Kornimate/medical-research-clean huggingface dataset:
evaluating the bioequivalence of hip1302, hgp1406

Conditions: Healthy

Summary: the purpose of this study is to investigate the bioequivalence after administration of hip1302 and hgp1406 in healthy male volunteers.

a randomized, open, 2-way cross-over, single dose study to evaluate and compare safety and pharmacokinetics of the hip1302 and hgp1406 in healthy korean male volunteers

Eligibility criteria:
inclusion criteria: * healthy male volunteers, age 19 to 50 years * the result of body mass index(bmi) is not less than 18.0 kg/m2, no more than 27.0 kg/m2 * subjects who have ability to comprehend the objectives, contents of study and property of study drug before participating in trial and have willingness to sign of informed consent in writing exclusion criteria: * presence of medical history or a concurrent disease that may interfere with treatment and safety assessment or completion of this clinical study, including clinically significant disorders in kidney, liver, cardiovascular system, respiratory system, endocrine system, or neuropsychiatric system.
study of sulfasalazine in treating painful neuropathy

Conditions: Painful Neuropathy

Summary: the investigators hypothesize that sulfasalazine, an fda-approved medication for rheumatoid arthritis and ulcerative colitis, may be beneficial in neuropathic pain conditions. in this study, the investigators will evaluate whether sulfasalazine improves pain due to painful peripheral neuropathy.


Eligibility criteria:
inclusion criteria: * painful neuropathy * michigan neuropathy screening instrument score of 3 or greater * no obvious alternative explanation for neuropathy * average baseline pain \> 4/10 exclusion criteria: * other severe pain * anticipated difficulty weaning off medications * past or current psychiatric disorder as determined by mini international neuropsychiatric interview * medical contraindication to sulfasalazine * not proficient in english (due to heavy use of questionaires) * pregnant or breast feeding women
neocate in infants and children with complex conditions

Conditions: Complex Conditions, Including Impairment of the GI Tract

Summary: infants and young children up to 10 years of age with a complex condition involving the gastrointestinal tract are at risk of poor nutritional status, including faltering growth. due to the complex condition, standard nutrition is often not tolerated and causes gastrointestinal symptoms. formulas in which protein is replaced by its smallest elements, amino acids are easier for the body to digest and absorb. these formulas might be tolerated better and reduce gastrointestinal symptoms in infants and young children with complex conditions. the objectives of the present, exploratory study are to gain clinical evidence related to the nutritional status and gastrointestinal tolerance in infants and young children with complex conditions receiving neocate as their primary source of nutrition. additional objectives are to describe the nutritional and pharmacological management of these infants and young children. study duration for each participant will be 52 weeks at maximum.


Eligibility criteria:
inclusion criteria: * infants and young children aged from 0 up to and including 10 years of age. * severe impairment of at least 1 organ system * impairment of the gastrointestinal tract, i.e. gastrointestinal disease, congenital abnormality, surgical resection, or gastrointestinal dysfunction (including symptoms of gastrointestinal dysmotility or malabsorption). * receiving at least 75% of their energy intake from neocate (neocate infant or junior powdered (marketed) product) at the time of study entry (v1). * expected to receive at least 75% of their energy intake from the study product for at least 4 weeks from study entry (v1). * written informed consent provided by parents/guardians and assent by the child, if applicable, according to local law. exclusion criteria: * infants born with a gestational age \<37 weeks that are \<40 weeks corrected age at the time of study entry (v1). * infants or children with endoscopically confirmed eosinophilic oesophagitis and prescribed an amino acid-based formula only for the management of the eosinophilic oesophagitis. * infants or children with a medical diagnosis that includes only (suspected) cow's milk allergy and/or multiple food allergy. * infants or children with renal dysfunction, e.g. acute or chronic kidney failure or kidney cancer. * infants or children with thyroid disorder or parathyroid disorder. * expected to receive parenteral nutrition during intervention from study entry (v1). * participation in any other studies involving investigational or marketed products concomitantly or within 1 month prior to study entry (v1). * investigator's uncertainty about the willingness or ability of the parents/guardians to comply with the protocol requirements.
safety of insulin detemir for the treatment of insulin dependent type 1 or type 2 diabetes mellitus

Conditions: Diabetes; Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this trial is conducted in north america. the aim of this trial is to evaluate the safety of insulin detemir for the treatment of diabetes.


