Kornimate/medical-research-clean huggingface dataset:
study of drug exposure in systemic circulation of primatene mist by oral inhalation, versus epinephrine injection by intramuscular injection and proair by oral inhalation in healthy individuals

Conditions: Pharmacokinetics; Epinephrine; Albuterol; Asthma; Anaphylaxis

Summary: to assess the drug exposure profile in systemic circulation of primatene mist by inhalation, versus epinephrine by intramuscular injection, and proair hfa by inhalation in healthy adults.


Eligibility criteria:
inclusion criteria: * agree to participate; understand and sign informed consent; * male and female adults, aged 18 to 50 years, inclusive at screening; * generally healthy and medically stable, with no clinically significant abnormalities based on physical examination and laboratory tests as determined by the investigators; * have good venous access; * have normal resting blood pressure and normal heart rate (hr) without history of syncope; a subject with out of range blood pressure may be enrolled in the study at the discretion of the principal investigator; * have a body mass index (bmi) of 18.0 - 30.0 kg/m\^2; * female candidates must be \>1 year post-menopausal or practicing a clinically acceptable form of birth control and confirmed by negative urine or serum pregnancy test at screening; * negative hiv-ab, hbs-ag and hcv-ab; * negative alcohol test (urine or breathalyzer); * negative drug screening results; * currently non-smoker; have not used any tobacco products for at least three (3) months prior to screening; and * demonstrate proficiency in the use of mdi and a consistent inhalation time \>2.0 seconds after training, for at least three (3) times, with a maximum of 5 attempts. exclusion criteria: * concurrent clinically significant cardiovascular, hematological, renal, neurologic, hepatic, endocrine, psychiatric, or malignant diseases. * known intolerance or hypersensitivity to any component of the study drugs (i.e., epinephrine, albuterol sulfate or any sympathomimetic drugs, hfa-134a, thymol, ethanol, ascorbic acid, nitric acid, and hydrochloric acid). * upper or lower respiratory tract infection, or other systemic infection within 6 weeks prior to screening; * clinically significant abnormalities in the screening/baseline ecg; prolonged corrected qt interval (qtcf) on ecg: men \>450ms, women: \>470ms; single or multiple premature ventricular contractions (pvc); * abnormal thyroid function test (if tsh is out of range, refer to t3/t4 for thyroid function assessment); * subject has been on other investigational drug/device studies within 30 days of screening visit or planned participation in another investigational drug trial at any time during this trial; * women who are pregnant or lactating or planning a pregnancy during the study period; * subject has donated or lost \> 500 ml of blood within 3 months of screening; * evidence of alcohol or drug abuse or dependency within 6 months prior to screening; or * use of any of the prohibited drugs without appropriate washout.
determining the impact of shunting and cerebrovascular reactivity on 7t mri (discover 7t mri)

Conditions: Cognitive Impairment

Summary: the purpose of this study is to use transcanial doppler (tcd) ultrasound to look for possible risk factors for ischemic brain injury. we will perform contrast tcd with agitated saline contrast to identify and contrast right-to-left shunt (rls) and breath holding to assess cerebrovascular reactivity (cvr) in the elderly.


Eligibility criteria:
inclusion criteria: 1. males and females ≥ 60 years of age. 2. fluent in english. 3. part of the nacc longitudinal cohort (protocol #: 068200) of the pmc/adcc with consensus conference designation of cognitively normal, mild cognitive impairment, or probable/possible alzheimer's disease. 4. has consented to participate in the adcc high-resolution mri sub-study. 5. nacc longitudinal visit must be within 6 months of the tcd study and brain mri study. 6. women: post-menopausal or surgically sterile. 7. willing and able to complete all required study procedures. 8. completed 6 grades of education. 9. geriatric depression scale less than 6 (assessed within 6 months at the nacc longitudinal visit). exclusion criteria: 1. prior clinically symptomatic ischemic or hemorrhagic stroke. 2. inability to tolerate or contraindication to tcd study in the opinion of an investigator or treating physician. 3. any medical or psychological conditions that, in the opinion of the investigator, would compromise the subject's safety or successful participation in the study.
molecular profiling in young (<50 years of age) patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: breast cancer is the most common cancer in women worldwide, especially in developed countries. in developing countries, including south korea, the incidence and mortality rate of breast cancer is rapidly increasing. one of the most important characteristics of breast cancer in south korea, as well as in other asian countries, is the younger onset of disease compared to western. medical treatment of breast cancer is evolving rapidly, incorporating immune checkpoint blockades and molecularly targeted agents. however, data and knowledge are still limited in terms of molecular characteristics of asian breast cancer, compared to that of western countries, and this remains a major hurdle for drug development in asian breast cancer patients. the primary objective of this study is to elucidate the genetic characteristic of young (\<50 years of age) korean patients with metastatic breast cancer using foundationone cdx.

