Kornimate/medical-research-clean huggingface dataset:
n-3 fatty acid infusion and type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this experimental study is to investigate whether an acute lipid infusion added marine n-3 fatty acids produces effects on insulin sensitivity in subjects with type 2 diabetes, when compared with an acute lipid infusion without marine n-3 fatty acids. furthermore other effects on intermediary metabolism are tested for.

evidence indicates that n-3 fatty acids exert several beneficial effects. however, the effects of marine n-3 fatty acids on intermediary metabolism have not been completely elucidated. in a previous study of a high intake of marine n-3 fatty acids during 9 wk we demonstrated reduced insulin sensitivity and altered proportion of carbohydrate vs. fat oxidation in subjects with type 2 diabetes. these results question the use of high doses of n-3 supplements in type 2 diabetes. it is not known to what extent such effects in type 2 diabetes can be reproduced by intravenous administration of n-3 fatty acids and/or whether short term intravenous administration has other effects.

Eligibility criteria:
inclusion criteria: * type 2 diabetes defined by clinical criteria and by absence of antibodies to glutamic acid decarboxylase. * hba1c 5,5 - 8,5 % * blood pressure ≤ 170 mm hg systolic and/or ≤ 105 mm hg diastolic exclusion criteria: * insulin treatment * hypertriglyceridemia (\> 2,1 mmol/l tg) * proliferative retinopathy, renal insufficiency (se-creatinine \> 150 μmol/l) * alcoholism, congestive heart failure or other serious diseases affecting the possibility of the subject to participate * supplement with fish oil or marine n-3 fatty acids during the last 6 months before baseline * dicumarol treatment * allergy to soya, fish or egg * pregnancy or lactation * smoking

Keywords: intralipid omegaven fish oil hyperinsulinemic isoglycemic clamps c-peptide glucagon test indirect calorimetry f2-isoprostanes
a pilot-study of sirolimus for the treatment of systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the purpose of the study is to examine the safety and effectiveness of sirolimus treatment for people with systemic sclerosis. the investigators perform a multi-centre, double-blind pilot trial with sirolimus in ssc.the investigators evaluate the effectiveness and safeness of sirolimus for systemic sclerosis by randomized controlled study (sirolimus 2mg/d (n = 36) versus placebo group (n = 36)).

each ssc patients (n=72) received sirolimus or placebo (active group: placebo group =1:1, 2mg/day， oral administration, (sir 2mg, po., qd) . the end points were the changement of modified rss and the adverse events or severe adverse events onset.

Eligibility criteria:
inclusion criteria: * meet the american college of rheumatology criteria for the diagnosis of ssc, 2013. * disease duration less than 5 years. * mrss was under stable level (\>1 month) at the time inclusion. * negative urine pregnancy test * written informed consent form exclusion criteria: * diagnosed with localized scleroderma . * added with immunosuppressor in one month such as mtx, aza, cyc. * added with anti-fibosis drug in one month. * prednisone \>10mg qd before inclusion. * sever chronic liver, kidney, lung or heart dysfunction; (heart failure (≥ grade iii nyha), hepatic insufficiency (transaminases\> 3n) ) * serious infection such as bacteremia, sepsis * mental disorder or any other chronic illness or drug-abuse that could interfere with the ability to comply with the protocol or to give information * cancer or history of cancer cured for less than five years (except in situ carcinoma of the cervix or basocellular carcinoma) * positive hiv test * positive urine pregnancy test * combined with the other connective tissue diseases
posterior approach to total shoulder arthroplasty

Conditions: Total Shoulder Arthroplasty; Osteo Arthritis Shoulders

Summary: the purpose of this study is to evaluate preoperative objective measurements and operative objective measurements to determine if there is any effect to postoperative outcomes. patients who were 18 years old or greater at the time of surgery were followed clinically and radiographically to determine best practice and optimal treatment and technique, risk and rate of complication, and postoperative outcomes.


Eligibility criteria:
inclusion criteria: 1. english speaking 2. \>18 years of age 3. underwent posterior approach to total shoulder arthroplasty by dr. michael greiwe at st. elizabeth healthcare exclusion criteria: 1. non-english speaking 2. \<18 years of age 3. loose bone in the anterior recess of the shoulder 4. severe arthritis with significant bony deformity
prognosis of atypical pituitary adenomas

Conditions: Pituitary Diseases

Summary: context: pituitary adenoma is generally indolent, but an aggressive subtype called atypical adenoma has uncertain prognosis, and an unclear relationship between prognosis and morphology. objective: this study investigated the prognostic factors of this tumor. design: retrospective analysis. setting: university and associated hospitals.


