Kornimate/medical-research-clean huggingface dataset:
expert statements concerning the tapering of oral corticosteroids (ocs) for the treatment of asthma

Conditions: Asthma

Summary: the objectives of this study are to use the delphi method to assemble an expert panel representing innovation in asthma treatment, to collect freely suggested recommendation statements concerning ocs tapering (and sub-topics) among severe asthma patients from this panel for peer evaluation, and finally to determine the level of consensus for each statement from the panel as a whole.

a series of anonymous questionnaires will be administered to a panel of experts. each questionnaire administered results in a body of information that is re-presented to the experts before performing the next round. initial brainstorming questionnaires are open in nature, and are used to generate statements that individual experts would like to see evaluated by their peers. subsequent ranking questionnaires require that each expert rank each statement according to a pre-defined likert scale. serial ranking questionnaires are administered electronically and continue until stopping rules are met, or the maximum number of allowed rounds is achieved (capped at three rounds for the present study). experts are recruited by invitation or response to open call (see eligibility criteria and url at the end of this declaration.)

Eligibility criteria:
inclusion criteria: * the expert is either a pulmonologist/respiratory disease specialist, an allergist, an endocrinologist, a paediatrician, a rheumatologist or a patient advocacy organisation representative * all clinicians involved must manage patients on a weekly basis and have clinical experience in managing disease following oral corticosteroid withdrawal/tapering. * patient advocacy organization representatives must represent a relevant patient group (and provide contact information for their group) exclusion criteria: * currently employed by a pharmaceutical company, or will have such employment in the upcoming 12 months * ownership in a pharmaceutical company or any other conflict of interest with the present study
cellular preconditioning for post-surgical myocardial ischemic complications - observational study

Conditions: Cardiac Complication; Myocardial Infarction; Myocardial Ischemia; Myocardial Injury

Summary: the goal of this observational study is to collect health data on people who are at high risk of having heart complications and are having a surgery that is not on the heart. the main questions it aims to answer are: * is this study feasible in terms of recruiting enough people to participate in this study? * how often do heart complications happen in people who are at high risk of heart complications and are having a surgery that is not on the heart? participants will have their usual care and will also be asked to: * have extra bloodwork done * complete some surveys * have two echocardiograms (ultrasounds of the heart) * continue to follow-up with the research team for one year after their surgery researchers will compare how often heart complications occur in this high risk population to a future study where participants will receive stem cells before their surgery.

this observational trial protocol is to collect baseline health data from participants undergoing intermediate to high-risk surgery and at high risk of developing perioperative myocardial ischemic complications for an upcoming phase 1 trial that determines the feasibility of intravenous delivery of umbilical cord-derived (uc) mesenchymal stromal cells (mscs) in the same patient population. participants enrolled in this protocol, however, will not receive cell product; they will receive standard of care and serve as a lead in control group for the interventional study.

Eligibility criteria:
inclusion criteria: a participant must meet all 5 inclusion criteria to be eligible: * referred for elective intermediate to high risk noncardiac surgery as defined by the american heart association guidelines (e.g., intrathoracic, open intraabdominal, or open vascular surgery) * 45 years of age or older * revised cardiac risk index ≥ 2 * nt-probnp level of ≥ 200 pg/ml * able to provide informed consent exclusion criteria: * experience an acute coronary syndrome, myocardial infarction, heart failure, or stroke within preceding 3 months * coronary revascularization anticipated during the study period * severe mitral/aortic valve stenosis * evidence of clinically significant arrhythmia in last three months. * major surgical procedure in previous 3 months * history of malignancy requiring surgery, chemotherapy, immunotherapy, or radiation within previous 5 years * ongoing malignancy requiring surgical resection * women who are pregnant, breastfeeding, or of childbearing potential who are unable to use a medically acceptable form of contraception throughout the study * received any experimental cell therapy previously * unable to provide written informed consent

Keywords: myocardial injury after noncardiac surgery perioperative myocardial infarction
rapid screening for olfactory disorders in covid-19 infection

