Kornimate/medical-research-clean huggingface dataset:
cerebral resonance magnetic imaging during rectal distention

Conditions: Ulcerative Colitis; Irritable Bowel Syndrome

Summary: irritable bowel syndrome is responsible for chronic abdominal pain, diarrhea and/or constipation. it is a very frequent problem. however, the exact cause of irritable bowel syndrome remains unknown. the purpose of this study is to look for a different cerebral response by magnetic resonance imaging after rectal stimulation in patients with irritable bowel syndrome compared to healthy subjects and to patients with digestive organic disease. our hypothesis is that irritable bowel syndrome could be a problem of cerebral integration of visceral stimulation.


Eligibility criteria:
inclusion criteria: * healthy subjects irritable bowel syndrome (rome ii criteria) colitis ulcerative exclusion criteria: pregnant or breast feeding metallic material implanted good tolerance of rectal distension acute phase of ulcerative colitis

Keywords: cerebral activity rectal distension colitis ulcerative irritable bowel syndrome magnetic resonance imaging
a study of ly900014 compared to insulin lispro (humalog) in adults with type 1 diabetes

Conditions: Type 1 Diabetes Mellitus

Summary: the purpose of this study is to see if ly900014 compared to insulin lispro (humalog), both in combination with insulin glargine or insulin degludec, is safe and effective in participants with type 1 diabetes (t1d).


Eligibility criteria:
inclusion criteria: * participants must have t1d for at least 1 year prior to screening and continuously using insulin for at least 1 year. * participants must have hba1c of ≥7.0 and ≤10.0%. * participants must have been treated for at least 90 days prior to screening with either multiple daily injection(s) (mdi) or premixed analog/human insulin regimens at least twice daily. * participants must have body mass index (bmi) of ≤35.0 kilograms per square meter (kg/m2). exclusion criteria: * participants must not have used other anti-hyperglycemic medications or therapies (inhaled, oral or injectable) except for metformin within 90-days prior to screening. * participants must not have had more than 1 severe hypoglycemic episode within 6 months prior to screening. * participants must not have had more than 1 hospitalization related to hyperglycemia or diabetic ketoacidosis within 6 months prior to screening.
safe or sorry? patient safety study of the prevention of adverse patient outcomes

Conditions: Pressure Ulcer; Urinary Tract Infection; Accidental Falls

Summary: the aim of safe or sorry? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls.

background patients in hospitals and nursing homes are at risk for the development of, often preventable, somatic complications. however, preventive care is not always optimal. although guidelines are available for many complications, compliance with the guidelines appears to be lacking. besides general barriers that inhibit implementation, this non-compliance is also associated with the large number of guidelines competing for attention. as implementation of a guideline is time-consuming, organisations can never implement all available guidelines. another problem is lack of feedback about performance using clear quality indicators and lack of a recognizable, unambiguous system for implementation. aim the aim of safe or sorry? is to develop and test an evidence based inpatient safety program for the prevention of three frequently occuring adverse events: pressure ulcers, urinary tract infections and falls. participants patients and nurses will be recruited from ten hospital wards and ten nursing home wards in the netherlands. all nurses and all adult patients who are admitted for more than three days, will be asked for informed consent. method this study consists of two phases. in the first phase the program will be developed. the content of the program is based on the evidence based guidelines on pressure ulcers, urinary tract infections and falls. the program consists of a computerized registration and feedback system, an educational program for nurses and caregivers, and educational material for the patients. in the second phase the program will be tested in a cluster randomised clinical trial. the program will be implemented on ten wards (5 hospital wards and 5 nursing home wards), i.e. the intervention group. the control group will continue to give care as usual. outcome measures primary outcome measure: incidence of pressure ulcers, urinary tract infections and falls secondary outcome measures: utilization of preventive interventions and knowledge of nurses and caregivers regarding the complications and their prevention.

