Kornimate/medical-research-clean huggingface dataset:
the plenaxis® experience study

Conditions: Prostate Cancer

Summary: praecis is currently conducting a 2000 patient experience study; this is a phase iv commitment postmarketing safety study in the food and drug administration (fda) indicated population of patients receiving plenaxis®. the purpose of the study is to estimate the incidence of immediate-onset systemic allergic reactions in the indicated population receiving plenaxis® and to determine whether the hazard rate changes over time.

this is a postmarketing patient safety study in the fda indicated population of patients receiving plenaxis®. on a quarterly basis, patients enrolled in the plenaxis® experience study will have their charts audited to record the number of immediate-onset systemic allergic reactions that may occur while receiving plenaxis®. the study will close when 2,000 patients have been enrolled. if immediate onset allergic reactions occur, patients may be eligible to enroll in a second protocol (skin testing in patients who experience an immediate onset allergic reaction). collection of all immediate-onset systemic allergic reactions will continue for each patient enrolled in the study until the patient discontinues plenaxis® for any reason, the patient withdraws consent to continue in the study or the patient is lost to follow-up.

Eligibility criteria:
inclusion criteria: a subject is eligible to participate in the study if he meets the following criteria: * male ≥ 18 years old with advanced symptomatic prostate cancer for whom lhrh agonist therapy is not appropriate and who refuses surgical castration * has at least one of the following: 1. risk of neurological compromise due to metastases, 2. ureteral or bladder outlet obstruction due to local encroachment or metastatic disease or 3. severe bone pain from skeletal metastases persisting on narcotic analgesia * patients or their legal representatives must be able to read, understand and sign an informed consent form to participate in the trial. exclusion criteria: * female patients, * pediatric patients, * patients with known hypersensitivity to any of the components in the abarelix injectable suspension

Keywords: advanced symptomatic prostate cancer advanced symptomatic prostate cancer
digital adherence monitoring of inhalative therapy in real- life conditions

Conditions: Asthma

Summary: this study is designed as a multicenter, observational, non-interventional, open label, 26-week study in order to observe how asthma control changes under treatment with mometasone fuorat/indacaterol/ glycopyrronium (mf/ind/gly) breezhaler® sensor system or under treatment with fixed-dose combination (fdc) triple therapy after 26 weeks of treatment.

subjects in one group will receive mf/ind/gly together with the propeller add-on sensor for the breezhaler® and access to the smartphone app according to label. subjects in the other group will receive any triple fdc according to label. the physician's decision to initiate or switch a patient to mf/ind/gly breezhaler® system or any other triple fdc must have been taken prior to and independently from the decision to include the patient in the study.

Eligibility criteria:
inclusion criteria: to participate in the study, all of the following inclusion criteria must be met: 1. patients (m/f/d) at the age of ≥18 2. written declaration of consent 3. asthma diagnosis according to german asthma guideline nvl, 4th edition 4. suitability for a therapy with mf/ind/gly in combination with the sensor system or another ics+laba+lama fdc according to spc 5. at least 6 months of inhaled therapy with ics+laba (high dose) or ics+laba+lama (medium or high dose) before switching or escalating asthma medication at baseline 6. change or escalation of the asthma medication to mf/ind/gly in combination with the sensor system or another ics+laba+lama fdc according to the therapy decision of the treating physician 7. availability of at least one act value of the last 6 months before consent 8. cohort treated with mf/ind/gly in combination with the sensor system * owning an android or ios smartphone or tablet on which the app can be installed (via wifi or mobile data network) and run (requires about 75 megabytes of storage space) and which is capable of establishing a bluetooth connection to the sensor the patient must agree to activate the app, the bluetooth connection and the mobile data connection regularly (at least once a month). * availability of an e-mail address exclusion criteria: to participate in the study, none of the following exclusion criteria must apply: 1. use of a digital inhaler-coupled inhalation tracking system to support adherence in the last 3 months prior to study entry 2. simultaneous participation in an interventional study or in another novartis-sponsored noninterventional study 3. asthma therapy with a biological agent, if not stable at the same dosage for at least 3 months

Keywords: mobile health mhealth propeller health mf/ind/gly breezhaler® fdc fixed dose combination mometasone fuorat indacaterol glycopyrronium
evaluating the safety of extended treatment with pegsunercept (peg stnf-ri)in subjects with rheumatoid arthritis (ra)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety of an additional 28 weeks of treatment with pegsunercept for subjects who have completed treatment in a previous double-blind study (20000201 or 20000198). in addition, this study will evaluate the efficacy and the feasibility of subject self-administration on an outpatient basis.


