Kornimate/medical-research-clean huggingface dataset:
denosumab for prevention of post-teriparatide bone loss in premenopausal women with iop

Conditions: Adult Idiopathic Generalized Osteoporosis

Summary: the purpose of this research study is to evaluate antiresorptive therapy with denosumab (prolia) for prevention of bone loss after stopping teriparatide (tptd) in premenopausal women with idiopathic osteoporosis. premenopausal women who have received tptd in the fda orphan diseases program-funded trial, "a phase 2 study of teriparatide for the treatment of idiopathic osteoporosis in premenopausal women" (nct01440803) may be eligible to participate in the current study, a 36-month open-label pilot study of denosumab (prolia®, 60mg subcutaneous (sc) every 6 months). the goals of the study are to estimate the effects of denosumab on central and peripheral, as well as trabecular and cortical, bone mass and microstructure and to obtain preliminary data to inform the design of a future randomized study. this study presents the first opportunity to study the effects of denosumab after tptd in this unique and severely affected group of young women. funding source: fda office of orphan products development (oopd).

osteoporosis in premenopausal women with normal menstrual function and no specific cause is termed idiopathic osteoporosis (iop). iop is a rare disease with an estimated prevalence of \<200,000 affected premenopausal women in the united states. denosumab, a potent inhibitor of osteoclast-mediated bone resorption, leads to continuous gains in both trabecular and cortical bone mineral density (bmd). moreover, denosumab is not retained in the skeleton, and may thus be preferable for use in young women who may be contemplating future pregnancies. the investigators hypothesize that denosumab, initiated after completion of two years of tptd, will maintain or improve central and peripheral areal and volumetric bmd, microstructure and stiffness in premenopausal women with iop.

Eligibility criteria:
inclusion criteria: * all women completing nct01440803 who remain without a disease or medication that causes osteoporosis will be offered enrollment into this study. * (premenopausal status is no longer be required for entry.) exclusion criteria: * renal insufficiency or liver disease: creatinine, transaminase (ast)/alanine transaminase (alt) above upper limit of normal * vitamin d deficiency: 25-hydroxyvitamin d (25-ohd) \<30 ng/ml * pregnancy: urine pregnancy test must be negative

Keywords: osteoporosis premenopausal denosumab idiopathic idiopathic osteoporosis in premenopausal women
cereal-based products fortified with legumes and effects on glycemic control and appetite regulation

Conditions: Appetite

Summary: legumes are rich source of proteins and dietary fibers which are associated with satiety and amelioration of postprandial glycemic response. the purpose of the study is to examine the effects of cereal-based products fortified with legumes on appetite regulation and body weight management.

postprandial glycemic response as well as response of hormones related to appetite regulation after consumption of cereal-based products fortified with legumes will be evaluated. apparently healthy subjects with normal body weight and overweight subjects will participate in the study (two protocols). certain effects on metabolites related to the composition of the different products will be examined. the results of the study will help in the design of a long-term clinical trial regarding the effects of the functional products on body weight management in overweight subjects.

Eligibility criteria:
inclusion criteria: * normal exercise and dietary habits * weight stable for at least 3 months before enrollment exclusion criteria: * pregnancy * diabetes * chronic medical illness * use of nutritional supplements * regular intense exercise * alcohol consumption \>2 drinks per day

Keywords: cereal-based products fortified with legumes appetite regulation postprandial glucose response postprandial hormone responses
analysis of cmv infections in patients with brain tumors or brain metastases during and after radio(chemo)therapy

Conditions: Cytomegalovirus Infections

Summary: radio(chemo)therapy is the standard therapy for both, brain tumors and brain metastases. neurological decline is observed in these patients and tumor progression or radiotherapy side effects have been made responsible for this. however cmv encephalitis may also be a reason. therefore the investigators aim to analyze the cmv status in patients during and after radio(chemo)therapy. it will be checked by cmv-dna (pcr analysis) and cmv antibodies (igg and igm elisa) in the blood of the patients. these findings will be correlated with changes in the brain, visualized by mri. in addition a detailed immunophenotyping in the peripheral blood will be performed.


Eligibility criteria:
inclusion criteria: * brain tumours (glioblastoma or anaplastic astrocytoma) * brain metastases from diagnosed primary tumours * legal age * planned chemoradiation and adjuvant chemotherapy \[metastases\] * planned chemoradiation and adjuvant chemotherapy with temodal (according to stupp et. al.) \[brain tumors\] exclusion criteria: * fertile patients who refuse effective contraception during study treatment * persistent drug and/or alcohol abuse * patients not able or willing to behave according to study protocol * patients in care * patients that are not able to speak german * patients with claustrophobia * patients with artificial joint or any metal parts in the body * patients with pacemakers
camostat with bicalutamide for covid-19

Conditions: Covid19; SARS-CoV Infection; Coronavirus Infection

Summary: this will be a randomized, open-label study to determine if camostat+ bicalutamide decreases the proportion of people with covid-19 who require hospitalization, compared to historical controls. patients with symptomatic covid-19, diagnosed as outpatients, will be randomized 1:1, stratified by gender, to treatment with standard of care alone (arm 1) or with camostat and bicalutamide (arm 2).


