Kornimate/medical-research-clean huggingface dataset:
social forces to improve statin adherence (study b)

Conditions: Medication Adherence; High Blood Pressure; Diabetes

Summary: to assess the effectiveness of social comparison in improving the outcome of statin adherence versus usual care as measured by an electronic pill bottle. subjects receiving weekly reports with their adherence and information about their place in the distribution of their peers will have the highest statin adherence of any arm, as measured by electronic pill bottle.

we propose to complete a randomized controlled trial (rct) of 201 subjects with medication treated diabetes and evidence of poor adherence to a statin medication (\<70% medication possession ratio (mpr) determined through pharmacy records; no combination meds). study subjects will use glowcaps to store their statin medication. arm 1 will receive weekly feedback containing general information about the subject's adherence (i.e., reminding the subject how many days that week he or she took the medication). arm 2 will be provided the same weekly feedback and the information of whether his or her adherence is above or below the average adherence in their arm, along with a message of encouragement tailored to their place in the arm distribution. subjects with perfect adherence will receive: "you took your pill every day for the last 7 days. great job! keep it up" with their weekly adherence report. subjects with less than perfect adherence and adherence rate in the top 50% of the arm will receive: "you took your pill for \*\* days out of the last 7 days. your medication adherence was as good or better than half of people in this study. taking your pill every day would improve your health even more" with their weekly adherence report. subjects with less than perfect adherence and adherence rate in the bottom 50% of the arm will receive: "you took your pill for \*\* days out of the last 7 days. your medication adherence was in the bottom half of the people in this study. if you took your pill more often, you could be in the top half of people in the study" with their weekly adherence report. adherence records will be displayed on each subject's way to health (wth) account in all arms. arm 3 will be the usual care control.

Eligibility criteria:
inclusion criteria: * the subject is humana insured * the subject is an english speaking adult * age range ≥18 years * the subject has diagnosis with diabetes for ≥12 months * the subject has an mpr \<70% to a statin medication * subjects denies side-effects to their statin medication exclusion criteria: * the subject is \<18 years old * the subject is considered part of a vulnerable population (is a prisoner, a cognitively impaired person, or a pregnant woman) * on statin combination medication * the subject does not identify an individual who agrees to serve as their map * the subject reports a clinically important side effect to the statin medication or active liver disease

Keywords: medication adherence high blood pressure diabetes statins
covid-19 serology screening and strict protocol in the endoscopy unit

Conditions: COVID

Summary: the novel coronavirus disease 19 (covid-19) outbreak has impacted daily activities in nearly 210 countries and territories worldwide. in ecuador, the city of guayaquil has nearly two-thirds of the covid-positive patients in the country and nearly 40% of infected individuals are health-care related personnel. nonemergent, emergent and urgent endoscopic procedures are necessary to be performed during the covid-19 pandemic. several experiences in the management of the endoscopic unit during the pandemic has been proposed. we aimed to prospectively evaluate a strict protocol for preventing potential nosocomial infection of covid-19.

consecutive patients with appointment for endoscopic examination and procedures will be contacted via a telephone call by a pulmonologist, who will perform a triage with a screening questionnaire between 24-48 hours before the scheduled procedure. the pulmonologist will seek for history of fever, respiratory symptoms, and/or close-contacts covid-patients. after exclusion of all respiratory symptoms or history suggestive of covid-19, patients will be evaluated for serum igg and igm levels using a rapid test. only after complete evaluation and revision of serological levels, body temperature will be measure before entering the endoscopy unit. patients will be isolated in an individual preoperative and recovery room after the endoscopic procedure, avoiding contacts with other patients. the endoscopy staff (endoscopists, nurses, administrative personal, anesthesia staff) will use personal protective equipment (ppe) including n95 face mask, face shield, shoe covers, gowns, and gloves. all the staff will be evaluated for nucleic acid pcr testing within three days before resuming activities in the endoscopy unit, all staff members will be evaluated for respiratory symptoms and changes in body temperature before starting daily activities. at the end of the study all the staff will be evaluated for igm and igg antibodies against covid-19.

Eligibility criteria:
inclusion criteria: * patients willing to participate * available serum samples for igg and igg antibodies against covid-19 * ability to complete the screening questionnaire exclusion criteria: * patients with respiratory symptoms * patients with covid-19 active infection
metformin therapy in hcv infection