Eligibility criteria:
inclusion criteria: - subjects who have completed 24 weeks of double-blind treatment in a previous protocol (20000201 or 20000198) - females of childbearing potential and males must practice adequate contraception, in the judgement of the investigator, during the course of the study - the subject or legally acceptable representative must give informed consent for participation in the study before any study specific procedures are performed exclusion criteria: - greater than a 7-day duration from the week 24 visit in the previous study to the first dose in this study - any medical disability or condition (e.g., evidence of clinically significant liver dysfunction, active infection requiring treatment with systemic anti-infective agents) that would interfere with the assessment of safety of the study material or would compromise the ability of the subject to provide adequate informed consent - concurrent treatment with an investigational agent

Keywords: rheumatoid arthritis, inflammation pegsunercept, peg stnf-ri autoimmune, amgen clinical trials
spinal manipulation and patient self-management for preventing acute to chronic back pain

Conditions: Acute Pain; Low Back Pain, Mechanical

Summary: this is a study of adults with acute low back pain flare-up at risk of becoming chronic and disabling. the study tests how well spinal manipulation and guided selfcare work compared to standard medical care. the treatments last up to eight weeks and participants will be followed for one year.

the long-term goal is to reduce overall low back pain (lbp) burden by evaluating, first-line, non-drug treatment strategies that address the biological, psychological and social aspects of acute lbp and prevent transition to chronic back pain. the study will also assess barriers and facilitators that impact future implementation of the non-drug treatments into clinical practice. the us faces an unprecedented pain management crisis. lbp is the most common chronic pain condition in adults and one of the leading causes of disability worldwide. guidelines have recommended non-drug treatments like spinal manipulation and behavioral and selfcare approaches for lbp for nearly a decade, yet uptake and adherence has been poor. little is known about the role of these treatments in the secondary prevention of chronic lbp, especially for patients at risk of developing severe low back pain. due to high societal costs, and side effects of commonly used drug treatments, including opioids, there is a critical need for research on how well non-drug treatments work for preventing serious chronic lbp.

Eligibility criteria:
inclusion criteria: * at least 18 years of age * acute or sub-acute low back pain * average low back pain severity ≥3 on the 0-10 numerical rating scale over 7 days * medium or high risk for persistent disabling back pain according to the start back screening tool * ability to read and write fluently in english exclusion criteria: * non-mechanical causes of low back pain * contraindications to study treatments (e.g,. surgical fusion of lumbar spine) * active management of current episode of low back pain by another healthcare provider * serious co-morbid health condition that either requires medical attention or has a risk for general health decline over the next year * pregnancy, current or planned during study period and nursing mothers * inability or unwillingness to give written informed consent

Keywords: acute/subacute low back pain randomized clinical trial self-management behavioral modification spinal manipulation therapy standard medical care secondary prevention
feasibility evaluation of a dance fitness program

Conditions: Postpartum Depression

Summary: the objective of this pilot project is to assess the feasibility, acceptability, and mental health impact of oula for women with postpartum depression (ppd).

the proposed project is a pilot two-arm randomized controlled trial (rct), with specific aims to evaluate the feasibility and acceptability of implementing an rct of oula (named after missoula, mt) for the treatment of postpartum depression, and to explore between-subject changes in postpartum depression and postpartum anxiety following 8-weeks of oula or waitlist control.

