Kornimate/medical-research-clean huggingface dataset:
patient provider partnership: improving diabetes care in the community

Conditions: Diabetes

Summary: with the advent of managed care, increasing responsibility for the care of patients with diabetes is being placed on primary care physicians. evidence exists that physicians are not meeting established practice guidelines, and outcomes in patients with diabetes are less than optimal. it is thus the objective of this study to institute a community-based diabetes education intervention for both physicians and patients to enhance adherence to guidelines and improve patient outcomes. we will conduct a chart review (submitted under a separate irb: #000733) in primary care practices to determine health status and guideline adherence. following the chart review, physician practices will be assigned to one of three groups: physician + patient education, physician education alone, and usual care. following the intervention, a repeat chart review will be conducted. pre and posttest comparisons will be conducted to examine changes primarily in glycemic control, quality of life, patient knowledge, and physician adherence to practice guidelines. secondarily, we will examine changes in therapeutic intervention, body mass index, and barriers to diabetes care. we will also examine individual barriers to diabetes care and their influence on outcomes in this population. the last phase of the study will encompass a second follow-up visit in which we will examine behavioral factors related to clinical change and sustainability of the intervention.


Eligibility criteria:
inclusion criteria: * over age 18, diagnosed diabetes, physician is participating in study exclusion criteria: * pregnancy, imprisonment

Keywords: chronic care model, diabetes, community, diabetes education
feasibility and comparison of continuously monitored vital signs in pediatric patients with cancer.

Conditions: Pediatric Cancer; Febrile Neutropenia; Oncology; Chemotherapy-induced Neutropenia

Summary: in this pilot study the feasibility continous recording of vital signs in pediatric patients under chemotherapy for cancer, is studied. vital signs and are recorded with two different wearable devices (wds): everion®, by biovotion (now biofourmis), zurich, switzerland and core® by greenteg, zurich, switzerland. patients can choose if they want to wear one or both wds during this study. those opting to wear two wds can choose if they want to wear them in parallel, or sequentially. results from the two different wds will be compared. study duration for each participant is 14 days per device.

in a previous study (bern 2019 wd pilot, nct04134429) the investigators found that continuous recording of vital signs with the everion® is feasible in good quality across a wide age range (3 to 16 years) of pediatric patients undergoing chemotherapy for cancer. however, the pre-defined criterion to claim feasibility was not formally reached and low compliance was the main reason identified. in this study the investigators want to assess the impact of measures aiming to increase compliance on feasibility for the everion®. second, the investigators want to assess the feasibility of a second device, made commercially available only in october 2020, the core® wd by greenteg. results from the two different wearable devices will be compared. study duration for each participant is 14 days per device.

Eligibility criteria:
inclusion criteria: * chemotherapy treatment because of any malignancy, expected to last ≥1 month at time of recruitment for myelosuppressive therapy; or at least one cycle of myeloablative therapy requiring autologous (bern/basel) or allogeneic (basel) hematopoietic stem cell transplantation. * age from 1 month to 17.99 years at time of recruitment * written informed consent from parents and participants, where applicable exclusion criteria: * local skin diseases prohibiting wearing of the wd. * denied written informed consent from participants

Keywords: wearable device everion® core® continuous recording vital signs pediatric oncology
needs assessment of mediterranean adolescents with type 1 diabetes about therapeutic education sessions