Eligibility criteria:
inclusion criteria: * diagnosed with type 1 or type 2 diabetes * using a basal/bolus insulin regimen exclusion criteria: * subjects who are unlikely to comply with protocol, e.g., uncooperative attitude, inability to return for the final visit * subjects who previously enrolled in this study * subjects with a hypersensitivity to insulin detemir or to any of the excipients
long-term safety, curvature deformity characterization, and immunogenicity over time in subjects previously treated with aa4500 for peyronies disease

Conditions: Peyronie's Disease

Summary: this a phase 4 non-treatment, long-term follow-up study of subjects who received aa4500 in a 12-month double blind placebo-controlled study (aux cc 803 or aux-cc-804) or in a 9-month open label study (aux-cc-802 or aux-cc-806) sponsored by auxilium pharmaceuticals, inc. after participation in one of the aforementioned studies, subjects will be followed yearly for up to 4 consecutive long-term follow-up visits with at least 6 months between consecutive visits

at each long-term follow-up visit, subjects will be assessed for adverse events relative to their previous long-term follow-up assessment. blood samples for the determination of antibodies to aux-i and aux-ii and neutralizing antibodies to aux-i and aux-ii will be collected at each long-term follow-up visit. at each long-term follow-up visit, a flaccid penile examination will be performed and a curvature deformity measurement (with the penis in the erect state) will be recorded. subjects will also be asked to complete the peyronie's disease questionnaire (pdq) and the international index of erectile function (iief) questionnaire. at each visit, medical, surgical, or other treatments for peyronie's disease since the last assessment will also be collected and recorded.

Eligibility criteria:
inclusion criteria: 1. have received at least one injection of aa4500 and completed at least the first or last follow-up visit in one of the auxilium-sponsored studies (aux cc-802, aux-cc-803, aux-cc-804, or aux-cc-806). 2. be able and willing to comply with the follow-up assessments outlined in the protocol, as determined by the investigator. 3. voluntarily sign and date an informed consent agreement approved by the institutional review board/independent ethics committee (irb/iec). - exclusion criteria: none -

Keywords: curvature bend
fire fighter fatigue management program: operation healthy sleep

Conditions: Shift-Work Sleep Disorder; Insomnia; Restless Leg Syndrome; Obstructive Sleep Apnea; Impaired Driving; Injuries

Summary: firefighters work some of the most demanding schedules known under highly stressful and demanding conditions. the need to work frequent extended shifts and long work weeks leads to acute and chronic partial sleep deprivation as well as misalignment of circadian phase. sleep disorders are common, costly, and treatable, but often remain undiagnosed and untreated and it is likely that a significant proportion of firefighters suffer from undiagnosed sleep disorders which will further impair their sleep and exacerbate fatigue.in the current proposal, we aim to address the health, performance and safety issues related to fatigue in firefighters and test the effectiveness of a comprehensive firefighter fatigue management program (cffmp) that we have termed 'operation healthy sleep.'

we propose to use a station-level, randomized experimental design to test the hypotheses that implementation of a comprehensive firefighter fatigue management program will: 1. improve the mean total sleep, alertness and cognitive performance of firefighters; 2. improve firefighter safety, as determined by: 1. decreased rates of motor vehicle crashes; 2. decreased on-the-job injuries; 3. improve firefighter performance, as determined by decreased response time; 4. improve firefighters' health, as determined by: 1. diagnosis and treatment of sleep disorders 2. improved general health indices 3. decreased number of 'sick' days 5. improve firefighters' and families' job satisfaction and ability to cope with extended work hours.

Eligibility criteria:
inclusion criteria: * this proposal includes research involving human subjects (fire department employees). * active firefighters working in the study fire department will be eligible to participate in the study. * all applicants will be considered without bias, regardless of race, ethnicity, or national origin. exclusion criteria: * non fire department employees

Keywords: sleep firefighter fire apnea insomnia shift narcolepsy restless leg rls fatigue actigraph actigraphy actiwatch safety sleepiness sleepy work hours federal emergency management agency drowsy
three-dimensional study on the structural destruction of pelvic anatomy in cervical cancer

Conditions: Cervical Cancer; Postoperative Pelvic Floor Dysfunction

Summary: cervical cancer is one of the most prevalent malignancies in female .to the younger patients, radical hysterectomy which is a standard operation during the earlier and middle therapy stage as well as more effective technique like radiotherapy and chemotherapy give them a longer life expectancy. however, the operation destroys patients' normal pelvic anatomy, nutrient supplements and internal secretion so that postoperative pelvic floor functional dysfunction has a destructive effect for their life. there are tremendous studies on clinical symptoms while few on anatomical changes and the relationship between pelvic floor symptoms and the dysfunction. two-dimensional magnetic resonance imaging(mri), transperineal ultrasonography， urodynamic examination and anorectal manometry are frequently used in the fine-structure varies and pelvic floor function. now three-dimensional mri has more advantages in fine change of pelvic anatomical and space position，as well as clearly showing the relationships between the change and space with the pelvic floor function. based on an eight-year-study on three-dimensional mri, we can analyze the postoperational anatomical changes and the relationship between the changes and the dysfunction by combined anatomic parameters which are measured on static-dynamic three- dimensional model with clinical symptoms, transperineal ultrasonography,urodynamic examination and anorectal manometry. we expect our study could provide scientific basis for on protective and repaired measures of pelvic floor.


