be performed in a hospital surgical environment as an outpatient (without being admitted) or in a non-surgical environment such as a clinic or office procedure room. the procedure will be performed under varying levels of anesthesia ranging from no anesthesia to general anesthesia (fully asleep). stones will be limited to ≤ 10 mm for lower pole stones and ≤ 20 mm everywhere else. safety will be measured by the self-reported occurrences of adverse events, unplanned emergency department or clinic visits, and the need for further intervention. fragmentation will be measured by self-reported stone passage and a comparison of computed tomography (ct) images before and after the procedure.


Eligibility criteria:
inclusion criteria: * individuals presenting with at least one kidney stone apparent on ct. * stones must be within the upper urinary tract. * stones are indicated for swl treatment per the american urology association (aua) 2016 guidelines.8 * stones must be measured under ct to be within the aua 2016 swl guidelines (i.e. ≤ 10 mm for lower pole stones and ≤ 20 mm for non-lower pole stones). exclusion criteria: * acute untreated urinary tract infection or urosepsis. * uncorrected bleeding disorders or coagulopathies. * pregnancy. * uncorrected obstruction distal to the stone. * patients receiving anticoagulants and who are unable or not willing to cease the medication for the break wave procedure. * stones that are not echogenically visible or cannot be positioned within the break wave therapy focus. * individuals belonging to a vulnerable group (pregnant, mentally disabled, prisoner, etc.). * patients unwilling to comply with the follow-up protocol, including post-procedure ct. * individuals under 18 years of age. * anatomic presentations preventing adequate positioning or delivery of the break wave pulse. * calcified abdominal aortic aneurysms or calcified renal artery aneurysms. * solitary kidney * comorbidity risks which, in at the discretion of the physician, would make the patient a poor candidate for the break wave procedure, such as anatomical anomalies that may not be conducive to adequate stone fragment passage.

Keywords: stone lithotripsy calculi
auricular stimulation vs. relaxation for pre-exam anxiety

Conditions: Anxiety

Summary: title of the study: auricular acupuncture (aa) vs. progressive muscle relaxation for pre-exam anxiety - a randomised crossover study study period: 04 / 2015 - 07 / 2015 principal investigator: pd dr. t. usichenko department of anaesthesiology and intensive care, university medicine of greifswald aim of the study: to investigate the anxiolytic effect of aa vs. progressive muscle relaxation and vs. no intervention in students, passing the oral exams in anatomy at the university of greifswald design: prospective randomised crossover trial interventions: 1. aa using indwelling fixed needles, retained 24 h in situ 2. progressive muscle relaxation number of volunteers: n = 30 healthy medical students at the university of greifswald participants of the oral anatomy exams in spring/summer 2015 without previous anxiolytic, sedative and analgesic medication no pregnancy or lactating informed consent outcome measures: anxiety level heart rate, blood pressure salivary α-amylase


Eligibility criteria:
inclusion criteria: 1. medical students at the university of greifswald 2. going to take part in oral exams of human anatomy 3. participants without previous anxiolytic medication 4. ability to understand and perform pmr 5. written informed consent exclusion criteria: 1. recidivist alcoholics 2. local auricular skin infection 3. pregnant or lactating women 4. participants with prosthetic or damaged cardiac valves, intracardiac and intravascular shunts, hypertrophic cardiomyopathy and mitral valve prolaps (risk of bacterial endocarditis according to guidelines of aha) 5. participants who are unable to understand the consent form 6. history of psychiatric disease
comparison of oral isotretinoin vs ancomparison of oral isotretinoin vs antibiotics on corneal thickness with av

Conditions: Cornea

Summary: comparison of oral isotretinoin versus comparison of oral isotretinoin versus antibiotics on corneal thickness in patients with acne vulgaris

acne is the most common skin disease requiring attention of health practitioners. it is a self-limiting disease of the pilosebaceous unit, which can lead to devastating and frustrating scars and pigmentary alterations.

