Kornimate/medical-research-clean huggingface dataset:
health-related quality of life, psychological distress and fatigue in metastatic crpc patients treated with radium-223

Conditions: Castrate Resistant Prostate Cancer; Bone Metastases

Summary: the aim of the current prospective multicenter study is to evaluate cancer-specific and bone metastases related hr-qol, psychological distress and fatigue in mcrpc patients before, during and after treatment with radium-223 in daily practice. furthermore, the investigators aim to determine patient groups with identical health-related quality of life patterns over time, in order to identify variables related to health-related quality of life deterioration during the course of treatment, as patients with health-related quality of life deterioration may need specific attention to preserve health-related quality of life.

radium-223 is a registered treatment option for patients with symptomatic bone metastatic castration-resistant prostate cancer. previously, the phase 3 alsympca trial demonstrated that radium-223 improved overall survival and prolonged the time to the first symptomatic skeletal event and the time to first opioid use, irrespective of prior docetaxel chemotherapy. subsequent analysis of the alsympca study showed that a significantly higher percentage of patients receiving radium-223 experienced meaningful hr-qol improvement, as measured by the eq-5d questionnaire and the fact-p questionnaire, when compared to patients treated with placebo. however, studies evaluating health-related quality of life, psychological distress and fatigue in metastatic castration-resistant prostate cancer patients treated with radium-223 in daily practice are lacking.

Eligibility criteria:
inclusion criteria: * metastatic castration-resistant prostate cancer; * undergoing treatment with radium-223 according to standard of care; * ability to comply with the study protocol, including completion of questionnaires on health-related quality of life; * written informed consent to the treating physician at the hospital site. exclusion criteria: * prior radium-223 therapy; * impaired cognitive functioning and/or illiteracy.

Keywords: radium-223 health-related quality of life psychological distress fatigue
asthma intervention research 2 (air2) trial

Conditions: Asthma

Summary: the objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the alair system in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists. the primary efficacy endpoint will be the difference between study groups in the change in asthma quality of life questionnaire (aqlq) score from baseline and the average score from the 6-, 9-, and 12-month follow-up visits. all other outcome measures assessed at 12 months post-treatment. this will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the alair system to conventional therapy of inhaled corticosteroids (ics) and long-acting β2-agonists (laba). a bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two alair group subjects for every one control group subject).


Eligibility criteria:
inclusion criteria: * subject is an adult between the ages of 18 to 65 years. * subject has asthma and is taking regular maintenance medication that includes inhaled corticosteroid (ics) and long acting ß2-agonist (laba). * subject has a pre-bronchodilator forced expiratory volume in one second (fev1) of greater than or equal to 60% of predicted after medication stabilization during the baseline period. * subject has a pc20 \< 8 mg/ml per methacholine inhalation test using standardized methods. pc20 is a provocative concentration of provocholine® (a brand of methacholine chloride) resulting in a drop of fev1 of 20% or more from baseline. * subject has at least two days of asthma symptoms during the 4-weeks of the baseline diary period. * subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history). exclusion criteria: * subject has a post-bronchodilator fev1 of less than 65%. * subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; or a history of life-threatening asthma, defined by past intubations for asthma, or icu admission for asthma within the prior 24 months. * subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months). * subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months). * subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines). * subject has known systemic hypersensitivity or contraindication to methacholine chloride or other parasympathomimetic agents. * subject has other medical criteria.

Keywords: asthma
freedom - a frequent optimization study using the quickopt method

Conditions: Cardiac Arrhythmias; Heart Failure

Summary: the objective of this study is to demonstrate that frequent atrio-ventricular (av/pv) and inter-ventricular (v-v) delay optimization using quickopt in patients with cardiac resynchronization therapy device results in improved clinical response over standard of care (i.e. empiric programming or one-time optimization using any non-intracardiac electrogram optimization methods).

* this is a prospective, double-blinded, multicenter, randomized study * patient could be enrolled up to 2 weeks post crt-d implant and are followed for 12 months post implant with follow-up visits at 3, 6, 9 and 12 months * patients will be randomized at enrollment to either group 1 ("quickopt group") or group 2 ("control group"). * group 1 - the patient's device is programmed to sequential biventricular pacing mode with av/pv and vv delays optimized using quickopt. for group 1 patients, optimization using quickopt is performed at enrollment, 3 month, 6 month, 9 month, 12 month and at any unscheduled follow-up visits. * group 2 - the patient's device is programmed to either simultaneous or sequential biv pacing mode as per physician's discretion. the av/pv and inter-ventricular (vv) delays could be programmed empirically or optimized using any non-iegm based method as per sites standard of care. however, the group 2 patients can be optimized only once within the first 4 weeks post implant. any av/pv and vv delay optimizations performed after 4 weeks post implant in group 2 patients will be considered protocol deviations.

