Kornimate/medical-research-clean huggingface dataset:
sex differences in morton's extension application on plantar pressure distribution in different foot regions in female and male patients without deformities: a pre-post test study

Conditions: Healthy

Summary: the aim of this study is to simulate the orthopedic treatment called morton's extension on non-deformed patients to check the different effects producted by sex in footprint.

the objective of this study is to perform an assimilation of the orthopedic treatment called morton extension on non-deformed patients to verify the difference effects due by sex on each metatarsal head and rearfoot on its static footprint, and plantar pressures variables in dynamic footprint.

Eligibility criteria:
inclusion criteria: * no history of trauma to the foot; * the presence of at least 10° of dorsiflexion at the ankle with the knee fully dorsiflexed; * unrestricted motion of the functional subtalar joint of 30°; * unrestricted motion along the longitudinal axis of the midtarsal joint of 15°; * unrestricted nonweight-bearing motion of the first ray of at least 8 mm; * greater than 50° of dorsiflexion of the hallux to the first metatarsal bisection during nonweight-bearing; * age greater than 18 years and younger than 60 years; * at the time of data collection, no lower limb dysfunction or chronic injury; and * no evidence of a non-fixed deformity at first metatarsophalangeal and first metatarsal cuneiform joints. exclusion criteria: * plantar corns and calluses, * hallux valgus and lesser toe deformities, * diabetes, * any abnormality in the lower extremity that may affect gait.

Keywords: metatarsalgia foot orthopedics women
a placebo-controlled, two-part study, oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of cntx-6970 in healthy subjects

Conditions: Chronic Pain; Nociceptive Pain

Summary: a phase 1, placebo-controlled, two part study with either single dose or multiple increasing oral dose to evaluate the safety, pharmacokinetics, and pharmacodynamics of cntx-6970 in healthy subjects.


Eligibility criteria:
key inclusion criteria: * is in good general health as determined by the investigator's review * has a body mass index (bmi) between 18 and 35kg/m\^2, inclusive * for females, is not currently pregnant or breastfeeding and is either of non-childbearing potential or willing to use an adequate method of birth control * for males, must agree to use barrier contraception and not to donate sperm key exclusion criteria: * has a history of cardiac disease, including congestive heart failure, angina, or any arrhythmia * has diabetes mellitus, acromegaly, clinically active thyroid disease, or other active endocrinopathy * has any history or currently active type of cancer except excised or cured basal cell carcinoma * has a gastrointestinal disorder that could interfere with the absorption of orally administered drugs * has asthma or other severe respiratory disease (e.g., chronic obstructive pulmonary disease) requiring daily prescription medicine * currently has kidney, neurologic, metabolic, or liver disease, or other organ system disease * has a history, current evidence, or is being treated for depression, suicidal ideation, suicide attempt, or any other current psychiatric condition requiring active treatment * has an immunological disorder such as, but not limited to, human immunodeficiency virus (hiv), acquired, or congenital immune deficiency syndrome; autoimmune diseases, such as, but not limited to, rheumatoid arthritis, systemic lupus erythematosus, seronegative spondyloarthropathies or vasculitis, or any infection * has positive screening test for hepatitis b virus (hbv) or hepatitis c virus (hcv); * is pregnant, lactating, or planning a pregnancy during the study * has used any prescribed medication within 30 days prior to the first admission or has plans to use any prescribed medication during the study (with the exception of hormonal contraceptives) * has used within 14 days prior to the first admission or has plans to use during the study any over-the-counter medicinal products, including herbal and dietary supplements (except for occasional use of acetaminophen or nsaids, such as ibuprofen or naproxen; calcium; or vitamin d) * use of any of the following: * human growth hormone, octreotide, anti-diabetic medication, or thyroid suppressors or supplements * immunosuppressive drugs within 30 days of study start, or 5 half-lives of the drug (whichever is longer), or plans to use during the study

Keywords: chronic pain nociceptive pain mixed pain
study to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of shr-2017 injection in postmenopausal women