Eligibility criteria:
inclusion criteria: * pituitary adenomas of more than 3 % of ki67 labeling index surgically treated at tohoku university and associated hospital exclusion criteria: * pituitary adenomas of less than 3 % of ki-67 labeling index surgically treated at tohoku university and associated hospital

Keywords: atypical adenoma ki-67 p53 pituitary prognosis
development of a mhealth intervention for ambivalent smokers

Conditions: Tobacco Use Disorder; Smoking Cessation; Motivation; Behavior, Smoking

Summary: the current pilot study will assess the feasibility and acceptability of a novel mhealth app designed for people who are ambivalent about quitting smoking. results will be used to refine the intervention and plan for a future randomized effectiveness trial.


Eligibility criteria:
inclusion criteria: * 18 years or older; * can speak/read english; * current smoker; * own and regularly use an eligible smartphone; * no vision impairments; * willing to install and use the study program; * willing to use birth control if elect to use nicotine replacement during the study (females); * meet definition for ambivalence * not actively using treatment exclusion criteria: * smoke less than 10 cigarettes per day * self-report a lifetime history of dementia, manic depression, bipolar disorder, or schizophrenia; * have medical contraindications for nicotine replacement therapy; * another household member is enrolled in the study * unable to verify contact information * fail to install app

Keywords: mhealth smoking smoking cessation motivation
access a master digital surveillance protocol for covid-19

Conditions: Coronavirus; COVID; COVID-19; COVID19; Corona Virus Infection; Coronavirus Infection

Summary: access enables individuals to contribute to critical research, via an ios and android smartphone mobile application. access combines patient reported outcomes, data from wearable devices and real-world data (such as claims, ehrs, etc), with an opt-in to participate in current and future studies for diagnostics, treatments and vaccines. the data that people share can be quickly and anonymously matched to research studies, providing researchers with a foundational framework for dynamic research at scale and participants a way to be personally matched and prescreened for future research.

in the urgency of the covid-19 outbreak, medable will enable an observational study protocol under which clinical trials can rapidly be conducted. the observational study protocol will include the conduct of smartphone based research to capture an essential dataset to improve our understanding of disease evolution, risk factors, and outcomes as well as enable population-based monitoring to reduce the spread of disease. under this protocol, sub-studies and clinical trials can be conducted for interventions, including vaccine trials. the work may include new tools such as surface environmental or personal swabs to test for presence or absence of disease. data collection efforts on behalf of rapidly evolving multiple study designs and participant opt-in data sharing, will enable the compilation of critical epidemiological and other data across the united states to accelerate the understanding for effective mitigation and treatment of covid-19. access (american covid-19 collaborative enabling seamless science), a novel covid-19 digital research infrastructure, provides a mobile app tool for participants to report specific data and facilitate remote access to accelerate critical research and clinical treatment development. access leverages leading digital health technologies to facilitate at-home research, clinical trials, and population-based long-term outcome studies and data de-identification measures (data coding/tokenization). the infrastructure combines opt-in wearable sensors, patient reported data and outcomes, opt-in data aggregation and additional opportunities for users to participate in clinical trials and share their de-identified data based upon reported information. prior to covid-19, the fda expressed an interest in expediting drug development through developing trial designs that test multiple drugs and/or multiple subpopulations in parallel under a single protocol, without a need to develop new protocols for every trial. this has become even more important during the covid-19 pandemic. this type of work will also be enabled under the access system.

Eligibility criteria:
inclusion criteria: 1. aged 18 years or older 2. able to provide electronic informed consent 3. us resident 4. read and comprehend english exclusion criteria: 1. do not have a personal smartphone

Keywords: covid covid-19 corona coronavirus covid19 coronavirus infection
the impact of branched-chain amino acid metabolism on limb dysfunction in pad

Conditions: Peripheral Arterial Disease

Summary: test the theory that abnormalities in the large blood vessels that deliver blood to your leg and the very small blood vessels in your leg's muscles (invisible to the eye) work together to worsen your leg function and walking.