Eligibility criteria:
inclusion criteria: * patients on participating wards admitted for more than three days * all nurses on participating wards exclusion criteria: * students on participating wards

Keywords: patient safety adverse event prevention knowledge inpatient hospital nursing home long term care nurse
surgical outcome of macular membrane peeling associated with significant macular drusen

Conditions: Epiretinal Membrane; Macular Holes; Age Related Macular Degeneration

Summary: surgical outcome of patients with macular drusen and co-existing abnormalities of the vitreoretinal interface, who routinely undergo pars plana vitrectomy with membrane peeling, is evaluated. best corrected visual acuity as well as optical coherence tomography data are compared at baseline and last follow up. the rate of development of choroidal neovascularization postoperatively is noted.


Eligibility criteria:
inclusion criteria: 1. participants diagnosed with erm or ftmh and co-existing macular drusen; 2. undergone pars plana vitrectomy with ilm and epiretinale membrane peeling; 3. sd-oct at the initial visit and at last follow up visit with image quality score \>30; 4. no evidence of cnv on initial fluorescein angiography (fa). exclusion criteria: 1. history of other macular disease, severe non-proliferative or proliferative diabetic retinopathy, other retinal vascular diseases, glaucoma, myopic retinopathy, or other diseases interfering with oct images in any one of the eyes; 2. active cnv or history of cnv
information needs around parenteral nutrition in cancer

Conditions: Cancer; End Stage Cancer; Terminal Cancer; Neoplasms; Tumor; Malignancy; Malignant Neoplasm

Summary: this study will explore the information needs of patient's with advanced cancer, and their carers, when making a decision to commence or discontinue parenteral nutrition. interviews will be conducted with both patients with advanced cancer, and their carers to determine the information they need to make a shared decision with the healthcare team.

parenteral nutrition (pn) is a type of nutritional liquid that is given directly into a vein, and is usually given when a person does not have a working gut. this type of nutrition is managed by a team of healthcare professionals and requires regular monitoring, such as bloods tests, to allow the team to provide the right balance of nutrients to the individual patient. this is an important decision, and the benefits, risks and consequences of having this type of nutrition should be fully explained to the patient and carer, to make sure they can make an informed decision. the aim of this study is to find out what information both patients and carers feel they need to be able to make a decision to start, and a later date stop, parenteral nutrition, with a diagnosis of advanced (incurable) cancer. it is not clear if patients and carers get all the information they need before making this decision, and often the decision is made by a doctor and other healthcare professionals. however, patients and carers have a right to make decisions about their care. we will therefore interview patients and carers who have experience of making this decision, or in the process of making this decision, to find out what information is important to them. our aim is to use the results from this research to improve the experience that patients and carers have in the future.

Eligibility criteria:
inclusion criteria: * adults aged 18 years and over * fluent english speaker * is aware of diagnosis of advanced cancer * patient considering starting pn, is currently receiving pn or has previously received pn or * carer of a patient considering, receiving or who has received pn * nhs patient * assessed as having capacity to give consent and participate * current patient at one of the recruiting hospital sites exclusion criteria: * private patients
study comparing olanzapine with haloperidol for the relief of nausea and vomiting in patients with advanced cancer

Conditions: Nausea; Neoplasms

Summary: the purpose of this study is to compare the efficacy and safety of haldol (haloperidol) and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.

the purpose of this study is to compare the efficacy and safety of haloperidol and olanzapine in the control of chronic nausea with advanced cancer patients who have failed first line antiemetic therapy.