Eligibility criteria:
inclusion criteria: * \>= 60 years of age * covid-19 infection, confirmed by polymerase chain reaction (pcr) test \<=5 days from enrollment done in the ambulatory setting * able to provide informed consent * symptom related to covid-19. this includes: fever or chills, cough, shortness of breath or difficulty breathing, fatigue, muscle or body aches, headache, new loss of taste or smell, sore throat, congestion or runny nose, nausea or vomiting, diarrhea or other symptom recognized by the centers for disease control to be a symptom of covid-19. exclusion criteria: * patients who undergo asymptomatic screening test that is positive and remain asymptomatic during the eligible time window * patients who have had one or more positive more than 5 days prior to enrollment but within 60 days of enrollment (ex. if a patient has a positive test 10 days prior to enrollment and then a second positive test the day referred for enrollment, that patient would be excluded. if a patient had a positive test 5 months ago, and then another positive test the day he/she was referred for enrollment, that patient would be eligible) * unable to take oral medication * male patients with female partners of reproductive potential who are unable to maintain effective contraception during the recommended time period (during treatment and for 130 days after the final dose) * symptoms requiring hospitalization or immediate referral to hospital * taking bicalutamide, any systemic hormonal therapy, or camostat within one month of study entry * known hypersensitivity to bicalutamide, or camostat, or its components. * on coumadin anticoagulation (because of drug-drug interaction with bicalutamide) * self-reported past medical history of chronic liver disease or cirrhosis * self-reported myocardial infarction within 6 months or past medical history of congestive heart failure with known ejection fraction \< 40% * taking any other investigational treatment for covid-19 or covid-19 prophylaxis (covid-19 vaccines and treatments allowed under fda emergency use authorization are allowed.) women and people from all ethnic and race groups are eligible for this study.

Keywords: covid-19 coronavirus camostat bicalutamide tmprss2 sars-cov-2
introduction seminar about patient participation and treatment options for psychiatric patients on waiting list

Conditions: Mental Disorders

Summary: patient participation is a central concept in norwegian health policy. it is mandatory in hospitals and emphasised as one of the most prioritised areas by the government. studies from norway have repeatedly found that patients who seek help in community mental health centres ("dps") are dissatisfied with the information they receive and about their possibility for real influence in their treatment. one way to improve individual patient participation might be to give patients information before they start their treatment. this can be done as group based patient education to reduce the resources needed. furthermore, as there are waiting lists for treatment, such introduction seminars could be held while patients are waiting to use this time in a meaningful way. the present study therefore aims at testing the effect of an introduction seminar for patients on waiting list in a community mental health centre.


Eligibility criteria:
inclusion criteria: * patients older than 18 years referred for out patient treatment who get a guarantee of starting treatment between 2 and 6 months will be included. exclusion criteria: * patients with a guarantee of starting treatment in less than two months and * patients who do not understand the consequences of taking part in the study

Keywords: introduction seminar psychoeducation waiting list patient participation mental disorders
characterization of interventricular conduction measurements

Conditions: Heart Failure

Summary: this study is an effort to use left ventricular (lv) lead based measurements to identify late electrical activation and avoid scar.

the aim of this study is to characterize how right ventricular (rv) to left ventricular (lv) conduction delays are altered by pacing site in patients with a cardiac resynchronization therapy (crt) system. the study will be performed in conjunction with a crt implant.

Eligibility criteria:
inclusion criteria: * patient is greater than 18 years of age. * the patient or the patient's legally authorized representative is willing to give informed consent. * crt indicated guidelines. * patient is receiving a medtronic ipg or icd. exclusion criteria: * patients who are pregnant. * patient is in af. * patient with 3rd degree av block.
a comparison study of the efficacy of quetiapine and haloperidol in agitated adults in emergency room

Conditions: Agitation

Summary: in the psychiatric emergency room, agitated patients are treated routinely with an i.m. haloperidol "cocktail" (haloperidol 5 mg, lorazepam 2 mg, cogentin 2 mg), which has proved to be an effective treatment. however, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause eps (extrapyramidal symptoms). of late in our emergency room, we started using high dose quetiapine 300 mg po to replace the "cocktail" for treating agitation. it has shown promising results.

in the psychiatric emergency room, agitated patients are treated routinely with an i.m. haloperidol "cocktail" (haloperidol 5 mg, lorazepam 2 mg, cogentin 2 mg), which has proved to be an effective treatment. however, since it is an intramuscular injection, it is more complicated and perhaps less acceptable to patients as well as more likely to cause eps (extrapyramidal symptoms). of late in our emergency room, we started using high dose quetiapine 300 mg po to replace the "cocktail" for treating agitation. it has shown promising results. this study is designed to compare the efficacy and safety of quetiapine with the routine "cocktail for treatment of agitation. the primary purpose of this study is to determine the efficacy and safety of quetiapine by using high dose quetiapine (300 mg) po to treat agitated patients in the psychiatric emergency room. the secondary purpose is to test the immediate effect on agitation caused by illicit drug abuse or the alcohol abuse.

