Kornimate/medical-research-clean huggingface dataset:
efficacy and safety study of a steroid/antibiotic combination eyedrop to treat non-bacterial blepharitis

Conditions: Blepharitis

Summary: the purpose of this study is to evaluate the clinical efficacy and safety of isv-502 compared to azasite® alone, dexamethasone alone, and vehicle in the treatment of subjects with non-bacterial blepharitis.


Eligibility criteria:
inclusion criteria: * are at least 18 years of age at visit 1 (day 1, baseline) of either sex and any race. * signature of the subject or legally authorized representative on the informed consent form. * are willing and able to follow all instructions and attend all study visits. * are willing to avoid disallowed medication for the duration of the study. * if female is of childbearing potential, agree to and submit a urine sample for pregnancy testing. post menopausal is defined as having no menses for at least 12 consecutive months. * additional inclusion criteria also apply. exclusion criteria: * have known sensitivity or poor tolerance to any component of the investigational drug. * have an acute ocular infection (bacterial, viral or fungal) or active ocular inflammation other than blepharitis in the study eye. * have used topical corticosteroid medications or topical ophthalmic solutions that the investigator feels may interfere with the study parameters. * have used any non-diagnostic topical ophthalmic solutions in the study eye. * be currently pregnant, nursing, or planning a pregnancy; or be a woman that has a positive urine pregnancy test. * currently suffer from alcohol and/or drug abuse. * have prior (within 30 days of beginning dosing) or anticipated concurrent use of an investigational drug or device. * have a condition or a situation which, in the investigator's opinion, may put the subject at increased risk, confound study data, or interfere significantly with the subject's study participation. * additional exclusion criteria also apply.
molar: mapping oral health and local area resources

Conditions: Dental Diseases

Summary: the goal of this clinical trial is to test the impact of a screening and linkage intervention for adverse social determinants of health (asdoh) on oral health linkage to care for emergency department patients. researchers will compare three groups: patients in arm a will receive paper handouts with general oral health and asdoh resources. patients in arm b will receive paper handouts with geographically-proximate oral health and asdoh resources. patients in arm c will receive geographically-proximate oral health and asdoh resources plus active navigational assistance.


Eligibility criteria:
inclusion criteria: * to be eligible to participate in this study, an individual must meet all of the following criteria: * no evidence of lack of capacity to provide verbal informed consent (as documented in the chart). * willing to comply with all study procedures and be available by phone for the duration of the study (as reported by the patient) * unmet oral health needs as ascertained by the hope home (adult) or gazzaz (pediatric) questions * adult (age ≥18 years old) ed patient or pediatric ed patient (\>1 year of age) presenting with parent or legal guardian. parent will be the primary study participant but if age \> 7 years, the child will provide assent for medical record review. * ability to communicate in english or spanish (as reported by the patient) * emergency severity index (esi) 2-5 (as documented in the electronic medical record) * residence within catchment area of 3-hospital region (defined by mgb home hospital catchment area) at initial enrollment (as reported by the patient) * working phone number exclusion criteria: * patients on involuntary holds (per electronic medical record review) * presenting from carceral facilities (per electronic medical record review) * presenting for acute mental health care under evaluation for section 12 (per electronic medical record review) * patients presenting for assistance with intimate partner violence (ipv) or care following sexual assault
long-term follow-up of the helsinki businessmen study

Conditions: Quality of Life; Syndromes; Aging; Cardiovascular Disease; Death

Summary: the helsinki businessmen study (hbs) is a clinico-epidemiological longitudinal study started in 1964. it also included a 5-year randomized, controlled multifactorial primary prevention trial of cardiovascular diseases between 1974-1980. the cohort is being actively followed-up through national registers since the 1980, and since 2000 with regular questionnaire surveys. latest in 2015. also clinical and laboratory studies have been performed in random subcohorts. follow-up is ongoing with new hypothesis-generating research questions.

the helsinki businessmen study (hbs) was originally a convenient cohort of male executives and businessmen (born 1919-1934, n=3490), who participated in health check-ups between 1964-1973, but since the beginning of 1970s it has developed into a clinico-epidemiological longitudinal study. primary focus was on the prevention of cardiovascular diseases (cvd), but since 2000 focus has been shifting to geriatrics, and with its long follow-up (up to 50 years) hbs can be seen as a "life-course" study. traditional cvd risk factors are available from the 1960s and in 1974 participants (available n=3310) were divided in groups according to their clinical status and cvd risk. two high-risk groups (n=1222) and low-risk group (n=593) participated in a 5-year multifactorial primary prevention study in 1974-1980 (in-trial and post-trial results have been published in 1985 and 1991). the whole original cohort has been followed-up from national registers since 1985 and with regular questionnaire surveys since 2000. random subcohorts have been studied clinically with laboratory and genetic examinations in 2003 and 2011. the latest questionnaire survey was performed in winter 2015 by which two thirds of the original cohort had died. follow-up of the cohort is ongoing and new research questions formulated..