Eligibility criteria:
inclusion criteria： ①patients diagnosed as figo stage ia2、ib1、iia1 cervical cancer ; ②patients diagnosed as figo stage ib2、iia2 cervical cancer, eligible for rh after neoadjuvant chemotherapy; ③patients diagnosed as figo stage iia endometrial carcinoma; ④patients didn't have pelvic organ prolapse and urinary incontinence; ⑤ability to hold valsalva for dynamic mri; ⑥patients aged 20-70 years; ⑦patients undergone rh surgery; ⑧informed consent was signed. exclusion criteria： ①with mri or urodynamic examination contraindication; ②previously undergone pop or sui surgery; ③bmi\>30 with serious postoperative complications.

Keywords: cervical cancer radical hysterectomy postoperative pelvic floor dysfunction the injure of pelvic floor three-dimensional reconstruction structural destruction of pelvic organs structural destruction of pelvoic floor
autonomic imbalance and 24-h blood pressure change in patients with chronic renal disease

Conditions: Diabetes Mellitus; Essential Hypertension; Renal Failure; Chronic Nephropathy

Summary: many patients with chronic renal disease show a loss of the nocturnal decline of blood pressure (non-dipper). however, the mechanism is not yet fully understood. we evaluate 24-hour blood pressure in patients with chronic renal disease using an ambulatory blood pressure monitoring device (a \& d tm2425). we also analyze the power spectrum of heart rate variability as an index of autonomic cardiovascular modulation using the same device.

the ratio of lower frequency (lf) and higher frequency (hf) heart rate rhythmic oscillations is expressed as an index of sympathovagal balance. patients with chronic renal disease participate in the study. blood pressure and power spectrum of heart rate variability for 24 hours are measured when they receive no medication for at least 1 week. the mean waking and sleeping time systolic and diastolic blood pressure are calculated. lf/hf ratios in the chronic renal disease are evaluated to calculate the waking/sleeping ratio for lf/hf.

Eligibility criteria:
inclusion criteria: * hypertensive patients with diabetes mellitus * hypertensive patients * hypertensive patients with renal disease * patients with chronic renal disease exclusion criteria: * cardiac, hematologic or hepatic disease * cerebral infarction or hemorrhage * other major diseases.
acceptability of hpv self-sampling among canadian women aged 21 to 65

Conditions: HPV Infection; Cervical Cancer Screening

Summary: we propose a cross-sectional study to explore the acceptability and feasibility of hpv self-sampling among quebec women. the study will invite eligible women to self-sample for hpv at home. the hpv risk factors of patients included in the study will be taken into consideration (vaccination, smoking, number of partners, date of last screening, etc.).


Eligibility criteria:
inclusion criteria: * speak and understand french without help * have internet access (for completing forms) * have a mailing address exclusion criteria: * known positive hpv status • have already had a hysterectomy
safety study of prucalopride in healthy volunteers

Conditions: Healthy

Summary: in this study healthy volunteers received increasing doses of prucalopride to study the tolerability and cardiac safety of prucalopride. the study hypothesis was that prucalopride at doses up to 10 mg has no clinically relevant effect on the cardiovascular safety in healthy volunteers.

single-centre, double-blind, placebo-controlled, cross-over study in 33 healthy volunteers with 2 sessions. each session consisted of a run-in day for baseline assessments, 8 treatment days and 5 additional days for followup assessments. subjects were randomised to start with either the prucalopride or placebo session. the prucalopride dose was consecutively escalated in 2 mg steps per day, starting from 2 mg up to 10 mg once daily if a subject did not tolerate the 10- or 8-mg dose, 1 step back in the dosage scheme was allowed, from 10 to 8 mg on day 6, or from 8 to 6 mg on day 5. subjects with intolerance for doses of less than 6 mg, were withdrawn from the study. repeated dosing (6, 8 or 10 mg) was continued once daily until day 8, to achieve steady-state. during placebo, the number of placebo tablets was consecutively escalated in an identical way as described for prucalopride. between the 2 sessions, there was a washout period of 14 to 21 days, to avoid any carry-over effect.