Eligibility criteria:
inclusion criteria: * ages 20-39 years * have an infant 0-12 months old * self-report clearance from provider to engage in physical activity following birth * structured clinical interview for diagnostic statistical manual-5-research version (scid-5-rv) diagnosis of major depressive episode (mde) with onset during pregnancy or 12 months following childbirth * edinburgh postnatal depression scale (epds) score of 10 or above * english speaking * oula-naïve * if on first-line treatment for depression; antidepressant dose must be stable for 6 weeks; psychotherapy duration of treatment must be at least 4 weeks exclusion criteria: * unable to be physically active * current pregnancy * scid-5-rv diagnosis of bipolar disorder, schizophrenia, or current substance use disorder * active suicidal attempt or plan identified on the scid-5-rv * suicide attempt in the past 6 months * concurrent participation in another group dance fitness format * no access to internet via computer, tablet, or smart phone

Keywords: postpartum depression mind-body physical activity
the effect of a probiotic on hepatic steatosis

Conditions: Fatty Liver

Summary: non-alcoholic fatty liver disease (nafld) is an accumulation of fat and fibrous tissue in the liver. it is the most common cause of chronic liver disease in the united states. the exact cause of nafld is unknown, but it is more common among people with conditions such as adult-onset diabetes. nafld can strike people of all ages but most often affects adults between the ages of 40 and 60. research indicates that overgrowth of gut bacteria can start a chain of biological processes that stress the liver, causing liver inflammation. probiotics, living bacteria taken orally, may decrease the stress on the liver by reducing this bacterial overgrowth and/or strengthening the gut walls. because probiotics are generally safe, inexpensive, and easy to tolerate they are an attractive treatment option for nafld.


Eligibility criteria:
inclusion criteria: * adult-onset diabetes * liver biopsy in the previous 2 months with diagnosis of fatty liver and fibrosis stage f2-f3 exclusion criteria: * there are multiple exclusion criteria.

Keywords: hepatic steatosis adult-onset diabetes non-alcoholic fatty liver disease
trial comparing prone and supine intensity-modulated radiotherapy (imrt) after breast-conserving surgery in patients with large breast volume at high risk for skin toxicity and fibrosis

Conditions: Breast Carcinoma

Summary: 84 patients with a cup size c or more will be randomized to receive intensity-modulated radiotherapy in supine or prone position.


Eligibility criteria:
inclusion criteria: * female patients * multidisciplinary decision of adjuvant whole-breast irradiation (wbi) after lumpectomy for breast cancer * minimum 18 years * informed consent obtained, signed and dated before specific protocol procedures exclusion criteria: * mastectomy * need for axillary irradiation * bilateral breast irradiation * previous irradiation at the same time * mental condition rendering the patient unable to understand the nature, scope and possible consequences of the study * patient unlikely to comply with the protocol; i.e. uncooperative attitude, inability to return for follow-up visits, and unlikely to complete the study.
blood coagulation parameters in patients receiving intravitreal aflibercept for age-related macular degeneration

Conditions: Neovascular Age-related Macular Degeneration

Summary: this study aims to evaluate coagulation parameters in treatment naive patients with neovascular age-related macular degeneration (amd). treatment naive patients with neovascular amd, scheduled to undergo treatment with intravitreal injections of aflibercept will be enrolled in the study. blood samples will be collected before the first intravitreal injection and at 7 and 30 days after aflibercept administration.

neovascular age-related macular degeneration is one of the leading causes of severe visual loss in the aging population. intravitreal anti-vegf agents constitute the mainstay in the treatment of neovascular amd. aflibercept is a recombinant fusion protein targeting vascular endothelial growth factor a(vegf a) and placenta growth factor (plgf), developed for intravitreal administration in conditions such as neovascular age related macular degeneration, macular edema due to retinal vein occlusion, diabetic macular edema or myopic choroidal neovascularization. however, treatment with anti-vegfs like aflibercept, carries a potential risk of arterial thromboembolic events, including stroke and myocardial infarction.