Conditions: Chronic Hepatitis C Infection

Summary: hepatitis c virus infection (hcv) is a major cause of cirrhosis and death from liver disease worldwide. current therapy for hcv with interferon based therapies results in cure rates of around 5055% which leaves a significant number of patients without effective therapy. hcv induces (can bring on) insulin resistance and insulin resistance is a factor known to reduce the response to antihcv therapy. this finding stimulated initial studies looking at agents that may reduce insulin resistance as additional therapy in hcv infection. a study using metformin in addition to interferon and ribavirin showed a nonsignificant increase in cure rates (53% vs. 42%), but this was limited to patients with type 1 infection and demonstrable insulin resistance. the assumption was made that the potential effect of metformin was likely to be on insulin resistance and thus by modulating this enhances response. the investigators (prof m harris, university of leeds) have data (currently unpublished)suggesting that metformin may have an antiviral effect independent of its effect on insulin resistance, thus raising the possibility that metformin may have a direct antiviral effect in vivo. given that the development of specific antihcv agents which target viral proteins such as its polymerase and protease are in trial development but have so far proved either highly toxic or are likely to have a huge cost there is considerable rationale for looking at alternative potential antihcv agents and in this context metformin is cheap, readily available and has an excellent safety profile. this pilot study therefore addresses the question "does metformin therapy result in a significant drop in hcv viral load in chronically infected patients?"


Eligibility criteria:
inclusion criteria: * adult males and females (18-70 yrs old) able to give consent * chronic hepatitis c virus infection * women of child bearing potential (who have a negative pregnancy test) must agree to use methods of medically acceptable forms of contraception during the study; (e.g.intra-uterine device (iud) or a double-barrier method of oral contraception with condom) exclusion criteria: * type 2 diabetes. * patients with impaired renal function. * decompensated liver cirrhosis (stable patients with cirrhosis would be eligible). * patients who in the opinion of the investigator are considered unsuitable. * pregnant females.

Keywords: metformin therapy in hcv
prevalence of hypotension associated with preload dependence during continuous renal replacement therapy

Conditions: Kidney Injury; Renal Failure, Acute

Summary: per-dialytic hypotension is common in intensive care unit patients under continuous renal replacement therapy, and occurs in nearly 50% of the patients. to date, there is a lack of study having characterized the underlying mechanism of hypotension in this setting. new diagnostic methods are now available with high reliability to identify hypovolemia as the underlying cause of hypotension, among which change in cardiac index during passive leg raising may be the less affected by restrictive validity criteria. a change in cardiac index greater than 10% during this test is highly predictive of preload dependence, i.e the probability than cardiac index will increase if cardiac preload increases. the aim of this study is then to identify, among hypotensive episodes occurring during renal replacement therapy in intensive care unit patients, the percentage of episodes related to preload dependence as identified by passive leg raising.


Eligibility criteria:
inclusion criteria: * intensive care unit patients with acute kidney injury * under continuous renal replacement therapy initiated since less than 24 hours * under hemodynamic monitoring by the picco® device. exclusion criteria: * lower limb amputation * inferior vena cava compression * intracranial hypertension * age below 18 year * pregnancy * advance directives to withhold or withdraw life sustaining treatment, * lack of written informed consent by patient or next of kin * lack of affiliation to social security as required by french regulation * patient under a legal protective measure * previous inclusion in current study * inclusion in another research study
ha-wbrt-sib for brain metastasis of lung cancer

Conditions: Lung Neoplasm; Brain Metastases; Simultaneous Integrated Boost; Hippocampal Avoidance; Cognitive Function

Summary: patients with lung cancer and brain metastases undergo ha-wbrt-sib using image-guided radiotherapy, receiving a total dose of 30-36 gy delivered in 18-20 fractions to the whole brain (ctv), while the dose to the gtv is boosted to 44 gy-52 gy in 18-20 fractions, ﬁve times a week. the optimal mean dose (dmean) to the bilateral hippocampus should optimally be ≤ 8 gy, with a mandatory maximum dose (dmax) to the hippocampus not exceeding 10 gy; the preferred dmean to the hippocampus prv should optimally be ≤ 9 gy, while the mandatory dmax to the hippocampus prv should be ≤ 12 gy. the hvlt-r immediate recall scores are obtained at baseline and 1, 3, and 6 months after treatment.


Eligibility criteria:
inclusion criteria: 1. pathologically diagnosed primary lung cancer with brain metastasis confirmed via magnetic resonance imaging (mri); 2. 18-75 years old; 3. bm outside a 10 mm margin around either hippocampus; 4. at least one bm existed if prior resection of bm was done; 5. bm measuring less than 5.0 cm in maximal extent; 6. eastern cooperative oncology group (ecog) performance status scores of 0-2 exclusion criteria: 1. previous brain radiotherapy or brain metastasis resection; 2. history of malignancies other than lung cancer; 3. radiographic evidence of hydrocephalus or other architectural distortion of the ventricular system, leptomeningeal metastases 4. presence of other serious illnesses such as acute myocardial infarction, severe arrhythmia, or psychiatric disorders within the past 6 months.