secondary objective(s): 1. to evaluate the prognostic and predictive role of tumor mutation burden. 2. to reveal the correlation between genetic characteristics and immunohistochemical expression of selected proteins (including dna damage repair (ddr) molecules and various immune modulating molecules including pd-l1, pd-1, ido, and ox40). 3. compare molecular characteristics of breast cancer according to age groups (\<35 years vs. 35-50 years). 4. to offer genomic profiling guided therapy to patients as early as possible (preferably, 1st- or 2nd-line of treatment). in addition, to explore how genomic profiling guided therapy could improve patient outcome as an ad-hoc if sufficient number of patients can be followed up (compared to historic data).

Eligibility criteria:
inclusion criteria: * patients between 19 - 50 years of age on the day of signing informed consent. * able to provide written informed consent for voluntary participation in the trial. * with metastatic breast cancer * willing to provide biopsies from the primary tumor or lymph nodes at screening to the central laboratory. (with at least 10 unstained slides and 1 h\&e slide) exclusion criteria: * has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the study.

Keywords: young patient asian
the efficacy of penile rehabilitation using udenafil after total mesorectal excision of rectal cancer

Conditions: Rectal Cancer

Summary: sexual dysfunctions are well-recognized complications after rectal cancer surgery. damage to the pelvic plexus and pelvic splanchnic nerves results in ejaculatory dysfunction. the purpose of this study is to evaluate the efficacy of udenafil(zydena®, dong-a pharmaceutical co., ltd, seoul, korea) in penile rehabilitation for patients who undertake total mesorectal excision.


Eligibility criteria:
inclusion criteria: * age : 20-65 * rectal cancer within 15cm from anal verge * patients with more than 5 points decreased iief-5 after operation * patients with sexual activity exclusion criteria: * preoperative iief-5 : ≤14 * recent mi, cva, nitrate medication * severe cardiovascular disease, psychiatric disease * severe hepatic dysfunction (got, gpt ≥100iu/l) * renal dysfunction (cr ≥2mg/dl)

Keywords: udenafil rectal cancer penile rehabilitation total mesorectal excision
expected and actual preterm-birth and parental distress: impact on children's mental health

Conditions: Preterm Birth; Psychological Distress; Mental Health; Cognitive Functioning

Summary: the purpose of the present study is the assessment of the mental health and cognitive development of children 6-11 years after premature or term birth. impairments in children's' mental health are assessed focusing different disorders or problems (adhd, autism traits, affective disorders, oppositional-aggressive behavior) and using both questionnaires and a clinical interview. risk and protective factors will be analyzed, e.g., threat and/or actual premature birth compared to term birth, parents' mental health, positive coping, personality traits and social support in the peripartum period and afterwards, as well as medical parameters. the potential interaction of premature birth, medical complications, parental distress and children's mental health will be taken into consideration.

a follow-up survey is conducted based on a previous study on psychological distress in parents with preterm infants (nct01974531). medical records and previous questionnaire data will be used for grouping the children based on threat of preterm birth, actual preterm birth and term birth as well as to assess the risk and protective factors in the peripartum period. parents have been informed within the first study part that a second study part, including their children, would have been followed. parents were recontacted and asked for participation via telephone or email. those who agreed, will be contacted via questionnaires in a first step and then in a second step interviewed regarding their own and their children's mental health. the investigators use the following questionnaires to assess children's mental health: child behaviour checklist 6-18r (cbcl 6-18r), conners 3rd edition, social communication questionnaire (scq), revised children\&#39;s anxiety and depression scale (rcads). in addition, the investigators conduct clinical interviews with parents on their children's mental health and assess children's cognitive competencies using the wechsler intelligence scale for children (wisc-v). the following questionnaires are used to assess parental risk and protective factors: state-trait anxiety-depression inventory (stadi), parental stress scale (pss), parenting scale short form (ps), big five inventory short form (bfi).

Eligibility criteria:
children and their parents must have participated in the previous study. inclusion criteria of the previous study regarding the parents were: * pregnant women and their partners from the 24th week of gestation on * 18 years of age exclusion criteria of the previous study were: * psychiatric, mainly psychotic diseases * drug abuse * severe neurological disorders * stillbirth
using niatx strategies to implement integrated services in routine care

Conditions: Addiction; Mental Health Disorder

Summary: this is an implementation research study designed to evaluate a defined strategy, niatx, for its effectiveness in installing and sustaining evidence-based integrated services for persons with co-occurring substance use and mental health disorders. this study is a cluster randomized wait-list control group design, in which a cohort of 25 addiction treatment agencies receives the active niatx approach during an index 12 month period. the second (wait-list) cohort of 25 addiction treatment agencies activates niatx strategies during a second index 12 month period. the primary "subjects" of the research are the treatment agencies themselves. the study specific aims are: 1. relative to wait-list, to determine if niatx strategies improve implementation outcomes (integrated service fidelity and receipt of more integrated services) 2. relative to wait-list, to determine if niatx strategies improve patient care outcomes (psychiatric, alcohol and drug problem severity) 3. across entire sample, to evaluate variation in the extent of and fidelity to niatx strategies niatx implementation strategies consist of learning sessions, individualized coaching and peer to peer sharing.