Eligibility criteria:
inclusion criteria: * participants of director studies at the institute of occupational health in helsinki, finland, between 1964-1973 exclusion criteria: * non-participants

Keywords: cardiovascular disease frailty quality of life mortality prevention
the evaluation of immunogenicity and safety of nbp608 in healthy children 12 months to 12 years of age

Conditions: Varicella

Summary: this study evaluates the immunogenicity and safety of three different potencies of nbp608 and varivax which are indicated for active immunization for the prevention of varicella. total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned.

this is a multi-center, randomized, double blinded, active controlled, parallel-group study to evaluate the immunogenicity and safety of three different potencies of nbp608(low, middle, high potency) and varivax which are indicated for active immunization for the prevention of varicella. total of 152 subjects (38 subjects per each treatment arm) of 12 months to 12 years of age are enrolled, and each subject is administered with single dose of vaccine which is randomly assigned in 1:1:1:1 ratio. stratified randomization for age group is used to achieve the balance of treatment assignment within age strata. total of four visits are scheduled including two visits via telephone contact. blood sampling is conducted for immunogenicity assessment before and 6 weeks after vaccination at visit 1 and visit 3 respectively. safety is monitored 1 week, 6 weeks and 26 weeks after vaccination through visit 2\*, visit 3 and visit 4\* (\*telephone contact)

Eligibility criteria:
inclusion criteria: * healthy children aged between 12 months and 12 years old who are available for the follow-up during the study period * after menarche females who are confirmed to be negative in a pregnancy test on the day of vaccination and agree to practice birth control for 3 months after the vaccination exclusion criteria: * those with hypersensitivity to any component of the ips(investigational products), such as gelatin or neomycin * those who have received a varicella vaccine previously * those with a history of hypersensitivity to vaccination, such as guillain-barre syndrome * those with congenital or acquired immunodeficiency * those with active untreated tuberculosis * those who have received or are expected to receive salicylates from 14 days prior to ip(investigational product) vaccination to visit 3 * those who have received or are expected to receive other vaccines from 1 month prior to ip(investigational product) to visit 3 * those who have received or are expected to receive other ips(investigational products) in another clinical study from 1 month prior to ip(investigational product) vaccination to visit 3

Keywords: prevention of varicella varicella-zoster vaccine
feasibility of online based mindfulness interventions during covid-19 outbreak

Conditions: Stress

Summary: the investigators had designed weekly mindfulness sessions (details see intervention below), which is free-of-charge and will be made available to general public who feel distressed during the outbreak of covid-19. face-to-face delivery of mindfulness interventions was not possible due to mandatory quarantine. the investigators hypothesize that this intervention is feasible and acceptable by the participants. as secondary outcomes, the investigators also hypothesize that the intervention can reduce stress, depressive and anxiety symptoms and enhance participants' sense of coherence this will be a quasi-experimental study. participants will be invited to fill in an online informed consent and questionnaire around 2 days before each mindfulness online session and another set of questionnaire immediately after each session (see outcome measures). participants will be identified by their e-mail and therefore serial data could be obtained.


Eligibility criteria:
inclusion criteria: * at least 18 years of old, * able to speak and communicate in cantonese * can read chinese or english (because they will be asked to fill in an online questionnaire). exclusion criteria: * actively suicidal, * currently abusing restricted psychoactive substances * diagnosed to have an active psychotic disorder and self-reported active psychotic symptoms (including schizophrenia, bipolar disorder and dementia).
determinants of bone dimensional changes after extraction and alveolar ridge preservation

Conditions: Alveolar Bone Grafting; Bone Healing; Tooth Extraction Site Healing; Wound Healing

Summary: the main purpose of the study is to measure and localize immediate post extraction changes i.e. socket expansion versus no width change along the socket wall and identify whether the immediate post-extraction ridge width condition (expansion or no change) is a determinant of buccolingual ridge width and height changes 4 months following extraction and ridge preservation.

the null hypothesis for this study is that there is no difference in bone ridge width and height changes 4 months following extraction and alveolar ridge preservation at sites that undergo immediate post-extraction socket expansion or no immediate post-extraction ridge width change. patients of the graduate periodontics clinic at marquette university school of dentistry scheduled for extraction, bone graft and resorbable membrane will be recruited for this study. after providing informed consent and prior to local anesthesia and extraction, the following parameters will be recorded: age, gender, race, medical history, medications, tooth site, reason for extraction and tooth mobility. gingival width will be recorded prior to local anesthesia and extraction, and at 4 months. gingival thickness will be recorded after local anesthesia and prior to extraction, and at 4 months. buccolingual ridge width and ridge height will be recorded immediately before, immediately after extraction, and at 4 months. immediately after extraction, the following measurements will be recorded: buccal bone thickness, number of roots, root length and width, instruments used for extraction, need for flap elevation, duration of extraction, anesthetic amount, type and approach, and operator experience.