Keywords: lung neoplasm brain metastases simultaneous integrated boost hippocampal avoidance cognitive function
observational study to determine how physicians make treatment decisions in patients treated with tofacitinib for moderate to severe active rheumatoid arthritis

Conditions: Arthritis, Rheumatoid

Summary: this non-interventional study aims to identify key factors that are driving treatment decisions by rheumatologists in the treatment of rheumatoid arthritis (ra) patients starting treatment with tofacitinib in a real world setting.


Eligibility criteria:
inclusion criteria: patients aged ≥ 18 years confirmed diagnosis of rheumatoid arthritis by rheumatologist patient is eligible for tofacitinib treatment according to summary of product characteristics (smpc) evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. exclusion criteria: contraindications according to xeljanz® smpc receipt of any investigational drug within 3 months before study inclusion patients who have received any previous treatment with tofacitinib or other jak inhibitors patients who are investigational site staff members or patients who are pfizer employees directly involved in the conduct of the study.
impact of a decision aid regarding natural health products for menopausal symptoms

Conditions: Decision Making; Choice Behavior; Decision Support Techniques; Decision Aids

Summary: the aim of this study is to assess the impact of a patient decision aid regarding natural health products for menopausal symptoms on decisional conflict, knowledge and persistence for an option of women aged 45-64 years old. we are expecting a decrease in decisional conflict and an improvement on knowledge level. we are also expecting an intention to use the decision aid in the future and to discuss with the physician or pharmacist about the use, or the intention to use natural health products.

health decision making is a process known to be difficult, specially in uncertainty context. because of a lack of evidence, natural health products field remains uncertain. decision aids (or decision support interventions) have been elaborated in the past for several health decisions and previous studies showed that they seem to be effective on reducing decisional conflict. following a needs assessment with 40 women and 15 key informants, we developed a decision aid tool specific to the context of natural health products for menopause. in this study, we will assess its impact on decisional conflict, knowledge, persistence for an option, intention to use for a future decision in the same area, and intention to disclose use of natural health products to health professionals. comparison: an existing general information brochure on menopause compared to a decision aid tool that we developed based on the ottawa decision support framework.

Eligibility criteria:
inclusion criteria: women : * between 45 and 64 years old * reporting suffering from menopausal symptoms * considering the use of natural health products for menopausal symptoms * able to read, write, and understand french at a grade 8 level * able to give an informed consent for her participation to the study exclusion criteria: * manager and/or owner of a natural health products store,a pharmacy and/or a pharmaceutical company * person with close relationships with one or many collaborators of this study * reporting suffering from symptoms with no precise diagnosis

Keywords: decision making decision support decisional conflict menopause natural health products herbs complementary medicine complementary therapies
evaluating patient comfort and environmental conditions in the carecube negative pressure isolation chamber.1

Conditions: Infectious Diseases

Summary: this is a human non-significant risk (nsr) clinical study designed to objectively and participatively verify that the carecube negative pressure isolation chamber is a safe and non-hostile environment for the patients that will be contained within the chamber during normal operations.

device information: the carecube negative pressure isolation chamber is a patient isolation unit (piu) designed for the temporary isolation of patients within a hospital to prevent particulate (biological) cross-contamination between user and patient, while enclosing the contaminated patient from the external environment. study description: participants will be tasked to stay within the carecube negative pressure isolation chamber for a minimum of three consecutive time points (1 hour apart) illustrating a plateau level for all parameters, up to a maximum of 7 hours (readings will be taken at baseline and hourly thereafter). the carecube negative pressure isolation chamber will be set up indoors, in an emergency department and hospital floor environment. we will collect data and demonstrate that the carecube isolation chamber is a safe and non-hostile environment for the patients that will be contained within, during normal operations. each participant will be asked to come to a test center facility to complete and sign the informed consent and receive instruction to interact with the simulation. subjects will be tasked to stay within the carecube isolation chamber for at least 4 hours and have 3 consecutive timepoints illustrating a plateau level for all participants parameters. environmental data will be collected by physicians and nurses. additionally, atmospheric oxygen, carbon dioxide, humidity, and room temperature will be monitored and recorded. external to the room humidity and temperatures will also be recorded. the participant will be exposed to room temperature (° fahrenheit) and humidity (rh%), ranging from 65°- 90° fahrenheit and 30%-60% rh. participants will also be asked to record on a questionnaire, in order to demonstrate that the carecube negative pressure isolation chamber is a safe and non-hostile environment for the patients that will be contained during normal operations.