Eligibility criteria:
inclusion criteria: * treatment naive patients with neovascular amd scheduled to undergo treatment with intravitreal aflibercept(iva) in one eye. exclusion criteria: * patients under systemic treatment with anti-vegf agents * patients under intravitreal anti-vegf treatment in both eyes * patients unwilling to return 1 week and 1 month after the first iva * patients undergoing dialysis, with chronic liver disease or malignancy, under systemic treatment with nonsteroidal anti-inflammatory drugs or under anticoagulation therapy * patients with a history of any ate event during the last 6 months

Keywords: neovascular age-related macular degeneration aflibercept intravitreal anti-vegf coagulation platelet count d-dimer fibrinogen
persistent atrial fibrillation cryoballoon ablation

Conditions: Persistent Atrial Fibrillation

Summary: patients with persistent irregular heartbeats also called persistent atrial fibrillation usually have a lower probability of curing their arrhythmia with ablation with heat called radiofrequency then those with paroxysmal atrial fibrillation, as previous studies have shown. the emerging ablation with freeze(cryoablation) has not been studied for persistent atrial fibrillation but has been proven to be efficient in the paroxysmal type. we hypothesized that persistent atrial fibrillation will have a freedom of recurrence rate of 70% after use of cryoablation at one year of follow up.

this was a retrospective single center cohort study designed to assess the freedom from recurrence of atrial fibrillation in the sample of patients with long persistent atrial fibrillation. all patients who underwent cryoballoon ablation for atrial fibrillation at staten island university hospital in the period ranging from january 2010 to 2013 were included in the study. data was collected from the electronic medical record as well as from the physician's office records after institutional review board approval of the protocol .data collected included demographics, comorbidities pertaining to diabetes, heart failure, coronary artery disease, stroke occurrence, medications including antiarrhythmics and anticoagulants, procedural details including time of procedure and of fluoroscopy, vein ostial size, number of veins isolated, time to first recurrence after blanking period, complications of procedure and mortality. all patient identifiers were kept in a password protected computer.

Eligibility criteria:
inclusion criteria: * all patients included in the registry and who have symptomatic persistent atrial fibrillation presenting to the institution who favor ablation as first line therapy instead of antiarrhythmics * all patients with symptomatic persistent atrial fibrillation who have failed antiarrhythmic therapy. exclusion criteria: * patients refusing follow up by event monitor. * pregnant women.

Keywords: persistent atrial fibrillation cryoballoon ablation
pharmacokinetic and pharmacodynamic study of bococizumab alone and when combined with recombinant human hyaluronidase

Conditions: Healthy; Hypercholesterolemia

Summary: this is a phase 1, open-label, single-dose, randomized, dose escalation study in healthy and hypercholesterolemic subjects. each subject will receive 1 of 5 treatments as a single subcutaneous injection. subjects will remain confined at the research clinic for approximately 2 days. after discharge, subjects will return to the research clinic 15 times during 12 weeks.


Eligibility criteria:
inclusion criteria: * healthy and hypercholesterolemic subjects between the ages of 18 and 65 years. * healthy subjects must have fasting ldl-c \>/= 70 to \</= 190 mg/dl at two qualifying visits. * hypercholesterolemic subjects must be on a stable daily dose of statin for at least 45 days before dosing and fasting ldl-c must be \>/= 70 mg/dl. exclusion criteria: * use of prescription or non-prescription drugs within 7 days or 5 half-lives (whichever) is longer prior to the first dose of study medication. for hypercholesterolemic subjects the use of statin class medication is allowed. * prior exposure to bococizumab (also known as pf-04950615 or rn316) or other investigational pcsk9 inhibitors. * treatment with monoclonal antibodies within 6 months or 5 half-lives (whichever is longer) before dosing.

Keywords: pharmacokinetics pharmacodynamics rn316 recombinant human hyaluronidase
natriuretic peptides and metabolic risk in obesity

Conditions: Obesity; Hyperinsulinemia

Summary: the investigators are examining: 1. the relationships of insulin levels and natriuretic peptide hormone levels, and 2. the effects of administering an infusion of natriuretic peptide hormone on the breakdown of fat in healthy lean and otherwise healthy obese individuals.

the cardiac natriuretic peptide hormonal system may protect against the development of cardiometabolic risk. epidemiologic studies have shown that in relatively healthy individuals without heart failure, low natriuretic peptide levels are associated with unfavorable cardiometabolic phenotypes, including higher blood pressure, obesity, higher insulin levels, and diabetes mellitus. understanding the mechanisms behind the "natriuretic peptide deficiency" of obesity would illuminate an important way in which obesity interacts with the cardiovascular system. the investigators propose a prospective cross-over design in 40 healthy lean and otherwise healthy obese individuals. the investigators propose the following specific aims and hypotheses: aim 1: to study the effect of hyperinsulinemia on the response of the natriuretic peptide system to salt loading. hypothesis 1: hyperinsulinemia will suppress natriuretic peptide levels in both obese and lean individuals. aim 2: to examine the effect of an intravenous infusion of natriuretic peptide on acute markers of lipolysis. hypothesis 2: an intravenous infusion of natriuretic peptide will raise acute markers of lipolysis in both obese and lean individuals.

