Kornimate/medical-research-clean huggingface dataset:
do patients participating in oncology clinical trials understand the informed consent form?

Conditions: Cancer; Oncology Problem

Summary: the purpose of this study is to assess patients' understanding of clinical trials and to help researchers understand which areas of the informed consent need better explanation for future cancer clinical trial patients.

obtaining informed consent as part of a clinical study is a cornerstone of current day medical ethics; however, this has not always been the case. the development of the informed consent has been necessitated out of abuses committed in the name of medicine. informed consents have become increasing lengthy and complex. it is not unusual for an oncology clinical research informed consent to be greater than 20 pages. investigators will utilize the quic-a survey to evaluate patient understanding of the basic elements of informed consent required by federal regulations. the quic-a survey has been condensed from 20 questions to 14 questions by eliminating the 6 phase specific questions. the remaining 14 questions are designed irrespective of phase and address the basic elements of informed consent. investigators hypothesize that as informed consents have become more lengthy and complicated, in part due to required regulatory language and legal clauses inserted to protect the institution performing research, patient comprehension of the basic elements of informed consent has been hindered.

Eligibility criteria:
inclusion criteria: * patients \> 18 years of age * patients are receiving active treatment on an oncology clinical trial that utilizes chemotherapy, radiation, targeted agents, biologic therapy or hormonal therapy * patients must have been consented in english to an oncology treatment clinical study exclusion criteria: * not meeting all eligibility criteria

Keywords: questionnaire prior therapy prior study volunteer prior study patient cancer oncology
effect of increased pain tolerance on exercise performance

Conditions: Opioid Use; Exercise

Summary: clinical prescription and use of opioids is a clear problem in large parts of the world and has the recent years received an increasing publicity in sports. this is in particular due to the world anti-doping agency monitoring list, which reveal that endurance athletes utilize the opioid tramadol frequently with the aim to enhance performance according to anecdotal evidence. studies investigating the effect of tramadol on exercise performance in healthy humans is limited to one study in moderate trained subjects. however, this effect may be different in highly trained subjects due to the effects of chronic exercise. furthermore, ingestion of tramadol may impact motor-cognitive performance and it remains unknown whether tramadol can be detected in highly trained subjects following exercise. in the present study the investigators apply a randomized double-blind placebo-controlled counterbalanced cross-over design to investigate whether tramadol treatment improves a preloaded cycling time trial performance, whether it affects motor-cognitive performance and whether it is detectable following exercise.


Eligibility criteria:
inclusion criteria: * maximal oxygen uptake \< 55 ml o2/min/kg * plasma creatinine concentration between 60-105 umol/l * plasma alanine aminotransferase between 10-70 u/l * familiarized with endurance training for at least a few years exclusion criteria: * donated blood within the last 3 months * exposed to an altitude greater than 1000 m above sea level within the last two months * smoking
ultra-long acting bronchodilator therapy in asthmatics

Conditions: Asthma

Summary: asthma is a common condition which produces a significant workload for general practice, hospital outpatient clinics and inpatient admissions. asthma is caused by inflammation of the airways which irritates the muscles around the airways causing them to constrict. the mainstay of asthma treatment is inhaled steroids. if the patients' symptoms are still not adequately controlled, then a long-acting beta agonist (laba) inhaler which relaxes the muscles in the airways and opens it up is frequently added to the inhaled steroids. despite this, a substantial proportion of asthmatic patients still do not achieve adequate control of their symptoms. recent studies have shown when an alternative inhaler called a long-acting muscarinic antagonist (lama) is added to a laba - it reduced the number of asthma exacerbations (flare-ups) and improved airway narrowing. the mannitol challenge is a test of airway 'twitchiness', an important feature of asthma. there have been no previous studies assessing the combined effects laba and lama inhalers on mannitol challenge. the mannitol challenge is particularly relevant as it mimics stimuli encountered in real life which provoke an asthma attack. the investigators propose to directly compare indacaterol, a new once-daily laba with indacaterol plus tiotropium, a once-daily lama, as add-on treatment to inhaled steroids in persistent asthmatics using the mannitol challenge. the investigators hope that this study will help us understand how the combination of a laba and lama might help protect against flare-ups.