Conditions: Osteoporosis

Summary: the primary objective was to evaluate the safety and tolerability of shr-2017 after a single subcutaneous (sc) injection in postmenopausal women


Eligibility criteria:
inclusion criteria: 1. postmenopausal women ages ≥ 50 years. 2. body weight≥45 kg, body mass index (bmi) of 18.0 to 29.0 kg/m2 (inclusive). 3. understand in detail the content, procedure and possible adverse effects of the trial, and voluntarily sign the written informed consent form (icf). exclusion criteria: 1. history of malignancy. 2. menopause due to simple hysterectomy. 3. subjects with poor blood pressure control. 4. subjects with positive tests for infectious diseases. 5. have a history of diseases related to bone metabolism. 6. use of drugs that may affect bone metabolism before administration. 7. have a history of alcoholism, medical abuse, or drug use, or have a positive alcohol breath test or drug abuse screening. 8. female who are pregnant or breastfeeding. 9. unable to tolerate venipunctures or have a history of fainting needles and blood. 10. other reasons that the investigator consider it inappropriate to participate in the trial.
cross-over comparison of the v60 system to other bi-level noninvasive ventilators

Conditions: Respiratory Insufficiency; Respiratory Failure

Summary: the purpose of this study is to compare a new noninvasive ventilator to existing ventilators already used for patient care.

this study compares the respironics california v60 mask ventilator to conventional noninvasive ventilators in a cross-over study with the patient as his/her own control.

Eligibility criteria:
inclusion criteria: * age \> 7 years and \< 18 years * weight \> 20 kg (44 lbs) * respiratory failure or respiratory insufficiency * ability to cooperate with the investigators * designated adult able to provide informed consent exclusion criteria: * an endotracheal tube or tracheostomy in place * hemodynamically instability * prolonged apnea * inability to maintain the airway * a recent history of cardiac and or respiratory arrest * acute hemorrhage * multiple organ system failure * undrained pneumothorax * high risk for aspiration * metastatic or terminal cancer * do-not-resuscitate orders * inability to clear respiratory secretions * inability to fit a mask * facial surgery, trauma, or deformity * upper gastrointestinal or airway surgery * pregnancy * refractory delirium * pao2 \< 50 mmhg on present settings * designee unable or unwilling to provide informed consent

Keywords: noninvasive ventilation
evaluation of vascular pathology with 3d, time-resolved phase contrast magnetic resonance imaging (mri)

Conditions: Healthy

Summary: aortic coarctation is a relatively common cardiovascular condition with high associated mortality if not treated. even with successful repair, however, close follow up is needed as late complications can result in significant cardiovascular morbidity. mri, with is ability to provide both anatomic and hemodynamic information, is becoming the imaging option of choice for post-intervention surveillance. time-resolved, three-dimensional phase contrast magnetic resonance velocity (4d flow) profiling enables the acquisition of multidirectional blood velocity data. the technique is well suited for evaluation of blood flow patterns in the thoracic aorta. by comparing aortic flow patterns in patients status post coarctation repair with those of healthy volunteers using 4d flow, this study intends to characterize abnormal flow patterns in these patients with the eventual goal of better understanding and predicting late complications so that preemptive intervention may be taken. given the potential use of 4d flow for evaluation of other types of vascular pathology in the aorta and other vascular regions, we hope to investigate the use of the technique on a limited basis for a broader population of adult patients. other research groups have had success evaluating peripheral stenoses, as well as intracardiac and intracranial blood flow patterns with 4d flow.


Eligibility criteria:
inclusion criteria: patients: primarily status post intervention for repair of aortic coarctation and undergoing routine mri follow up, but also adult patients with other vascular pathologies undergoing routine mri evaluation, who may be good candidates for 4d flow blood flow analysis. healthy subjects: healthy members of the radiology residency program and staff at ucsf. exclusion criteria: anyone else.