Eligibility criteria:
inclusion criteria: * men and women ages 18-50 years * bmi 18 to \<25 kg/m2 (lean group, n=20) or bmi 30 to \<40 kg/m2 (obese group, n=20) exclusion criteria: * current use of antihypertensive medications * current use of glucocorticoids, metformin, or any antidiabetes medications * prior or current cardiovascular disease, renal disease, or liver disease * diabetes mellitus (taking insulin, other anti-diabetic agents, or diet-controlled) * atrial fibrillation * bleeding disorder or anemia * elevated lfts * estimuated gfr \< 60 ml/min * abnormal sodium or potassium level * positive pregnancy test, women of child-bearing age not practicing birth control, women who are breastfeeding

Keywords: natriuretic peptide insulin lipolysis hormones metabolism
fluciclovine (axumin) pet/ct vs. naf pet/ct in prostate cancer osseous metastatic disease

Conditions: Malignant Neoplasm of Prostate

Summary: the purpose of this study is to look at whether f-18 fluciclovine (i.e. axumin) is better or as good as f-18 sodium fluoride (f-18 naf) when looking at bone disease from prostate cancer. axumin is a radioactive agent used on a positron/computed tomography (pet/ct) camera to look for prostate cancer in general.

the study will assess the diagnostic performance of \[f-18\] fluciclovine pet/ct compared to \[f-18\] naf pet/ct as the reference standard. each bone lesion identified on \[f-18\] naf pet/ct will be compared with the level of \[f-18\] fluciclovine uptake the primary objective is to assess \[f-18\] fluciclovine efficacy in the evaluation of osseous metastatic disease in prostate cancer on a lesion-by-lesion comparison with \[f-18\] naf as a the reference standard.

Eligibility criteria:
inclusion criteria: * referred for initial staging or restaging of prostate cancers with clinical suspicion of bone metastases. * must understand and voluntarily sign an informed consent document exclusion criteria: -cannot tolerate imaging up to 60 minutes of total imaging
comparison of morphological and radiological data in patients with urolithiasis

Conditions: Urolithiasis

Summary: the aim of the study was to compare the ultrastructural changes in the renal parenchyma with the results of postprocessing ct analysis with contrast enhancement in patients with urolithiasis.


Eligibility criteria:
inclusion criteria for experimental group: 1. men and women \>18 years and \<45 years old; 2. established diagnosis of urolithiasis that does not interfere with the processes of urodynamics (there is no expansion of the overlying urinary tract); 3. planned surgery - percutaneous nephrolithotripsy; 4. stone size up to 20 mm., patients with multiple small two-sided stones; 5. patients with ct of the kidneys with contrast enhancement performed according to the required protocol. exclusion criteria for experimental group: 1. age \ 3; 2. with single kidney; 3. patients with coral stones; 4. the presence of concomitant systemic pathology (dm, ah), as well as kidney disease (glomerulonephritis), which can change the state of the renal parenchyma; 5. a history of injuries and surgical interventions on the kidneys, urinary tract, renal vessels; 6. taking nephrotropic drugs; 7. systemic intake of nephrotoxic drugs; 8. severe general somatic condition, making the operation impossible; 9. pregnancy. inclusion criteria for control group: 1. men and women \>18 years and \<45 years old; 2. absence of urolithiasis in the patient's anamnesis and in his family history; 3. renal tumors which have undergone partial nephrectomy or nephrectomy; 4. patients with ct renal data with contrast enhancement, performed according to the required protocol. exclusion criteria for control group: 1. urolithiasis in anamnesis; 2. a history of trauma and surgical interventions on the kidneys, urinary tract, renal vessels; 3. intercurrent background; 4. non-informative biopsy.