Eligibility criteria:
inclusion criteria: * male or female volunteers aged at least 16 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms of beclomethasone dipropionate or the equivalent * fev1 \> 50 % predicted * mannitol pd15 \< 635 mg * ability to give informed consent * agreement for their general practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being exclusion criteria: * other respiratory diseases such as chronic obstructive pulmonary disease, bronchiectasis or allergic bronchopulmonary aspergillosis * an asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 3 months of the study commencement * any clinically significant medical condition that may endanger the health or safety of the participant * smoking within one year or \>10 pack year history * participation in another trial within 30 days before the commencement of the study * pregnancy or lactation * unable to comply with the procedures of the protocol

Keywords: asthma long acting beta-agonists long acting muscarinic antagonists mannitol challenge
education program for patients receiving oral anticoagulation

Conditions: Cardiovascular Disease; Venous Thromboses; Atrial Fibrillation; Blood Coagulation Disorders, Inherited

Summary: the aim of the study is to test if patients under oral anticoagulation therapy who are going to participate in the education program will have better health-related quality of life, higher rate in pharmacological treatment adherence and better self efficacy to manage the treatment.

patients who are going to use oral anticoagulant will participate in an individual orientation, using instructional material (slides and illustrative booklet) during hospitalization period. after the discharge 2 phone calls will be done (after: a week and four weeks) focusing on the strategies to improve patient's self-efficacy to manage the oral anticoagulation. there will be a personal contact among researcher and participants when the patients return at the oral anticoagulant ambulatory, two months after the treatment start. at this time the following variables of interest will be evaluated: health-related quality of life; adherence to treatment and patients' self-efficacy.

Eligibility criteria:
inclusion criteria: * patients admitted in two public hospitals, in são paulo state interior and who are going to start the use of oral anticoagulant during this hospitalization * patients admitted in two public hospitals, in são paulo state interior and who are going to adjust therapeutically oral anticoagulant dosage or to start over treatment. exclusion criteria: * individuals who do not at all have any ability to understand the data collection instrument questions, measured by the instrument mental state mini-exam. * individuals who do not have a telephone to be contacted after hospital discharge; * individuals who are going to metallic valve prosthesis implant surgery in the last six months.

Keywords: quality of life medical adherence warfarin health education
intermittent hypoxia and upper extremity emg recordings in individuals with spinal cord injury

Conditions: Spinal Cord Injuries

Summary: in this current study, the examiners examine some of the mechanisms of how acute intermittent hypoxia (aih) effects the upper extremity of survivors of spinal cord injury. this is accomplished both with the use of a load cell to determine elbow strength changes and high density grid electromyography (emg) to record bicep muscle activations before and after bouts of aih

it has been shown previously that there is an increase in strength in survivors of spinal cord injury after brief bouts of acute intermittent hypoxia. in this study, participants are fitted with a high density emg electrode on the biceps brachii, and attached to a load cell at the wrist, they are asked to flex and extend their elbow at various levels of intensity. this is performed before and after the 30 minute session of aih. the investigators hope to identify specific types of motor units of the upper extremity of survivors of spinal cord injury after aih to help further our understanding of what mechanisms may be causing the known increase in muscle strength post aih

Eligibility criteria:
inclusion criteria: * history of spinal cord injury from c3-t4 * non-progressive spinal cord injury * more than 6 months since initial spinal cord injury * ability to understand and willingness to sign written informed consent exclusion criteria: * presence of any of the following medical conditions: congestive heart failure, arrhythmia, uncontrolled high blood pressure, uncontrolled diabetes mellitus, copd/emphysema and severe asthma * persons with known coronary artery disease, a history of myocardial infarction, or known carotid or intracerebral artery stenosis * medical clearance will be required if participant is taking any other investigational agents * women who are pregnant or nursing * individuals with tracheostomy * cannot pursue other research studies which may interfere * unable to consent * individuals who are not yet adults (infants, children, teenagers) * prisoners

Keywords: acute intermittent hypoxia motor unit upper extremity
urine gene analysis for pathogen detection

Conditions: Urinary Tract Infections

Summary: the objective of this study is the detection, quantification, and resistance gene identification of pathogens by using the urine of patients with urinary tract infection (uti) symptoms.


Eligibility criteria:
inclusion criteria: * adult men and women 60 years and older who have urinary tract infection * can participate in the informed consent process * presenting to the clinic with symptoms of uti or cystitis with no recent history of uti within the past 21 days * able to provide sufficient urine sample volume via clean catch or catheterization for urinalysis, conventional urine culture, and pcr * understand and are willing to comply with the study requirements. * sample collection able to be sent out the same day via courier exclusion criteria: * individuals under 60 years of age * unable to provide informed consent * urinary diversion of any type * chronic indwelling urinary catheter * no recent history of uti within the past 21 days * no antibiotic therapy within the past 21 days * no recent therapy with phenazopyridine

Keywords: urinary tract infection urine culture bacteriel growth antibiotics pcr
femtosecond laser-assisted keratoplasty