Keywords: post-intervention surveillance of aortic coarctation mra and 2d phase contrast imaging 4d flow velocity mapping patients undergoing routine post-intervention surveillance of aortic coarctation healthy volunteers
the effect of eyedrop size on pupillary dilation using the nanodropper bottle adapter

Conditions: Medication Delivery; Eye Drop Delivery

Summary: the average drop size produced by standard eyedrop bottle exceeds the maximal capacity that the human eye are absorb topically. this excess leads to medication waste, increased costs, and greater risk of side effects. the nanodropper is a commercially available, fda listed eyedrop bottle adapter that delivers a smaller drop size. the investigators hypothesize the nanodropper is noninferior to the standard eye drop bottle for pupil dilation. in this study, participants have one eye randomly chosen to be dilated with the nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes to see if there is a difference.

ophthalmic medications are available in eyedrop bottles that produce on average a drop size of about 40 ul, while the human eye can only hold about 7-10ul. this excess leads to medication waste, increased costs, and greater risk of side effects. the nanodropper is a commercially available, fda listed (class 1 medical device, 510(k) exempt) eyedrop bottle adapter that delivers a smaller drop size of 10 ul. the investigators hypothesize the nanodropper is noninferior to the standard eye drop bottle for pupil dilation. this is a prospective comparative matched pairs study of adults scheduled for routine bilateral eye dilation. exclusion criteria includes anisocoria and medications affecting pupil size. one eye is randomly dilated with the nanodropper and the fellow eye dilated with the standard bottle with a 50/50 mixture of tropicamide 1% and phenylephrine 2.5%. pupil size before and after 30 minutes of dilation are measured with a pupillometer and compared between fellow eyes within the same subject with a noninferiority margin of 0.5mm.

Eligibility criteria:
inclusion criteria: * age \>18 years old * scheduled for routine bilateral eye dilation exclusion criteria: * narrow angles * allergies to phenylephrine or tropicamide * concurrent use of any mydriatic agents (e.g., atropine, cyclopentolate, brimonidine) * baseline anisocoria (\>1 mm) * traumatic pupil, * surgical pupil * unilateral pseudoexfoliation.

Keywords: eye drops pupil dilation eye drop bottle device eye drop size
the johns hopkins transplant infectious diseases prospective cohort study

Conditions: Transplantation

Summary: the transplant infectious diseases prospective cohort study facilitates the prospective identification and collection of data of infectious disease complications in order to determine the epidemiology, risk factors, and outcomes of patients who receive solid organ or stem cell or plastic surgery transplants at johns hopkins and other transplant centers. it is essential for the care and treatment of this population to employ a mechanism for investigators to centralize these datasets, using standardized definitions of infectious complications. this protocol outlines the procedures to be utilized in order to prospectively follow the diagnosis and treatment of infectious complications in transplant patients.

patients are approached at their transplant screening visit, if possible, or during their hospital stay (before or after transplant) in order to introduce the study and obtain informed consent for participation. a letter to transplant physicians will introduce this study. data collection will begin immediately upon consent and continue for up to five years. the informed consent form specifically requests permission to contact the subject in the future to verify information or if the subject is lost to follow up by transplant services. the day of transplant will be considered day 0 for enrollment in this observational study. data will be collected on clinical template forms completed by study team members, as infectious complications become apparent in either outpatient id clinics or on the inpatient service. a member of the research team will complete data collection in the registry, maintained on the redcap platform. in addition, patient electronic records will be reviewed every 3 months to identify and record infectious complications, treatments administered, and outcomes. during these intervals, subjects will be contacted by phone to review the same outcomes. creation of the registry relies on use of standardized definitions to define infections. an electronic database has been constructed in the redcap system, documenting subject demographics, transplant variables, infection variables, treatments administered, and overall outcomes, during each interim time period.

Eligibility criteria:
inclusion criteria: hematopoietic stem cell (bone marrow) and solid organ transplant patients - exclusion criteria: -

Keywords: infection cohort prospective epidemiology outcome
web-delivered acceptance & commitment therapy for smokers with bipolar disorder

Conditions: Smoking; Bipolar Disorder

Summary: this purpose of the study is to develop and test a new website to help people who have bipolar disorder quit smoking.

the study consist of two separate phases. phase i consists of website usability testing. investigators will collect feedback and incorporate the feedback into our website that is tailored for people with bipolar disorder. in phase ii investigators will be comparing quit rates of two groups both utilizing nicotine replacement therapy and a website.