Conditions: Olfaction Disorders; COVID-19 Testing

Summary: loss of smell is very frequently found in europe during covid-19 attack. this symptom was not initially expected as part of the classic symptomatology. this loss of smell mainly concerns patients with few or no symptoms, without criteria of severity and usually treated on an outpatient basis. as a result, given the unexpected occurrence of this symptom (with less awareness in the general and medical population) and the potential risk of contamination of covid+ and anosmic subjects (due to their less symptomatic form), it is interesting to be able to propose large-scale screening for loss of sense of smell in order to preferentially direct subjects diagnosed as anosmic towards rt-pcr-type screening. in the medium term, the loss of smell seems to persist after the infectious phase, with delayed or persistent recovery, which can lead to negative psychological repercussions. the objective is to propose large-scale screening of the general population for loss of sense of smell during a pandemic period, in order to facilitate diagnostic orientation of the population. the diagnosis of loss of smell will be carried out using a simple olfactory test in the form of an olfactory stick to be smelled.


Eligibility criteria:
inclusion criteria: * subject presenting himself at the covid-19 screening centre set up by the city of nice exclusion criteria: * presence of a sensory deficit (auditory or visual) preventing the subject from answering the questions perfectly during the olfactory test. * subject receiving cancer chemotherapy

Keywords: olfaction disorders hyposmia dysosmia anosmia covid-19
a study on the effect of position on walking labour epidural efficacy

Conditions: Labor Pain; Analgesia, Epidural

Summary: this study is being done to better understand how patient positioning can affect pain relief after an epidural. in addition to pain, the investigators will assess how position affects epidural spread, and its effects on maternal blood pressure and fetal heart rate.

epidurals will be placed with parturients in the standard sitting position. an epidural catheter will be placed to a depth of 5 cm into the epidural space. after placement, parturients will be randomized to one of the four position groups (left uterine displacement, left lateral, right lateral, or seated upright). after successful positioning, a series of 5 cc bolus doses of 0.08% ropivacaine with 2 mcg per cc of fentanyl will be injected through the epidural catheter in 5 minute intervals for a total volume of 20 cc. after the initial loading dose of epidural solution has been injected in the first 20 minutes post-insertion, the patient will be able to return to whatever position they are most comfortable with. the parturient will be asked to rate their pain on a verbal pain scale of between 0 and 10 at the peak of their contraction at three time intervals. the spread of the blockade will be assessed with ice applied along both the left and right mid-clavicular lines. maternal blood pressure will be measured on the upper arm in all patients as per nursing protocol. fetal heart rate will be monitored intermittently with doppler ultrasound as per nursing protocol.

Eligibility criteria:
inclusion criteria: * active labour or admitted for induction of labour * requesting an epidural for labour analgesia * contractions occurring greater than once every 5 minutes exclusion criteria: * coagulation disorder * high risk pregnancy as per obstetrics * spinal pathology (included scoliosis, herniated disks, or previous lumbar back surgery)

Keywords: analgesia, obstetrical posture pregnancy female heart rate, fetal hypotension
non-invasive brain stimulation in patients with methamphetamine use disorder

Conditions: Craving; Depression, Anxiety; Amphetamine Addiction

Summary: the study aims to apply the intermittent theta burst transcranial magnetic stimulation (itbs) treatment and evaluate the effect in improving craving, affective symptoms, and cognitive function for those participants in the community with amphetamine use. an electroencephalography and blood biomarkers will also be examined to explore the possible mechanisms.

in this study, participants with amphetamine use will be recruited from psychiatric clinics. they will be randomly assigned to two different transcranial magnetic stimulation groups, the itbs and sham groups. those participants to receive 1-3 sessions in a single day at an interval of 15 minutes, and 5 high-frequency itbs sessions per week in total four weeks. after the completion of the four-week course, the severity of symptoms for the next one month and three months will be tracked.