Eligibility criteria:
inclusion criteria: * patients of either gender shall be enrolled for this study. * acne vulgaris patients taking oral isotretinoin and oral antibiotics shall be included. exclusion criteria: * patients with any ocular pathology shall be excluded. * patients with any systemic pathology other than acne vulgaris shall be excluded. * patients with history of contact lens wear, previous refractive surgery or injury shall be excluded.
conditions associated with poorly controlled diabetes in patients with type 2 diabetes and hba1c changes with therapy

Conditions: Type 2 Diabetes; Poorly Controlled Diabetes Mellitus

Summary: in turkey, only 55% of patients with type 2 diabetes have been diagnosed, and 91% of these patients have been receiving treatment. the rate of patients reaching the treatment target is 50%. the pandemic has also affected diabetic patients. we aimed to determine the characteristics of patients with type 2 diabetes (hba1c \>=10) with poor metabolic control and to evaluate the extent to which metabolic control can be achieved in 3 months.

patients who applied to istanbul medeniyet university goztepe prof. dr. suleyman yalcin city hospital diabetes polyclinics and have an hba1c levels of \>= 10% in their examinations will be admitted to the study. detailed history, including medication usage and previous blood tests will be questioned. the patients will be asked to complete questionnaires about their eating patterns (mindful eating questionnaire), their physical activities (general practice physical activity questionnaire), and whether they have depression (beck depression questionnaire). anthropometric measurements will be taken, and biochemical data will be recorded. patients will be grouped according to their previous hba1c values as a) newly diagnosed, b) those whose diabetes was previously controlled, c) those whose diabetes was previously not at the target range but now worsened, and d) those whose diabetes was poorly controlled from the beginning. diabetes follow-up will be continued by their respective physicians. the patients will be called again three months after their enrollment to record the most recent biochemical data. patient characteristics (age, gender, educational status, depression status, eating awareness, exercise characteristics) will be evaluated in accordance with the predetermined hba1c groups. again, according to the patient groups, the difference in hba1c after three months, the frequency of reaching the target, and possible factors associated with the findings will be evaluated.

Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes * give consent to the study * accessibility to the previous and recent test results exclusion criteria: * acute infection or inflammation lasting more than a week * acute metabolic decompensation * unable to attend to the follow-ups * having non-thyroid endocrine diseases * active oncologic treatment

Keywords: type 2 diabetes poorly controlled diabetes mellitus
clinical observational study: ibd patients with restless-legs-syndrome and iron deficiency syndrome

Conditions: Inflammatory Bowel Diseases; Restless Legs Syndrome; Iron-deficiency

Summary: patients with inflammatory bowel disease, such as crohn´s disease or ulcerative colitis, have recurring episodes of abdominal pain, diarrhea and loss of weight. besides this other clinical symptoms are possible e.g. deficiency syndromes such as iron deficiency. iron deficiency usually attended by symptoms like hair loss, pale skin, loss of concentration or fatigue. in some cases iron deficiency can lead to neurological manifestations such as restless-legs-syndrome (rls). restless legs syndrome is a neurological disorders which is accompanied by substantial urge to move legs or other parts of the body and unpleasant sensations. aim of this study is to to investigate the prevalence of rls in patients with inflammatory bowel disease and furthermore evaluate the effect of iron supplementation in patients with iron deficiency and concomitant rls.

restless legs syndrome (rls) is a common neurological disease significantly impacting live quality. two recent studies from north america and japan revealed a surprisingly high prevalence for rls in crohn´s disease and ulcerative colitis (30% and 21%, respectively). the underlying cause for this high prevalence remains elusive at this point. to address this gap, a cohort of 353 ibd patients from a tertiary ibd centre was prospectively evaluated by our ibd team as well as by the colleagues from neurology. ibd patients (age ≥ 18 years) presenting at our ibd outpatient clinic (tertiary referral center) between february 2014 and february 2015 were prospectively recruited for the study after written consent. the study was approved (16 january 2014) by the ethics committee of the charité - universitätsmedizin berlin, campus benjamin franklin (reference ea4/132/13). patients were screened for symptoms of iron deficiency (id) and rls by a self-developed questionnaire and explored for rls symptoms by a gastroenterologist. when at least one symptom of rls was present, patients were referred to a neurologist for rls or differential diagnosis. additionally patients with rls symptoms were screened for iron-, folic acid- and vitamin b12-deficiency. if a deficiency was detected, patients were substituted. in patients with deficiencies, follow-up visits were scheduled at week 4 and 11 after starting supplementation. follow-up visits were conducted by the neurologist and the irls was performed in all patients at each visit.

Eligibility criteria:
inclusion criteria: * written consent * age \> 18 * inflammatory bowel disease exclusion criteria: * \<18 years * no written consent
decisional regret in open partial horizontal laryngectomy

Conditions: Laryngeal Squamous Cell Carcinoma

Summary: prospective multicentric study to evaluate decisional regret and psychometric and functional outcomes in patient previously treated with open horizontal partial laryngectomy


Eligibility criteria:
inclusion criteria: * scc larynx treated with open partial horizontal laryngectomy exclusion criteria: * previous surgical treatment of the larynx * previous ct-rt of the head and neck district