Eligibility criteria:
inclusion criteria: 1. age 18 or older 2. daily smoker for the past year, averaging at least 5 cigarettes per day for the past 30 days, with expired-air carbon monoxide (co) level ≥ 4 ppm 3. motivated to quit smoking (i.e., endorse plans to quit in the next 30 days at the time of phone pre-screening) 4. meets lifetime criteria for bipolar i or ii disorder, based on dsm-v criteria 5. willing to be randomly assigned to either treatment group 6. has at least weekly access to a high-speed internet connection via a tablet, laptop or desktop computer 7. willing and able to read in english 8. is under care of a clinician for the treatment of bipolar disorder 9. willing to authorize communication with the clinician regarding study participation and clinical deterioration 10. willing to use the nicotine patch to help quit smoking exclusion criteria: 1. participating in other smoking cessation interventions 2. currently using any pharmacotherapies for smoking cessation 3. previous use of the smokefree.gov website 4. meets dsm-v criteria for current mania 5. meets dsm-v criteria for a current major depressive episode and symptoms are currently severe (patient health questionnaire-9 score \> 14) 6. current psychotic symptoms 7. psychiatric hospitalization within one month prior to enrollment 8. current suicidal or homicidal ideation 9. meets criteria for a dsm-v diagnosis of a moderate or severe substance use disorder in past month prior to enrollment 10. unstable medical condition 11. any medical or psychiatric condition that, in the opinion of the investigator, is severe enough to interfere with protocol adherence or ability to benefit from the intervention 12. any medical conditions that would preclude use of the nicotine patch (e.g., recent myocardial infarction, significant skin disorder, previous severe adverse reaction to nicotine patch, pregnant or breast feeding, assessed with our standard protocol for determining nrt eligibility) 13. employee or family member of the investigator or study center, or member of the same household as another research participant

Keywords: smoking cessation acceptance & commitment therapy cognitive behavioral therapy bipolar disorder
neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma

Conditions: Lung Cancer

Summary: the prognosis of patients with unresectable, locally advanced non-small cell lung cancer (nsclc) is poor. chemoradiotherapy is the main treatment modality for this disease. the newer drug regimens can be expected to improve survival in this subset of nsclc patients. modern targeted therapies have enhanced the outcomes of lung cancer treatment, especially for advanced nsclc. among the targeted approaches for the inhibition of angiogenesis is bevacizumab, a monoclonal antibody that represses vascular endothelial growth factor (vegf). bevacizumab in combination with platinum-based chemotherapy used as neoadjuvant chemotherapy may change the previous treatment modality. it allows some lung cancer patients to be downstaged to surgery rather than radiotherapy. thus, survival of these patients may be improved.

this trial investigates the role of neoadjuvant pemetrexed, carboplatin and bevacizumab in unresectable, locally advanced lung adenocarcinoma.

Eligibility criteria:
inclusion criteria: * histologically confirmed unresectable, locally advanced (iii a (bulky n2), iii b) lung adenocarcinoma * no previous chemotherapy, radiotherapy, surgery or biological therapy for lung cancer * adequate organ and bone marrow function exclusion criteria: * prior chemotherapy or radiation therapy for nsclc * prior treatment with bevacizumab or other agents specifically targeting vascular endothelial growth factor (vegf) * patients with known hypersensitivity to other recombinant human antibodies * history of stroke or transient ischemic attack (tia). * history of myocardial infarction or unstable angina within the past 12 months. * other serious illness or medical condition including unstable cardiac disease requiring treatment, history of significant neurologic or psychiatric disorders (including psychotic disorders, dementia, or seizures), symptomatic diverticulitis, or active uncontrolled infection. * women who are pregnant or breast-feeding

Keywords: lung cancer lung adenocarcinoma bevacizumab adjuvant chemotherapy surgical resection rate safety feasibility
respectful caring for the agitated elderly