Eligibility criteria:
inclusion criteria: 1. age ranged 20-65. 2. diagnosis as amphetamine use disorder by clinical psychiatrist according to dsm-v exclusion criteria: 1. major disorders other than substance use disorders in diagnostic and statistics manual-5 (e.g. schizophrenia, organic brain syndrome, and bipolar disorders). 2. epilepsy, head trauma, migraine, cardiovascular comorbidity, atypical parkinsonian disorder 3. patients with heart pacemakers, implanted drug delivery aids, artificial electronic ears, implantable defibrillators, and/or implanted nerve stimulators, and near the implants mentioned above. 4. patients with metal implants above the chest. 5. people who have damaged skin in areas of the patient's body that receive stimulation. 6. patients with multiple sclerosis. 7. patients who have extensive ischemic scarring. 8. pregnant women. 9. patients with a family history of spasms/epilepsy 10. patients taking medications that may lower the seizure threshold. 11. patients with severe sleep disorders related to previous rtms treatment. 12. patients with severe heart disease 13. patients with intracranial stress caused by uncontrollable migraines. 14. people who have been evaluated by a physician as unfit to participate in clinical trials.

Keywords: addiction amphetamine non-invasive theta burst stimulation
gloria-af registry program - second and third phases

Conditions: Stroke; Atrial Fibrillation

Summary: in this part of the registry program patients with non-valvular atrial fibrillation (af) at risk for stroke are enrolled to characterize the target population and to collect real world data on important outcome events. for administrative purposes the study is divided into two protocol numbers: 1160.129 for all non-eu (european union) and non-eea (european economic area) countries, and 1160.136 for eu and eea countries. the total number of patients enrolled in both protocols is estimated to be 48,000 patients, and all these patients will be included in the data analysis for study 1160.129.


Eligibility criteria:
inclusion criteria: 1. age =\>18 years at enrollment 2. male or female patient (or legally acceptable representative) willing and able to provide written informed consent 3. patient newly diagnosed (\< 3 months prior to baseline visit) with non-valvular af and at risk for stroke. other inclusion criteria apply. exclusion criteria: 1. presence of any mechanical heart valve, or valve disease that is expected to require valve replacement intervention; 2. patients who have received more than 60 days of vitamin k antagonist (vka) treatment in their lifetime; 3. af with a generally reversible cause; 4. patients with a medical condition other than atrial fibrillation for which chronic use of an oral anticoagulant (for example, a vka) is indicated other exclusion criteria apply
remote monitoring and virtual collaborative care for hypertension control to prevent cognitive decline phase ii

Conditions: Hypertension

Summary: this is a randomized, controlled, pragmatic trial designed as a "type i hybrid effectiveness-implementation trial" that tests a hypertension program integrating a virtual collaborative care clinic (vccc), home blood pressure monitoring, and telehealth for lowering blood pressure (bp) in two health systems.

this study tests a hypertension program integrating a virtual collaborative care clinic (vccc), home blood pressure monitoring, and telehealth for lowering blood pressure (bp) in two health systems (university of kansas health system \[ukhs\] and the university of utah health \[uutah\]). the vccc is staffed by clinical pharmacists who remotely monitor home bp and use telehealth to work with patients to lower systolic blood pressure (sbp) to \<130 mmhg, as recommended by the current american college of cardiology/american heart association (acc/aha) guidelines. eligible patients with uncontrolled hypertension (htn) are identified automatically through the electronic health record (ehr) during visits to their primary care provider (pcp) and referred for enrollment into the vccc.