Conditions: Type 1 Diabetes in Adolescence

Summary: background: in type 1 diabetes, adolescence is often associated with deterioration in glycemic control, attributed to a poorly monitored diet, little exercise, poor treatment compliance, risk behaviors, endocrine changes with puberty, leading to greater resistance to insulin. therapeutic patient education (tpe) is the key to successful management of the disease and treatment for adolescents with type 1 diabetes. ten tpe programs exist in the mediterranean region in france, and the care teams implementing them wish to promote joint reflection with sick teenagers and families to identify needs and expectations of everyone on priority skills to develop, to promote better management of the disease and improved quality of life. aim: to study the needs and expectations of adolescents with type 1 diabetes for skills to be developed during the educational sessions, to promote self-management of their disease and their treatment. method: four audio-recorded focus groups will be organized in all 10 clinical settings (adolescents, parents and health professionals). thematic analysis will be carried out from the transcript of the focus groups. expected results: the results will allow a joint reflection involving the participation of young patients, families, health professionals and the research team to build and implement new educational sessions that meet the identified needs. this action resulting from the research is expected to pool resources in different health facilities providing therapeutic education programs and to harmonize practices.


Eligibility criteria:
inclusion criteria: * aged between 11 and 16 years inclusive * type 1 diabetes diagnosis confirmed by a physician according to the diagnostic criteria * monitoring in the institutions participating in the research * speaking the french language (elementary level) * consent signed by the holders of the exercise of parental authority and the participant exclusion criteria: * pregnant women, parturient women or breastfeeding mothers * persons deprived of liberty by a judicial or administrative decision * those hospitalized without consent under articles l. 3212-1 and l. 3213-1 that do not fall under the provisions of article l. 1121-8 * persons admitted in a health or social institution for purposes other than research (art. l.1121-6 health public code)
investigating the effectiveness of pelvicsense(r) on pain and sexual outcomes in endometriosis

Conditions: Endometriosis

Summary: this study will examine the effectiveness of the pelvicsense 3-month online program on pain and other outcomes in those with endometriosis. this study is prospective in nature and will involve several assessment points: baseline, immediately post-treatment (at the end of the 3 month program), and 3-month follow up. all aspects of the study will be conducted remotely (e.g., online, email, video calls), and participants will be at least 18 years of age, fluent in english, and experience pain due to endometriosis for at least 3 months with a physician diagnosis. participants are expected to continue their treatment as usual and this information will be documented throughout the study.


Eligibility criteria:
inclusion criteria: * 18 years or older, fluent in english, and have a formal diagnosis of endometriosis for at least 3 months. exclusion criteria: * younger than 18 years of age, nonfluency in english, self-identified diagnosis, endometriosis duration of less than 3 months.
a study of transcutaneous electrical stimulation as a noxious stimulus for the glasgow coma scale

Conditions: Comatose

Summary: the purpose of this study is to determine whether electrical stimulation can be used to replace physical stimulation to test awareness of patients with impaired consciousness. physical stimulation can cause bruising, damaged nails and ribs, and other damage with repeated testing, and electrical stimulation may be safer and cause less distress with time. this device has not been approved by the u.s. food and drug administration (fda).

for patients enrolled in this study, the study doctor or study staff will give non-invasive electrical stimulation to measure response. depending on what study group, the study team may apply this stimulation several times at one (phase 1) or two (phase 2) separate time points approximately 2 hours apart (when gcs would normally be collected as part of clinical care). in addition to gcs using normal physical stimulation, the study team will test responses to electrical stimulation. to do this, electrodes (special wired stickers that conduct electricity) will be placed on the forehead, finger, and toe. stimulation will be applied to one area at a time by connecting the electrode to a stimulator. for each physical and electrical stimulation, response will be measured (such as flinching, opening eyes, making sounds, etc.). the goal is to create electrical stimulation patterns that cause the same response as the physical exam without causing any physical damage. a video recording will also be taken of the participant's telemetry unit (the screen showing their heart rate and other vital signs throughout the study. this video, in addition to the information from the participant's medical record, is to make sure that there are no unexpected changes in vital signs during the study. the participant will not be visible on this video.