Conditions: Dementia

Summary: the treatment of behavioural and psychological symptoms of dementia (bpsd) continue to raise difficult problems. both the pharmacologic and non-pharmacologic therapies often fail to achieve the expected results. the aim of this study is to assess the short- and long-term efficacy of an intervention, the special care unit for patients with bpsd (scu-b), already implemented in some countries but not validated so far, as well as its cost-effectiveness

two cohorts of 250 patients each will be recruited by six clinical centres endowed with a scu-b (one cohort) and six centres lacking this structure. the follow-up will last 3 years, during which patients will be visited every 6 months and submitted to a battery exploring the severity of the bpsd and the quality of life. all adverse events will be registered, as well as some anticipated occurrences (admissions to the general hospital for intercurrent diseases, admissions to a scu-b pertaining to the clinical participating centre and, if any, admissions to a scu-b not pertaining to the consortium member, nursing home placement). at the same time the quality of life of the primary caregivers will be measured, as well as their attitude toward dementia. a cost-effectiveness analysis will be performed comparing the cohorts. finally the time to the nursing home placement will be recorded and compared between the two cohorts

Eligibility criteria:
inclusion criteria: * diagnosis of primary dementia (dsm iv) * mmse score ≤ 24 * npi global score ≥ 32/144 * a caregiver (informal/family member or formal caregiver) who commits her/himself to accompany the patient along the three-year course of the study * living at home (nursing home residents are excluded). exclusion criteria: * presence of uncontrolled medical disease potentially contributing to the cognitive decline and bpsd * concomitant psychiatric disorders or chronic alcoholism * concomitant diseases severe enough to reduce life expectancy \< 6 months

Keywords: psychiatric aspects
feasibility study on a nordic lifestyle intervention trial among men with prostate cancer

Conditions: Prostate Cancer

Summary: purpose: to evaluate the feasibility of a future nordic intervention trial, including vigorous activity and a high intake of whole grain rye, among prostate cancer patients on active surveillance. additionally, to investigate effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among prostate cancer patients on active surveillance.

in the present feasibility study it will be established whether it is possible to enroll participants for this particular kind of intervention among this particular patient group, and if compliance with the intervention is possible to gain by the tools planned: individual counselling with a dietician and a physiologist, interviews on diet, exercise tests and diaries on diet, exercise and steps taken. furthermore, the investigators will investigate if we are able to detect effects of the lifestyle intervention according to cancer progression, the metabolic profile, inflammation and quality of life among the participants (24 men) within the short intervention period (6 months) for this particular feasibility study. biomarkers of effect and compliance are measured in blood, urine and prostate tissue samples. metabolomics and the following biomarkers are measured in blood and urine samples: alkyl resorcinols, enterolactone, tnf receptor 2, e-selectin. icam1, il1-alpha, il6, triglycerides, hdl/ldl, s-insulin, hba1c, c-peptide, crp, igf1, glp1, cholesterol, cathepsin and glucose.

Eligibility criteria:
inclusion criteria: * biopsy proven prostate cancer within 2 years prior to enrolment * psa ≤ 10 ng/ml, gleason-score ≤ 6, clinical localized prostate cancer ≤ ct2a or psa ≤ 10 ng/ml, gleason-score ≤ 7, clinical localized prostate cancer ≤ ct2a. * maximum 1/5 tumor positive biopsy rate * on active surveillance (elected to forgo treatment) * level of testosterone normal in sera exclusion criteria: * prior history of cancer, except for non-melanoma skin cancer, unless considered cured without signs of treatment failure for at least five years * less than 10 years of life expectancy * conditions or behaviors likely to affect the capability of participating fully in the intervention * moderate to severe co-morbidity (kidney, liver, heart or respiratory problems) or the general physical constitution * gluten intolerance * inflammatory bowel disease (e.g. crohn, colitis) * physical handicaps

Keywords: prostate cancer progression active surveillance whole grain rye exercise insulin sensitivity quality of life