Eligibility criteria:
inclusion criteria: * age 65 and older * active patient in participating primary care clinic * access to compatible "smartphone" or device (i.e., android, kindle or apple with internet connectivity or mobile network) * elevated bp as defined by * sbp \>140 at current visit and documented history of hypertension or sbp \> 140 at current visit and at another visit in last 18 months or sbp \>160 at current visit * sufficiently fluent in english to participate in study procedures * adequate hearing to complete study procedures * able to give their own signed consent * health insurance coverage by medicare exclusion criteria: * clinically significant illness that may affect safety or completion per their treating pcp or study physician * needing interpreter for clinic visits (through electronic health record) * currently in hospice care * currently receiving chemotherapy * unable to take accurate bp measurement, either due to inability to follow protocol to check bp or due to medical conditions such as lymphedema or dialysis access on both arms. * currently participating in another intervention trial * end stage kidney disease on dialysis * diagnosis of dementia (i.e., dementia, alzheimer's disease, vascular dementia, dementia with lewy bodies, frontotemporal dementia) * chronic active disease with expected life expectancy \< 2 years as determined by the study team
coadministration of abt-450/ritonavir/abt-267 (abt-450/r/abt-267) with ribavirin (rbv) in adults with genotype 4 (gt4) hepatitis c virus (hcv) in egypt

Conditions: HCV; Hepatitis C Infection; Genotype 4

Summary: this study evaluates the efficacy and safety of abt-450/r/abt-267 with rbv in treatment-naive and treatment-experienced hcv gt4 subjects without or with compensated cirrhosis.

non-cirrhotic subjects were directly enrolled into arm a. cirrhotic subjects were randomized to either arm b (12 weeks of treatment) or arm c (24 weeks of treatment).

Eligibility criteria:
inclusion criteria: * chronic hepatitis c, genotype 4-infection (hepatitis c virus \[hcv\] ribonucleic acid \[rna\] level greater than 1,000 iu/ml at screening) * subjects must meet one of the following: * treatment-naive: subject has never received antiviral treatment for hcv infection or * treatment experienced (prior null responders, partial responders or relapsers to pegylated-interferon \[pegifn\]/rbv); * females must be post-menopausal, of non-child bearing potential or practicing specific forms of birth control * in substudy 1, demonstrated absence of liver cirrhosis as confirmed by liver biopsy or fibroscan * in substudy 2, evidence of liver cirrhosis as confirmed by liver biopsy or fibroscan with child-pugh score less than or equal to 6 at screening and confirmed absence of hepatocellular carcinoma exclusion criteria: * females who are pregnant or breastfeeding * positive screen for hepatitis b surface antigen or anti-human immunodeficiency virus antibody * hcv genotype performed during screening indicating unable to genotype or co-infection with any other hcv genotype * abnormal laboratory tests * self-reports current drinking more than 2 drinks per day * current enrollment in another investigational study * previous treatment with a direct acting antiviral agent (daa) containing regimen * in substudy 1, evidence of liver cirrhosis * in substudy 2, evidence of current or past child-pugh b or c classification and confirmed presence of hepatocellular carcinoma

Keywords: genotype 4 non-responder treatment experienced hcv naive relapser hepatitis infection compensated cirrhosis hepatitis c cirrhosis egypt null responder partial responder
phase i/ii study of recombinant human hepatocyte growth factor in fulminant hepatic failure

Conditions: Liver Failure, Acute

Summary: the purpose of this study is to determine whether recombinant human hepatocyte growth factor is safe and effective in the treatment of fulminant and late-onset hepatic failure.

fulminant and late-onset hepatic failure (lohf) is intractable disease with high degree of fatality (70-80%). only liver transplantation is established as a therapeutic modality to rescue patients with fulminant hepatic failure or lohf. however, approximately 75% of the patients are not able to receive liver transplantation in japan, and effective non-surgical treatment has not been established yet. hepatocyte growth factor (hgf) is one of major agents stimulating liver regeneration and ameliorating hepatic injury. in this study, recombinant human hgf is administered to patients with fulminant hepatic failure or lohf, who can not receive liver transplantation.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of fulminant or late-onset hepatic failure * must be unable to receive liver transplantation exclusion criteria: * under 16 years old * cancer patients * pregnancy-aged women * impaired renal function * impaired cardiac function * severe complications including pneumonia, sepsis, dic and so on
effects of microprocessor-controlled knee joints on community outcomes