Eligibility criteria:
inclusion criteria: * patient meets current crt-d indications and be implanted with a st. jude medical (sjm) crt¬d device with vv timing and a compatible lead system. * patient has the ability to complete a 6-minute hall walk with the only limiting factor to be fatigue or shortness of breath. * patient has the ability to independently comprehend and complete a qol questionnaire. exclusion criteria: * patient has an epicardial ventricular lead system. * patient has the ability to walk ≥ 450 meters in 6 minutes * patient has limited intrinsic atrial activity (≤ 40 bpm). * patient has persistent or permanent atrial fibrillation (af). * patient has a 2° or 3° heart block. * patient's life expectancy is less than 1 year. * patient is pregnant. * patient is on iv inotropic agents.
the effect of patient optimism & pessimism on recovery from elective cardiac surgery

Conditions: Mental Stress

Summary: before a heart operation, patient outlook may be either pessimistic or optimistic. previous research on this topic has focused on patient reported quality of life but has never examined measurable clinical outcomes such as length of hospital stay.this pilot study hopes to establish whether patient outlook (optimistic or pessimistic) before a heart operation can influence recovery and length of hospital stay. if there is a difference, then a case can be made for providing psychological support before an operation in the hope of modifying outlook and thus improving patient care and reducing hospital stay and nhs costs. patients will be recruited over a 12month period. their outlook (pessimistic or optimistic) will be ascertained using two standardised questionnaires. their recovery and length of stay will be recorded. the study will answer the research question and determine whether outlook has an impact on recovery. depending on the results, this study could provide opportunities for additional future research into modifying outlook with a view to improving patient care and recovery.


Eligibility criteria:
inclusion criteria: * age over 18 * elective planned cardiac surgery * consent to participate exclusion criteria: * patients diagnosed with clinical depression * patients deemed not competent to provide consent

Keywords: optimism pessimism recovery elective cardiac surgery
olmesartan pediatric pharmacokinetic (pk) study

Conditions: Hypertension

Summary: determine single dose pharmacokinetic parameters of olmesartan in pediatric patients with hypertension in ages 12 months - 16 years


Eligibility criteria:
inclusion criteria: * age 12 months to 16 years inclusive * signed parental/guardian informed consent and assent from the subject * current treatment for hypertension, or, if not currently treated for hypertension, systolic blood pressure (sbp) greater than or equal to 95th percentile for gender and height-for-age, or, if not currently treated for hypertension, systolic blood pressure or diastolic blood pressure greater than or equal to 90th percentile for gender and height-for-age and diabetic or having a family history of hypertension * glomerular filtration rate (gfr) greater than or equal to 30 ml/min/1.73 m2, estimated using the schwartz equation * sexually active females of child-bearing potential must be practicing an acceptable method of birth control * negative serum beta-human chorionic gonadotropin at screening and at admission (female of child-bearing potential only) exclusion criteria: * clinically significant cardiac, gastrointestinal, hematologic, hepatic or hepatobiliary, neurologic, or pulmonary (except asthma) disorder * history of severe or symptomatic hypertension associated with stroke, seizures, encephalopathy, or other significant neurologic findings within 1 year prior to screening * current treatment with more than 2 antihypertensive medications * secondary hypertension from uncorrected coarctation of the aorta, bilateral renal artery stenosis, or unilateral renal artery stenosis in a single kidney * serum albumin \< 2.5 g/dl * major organ or bone marrow transplantation except for prior kidney transplantation of at least 6 months and with stable renal function meeting the inclusion criteria

Keywords: olmesartan pk in children
a post-marketing-observational study (pmos) to determine the effectiveness of combined adalimumab treatment and active supervised training in patients with axial spondyloarthritis (axspa)

Conditions: Axial Spondyloarthritis

Summary: this study is a non-interventional, longitudinal and non-confirmatory study to compare an active supervised training (ast) with standard of care (soc) physiotherapy in patients with axial spondyloarthritis and stable response to adalimumab (humira®) with respect to health-related outcomes. the primary objective is the improvement in spinal mobility after a 6 month training program.

treatment of axspa patients with adalimumab (humira®) was according to the local adalimumab product label and local standard of care. axspa patients who responded to newly initialized adalimumab treatment based on physicians' decision, and who were eligible for active physiotherapy were enrolled in the study. although this was a non-interventional study, participants were randomly assigned to receive either active supervised and standardized training physiotherapy or standard of care physiotherapy in order to provide adequate numbers of participants in each comparison group. participants who consented to participate in the study were observed for up to 12 months from baseline (defined as the randomization visit where participants were assigned to one of the two physiotherapy options).