Eligibility criteria:
inclusion criteria: * aged between 18 and 45 years. * normal weight. * healthy on the basis of a pre-study physical examination, medical history, anamnesis,ecg, 24-hour holter monitoring, echocardiogram and the results of blood biochemistry and haematology tests and a urinalysis carried out in 3 weeks preceding randomisation. exclusion criteria: * history or suspicion of alcohol, barbiturate, amphetamine or narcotic abuse. * smoking more than 10 cigarettes, or 2 cigars, or 2 pipes per day for at least 6 months prior to selection. * history of cardiac arrhythmias, bronchospastic or cardiovascular disease (e.g. ischaemic heart disease or cerebrovascular accident), diabetes mellitus, thyrotoxicosis,parkinsonism. * presence of prolonged qtc (bazett) on ecg at screening (qtc \>450 ms in male subjects, qtc \>470 ms in female subjects). * use of concomitant medication, except for oral contraceptives and paracetamol. * participation in an investigational drug study in 30 days prior to the first visit. * donation of blood in the 60 days preceding the first visit. * pregnancy or breast-feeding female. * female subjects of childbearing potential without adequate contraceptive protection during the study.

Keywords: electrocardiographic safety pharmacokinetics
hearing impairment, cognitive therapy and coping

Conditions: Hearing Loss; Tinnitus; Stress, Psychological; Mental Fatigue

Summary: a randomized controlled study with hearing impaired workers, who have voluntarily signed up for an 8 session cognitive therapy (cbt) course the cbt intervention will be compared to a waiting list control group. participants who are allocated to the intervention group will be offered to start on the cbt-course immediately, while the control group that will be offered the same course 12 months later. main outcome measures are assessments of mental distress and vocational coping. we will also assess the distress associated with tinnitus, which is a potential moderator variable.

although the relationship between hearing loss and mental distress is not linear, it is known that hearing impaired individuals have increased vulnerability for development of symptoms of distress and fatigue. it is assumed that distressed hearing impaired individuals will have a tendency to use maladaptive and passive coping strategies, such as social withdrawal or reluctance to make use of hearing aid devices. on the other side, it is well documented that hearing impaired employers who are open about their handicap and make others aware of their situation, i.e. take an active coping approach, have fewer symptoms of distress and have better vocational functioning. the level of knowledge is limited and mainly based on cross sectional studies, and the way people cope with hearing impairment has been measured indirectly by questionnaires focusing on communication problems. we plan to conduct a randomized controlled study with hearing impaired workers, who have voluntarily signed up for an 8 session cognitive therapy (cbt) course the cbt intervention will be compared to a waiting list control group. participants who are allocated to the intervention group will be offered to start on the cbt-course immediately, while the control group that will be offered the same course 12 months later. main outcome measures are assessments of mental distress and vocational coping. we will also assess the distress associated with tinnitus, which is a potential moderator variable.

Eligibility criteria:
inclusion criteria: * eligible participants need to be within the age range of 18-70 years, contain some formal employment and be able to document a mean, bilateral hearing loss of at least 40 db. * eligible participants need to have a had score of 7 or beyond exclusion criteria: * individuals without a clear vocational status (for instance on permanent/temporarily sick leave) and a mean bilateral hearing loss beneath 40 db. * individuals with a had score beneath 8 are excluded.

Keywords: hearing impaired persons tinnitus life change events adaptation, psychological rehabilitation, vocational cognitive therapy avoidance learning escape reaction
frailty, outcomes, recovery and care steps of critically ill patients

Conditions: Critical Illness

Summary: this pilot study will study the impact of critical illness and icu processes of care on the trajectory and development of frailty. it is hypothesize that frailty in survivors of critical illness will be measurable at hospital discharge, will correlate with processes of care while in icu and will better discriminate long term outcomes when compared to severity of illness or the degree of frailty present on icu admission. this pilot study will be conducted in a tertiary medical surgical icu at kingston general hospital- kingston, ontario. it will inform the feasibility, timelines and sample size for the multi-center study and will allow for the refinement of study procedures and data collection methods. this study will be published separately as a stand-alone pilot.

single center observational pilot study to inform on the conduct of a multi-center observational study.

Eligibility criteria:
inclusion criteria: 1. age \> 55 years 2. admission to icu for over 24 hours 3. receipt of at least one therapeutic life support intervention that can only be delivered in the icu such as mechanical ventilation (both invasive and non-invasive), vasoactive medications (vasopressors or inotropes) or acute renal replacement therapy. exclusion criteria: 1. lack of consent for study inclusion or lack of consent to be contacted for long term follow-up. 2. expected to survive for less than 72 hours after icu admission. 3. inability to obtain baseline blood work less than 48 hours after icu admission (i.e. study enrollment must occur within 48 hours of icu admission allowing for the blood work to be done in the time allowed). 4. no family or caregivers available to collect collateral history. 5. not able to speak english with lack of available medical translators. 6. admission to icu with acute structural neurological disease: 1. massive stroke requiring icu care 2. spinal cord injury with neurological deficit

Keywords: frailty