Eligibility criteria:
inclusion criteria: * \>18 years of age * significant nausea/vomiting * failed maxeran and domperidone * underlying treatment of causes has failed * adequate cognitive function * communicates well exclusion criteria: * partial/complete bowel obstruction * currently taking haldol or olanzapine * has drug induced extrapyramidal symptoms * parkinson's disease * undergoing chemotherapy or radiotherapy (rt) to brain, abdomen, stomach or esophagus

Keywords: olanzapine haldol cancer nausea second line treatment refractory nausea
study comparing muraglitazar with glimepiride in type 2 diabetics who are not controlled with metformin alone

Conditions: Diabetes Mellitus, Type 2

Summary: the purpose of this clinical research study is to learn whether a muraglitazar-metformin combination is at least as effective as a glimepiride-metformin combination to treat type 2 diabetics who are not sufficiently controlled with metformin alone. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * subject with type 2 diabetes receiving treatment with at least 1,500 mg but not greater than 3000 mg of stable metformin therapy for at least 6 weeks prior to screening * hba1c \>or = 7% and \< or = 10% * fasting c-peptide \> or = 1.0 umol * body mass index \< or = 41 kg/m2 * mean serum triglycerides \< or = 600 mg/dl

Keywords: diabetes
continuous monitoring of physiology and self-reported pain score amongst post-surgical knee patients

Conditions: Knee Arthroplasty

Summary: the aim of this observational study is to assess whether patient reported pain levels correlate with a pain index derived from deviations in multivariate physiology biomarkers captured in real-world setting. this study will be conducted using a clinical-grade wearable sensor to continuously monitor patient's physiology (pain related biomarkers) and allow subject participant to actively report their pain score, symptoms and quality of life using a mobile-based application.

the designated clinical-grade wearable sensor used in this study is the biovotion everion md (see annex for product description), a bluetooth-compatible device that will automatically sync with the mobile application used in this study. this study will recruit 55 patients aged 21 to 80 years who will be undergoing knee replacement, anterior cruciate ligament(acl), knee arthroscopy and foot \& ankle related surgery. all study participants will be followed for an estimated total of 30 days(+6/-2 days, if visit schedule is fall on weekend), beginning four days before surgery, the entire period as an in-patient (four to five days), and 20-days post-discharge. the changes in multivariate physiological biomarkers will be used to generate a pain index, and the pain index will be assessed against patient reported numerical rating scale (nrs) pain.

Eligibility criteria:
inclusion criteria: * men and women aged 21 to 80 years * patients undergoing knee replacement surgery ( total knee replacement (tkr), unicompartmental knee arthroplasty (uka), bilateral knee replacemenent, patello-femoral-joint (pfj) knee replacement), anterior cruciate ligament(acl), knee arthroscopy and foot \& ankle related surgery such as bunions, hammer toes, metatarsal, ankle fusion, triple fusion, ankle replacement, achilles tendon \& tibialis posterior disorder * ability to provide informed consent * able to commit to using the app and inputting data as needed during the study duration * has access to an iphone (minimum requirement iphone 5s) exclusion criteria: * previous myocardial infarction (mi) * known coronary artery disease - prior coronary revascularization * previous stroke. stroke is defined as new focal neurological deficit perspective more than 24 hours. * more than ongoing use of 2 or more anti-hypertensive agents. * expected life expectancy less than 1 year. * asthma or chronic lung disease requiring long-term medications or oxygen * mental illness that in the clinical judgment of the investigator will affect participation in the study e.g. dementia * inability to comply with the study protocol * any other acute or chronic medical or physical condition deemed by the investigator to affect study outcomes

Keywords: knee replacement wearable pain score quantification
systemic absorption of dexamethasone oral rinse in patients with oral lichen planus

Conditions: Oral Lichen Planus; Oral Lichenoid Reaction

Summary: the objective of this study is to see the amount of systemic absorption of a standard dose of dexamethasone oral rinse for patients with symptomatic oral lichen planus (olp) or oral lichenoid reactions (olr) and healthy subjects (those who do not have olp or olr aka the control group).