Eligibility criteria:
inclusion/exclusion criteria for healthy subjects inclusion criteria * male or female, age ≥ 50 years old * non-smoker exclusion criteria * presence of peripheral artery disease * history of a heart attack or stroke * diabetes * active cancer * severe renal disease (crcl \< 60) * severe liver disease * active rheumatological diseases inclusion/exclusion criteria for pad subjects inclusion criteria * male or female, age 50 years or older * atherosclerotic pad, abi ≤0.85 * willing to comply with protocol, attend follow-up appointments, complete all study assessments, and provide informed consent * for aim 3, subjects will have rutherford stage 4 or 5 disease * for aim 3, subjects will be undergoing revascularization as standard of care exclusion criteria * presence of a femoral, popliteal or tibial aneurysm of the index limb * life expectancy less than 2 years * a vascular disease prognosis that includes an anticipated above ankle amputation on index limb within 4 weeks of index procedure * renal dysfunction defined as mdrd egfr ≤ 20ml/min/173 m2 at the time of screening * currently on dialysis or history of a renal transplant * cirrhosis or active hepatitis * a documented hypercoagulable state * myocardial infarction within 6 months * stroke within 6 months * nonatherosclerotic occlusive disease of the lower extremity * any prior infrainguinal revascularization on index limb * current immunosuppressive medication, chemotherapy or radiation therapy * inability to have an mri * exercise limitation aside from that due to pad (i.e. copd, degenerative joint disease, etc.) * women who are pregnant * women who are nursing * primary indications for systemic oral anticoagulation for active arterial or venous thromboembolic disease.
a study in healthy volunteers investigating how quickly and to what extent bay1817080 is taken up, distributed, broken down and eliminated from the body, as well as the difference between 2 different types of tablets of bay1817080 and the difference between oral dose and dose in the vein

Conditions: Biological Availability

Summary: the main purpose of this study is to investigate how quickly and to what extent bay1817080 is absorbed (taken up), distributed, metabolized (broken down) and eliminated from the body (this is called pharmacokinetics). the pharmacokinetics of bay1817080 administered as tablets will be compared to the pharmacokinetics of bay1817080 administered as intravenous (iv; in the vein) infusion (this is called absolute bioavailability). furthermore, 2 different types of tablets with bay1817080 (formulation a and formulation b) will be compared with regard to pharmacokinetics (this is called relative bioavailability). the effect of a meal on the pharmacokinetics of bay1817080 administered as tablets will be investigated as well. finally, it will also be investigated how safe bay1817080 is and how well bay1817080 is tolerated.


Eligibility criteria:
inclusion criteria: * healthy male subject * age: 18 to 55 years (inclusive) at the time of informed consent and first dose of study medication * body mass index (bmi) above/equal to 18 and below/equal to 30 kg/m\^2 at screening * body weight of at least 45 kg at screening exclusion criteria: * presence or history of clinically relevant cardiovascular, central nervous system (cns), hepatic, hematopoietic disease, renal dysfunction, metabolic or endocrine dysfunction, serious allergy, asthma hypoxemia, hypertension, seizures, or allergic skin rash * known hypersensitivity to the study drugs * known severe allergies or significant non-allergic drug reactions * febrile illness within 1 week before study drug administration * current or recent (within 6 months) gastrointestinal disease that would be expected to influence the absorption of drugs * subject has a history of cancer, except basal cell carcinoma which has been in remission for at least 5 years prior to screening * poor peripheral venous access * regular use of medicines within 6 months prior to screening * clinically relevant findings in the electrocardiogram (ecg), physical examination or laboratory examination

Keywords: endometriosis refractory chronic cough
the effect of cancer pain management protocol on hospitalized cancer patients: a pilot study

Conditions: Cancers, Pain

Summary: the purpose of this study was to prospectively evaluate the effect of cancer pain management protocol on hospitalized cancer patients.


Eligibility criteria:
inclusion criteria: * hospitalized patient with the somatic and/or visceral pain having an untreated intensity greater than 3 on a 10 cm visual analog scale (vas; 0 = no pain, 10 = unbearable pain)over the week prior to enrollment * a minimum age of 18 years exclusion criteria: * opioid intolerance * no longer treatment for their underlying disease. * intracerebral primary or metastatic lesion * impaired sensory or cognitive function * pregnant or lactating woman * women of child bearing potential not using a contraceptive method * sexually active fertile men not using effective birth control during medication of study drug and up to 6 months after completion of study drug if their partners are women of child-bearing potential * any patients judged by the investigator to be unfit to participate in the study

Keywords: cancer pain opioid guideline
topo-pachimetric accelerated epi-on cross-linking compared to dresden protocol using riboflavin with vitamin e tpgs

Conditions: Keratoconus

Summary: in the present study the investigators compare the clinical outcome corneal cross linking with either the stand-ard dresden (scxl) or the accelerated custom-fast (acfxl) ultraviolet a irradiation protocol using riboflavin-d-α-tocopheryl polyethyleneglycol1000 succinate for progressive keratoconus.