Eligibility criteria:
inclusion criteria: * organizations who are licensed addiction treatment providers in the state of washington were identified and provided the opportunity to participate in the study. eligibility criteria include: * outpatient and/or intensive outpatient services * tax-exempt, government status or at least 50% publicly funded (e.g., block grants, medicare, medicaid) * no prior participation in niatx research studies (this last criterion excludes 39 agencies who were involved in the nida funded niatx 200) exclusion criteria: * public mental health and private addiction treatment agencies are also excluded because only addiction treatment providers in washington are required to use the state clinical information system, and therefore cannot provide the necessary standardized data

Keywords: implementation strategies sustainability integrated services
bone marrow collection in healthy volunteers (icell)

Conditions: Spinal Cord Injury

Summary: this is a observational study in which healthy found volunteers are recruited to donate 50 ml of bone marrow aspirate to enable preclinical studies to obtain proof of concept and safety of a bone marrow derived stem cell preparation named amarcell. the prepared amarcell is only for animal studies and after completion of the preclinical program, the intention of amarcell is to treat humans with a traumatic spinal cord injury.

coded anonymized patient data

Eligibility criteria:
inclusion criteria: * men in the age range of 21-30 years and/or women in the age range of 21-30 years and taking birth control medication to prevent pregnancy * written informed consent * healthy as concluded by the answers given to questions in a short health questionnaire exclusion criteria: * pregnancy or lactation period * volunteers who are unable to comply with the rules of this project. important is if the volunteer can not follow the schedule of the appointments. * abuse of alcohol, medicines or illicit drugs. * legally protected people

Keywords: autologous stem cells spinal cord injury preclinical
safety and efficacy study of recombinant human growth hormone in adult growth hormone deficiency patients

Conditions: Adult Growth Hormone Deficiency

Summary: the purpose of this study is to assess the safety, tolerability and pharmacokinetic/ pharmacodynamic (pk/pd) profile of three doses of hm10560a on an every week (ew) regime and one dose on every other week (eow) regime administered for a period of 24 weeks initial study.

* to select the optimal dose and dosing regimen of hm10560a for the subsequent phase iii study on the basis of the safety and pk/pd profile after 24 weeks of treatment * to assess the long term safety of hm10560a when administered in optimal dose range and dose frequency for additional 48 weeks (followed with 2 weeks safety follow up)

Eligibility criteria:
inclusion criteria: * ghda subjects, males and females, of age between 23 and 60 years as defined in the consensus guidelines for the diagnosis and treatment of adults with gh deficiency ii (2007) as well as american association of clinical endocrinologists medical guidelines for clinical practice for growth hormone use in growth hormone-deficient adults and transition patients (2009); * r-hghdrug naïve or any registered or investigational r-hgh replacement therapy was not given for more than 6 months before the screening. * body mass index (bmi, kg/m2) of both male and female patients must be between 22.0 to 35.0 kg/m2. * female patients must have a negative serum pregnancy test at inclusion. * confirmed to be negative for anti r-hgh antibodies at the time of screening. * willing and able to provide written informed consent prior to performing any study procedures. exclusion criteria: * patients with childhood onset of ghd treated with r-hgh before the age of 18. * current antitumor therapy. * subjects presenting with any clinically significant ecg abnormality. * evidence of intracranial hypertension. * significant hepatic dysfunction (persistent elevation of alanine transaminase \[alt\] or aspartate transaminase \[ast\] \>1.5 x upper limit of normal). * pregnancy and breastfeeding;

Keywords: aghd
study to validate the instructions for use of tobi® podhaler™ in cystic fibrosis patients

Conditions: Cystic Fibrosis

Summary: the purpose of this actual use human factors (hf) study is to validate the approved us tobi podhaler instructions for use (ifu), by establishing that the ifu effectively communicates the information necessary to achieve safe and effective use of the podhaler device.

the objective of the hf study is to determine whether cystic fibrosis patients in the us, representative of potential tobi podhaler users, can understand and follow the approved ifu and the extent to which the approved ifu supports safe and effective use of the podhaler device. this study is an 'actual use' study, in that patients will inhale the contents of placebo capsules through the podhaler device. due to the use of placebo capsules, the study is considered a clinical study and will be conducted accordingly. the study is therefore a human factors observational use study conducted within a clinical study. it is an open label, unblinded, non-randomized study and consists of two visits. at visit 2 patients who are eligible will participate in a human factor assessment to determine whether or not a patient understands the ifu content and can demonstrate safe and effective use of the podhaler device.