Eligibility criteria:
inclusion criteria: 1. over 18 years old 2. non-pregnant 3. newly diagnosed subjects with olp/olr. definition of 'newly" in this case : new patient with complaint regarding oral erosions and ulceration, and diagnose clinically with olp or olr for the first time 4. those not exposed to topical or systemic corticosteroids for the previous 1 month. meaning, those willing to not take this olp/olr treatment for 1 month before their visit 5. experimental group is clinically diagnosed with olp/olr 6. controls must have no history of olp/olr exclusion criteria: 1 . under 18 years old 2. pregnant women 3. recent history (\< than one month) of exposure to topical or systemic corticosteroids. 4. history of advanced kidney, liver disease, or systemic fungal infection. 5. corticosteroids hypersensitivity. 6. active oral candidiasis 7. patients on blood thinners medication ,anemic or suffer from bleeding disorders
model 4965 post-approval study

Conditions: Heart Failure; Pacing; Bradycardia; Arrhythmia

Summary: safety and effectiveness will be summarized for the model 4965 lead. this study was conducted within medtronic's system longevity study (sls).

as part of the requirement to satisfy the pma conditions of approval for the medtronic model 4965 capsure epi® steroid-eluting unipolar epicardial pacing lead, 50 adult subjects who were ≥19 years old at time of implant were followed for one-year post-implant.

Eligibility criteria:
inclusion criteria: * subjects or appropriate legal guardians provide written informed consent and/or authorization for access to and use of health information, as required by an institution's irb/mec/reb and one of the following (a, b, or c) must also apply: a. subjects indicated for implant or within six months post-implant of a medtronic market-released lead connected to a market-released ipg, icd, or crt device. the medtronic lead must be used for a pacing, sensing, or defibrillation application. b. subjects who participated in a qualifying study of a medtronic cardiac therapy product and for whom: * product is market-released * complete implant and follow-up data, including product-related adverse events, are available * subject or appropriate legal guardian authorizes release of subject study data to sls c. subjects implanted with medtronic capsure epi leads (model 4965 and 4968) at a minimum of three pre-selected sites to retrospectively collect data for post approval requirements. post approval requirements indicate 50 adult subjects implanted with a model 4965 and 100 subjects (pediatric and adult) implanted with a model 4968. the study plans to enroll approximately 100 subjects with a model 4965 lead and approximately 200 subjects with a model 4968 lead. note: subjects currently active in the chronic lead study or tachyarrhythmia chronic systems study will continue in the follow-up phase of the sls. exclusion criteria: * subjects receiving an implant of a medtronic lead at a non-participating center and the implant data and current status cannot be confirmed within 30 days after implant * subjects who are, or will be inaccessible for follow-up at a sls center * subjects implanted with a medtronic cardiac therapy device whose predetermined enrollment limit for that specific product has been exceeded * subjects with exclusion criteria required by local law (emea only)

Keywords: epicardial pacing lead
observational study on anti-tat immune response in hiv-1-infected asymptomatic adult subjects

Conditions: HIV Infections

Summary: the present study is designed as a prospective observational study directed at evaluating the frequency, magnitude, quality and persistence (primary endpoint) of the anti-tat immune response in hiv-1 infected asymptomatic individuals, and to prospectively evaluate the immunological, virological and clinical outcome of anti-tat positive versus anti-tat negative drug naїve subjects (secondary endpoint) in order to determine the impact of anti-tat immunity on hiv disease progression as well as the potential use of anti-tat immune response assessment for the clinical and therapeutic management of infected patients. this survey provided important information for the design, planning and conduction of future therapeutic vaccine trials based on the hiv-1 tat protein in asymptomatic subjects.


Eligibility criteria:
inclusion criteria: * to be clinically asymptomatic hiv-1 infected individuals with cd4+ t cell counts ≥400/μl * to be naïve for antiretroviral therapy * levels of plasma viremia ≤100,000 copies/ml at baseline * age ≥ 18 years * signed informed consent exclusion criteria: * current therapy with immunomodulators or immunosuppressive drugs or chemotherapy for neoplastic disorders * concomitant treatment for hbv or hcv infection

Keywords: hiv therapeutic vaccine
a study of neurofeedback for the treatment of parkinson's disease

Conditions: Parkinson Disease

Summary: this study aims to reveal relationship between brain activities and the symptoms of parkinson disease when a neurofeedback training was applied for them.