Eligibility criteria:
inclusion criteria: * documented progressive keratoconus * changes in uncorrected distance visual acuity (udva) above 1.00 d * corrected distance visual acuity (bcva) above 1.00 d * spherical equivalent greater than 0.50 d exclusion criteria: * corneal pachymetry of less than 400 µm * less than 2000 cells/cm2, * corneal scarring, * nystagmus or any motility disorder that prevented a fixed gaze during the examination * current contact lens use
just in time - intervention with dance and yoga for girls with recurrent abdominal pain

Conditions: Functional Abdominal Pain; IBS

Summary: recurrent abdominal pain affects up to 37% of school-age children, mostly girls. these problems results in decreased quality-of-life, absence from school, lower sleep quality and increased health-care consumption. long-term effects are lasting pain-symptoms and increased risk for psychiatric illness. the scientific evidence for interventions towards long-term pain in children is limited and pharmacological treatment is not effective. cognitive behavioral therapy has shown some effect but is time- and resource consuming. dance and yoga can enhance positive protective factors through better body awareness and increased self-regulation. relaxation in yoga also has positive effect on abdominal pain. the aim of this study is to evaluate the effects of an intervention with dance and yoga for girls, 9 to 13 years old, with recurrent abdominal pain. the participants will be identified through pediatric clinics in örebro county, primary health care and school health care. they will be randomized to intervention with weekly dance- and yoga class for 8 months or control group with standard treatment. primary outcome is the fraction of girls in each group who, direct after intervention, has decreased their maximum pain measured by faces pain scale. secondary outcomes are stress, psychical health, well-being, school and sleep functions, physical activity and health-economy. the study group will be followed up for two years. just-in-time is an interdisciplinary research group with expertise in interventions for psychosomatic problems in children and adolescents. time, which stands for try, identify, move and enjoy, also characterizes this project, aiming at decreasing recurrent abdominal pain through an intervention with dance and yoga for 9-13 year old girls.


Eligibility criteria:
inclusion criteria: girls 9-13 years old as of pediatricians receive or have received the diagnosis functional abdominal pain or ibs according to the rome iii criteria and stating that they have persist symptoms for at least 2 months after completed investigation from pediatricians. persistent symptoms are measured by pain diary at baseline and means that the girl at least once in the pain diary estimates 4 or higher as measured by the faces pain scale (fps-r). exclusion criteria: * simultaneous celiac disease or inflammatory bowel disease (ibd). * difficulties in following verbal instructions such as hearing impaired or mentally retarded. * girls who are deemed to have such serious psychological symptoms that other treatment is required. all participants in the study, which estimates over 13 at the children's depression screener (child-s), will meet a psychologist / psychiatrist to assess whether they can participate in the study or have direct access to the children and youth psychiatry. * children treated with cbt.

Keywords: dance-intervention yoga adolescents recurrent abdominal pain
health education for diabetes mellitus

Conditions: Diabetes Mellitus

Summary: through the construction and study of standardized diabetic health education management model. routine diabetes health education management model was used in control group and standardized diabetes mellitus health education management model was used in intervention group. the changes of diabetic knowledge, self-management ability, quality of life,patient empowerment, hba1c, and other metabolic indexes were observed.

the aim was to develop a standardized patient education model reflecting the core educational elements recommended by chinese diabetes society guideline, which could be delivered by nurses to hospitalized diabetes patients, and which could be easily scaled-up and implemented in china tier 3 hospital setting. management mode of standardized diabetes mellitus health education in intervention group.the control group carries on the routine diabetes mellitus health education management. in intervention group , all participants received management mode of standardized diabetes mellitus health education.the standardized patient education included one-week personalized education on diabetes knowledge, diet and excise, glucose monitoring and hypoglycemia self-management and others during the hospitalization period. after discharge, patients were followed through the phone call at 2and 4 weeks. follow-up of diabetic education outpatients at 12 and 24 weeks after discharge. the education nurse gave recommendations according to patent's problem during the follow-up. full-time education nurses carry on education according to diabetes mellitus health education path table. in routine, after hospitalization, the responsible nurses interspersed with diabetes health education during the hospitalization. the health education is mainly about the problems observed by the responsible nurses and the problems raised by the patients. the patients were followed up by telephone 2 weeks after discharge.

Eligibility criteria:
inclusion criteria: * type 2 diabetes patients with world health organization(who) diagnosis (1999); * hba1c ≥ 7.5%; * history of diabetes \< 2 years; * age from 18 to 70 years; * having the ability of autonomous behavior, informed consent and voluntary participation in the study. exclusion criteria: * type 1 diabetes mellitus, gestational diabetes mellitus and other special types of diabetes; * severe acute and chronic diseases, severe psychological failure, lung failure, tumor, etc. * is participating in other researchers.

Keywords: diabetes mellitus health education for diabetes