Eligibility criteria:
inclusion criteria: * male and female subjects aged 6 years and older at screening * confirmed diagnosis of cf * pulmonary function fev1 value at least 25% of normal predicted values * must be physically and cognitively able to read, alone or with the assistance of their caregiver exclusion criteria: * subjects currently enrolled in studies that are not considered observational noninvestigational studies. * subjects who have used the podhaler device previously * hemoptysis more than 60ml at any time within 30 days prior to study drug administration * history of hypersensitivity to inhaled dry powder * signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax

Keywords: human factors, tobi® podhaler™, instructions for use, ifu, cf patients
anxiety and work resilience among tertiary university hospital workers during the covid-19 outbreak: an online survey

Conditions: Critical Illness; Sars-CoV2; SARS Pneumonia; Coronavirus Infection; Stress Disorders, Post-Traumatic

Summary: for limiting covid-19 spreading, the world health organisation (who) recommended worldwide confinement on 2010. in france, unessential institutions were closed on march 14th and population confinement was decided on march 17th. quarantine and/or confinement could lead to psychological effects such as confusion, suicide ideation, post-traumatic stress symptoms or anger covid-19 outbreak highlighted a considerable proportion of health care workers (hcw) with depression, insomnia, anxiety and distress symptoms. in front line, facing the virus with the fear of contracting it and contaminate their closest. during previous outbreaks (h1n1, sars), hcws have been shown to experience such negative psychological effects of confinement as well as work avoidance behaviour and physical interaction reduction with infected patients (4-7). in france, covid 19 outbeak led to increase icu bed capacity with a full reorganization of the human resources. some caregivers were reassigned to newly setup units admitting or not covid-19 patients. in the same time, non-caregivers were also encouraged to work at home whenever possible. thus, every hospital staff member's private and professional life could be altered by the covid-19 outbreak. as all these changes in the daily life could induce psychological disturbances, the present study was aimed at assessing the acute anxiety level (main objective) of the staff in our tertiary university hospital, (6300 employees). secondarily, the self-reported insomnia, pain, catastrophism and work avoidance behaviour levels were assessed


Eligibility criteria:
inclusion criteria: * employees of chu nîmes during covid-19 pandemic * approved to participate exclusion criteria: • participation refusal
reform clinical study: treatment of renal artery stenosis with the formula balloon-expandable stent

Conditions: Renal Artery Stenosis

Summary: the purpose of the study is to evaluate the safety and effectiveness of the formula balloon-expandable stent in treatment of renal artery stenosis.


Eligibility criteria:
key inclusion criteria: * renal artery stenosis * appropriate size and location of the lesion * suboptimal angioplasty key exclusion criteria: * less than 18 years old * failure or inability to give informed consent * simultaneously participating in another drug or device study

Keywords: renal artery stenosis hypertension renovascular renal artery blockage renal artery disease renal arteries angioplasty renal artery renal artery stent renal artery doppler renovascular hypertension kidney stenosis renal artery stent stenting kidney disease renal failure atherosclerosis arterial hypertension stenosis
renal denervation for resistant hypertension

Conditions: Hypertension

Summary: this is a study investigating the effectiveness of renal denervation in lowering blood pressure in people whose blood pressure is not adequately controlled despite treatment with 3 or more blood pressure lowering drugs. the study is designed to compare the effects of renal denervation to a usual care group receiving additional blood pressure lowering drugs.

previous studies have shown that the renal denervation procedure is safe and effective in reducing blood pressure in patients with resistant hypertension. a total of 100 participants with uncontrolled blood pressure, treated with three or more blood pressure lowering medications will be recruited into the study. patients will be assigned to one (1) of two (2) groups with the aim of attaining blood pressure control. participants in group 1 will be assigned to renal denervation, participants in group 2 will receive additional antihypertensive medication according to current guidelines and best practice in an attempt to reach blood pressure targets.

Eligibility criteria:
inclusion criteria: * systolic bp ≥140mmhg or ≥130mmhg for patients with diabetes * concurrent treatment with ≥3 anti-hypertensive drugs exclusion criteria: * renal artery anatomy ineligible for treatment * egfr \<15ml/min/1.73m2 (using modification of diet in renal disease (mdrd) calculation) * female participants of childbearing potential must have negative pregnancy test prior to treatment

Keywords: renal denervation blood pressure cardiovascular risk target organ damage sympathetic activity