Eligibility criteria:
inclusion criteria: * subjects with age more than 20 * subjects obtained the consent * subjects with parkinson disease and healthy subjects exclusion criteria: * the subjects who can not conduct the tasks * subjects with severe illness * subjects whom the experimenter think as in appropriate * subjects with implantable devices such as pacemaker

Keywords: parkinson's disease magnetoencephalography neurofeedback
evaluation of the effect of a visio-hearing training protocol on spatial hearing in subjects with hearing loss

Conditions: Cochlear Nerve Deafness; Cochlear Diseases; Cochlear Hearing Loss; Hearing Loss; Deafness

Summary: we recently developed a new neuro-immersion system based on virtual reality and 3d (dimension) motion tracking. this tool makes it possible to evaluate and record the spatial localization performance of sounds and to highlight localization deficits in the three dimensions of space in deaf patients. unfortunately, there is currently no suitable support to compensate for these localization deficits. however, the discomfort felt by the patients is clearly verbalized. thanks to the new virtual reality system, we are now able to develop a training protocol based on spatial sound localization tasks.


Eligibility criteria:
inclusion criteria: for all participants (patients and normal hearing adults): * ages 18 and 65 * normal vision (with or without correction) * able to understand experimental instructions * member of the social security scheme * informed of the study and signed the consent form for hearing standards (nh): - no hearing problems for patients (su, uic and bic): * regular follow-up in the ent (ear, nose, and throat) department of the edouard herriot hospital in lyon or the purpan hospital, in toulouse * unilateral deep deafness (only for su patients) * holder of one cochlear implant for more than one year (only for uic patients) * holder of the second cochlear implant for more than one year (only for bic patients) exclusion criteria: * oculomotor disorder * bilateral vestibular areflexia * neurological and/or psychiatric history * person placed under legal protection, guardianship or trusteeship * pregnant or nursing woman
contribution of a video support to inform the patient before a complementary examination in infectious diseases

Conditions: Infectious Disease

Summary: the purpose of this study is that a video tool coupled with standardized information can increase the patient's understanding of the information and thus optimize their medical care

patients admitted to the infectious and tropical diseases department (mit) undergo a large number of complementary examinations. in view of their specificity, justified by the often lengthy diagnostic process, as well as by the complexity and diversity of the pathologies, the site of infection and the patient's background (adolescents and adults, migrant patients, immunocompromised patients, human immunodeficiency virus, primary immunodeficiencies, organ transplants, patients with haemopathies, marrow transplants, among others). as a matter of practice, the doctor informs the patient of the prescribed examinations, explaining their purpose and procedure, and outlining any benefits and risks. the intention is to introduce a tool that complements the information usually provided, and that can be of high quality to improve the patient's perception of understanding. to this end, investigators hypothesize that a tool in video format, built in collaboration with the experience of various technical platforms, could make the experience of understanding information more complete and more accessible to all patients.

Eligibility criteria:
inclusion criteria: * patient aged ≥ 18 years * french speaking language * hospitalized in the department of infectious and tropical diseases at hôpital necker- enfants malades * prescription, for the first time in its medical history, of one of the following complementary examinations: * bronchial fibroscopyirm * picc line insertion * pet scanner * no expressed oral opposition exclusion criteria: * patients with dementia or cognitive impairment * non-french-speaking patient caregivers' inclusion criteria: * caregiver belonging at nurse or doctor's category * caregiver working in the infectious and tropical diseases department at necker hospital * no expressed oral opposition * caregivers who are not in contact with patients

Keywords: patient information tool understanding of delivered information complementary examinations video information