Eligibility criteria:
inclusion criteria: 1. patient is admitted to the barrow neurological institute's neuro icu 2. patient is in a comatose state, which is defined as a patient who is both non-responsive and has a gcs eye or motor response sub-score that requires noxious stimulation 3. age greater than or equal to 18 years 4. patient has an available surrogate decision maker with the capacity to consent for participation in a research study exclusion criteria: 1. a neurologic decline immediately prior to study participation that requires urgent or emergent workup or management\* 2. patients in whom the frequency or extent of neurologic assessments is being limited due to concern that noxious stimulation may provoke intracranial hypertension, cardiorespiratory instability, or other adverse events 3. patients with an implantable or external pacemaker that is currently in use 4. ongoing refractory cardiorespiratory instability 5. pregnant females 6. prisoners

Keywords: glasgow coma scale coma transcutaneous stimulation
kaletra in combination with antiretroviral agents

Conditions: Human Immunodeficiency Virus

Summary: the purpose of this study is to investigate the tolerability of kaletra (lopinavir/ritonavir) in combination with new substances such as integrase inhibitors (inis), c-c chemokine receptor type 5 (ccr5) antagonists, and new non-nucleoside reverse transcriptase inhibitors (nnrtis), as there are many reasons (intolerability, complex resistant patterns or even personal reasons) which may result in a change from the daily clinical routine and lead to the use of a newly approved antiretroviral agent in combination with kaletra.

this study was designed as a non-interventional observational study. kaletra was prescribed in the usual manner in accordance with the terms of the local market authorization with regards to dose, population and indication as well as local guidelines.

Eligibility criteria:
inclusion criteria: * patients ≥ 18years of age * written informed consent (authorization to the investigator to use and/or disclose personal and/or health data before entry into the kaletra® post marketing observational study) * hiv-1 infection * patients treated with kaletra®, independent from their participation in this study * patients treated with novel antiretroviral therapy (for at least 8 weeks according to the study amendment), independent from their participation in this study exclusion criteria: * hypersensitivity against kaletra or other ingredients or inis or nnrtis or ccr5 antagonists * severe liver insufficiency * no concommitant astemizole, terfenadine, oral midazolam, triazolam, cisapride, pimozide, amiodarone, ergotamine, dihydroergotamine, ergometrine, methylergometrine, vardenafil and/or st. john's wort

Keywords: infection rilpivirine ccr5 antagonists etravirine human immunodeficiency virus maraviroc safety and efficacy non nucleoside reverse transcriptase inhibitors (nnrtis) integrase inhibitors raltegravir kaletra
study in pediatric volunteers of a handheld device versus a standard diagnostic device in ophthalmic refraction

Conditions: Refractive Errors; Accomodation; Diagnostic Self Evaluation

Summary: this study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in children.

this study is exploratory and examines whether the refraction results obtained from a novel optical device yields results similar to the ophthalmic refraction measurements obtained from an autorefractor in the age stratum of 6 through 17 years.

Eligibility criteria:
inclusion criteria: * male or female * ages ≥6 y.o. and \<18 y.o. * binocular vision * parent(s) or guardian(s) willing and able to give informed consent on behalf of the subject. * subject able to follow all study procedures and requirements exclusion criteria: * spherical correction \> +8 or \< -10 * using anticholinergic medications (including first-generation antihistamines) or other medications known to affect visual acuity within the greater of 3 days or 5 half-lives prior to enrolling in this study. * using an investigational drug or approved therapy for investigational use within the greater of 3 days or 5 half-lives prior to enrolling in this study. * has initiated any new medication in the past 2 weeks that, in the best medical judgment of the investigator, would impact their participation in the study or ability to use the eyeque eq103 device, * any self/caregiver-reported mental illness or condition of the subject, including but not limited to claustrophobia, fear of simulators, nyctophobia. * any self/caregiver-reported neurological diseases of the subject, including but not limited to: epilepsy, nystagmus. * any self/caregiver-reported glaucoma diagnosis of the subject. * eye disease, including but not limited to: * cataracts * macular degeneration * eye infection (by self-report or observation) * keratoconus * diabetic neuropathy/retinopathy * cytomegalovirus retinitis * color blindness (any color deficiency) * diabetic macular edema * amblyopia * chronic or acute uveitis * strabismus * astigmatism \> 3 diopters * macular hole * lack physical dexterity to properly operate the eyeque device. * lack the ability to follow instruction. * lack binocular vision. * are colorblind. * had eye surgery within the last 12 months.