Conditions: Keratoconus

Summary: the purpose of this study will be to determine optimal surgical technique for performing flak including laser parameters, keratoplasty shape and suture technique in order to standardize surgical technique and to collect safety and efficacy data. this will be compared to data of patients with full thickness pkp to measure visual outcomes, refraction, astigmatism, surgical methods and wound healing.

flak instrument: the femtosecond laser (intralase corporation, irvine, ca) is a focusable infrared laser, similar to the more familiar neodymium-yttrium-aluminum-garnet (yag) laser, but uses shorter pulses in the hundred-femtosecond (100 x 10-15 seconds) duration range. there is minimal postoperative inflammation and collateral tissue damage. subjects: we will be enrolling subjects 18 years or older that need keratoplasty based on clinical findings. subjects will be enrolled regardless of race or gender on a first come first serve basis. subjects will be recruited from the physicians own clinic. pkp subjects: we will do a retrospective chart review on subjects who have undergone traditional pkp. flak eyes will be age and gender matched to these pkp eyes to compare visual outcomes, wound healing and complications.

Eligibility criteria:
inclusion criteria: 1. corneal opacification. 2. reduced etdrs-measured, best corrected, distance visual acuity to 20/40 or worse. 3. ability to participate in follow-up visits.. exclusion criteria: 1. corneal opacification adequately dense to obscure visualization of iris. 2. etdrs-measured, best-corrected, distance visual acuity of 20/30 or better. 3. corneal thickness greater than 1200 µm at the 9 mm peripheral zone. 4. severe corneal thinning including descemetocoele with impending corneal rupture. 5. prior pkp or incisional surgery that may provide a potential space into which the gas produced by the procedure can escape. 6. poor visual potential in the non-study eye (va of 20/100 or less, without potential for improvement by the examining ophthalmologist's judgment). 7. history of glaucoma, including steroid response rise in intraocular pressure. 8. active intraocular inflammation or infection. 9. age 18 or younger (consideration will be given to an upper age limit). 10. unable to return for scheduled follow-up examinations. 11. other medical condition(s) that will likely prevent long term follow-up.

Keywords: keratoconus, pkp, femtosecond laser assisted keratoplasty
study of krn951 in patients with solid tumors

Conditions: Solid Tumors

Summary: the purpose of this study is to assess the safety and tolerability of krn951 administered to patients with solid tumors. in the single dose period, patients in each cohort will receive one oral dose of krn951 in the first day, followed by a 6-day rest period during which no treatment is received. after that, patients in each cohort will receive one oral dose of krn951 daily over a 21-day treatment period, followed by a 7-day rest period during which no treatment is received. treatment will be continued in the absence of disease progression or unacceptable adverse events.


Eligibility criteria:
inclusion criteria: * signed written informed consent * solid tumors to be unresponsive to, or untreatable by standard therapies * ≥ three-month life expectancy * eastern cooperative oncology group performance status score of 0, 1 or 2 exclusion criteria: * hematologic abnormality * myocardial infarction or clinically symptomatic left ventricular failure * active hypertension or controllable hypertension more than 3 antihypertensive medications * symptomatic cns metastasis * unhealed wounds * active infections * hepatic or renal functional disorder * any of the hbs antigen, hcv antibody and hiv antibody positivity * prior use of any chemotherapy, radiotherapy, immunotherapy or surgery within four weeks previous to first dose of study drug * pregnant or lactating women * women of childbearing potential and fertile men, unless willing to use adequate contraceptive protection
a study of the efficacy and safety of guselkumab in participants with moderately to severely active crohn's disease

Conditions: Crohn's Disease

Summary: the purpose of this study is to evaluate the clinical efficacy (galaxi 1), clinical and endoscopic efficacy (galaxi 2 and galaxi 3) and safety of guselkumab in participants with crohn's disease.

this program consists of 3 separate studies: a 48-week phase 2 dose-ranging study (galaxi 1) and two 48-week phase 3 confirmatory studies (galaxi 2 and galaxi 3). in phase 2, safety and efficacy of guselkumab dose regimens will be evaluated to support the selection of induction and maintenance dose regimens for confirmatory evaluation in phase 3. participants who complete the 48-week phase 2 or phase 3 studies may be eligible to enter the long term extension (lte). throughout the 3 studies, efficacy, pharmacokinetic, biomarkers, and safety will be assessed.