Conditions: People With Trans-femoral Amputation

Summary: about 21% to 35% of people with limb loss are those who lost their limb at trans-femoral level (i.e. above the knee). the increasing number of diabetes-related limb loss (amputation) and the rising proportion of older adult amputees indicates more amputees with limited mobility in the future. among other factors, prosthesis success highly depends on the function of the knee joints during daily activities. presently, there are two categories of prosthetic knee joints; microprocessor-controlled knees (mpks) and non-microprocessor-controlled knees (n-mpks). whilst the n-mpks are unable to change the knee stiffness, the mpks alter the joint stiffness and speed of movement according to the users' walking speed. although past studies indicate that mpks could result in reduced risk of falls, improved balance and activity in limited mobility amputees, there is a lack of strong evidence on the effect of mpks on community outcomes. the aim of this study is to compare activity, mobility, social functioning, depression, anxiety, and health-related quality of life in limited mobility trans-femoral or through-knee (i.e. knee disarticulation) amputees who are users of mpks prosthesis with users of a prosthesis with n-mpks.


Eligibility criteria:
inclusion criteria: * unilateral transfemoral amputation or knee disarticulation * ≤ k2 mobility grade or sigam grade d or below; i.e. able to walk ≤ 50 meters on level ground, * users of either mpk or n-mpk for at least 6 months prior to the recruitment date. exclusion criteria: * not meeting inclusion criteria

Keywords: trans-femoral amputation limb prosthesis microprocessor controlled knee joints community outcome measures
clinical trial of anti-pla2r-igg detection kit (time-resolved fluorescence immunoassay)

Conditions: Nephropathy

Summary: conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

conduct comparative experimental studies on clinical serum samples using assessment reagents and approved products, and evaluate the equivalence between assessment reagents and comparison reagents.

Eligibility criteria:
inclusion criteria: clear background information and traceable sources of samples from kidney disease patients (number, age, gender, and clinical diagnostic information). exclusion criteria: exclude serum samples that meet one of the following conditions: ① samples with insufficient sample size, ② samples with incomplete sample information.
chronic effects of freeze-dried strawberry beverage on cardiovascular risk factors

Conditions: Dyslipidemia; Obesity

Summary: berry anthocyanins have been shown to improve lipid profile in subjects with dyslipidemia while no such studies with whole strawberries have been reported in the us population. the investigators propose to examine the effects of low and high doses of freeze-dried strawberries on serum glucose, insulin, and lipid profile, biomarkers of oxidative stress and inflammation, in a 12-week randomized controlled trial. subjects with abdominal adiposity and dyslipidemia (n=15/group) will be recruited at ouhsc and osu, and randomly assigned to the low (25g/day) or high (50g/day) strawberry dose, or matched control (fiber and calories) group. the strawberry group will consume freeze-dried strawberry beverage (2 cups/day) and the controls will consume 2 cups beverage (fiber +calories) daily for 12 weeks. blood draws, anthropometrics, blood pressure, and dietary data will be collected at screen, 6 and 12 weeks of the study to determine chronic and acute effects of strawberry intervention. serum or plasma samples will be analyzed for fasting glucose, insulin, lipid profile including total cholesterol, ldl-, and hdl-cholesterol, triglycerides, lipid particle size, and levels of oxidative stress (malondialdehyde, oxidized ldl, myeloperoxidase), inflammation (high sensitivity c-reactive protein, adiponectin, interleukins) and adhesion molecules. repeated measures anova will be performed using a 5% significance level. we anticipate a dose response effect in decrease in lipids, oxidative stress or inflammation following strawberry intervention versus controls.

the overall objective of this clinical trial is to investigate the effects of low and high doses of freeze-dried strawberries in cardiovascular risk factors in subjects with abdominal adiposity and dyslipidemia versus age and gender-matched controls.

Eligibility criteria:
inclusion criteria: * dyslipidemia * abdominal adiposity (\>35 inches for women, \>40 inches for men) exclusion criteria: * on statin therapy * taking hypoglycemic agents

Keywords: strawberries heart health anthocyanins