Eligibility criteria:
inclusion criteria: * participants diagnosed with axial spondyloarthritis (axspa) (either ankylosing spondylitis (as) or non-radiographic axial spondyloarthritis (nr-axspa)), fulfilling the assessment of spondyloarthritis international society (asas) classification, aged at least 18 years * prescription of humira® (adalimumab) for treating axspa according to the local product label * eligibility for active physiotherapy according to the rheumatologist and physiotherapist * participants must have signed written informed consent before starting any study related assessments or procedures. exclusion criteria: * participants with total spinal ankylosis based on the investigators' assessments of available radiographs * participants who are not eligible for active supervised training or active physiotherapy at the discretion of the rheumatologist and/or the physiotherapist * participants with poorly controlled medical condition(s), which in the opinion of the investigator, would put the participant at risk by participation in the protocol * any prior treatment with a biologic disease-modifying antirheumatic drugs (dmard) is prohibited.

Keywords: axial spondyloarthritis active supervised training physical training adalimumab spinal mobility physiotherapy physical function health-related quality of life pain disease activity psychosocial risk factors workability bath ankylosing spondylitis metrology index (basmi)
dose-finding study of cd07805/47 topical gel in subjects with erythematotelangiectatic rosacea

Conditions: Erythematotelangiectatic Rosacea

Summary: this is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of cd07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. subjects will be randomized in a 1:1:1:1 ratio to receive either one of three cd07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or vehicle gel. all subjects will be treated with a single application (once daily dosing for one day) of study medication.


Eligibility criteria:
inclusion criteria: * male or female who is at least 18 years of age. * clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. * cea (clinician's erythema assessment) score greater than or equal to 3 at screening and on treatment visit at baseline. * psa (patient self assessment) score of greater than or equal to 3 at screening and on treatment visit at baseline. * presence of 2 or fewer inflammatory facial lesions. exclusion criteria: * history of raynaud's syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression. * history of refractive surgery such as photorefractive keratectomy. * the subject is being treated with monoamine oxidase (mao) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants. * the subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the treatment visit.

Keywords: erythematotelangiectatic rosacea
reactiv8 stimulation therapy vs optimal medical management: a randomized evaluation

Conditions: Chronic Low-back Pain

Summary: this study is a prospective, randomized study comparing reactiv8 therapy to optimal medical management (omm).

this study is a prospective, randomized study comparing reactiv8 therapy to optimal medical management (omm), where omm means the patient is managed according to available guideline-directed treatments (e.g., medication, physical therapy, injections) individualized to meet the patient needs. all patients who satisfy the enrollment criteria are randomized (1:1) to receive either reactiv8 (treatment group) or omm (control group).

Eligibility criteria:
inclusion criteria: 1. age ≥21 years 2. evidence of lumbar multifidus muscle dysfunction 3. intractable chronic low back pain that has persisted \>6 months resulting in pain most of the days in the past 12 months 4. failed therapy including pain medications and physical therapy 5. not a candidate for spine surgery 6. low back pain nrs of ≥6 and ≤9 7. oswestry disability index score ≥30 and ≤60 8. willing and capable of giving informed consent 9. able to comply with this protocol 10. on optimal medical management per the investigator exclusion criteria: 1. contraindicated for the reactiv8 system 2. bmi \> 35 3. any surgical correction procedure for scoliosis at any time, or a current clinical diagnosis of moderate to severe scoliosis 4. an independent mri assessment identifying a pathology that is likely the cause of the clbp and is amenable to surgery 5. leg pain described as being worse than back pain, or radiculopathy (neuropathic pain) below the knee 6. any condition unrelated to clbp which, in the opinion of the investigator, could limit physical movement or compliance with the protocol, or interfere with the assessment of efficacy 7. surgical and other procedure exclusions 8. psycho-social exclusions 9. protocol compliance exclusions 10. general exclusions

Keywords: neurostimulation stimulation multifidus restorative neurostimulation multifidus muscle control neurostimulator
a pilot study of working women and breast cancer

Conditions: Breast Cancer

Summary: the purpose of this research is to better understand the relationship between employment and breast cancer. research is being conducted to understand how workplace factors influence breast cancer patients' ability to adhere to recommended cancer treatment and effectively recover from cancer. investigators hope to use the findings from the study to help working breast cancer survivors make informed decisions about treatment and employment in collaboration with their employers and healthcare providers.

patients enrolled will be interviewed three times over a six month period. they will be asked questions about their experiences in managing their cancer while taking care of their job responsibilities. patients will be asked to complete a survey that asks questions about their breast cancer treatment, their job, and how they manage their responsibilities while undergoing cancer treatment. the first initial meeting will be conducted at a time and location that is convenient for the patient. this meeting should last about an hour to an hour and a half. three and six months after the initial interview, study participants will be asked to complete a follow-up survey by either telephone or internet/web, depending on their preference. these telephone surveys will last between 15-30 minutes.