Eligibility criteria:
inclusion criteria: * have crohn's disease (cd) or fistulizing crohn's disease of at least 3 months duration (defined as a minimum of 12 weeks), with colitis, ileitis, or ileocolitis, confirmed at any time in the past by radiography, histology, and/or endoscopy * have moderate to severe cd as assessed by cdai, stool frequency (sf), and abdominal pain (ap) scores, and simple endoscopic score for crohn's disease (ses-cd) * have screening laboratory test results within the protocol specified parameters * a female participant of childbearing potential must have a negative urine pregnancy test result at screening and baseline * demonstrated intolerance or inadequate response to conventional or to biologic therapy for cd exclusion criteria: * current diagnosis of ulcerative colitis or indeterminate colitis * has complications of crohn's disease, such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation * unstable doses of concomitant crohn's disease therapy * receipt of crohn's disease approved biologic agents, investigational agents, or procedures outside of permitted timeframe as specified in the protocol * any medical contraindications preventing study participation
study on the incidence of influenza and its complications, in subjects aged 50 years and over vaccinated with fluarix™

Conditions: Influenza

Summary: a study to investigate the incidence of influenza and influenza-related complications, in adults between 50-64 years and elderly adults 65 years and over vaccinated with fluarix™


Eligibility criteria:
inclusion criteria: * a male or female age 50 years or older at the time of the first vaccination. * non-childbearing female * availability to follow up by phone * subjects with residence status allowing free mixing with general community exclusion criteria: * use of non-registered products * pregnancy * hypersensitivity to a previous dose of influenza vaccine * acute disease at the time of enrolment/vaccination. * history of allergy or reactions likely to be exacerbated by any component of the vaccine * any contra-indication to intramuscular administration of fluarix™ * for subjects enrolled in the immunogenicity subset only: administration of immune-modifying drugs within 7 days prior to the vaccination

Keywords: influenza vaccine
improving drop instillation comfort of a cyclosporine a solution

Conditions: Dry Eye Disease

Summary: patients who suffer from dry eye disease are often prescribed eye drops containing cyclosporine a that help with reducing inflammation. the newest eye drop containing cyclosporine a is called cequa (sun pharma, canada). unfortunately, nearly a quarter of (24.2%) of patients using cequa have reported some form of discomfort (burning and stinging) when instilling the drops. this potentially discourages patients from continuing the eye drop, which prevents their dry eye disease from being managed effectively. this study is trying to determine if refrigerating the eye drops would allow the drops to feel more comfortable when they are instilled in the eye.


Eligibility criteria:
inclusion criteria: * over 18 years of age. * ocular surface disease index score \>= 23. * strip meniscometry \< 5 mm. exclusion criteria: * contact lens wearers. * have corneal neuropathic or neurotrophic disease. * have an ocular or medical condition or taking medications that could confound a study outcome. * currently pregnant or breastfeeding (cyclosporine is a fda pregnancy category c drug). * have an ocular or medical condition for which cequa is contraindicated (e.g., allergy to cyclosporine or other ingredients in cequacurrent eye infection, cancer or precancerous condition in or around the eyes). * have an allergy to fluorescein.

Keywords: dry eye disease cyclosporine eye drop
a continuation protocol for patients previously enrolled in a study of toca 511

Conditions: Glioblastoma Multiforme; Astrocytoma; Gliomas, Malignant

Summary: this is a multicenter, open-label, continuation study to allow subjects who have previously received toca 511 to continue to receive toca fc and to allow for extended safety observations. subjects will be seen on an every six week basis for 1 year or longer. subjects who continue to receive toca fc will receive the dose described in the "parent" protocol. if the toca fc dose is adjusted for any reason, the serum concentration will be monitored. gadolinium (gd)-enhanced magnetic resonance imaging (mri) scans will be performed as per standard of care. if the subject has recurred/progressed, repeat intracranial injection of toca 511 followed by toca fc treatment may be offered to consenting patients. subjects who enter the study to continue toca fc and subsequently discontinue toca fc, and subjects who are only willing or able to perform limited testing will have viral testing alone, at the appropriate intervals. after the first year, subjects will be seen twice yearly for the next 4 years and then contacted yearly for the next 10 years. all subjects will be followed on study for at least 5 years regardless of whether they are taking toca fc.


Eligibility criteria:
inclusion criteria: * informed consent form * subject received toca 511 in prior study. * subject is willing to abide by protocol exclusion criteria: * subject has history of allergy or intolerance to flucytosine

Keywords: glioma glioblastoma glioblastoma multiforme grade iv astrocytoma brain cancer recurrent glioblastoma gbm aa aod anaplastic astrocytoma anaplastic oligodendroglioma anaplastic oligoastrocytoma high grade glioma