Eligibility criteria:
inclusion criteria: male, female, non-binary between the ages of 19-65 no existing medical condition that would impact the subject from staying within the containment system for the specified time-period. patient is not pre-dispositioned for claustrophobia exclusion criteria: subjects that have a pre-existing condition of claustrophobia subjects that have a history of hypertension subjects with a clinical diagnosis of generalized anxiety disorder (gad) subjects with a clinical diagnosis of major depressive disorder (mdd) morbidly obese patients (bmi above 40) subjects who are women of child bearing potential (wocbp) who either are pregnant or suspect they are pregnant
therapeutic intervention with neuromodulation and inverse virtual reality in patients with fibromyalgia

Conditions: Fibromyalgia

Summary: introduction: fibromyalgia is a chronic condition of generalised pain that entails significant limitations in daily and social life due to pain, fatigue, sleep disturbances and mood alterations. rehabilitation programmes try to alleviate the symptoms and seek intervention methodologies that contribute to improving the quality of life and reduce the socio-economic cost. innovation, technology and new neurophysiologically based therapeutic interventions are being integrated into rehabilitation clinics and although there are foundations and research into the potential benefits that can be obtained, research is still needed to determine intervention protocols that are more effective and efficient. the company xxx has state-of-the-art technology and equipment in order to be able to offer high quality and professional services in extremadura and is motivated to participate in scientific, innovation and development projects in order to analyse and take advantage of the great potential of the equipment and thus offer it to society. objective: this project aims to compare the influence of the use of immersive virtual reality combined with exopulse neuromodulation suits on patients with fibromyalgia. methodology: a clinical trial is proposed with probabilistic random assignment in three groups, a control group (g1) in which patients will wear the suit on, but it will not emit any type of current. a suit group (g2), in which only the neuromodulation suit will be used, and an experimental group (g3) in which, in addition to the neuromodulation suit, virtual reality glasses will be used in full immersive mode. the variables to be analysed are: pain, postural stability, muscle activity, muscle oxygenation, thermographic distribution, heart rate variability, stress, anxiety. the acute effects will be analysed after one intervention session (pre-post intervention of one session) and the effects after a programme of 8 sessions. resources: the intervention equipment will be provided by the company and the assessment equipment by the research group.


Eligibility criteria:
inclusion criteria: * age between 18 and 65 years. * diagnosis of fibromyalgia at least 3 months in advance. * minimum perceived pain intensity of 3/10 according to the numeric pain rating scale. exclusion criteria: * having received physiotherapy 4 weeks prior to data collection. * personal psychological apprehension scale (ppas) score greater than 37.5. * contraindication to the use of electrotherapy. * use of opioid medication that may generate changes at the level of the autonomic nervous system. * ineligibility to participate in the study for other reasons deemed appropriate by the investigators.

Keywords: neuromodulation fibromyalgia virtual reality
characterization of laboratory response to ddavp in adult hemophilia a carriers

Conditions: Hemophilia A

Summary: the purpose of this study is to determine how female hemophilia a carriers respond to a medication called ddavp (desmopressin).

ddavp (desmopressin) is commonly used in the treatment of persons with bleeding disorders such as hemophilia, von willebrand disease, or qualitative platelet disorders to help them clot better. the investigator wants to assess the increase in the subjects' clotting factors in response to intravenous ddavp (desmopressin) and the levels of these internal clotting factors will be measured at different times after the medication is given. the investigator will compare the response to ddavp (desmopressin) in adult hemophilia a carriers to women with a diagnosis of qualitative platelet dysfunction.

Eligibility criteria:
inclusion criteria: inclusion criteria for hemophilia a carriers: * females 18-60 years of age at time of enrollment * genetically verified or obligate hemophilia a carrier (mother of 2 boys with hemophilia a, daughter of a father with hemophilia a or mother of a son and another male relative with hemophilia a) * to stratify patients by carriage of mutation type 10 hemophilia carriers of mild mutations that are predicted to lead to reduced fviii secretion, protein stability or thrombin cleavage site interference and 10 hemophilia carriers of severe mutations that lead to predicted negative cross reactive material will be selected. predicted fviii function of the mutation will be verified by eahad (european association for haemophilia and allied disorders) coagulant factor variant database at www.eahad-db.org) * weight \>40kg to ensure volumes of blood to be drawn are within accepted safe range inclusion criteria for non-hemophilia a carriers (females with mild qualitative platelet dysfunction): * females 18-60 years of age at time of enrollment * whole blood or platelet rich plasma lumiaggregometry consistent with reduced aggregation to at least 1 agonist on at least one occasion (excluding evidence of glanzmanns thrombasthenia or bernard soulier syndrome) or determined by primary hematologist as having a qualitative platelet disorder * age-matched by 10 years to carrier enrolled * weight \>40kg to ensure volumes of blood to be drawn are within accepted safe range exclusion criteria: * personal history of concomitant bleeding or clotting disorder * cardiac condition that requires the daily use of aspirin or clopidogrel * inability to comply with fluid restriction protocol for 24 hours following desmopressin (ddavp) * personal history of a myocardial infarction, renal or hepatic insufficiency or epilepsy

Keywords: factor viii antigen von willebrand factor (vwf) antigen mutation type