Keywords: refraction telehealth vision accommodation
intensive education on lipid management

Conditions: Acute Coronary Syndrome

Summary: among the patients with coronary heart disease, those with acs (acute coronary syndrome) are extremely high-risk patients. therefore, management outside hospital, especially the regular administration of drugs, is vital to prevent the recurrence of cardiovascular events. however, most patients often fail to stay on a long-term administration regimen, especially the administration of statins. according to the statistics, the average duration adhered with statin in patients with acs is less than 3 months, use of statin at hospital discharge was only 80% and 65% in 6 month, with a very low ldl-c control rate (about 11% at 6 months), which poses a threat to the recurrence rate of cardiovascular events in patients with acs. it was found in previous studies that there were many factors influencing patients' compliance, in which patients' refusing to take medicine accounted for a higher proportion. it suggests that patient had not recognized the importance of long-term administration. therefore, it is extremely important for physicians to strengthen patient education and regular follow-up visits during disease management. moreover, the effectiveness of patient education during chronic disease management has already been proved in some studies abroad, and the interventional effect of multiple patient education process outweighs that of single approach education. thus, we intend to conduct a randomized and controlled study to explore the effect of multi-channel intensive patient education on ldl-c target achieving rate and statin adherence in patients with acs in china.


Eligibility criteria:
inclusion criteria: 1. the patients admitted to the hospital with a diagnosis of acs including those for first consulting or with recurrence. the patient was prescribed atorvastatin (lipitor®) by physicians in hospital; 2. the age of patient enrolled will be ≥18 years old; 3. the patient is able to understand and complete questionnaire. 4. the patients agree to accept follow-up visits, and willing to participate in patient education courses and sign informed consent form. exclusion criteria: 1. the patient has contraindications to statins, such as active hepatic disease, patient has a history of intolerance or hypersensitivity to statins or has a history of prior rhabdomyolysis on a statin. 2. the patient who uses other statins except lipitor® when discharged from the hospital; 3. cardiac function class of the patient is class iv(nyha); 4. the patient has a malignant tumor; 5. the patient has a severe arrhythmia.

Keywords: acute coronary syndrome statins ldl-c intensive education
study about complications of totally implanted venous access devices (tivads) in people with cystic fibrosis (cf)

Conditions: Cystic Fibrosis

Summary: pulmonary infections are the major cause of mortality and morbidity in cystic fibrosis (cf); patients frequently have to take antibiotics which often cannot be given orally or by aerosol but have to be administered intravenously. in order to reduce the number of venepunctures, totally implanted venous access devices (tivad) or ports have been used to administer antibiotics and other infusions. the use of port systems has been increasing in recent years, especially for those patients requiring frequent intravenous treatments. having a tivad in place makes venous access quicker and also reduces trauma, suffering and pain. however, there are important complications associated with tivads which can be early (pneumothorax, arterial puncture, severe bruising) or late (infections, thromboembolic complications and occlusion). although the use of tivads in cf is increasing, there is little cf-specific literature available on the epidemiology and risk of tivad complications. also, literature is scarce about clinical criteria for deciding to insert a tivad. therefore, so far clinical decisions were based mainly on experiences of tivad use in other diseases, such as cancer. with this prospective observational study we will survey a large population of italian cf people with tivad in order to: collect data about current clinical conditions of cf people with tivad; investigate about clinical criteria that led to the decision of positioning a tivad; observe the possible onset of late complications.