Eligibility criteria:
inclusion criteria: 1. english or spanish speaking patients 2. provision of written informed consent-english and spanish 3. males and females age 18 to 60 years. females who are pregnant by inspection should not be included. 4. provision at diagnosis meeting the diagnostic and statistical manual of mental disorder, 4th edition (dsm-iv) criteria for axis i documented who present in an agitated state. panss-ec score should be \>15. 5. ability, in the treating physician's opinion, to co-operate with taking oral medication exclusion criteria: 1. pregnant females who will thus receive routine care in the treating physician's opinion 2. unstable medical illness 3. withdrawal stage from any illicit drugs 4. psychosis that prohibits participation in trial 5. females of childbearing age where pregnancy cannot be confirmed or denied by screening 6. patients who required continued intervention or prolonged restraint
effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer

Conditions: Breast Cancer

Summary: rationale: aromatase inhibitor therapy is used in treating postmenopausal women who have hormone-dependent breast cancer. it is not yet known what effect aromatase inhibitor therapy has on blood vessel function. purpose: this clinical trial is studying the effect of aromatase inhibitor therapy on blood vessel function in postmenopausal women with breast cancer.

objectives: * determine the effect of adjuvant aromatase inhibitor therapy on endothelial function in postmenopausal women with breast cancer. outline: this is a multicenter study. patients are assigned to 1 of 2 treatment groups according to breast cancer hormone-receptor status (positive vs negative). * group 1 (hormone receptor-positive): patients receive aromatase inhibition therapy for up to 6 months in the absence of unacceptable toxicity. * group 2 (hormone receptor-negative): patients do not receive adjuvant treatment. endothelial function is measured in both groups at baseline and at follow up by the room temperature peripheral arterial tonometry (rt-pat) index using the endopat method.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * ductal carcinoma in situ (dcis) allowed provided the patient will not receive tamoxifen as part of treatment for their cancer * may not have had a prior mastectomy with requirement for mastectomy of the contralateral breast * no requirement for axillary lymph node dissection with a history of contralateral mastectomy and/or contralateral axillary lymph node dissection * hormone receptor status meeting 1 of the following criteria: * hormone receptor negative and not eligible for aromatase inhibitor therapy (ai) * hormone receptor positive and are not receiving an ai patient characteristics: * postmenopausal * no known or symptomatic coronary artery disease * no significant co-morbidities, including any of the following conditions: * active renal or hepatic disease * known uncontrolled and/or untreated peripheral arterial disease * uncontrolled and/or untreated hypertension * uncontrolled and/or untreated diabetes * uncontrolled and/or untreated hyperlipidemia prior concurrent therapy: * see disease characteristics * more than 7 days since prior hormone replacement therapy or hormone-based contraception * more than 12 months since prior and no concurrent tamoxifen or aromatase inhibitor therapy for this disease * more than 12 months since prior and no concurrent chemotherapy for this disease * no prior bilateral mastectomy

Keywords: stage ia breast cancer stage ib breast cancer stage ii breast cancer stage iiia breast cancer stage iiib breast cancer stage iiic breast cancer stage iv breast cancer ductal breast carcinoma in situ
efficacy and safety of icd remote monitored exercise testing to improve heart failure outcomes: remote hf-action

Conditions: Heart Failure

Summary: this single center randomized controlled trial will involve 50 medically stable outpatients with hf, reduced ejection fraction, and previously implanted icd or crt-d devices followed longitudinally on the abbott medical merlin remote patient monitoring network. patients will be randomized in a 1:1 fashion to usual care plus a remotely administered home based weekly prescription for aerobic exercise (intervention) or usual care alone (control). usual care will include regularly scheduled visits with the clinical heart failure care team and medical therapy as prescribed by that team. the exercise prescription will be created by an exercise physiologist after incorporating remotely collected data from a patient directed smartphone app assessing hf symptom severity, vital signs, weight, and blood sugar, implantable device measures of physical activity, heart rate, heart failure volume status and heart rhythm, and fitbit measures of physical activity.