Eligibility criteria:
inclusion criteria: * women age 18-65 * working at least 20 hours per week * currently patients of the university of kentucky markey cancer center * are able to read, write, and communicate in english * have reliable telephone or internet/web access in or outside the home exclusion criteria: * self-employed * unemployed * cognitively impaired

Keywords: breast cancer working women
psychopharmacological treatment of emotional distress

Conditions: Suicide Crisis Syndrome; Psychological Distress

Summary: this is an inpatient four-arm randomized control trial comparing single drug clonazepam (s arm), a two-drug combination clonazepam/olanzapine (d arm), and a three-drug combination clonazepam/olanzapine/buprenorphine (t arm) with treatment as usual (tau arm) in the treatment of emotional distress, specifically the suicide crisis syndrome (scs). all participants in experimental arms receive 2-day pulse treatments targeting four out of five of the acute emotional distress symptoms. the primary outcome measure is scs at discharge and one-month follow-up. the secondary outcome measures include questions about suicidal behaviors associated with emotional distress at a one-month follow-up.


Eligibility criteria:
inclusion criteria: * patient admitted to an inpatient unit and ruled in for scs diagnosis using scs-c * willing to stay in the hospital voluntarily, if medically necessary, for at least 4 days after enrolling in the study. * patient admitted to an inpatient unit as a result of a recent (i.e., past-month) suicide attempt, as defined by the c-ssrs (columbia suicide rating scale). * admitted to an inpatient unit in the last 36 hrs. * able to understand the nature and the substance of the consent form. * currently domiciled. * able and willing to provide verifiable contact information for follow-up. exclusion criteria: * intellectual disability, cognitive impairment, or linguistic limitation precluding understanding of the consent or research questions. * past adverse reactions to clonazepam, olanzapine, or buprenorphine * past history of opiate or benzodiazepine use d/o in the last 2 years * on agonist therapy for opiate addiction * ongoing treatment with clonazepam or olanzapine. * significant medical or neurological disease or possible delirium that might interfere with study participation or capacity to provide informed consent. * receiving involuntary treatment in psychiatric unit * clinical suspicion of malingering by a cp. * undomiciled.
"additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache'

Conditions: Cervicogenic Headache

Summary: this study is a randomised control trial and the purpose of this study is to determine the "additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache".

cervicogenic headache is a common headache that causes disability and affects everyday activities. headache related disorders are the second most common reason for years lived with disability all over the world. according to the latest international headache society model, cervicogenicheadache (cgh) is a secondary headache having c1-c2 dysfunction. there is marked limitation in cervical rom specially rotation. treatment indicated involves use of electrotherapy and thermal modalities. in addition, use of different manual therapy techniques are advocated to eliminate the root cause i.e. c1-c2 dysfunction treating. patients with cervicogenic headache are mostly presented with forward head posture and weak deep neck flexors which may excerbate the headache symptoms.therefore the purpose of this study is to determine the ""additional effects of sternocleidomastoid release along with suboccipital muscle release in management of cervicogenic headache

Eligibility criteria:
inclusion criteria * participants will be included according to international classification of headache criteria which includes: * headache with neck stiffness * headache at least once a month in the last 3 months * headache with at least 4 score in numeric pain rating scale(nprs) * unilateral headache with no shift of side * positive flexion rotation test (rotation restriction is greater than 10 degrees) * c1-c2 dysfunction * headache precipitated by sustained neck movements,myofacial trigger points palpation in neck * age group 18-45 * both male and female exclusion criteria: * cervical spondylosis * headache of non-cervical origin * dizziness or visual disturbance * cervical radiculopathy/ nerve root involvement/ disc herniation * cervical instability/ fracture * vertebrobasilar insufficiency * thoracic outlet syndrome * cervical spine surgery * cervical spondylolisthesis * spinal infection or tumors * osteoporosis * meningitis * subarachnoid hemorrhage