to be included in the study, subjects need to fulfil the following requirements: * diagnosis of cf, made accordingly to the cf foundation guideline; * ability to consciously express owns informed consent, if aged 18 or more. if minor, presence of at least one legally authorised parent able to consciously express informed consent; * have a tivad implanted; * have no current complications in the tivad (infection, thromboembolic complications or occlusion) outcome measures measured outcomes will be: 1. incidence of tivad infections (port pocket infection, cutaneous site infection,catheter-related infection; 2. incidence of tivad thrombosis; 3. incidence of tivad occlusion. the observational phase will last 12 months for each subject involved

Eligibility criteria:
inclusion criteria: * diagnosis of cf, made accordingly to the cf foundation guideline * ability to consciously express owns informed consent, if aged 18 or more. if minor, presence of at least one legally authorised parent able to consciously express informed consent * have a tivad implanted * have no current complications in the tivad (infection, thromboembolic complications or occlusion)

Keywords: tivad complications nursing cystic fibrosis implanted
a study of avelumab in penile cancer who are unfit for or have progressed after platinum-based chemotherapy

Conditions: Penile Cancer; Advanced Cancer; Metastatic Cancer

Summary: this is a phase 2 study whose purpose is see how useful investigational drug, avelumab, is in patients with locally advanced or metastatic penile cancer who are unfit for or progressed on platinum-based chemotherapy. the usefulness of avelumab in this study population will be determined by anti-tumor activity assessed by objective response rate. avelumab is a monoclonal antibody that binds to a protein called programmed death-ligand 1 (pd-l1) and blocks its communication with another protein called programmed death protein 1 (pd-1). the communication of these proteins are thought to be important in the growth of tumors. blocking these proteins from communicating may stop or shrink tumors.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma of the penis * measurable disease per immune-related response evaluation criteria in solid tumors (irecist) * unresectable/metastatic disease that is unfit for platinum-based chemotherapy or disease that has progressed on or after treatment with platinum-based chemotherapy * ≥18 years of age * eastern cooperative oncology group (ecog) performance status 0-2 exclusion criteria: * prior immunotherapy with il-2, ifn-α, or an anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or ctla-4 antibody (including ipilimumab), or any other antibody or drug specifically targeting t-cell co-stimulation or immune checkpoint pathways * major surgery ≤4 weeks or major radiation therapy ≤2 weeks prior to enrollment * known symptomatic central nervous system (cns) metastases requiring steroids * active autoimmune disease that might deteriorate when receiving an immunostimulatory agent * diagnosis of prior immunodeficiency or organ transplant requiring immunosuppressive therapy
mini-mental state (mms-ls) and sign language

Conditions: Prelingual Deafness; Retention Disorders, Cognitive

Summary: in france the prevalence of pre-lingual deafness is between 1 and 1.4 per 1000 habitants, and according to very conservative estimates, about 44 000 deaf persons use the sign language. additionally, the prevalence of dementia in france is close to 1% (850 000 dements for a total population of 65 millions). the prevalence of dementia in pre-lingual deaf adults has also been described and is between 1 and 1.4 /100 000 habitants. the mini mental state examination (mmse) of folstein is a test recommended to perform the cognitive evaluation for the detection of mental disorders including dementia, and a consensual french version exists prepared by greco (group of research and cognitive assessments). however, to date, there are no simple, rapid and validated screening tests to study cognitive disorders in deaf persons who use the sign language. the only tests available allow a late diagnosis avoiding an optimal treatment of the patients.

the objective of this study is to assess the intrinsic quality of the tool mms-ls, a mini-mental state examination that has been adapted to the sign language in order to monitor cognitive disorders in deaf people who speak sign language.

Eligibility criteria:
inclusion criteria: * adults\> 18 years * pre-lingual deafness * use of french sign language exclusion criteria: * refusal to sign the consent * severe visual impairment with lower acuity (less than 0.5) * severe motor difficulties impeding the practice of sign language

Keywords: prelingual deafness retention disorders, cognitive sign language mini-mental state