Eligibility criteria:
inclusion criteria: * patients have a merlin patient registry record for an icd or crt-d implantation between 01/01/2010-12/31/2020 * age \> 18 years * left ventricular ejection fraction \< 50% by echocardiogram, nuclear cardiology scan, cardiac magnetic resonance imaging, or invasive left ventriculography within the past 12 months. * ongoing nyha class ii, iii, or iv hf symptoms by questionnaire * ongoing use of beta-blocker and ace-inhibitor or angiotensin receptor blocker or willingness to start them- assessed by duke epic emr screening. * life expectancy \> 12 months * to allow for a post-surgical adjustment period, patients must be \>30 days out from device implantation exclusion criteria: * prior participation in cr- by patient questionnaire * unwillingness to sign informed consent form * currently performing \> 240 minutes of device detected daily pa- by icd/crtd remotely collected data. * lack of a smartphone or unwillingness to use an app or fitbit device * prior left ventricular assist device (lvad) implantation or heart transplantation * icd tachyarrhythmia therapies programmed off * inherited arrhythmia condition with contraindication to exercise (eg lamin a mutation or arvc) * no transmissions through merlin.net in past 12 months

Keywords: remote exercise prescription cardiac implant
oral health training program for pediatric residents

Conditions: Preventive Oral Health

Summary: the purpose of this study was to compare the effect of the addition of hands on training by a pediatric dentist on the pediatric residents skills, confidence, opinions and practice related to preventive oral health.

objectives: to compare the addition of hands on training (hot) to web based training (wbt)on residents' skills, confidence, opinions and practice . methods: pediatric residents participated in wbt on preventive oral health. then the wbt subjects were randomly assigned to receive hot by a dentist, or wbt alone. all subjects were assessed on skills in the performance of an oral exam, by direct observation. residents' confidence regarding oral health counseling, and their opinions about the importance of the incorporation of oral health into the well child visit, was measured by surveys utilizing a likert scale. residents' change in practice was assessed by a retrospective chart audit.

Eligibility criteria:
inclusion criteria: pediatric residents in the continuity care clinics at children's mercy hospital during the months of january and february 2007 exclusion criteria: 1. residents on leave of absence 2. residents who have their continuity care clinics off site 3. residents refusing consent for inclusion of results in study

Keywords: educational research, instructional methods, hands on training, web based training, pediatric residents preventive oral health, dental caries, instructional strategies in preventive oral health web-based training on preventive oral health hands on training on preventive oral health
patiromer for the management of hyperkalemia in subjects receiving raasi medications for the treatment of heart failure (diamond)

Conditions: Hyperkalemia

Summary: the purpose of this study is to assess the effects of patiromer compared with placebo on serum k+ in hf patients.

prospective phase 3b multinational, multicenter, double-blind, placebo-controlled, randomized withdrawal, parallel group study that includes screening and up to 12 weeks run-in phase (all subjects will have patiromer initiated and raasi medications, including mineralocorticoid receptor antagonist (mra) optimized) and a randomized withdrawal blinded treatment phase. the study population includes subjects with heart failure (hf) with reduced ejection fraction (hfref) who are hyperkalemic (serum potassium \[k+\] \> 5.0 meq/l) while receiving treatment with renin angiotensin aldosterone system inhibitor (raasi) medications or who are normokalemic (serum k+ 4.0 - 5.0 meq/l) but have a history of hyperkalemia prior to screening with subsequent reduction or discontinuation of a raasi medication. each subject's participation includes a run-in phase (maximum 12 weeks) followed by the treatment phase (variable per subject). study duration for individual subjects will vary, depending on their individual enrollment date. subjects who prematurely discontinue patiromer/placebo will remain in the study for the collection of clinical events data and will receive usual care.

Eligibility criteria:
inclusion criteria: * age at least 18 years or greater * symptomatic low ejection fraction heart failure (weak heart muscle) * receiving any dose of a beta blocker for the treatment of hf (unless not able to tolerate) * kidney function not more than mild or moderately impaired * high blood potassium (\>5.0 meq/l) currently while receiving medications for heart failure or normal blood potassium currently but previously had high potassium in the12 months prior to screening which caused a permanent reduction or discontinuation of heart failure medications * hospitalization for heart failure or treatment in an out patient setting with intravenous medications within the last 12 months before screening. exclusion criteria: * current acute decompensated hf, within 4 weeks before screening. subjects with a discharge from a hospitalization for acute decompensation of hf longer than 4 weeks before screening may be included * significant primary aortic or mitral valvular heart disease (except secondary mitral regurgitation due to left ventricular dilatation) * heart transplantation or planned heart transplantation (i.e., currently on a heart transplant waiting list) during the study period

Keywords: treatment of hyperkalemia chronic kidney disease hypertension hyperkalemia potassium spironolactone heart failure renin angiotensin-aldosterone system inhibitor (raasi) raasi high potassium eplerenone reduced ejection fraction