Eligibility criteria:
inclusion criteria: * adult patients (18-75 years) * good general health (controlled conditions) * controlled periodontal disease * scheduled for single tooth extraction with bone graft placement and resorbable membrane * tooth to be extracted must have adjacent teeth * socket wall integrity exclusion criteria: * smoking * pregnancy * active periodontal disease * systemic conditions that affect healing * lack of socket wall integrity (bone loss ≥50 %) prior to extraction, teeth with severe infection requiring pre-extraction antibiotic treatment to control infection), and contraindications for tooth extraction.
pediatric and caregiver traumatic stress intervention (pacts)

Conditions: Traumatic Injury

Summary: the purpose of this study is to learn more about how to help the caregiver and child survivor of a traumatic injury handle post-traumatic stress disorder and/or depression.

this study is a trial to determine if a caregiver-child dyadic screening and caregiver intervention with pediatric trauma patients reduces traumatic stress symptoms in both child and caregiver, and depressive symptoms in caregivers compared to the current standard of care. the purpose of the pacts intervention is to identify and address the needs of the caregiver and the child survivor who are at-risk for developing post-traumatic stress disorder and/or depression following traumatic injury of the child.

Eligibility criteria:
inclusion criteria: * child requires inpatient treatment for an unintentional injury (e.g. burns, dog bite, road traffic accident) in the pediatric trauma and/or pediatric burns units * english-speaking adults, with english denoted as the primary language in the electronic medical record (emr) * caregiver-child dyads who screen positive with the peritraumatic distress inventory (pdi) tools will be invited to participate in the randomized controlled trial. exclusion criteria: * patients and/or caregivers with cognitive deficits, with psychotic symptoms, refusing treatment, and leaving the hospital against medical advice (ama) were unable to participate in counseling interventions by condition or by choice and are excluded from the study population

Keywords: posttraumatic stress disorder depression pediatric injury
contrast enhanced mri of the prostate

Conditions: Prostatic Neoplasms

Summary: prostate cancer detection and disease progression monitoring relies on systematic multi-core biopsies. minimal invasive imaging capacities for lesion targeting and monitoring are badly needed. the purpose of this study is to determine if a new mri technique can identify and monitor prostate disease progression. if so biopsy core number can be reduced to as small as one, and frequency for biopsy repeat can be reduced. the new technique is about a new way of analyzing the pictures taken as part of prostate mri exam. this part is called dynamic contrast-enhanced mri. it involves an injection of contrast reagent (or dye) through the arm vein during a time period when prostate mri pictures are continuously taken.

the aim of the study is to perform contrast-enhanced (ce) magnetic resonance imaging (mri) at ohsu on subjects with diagnosed prostate cancer. this pilot project will study 20 subjects prior to their next scheduled clinical procedures (biopsy or radical prostatectomy). data from this project will be used to explore new capabilities of the software platform developed under current sbir funding. ce-mri will involve the use of an extracellular (gadolinium based, gd) contrast agent. when gd is used, (dynamic-contrast-enhanced) dce-mri signal intensity time-course data will be analyzed analytically using the so called "shutter-speed" paradigm which takes into account of the effects of finite water exchange kinetics. region of interest (roi) and high resolution (\~millimeter) parametric maps of pathophysiologic quantities, such as tumor vessel permeability, tumor perfusion, extracellular extravascular volume fraction, will be generated from the dce-mri data. all parameters will be compared to literature results for software validation and correlated with pathology for clinical potential.

Eligibility criteria:
inclusion criteria: * men, age \>18 years. * any patient scheduled for prostate biopsy repeat or radical prostatectomy. * ability to understand and the willingness to sign a written informed consent document. exclusion criteria: * patients who would be normally excluded from undergoing an mri examination - patients with a pacemaker, aneurysm clip or any other condition that would warrant avoidance of a strong magnetic field. * patients who are unable to cooperate for an mri exam. * major surgery within a month of enrollment. * prostate biopsy six weeks prior to enrollment. * subject-reported reaction to gadolinium contrast reagent.
curcumin supplementation and patients with type 2 diabetes

Conditions: Non Insulin Dependent Diabetes

Summary: diabetes mellitus is the most common endocrine disorder, causes many complications such as micro- and macro-vascular diseases. various kinds of antidiabetic drugs have been developed, but most of them have side effects. recently, the use of natural plant products has gained more attention among scientists in order to prevent diabetic vascular complications. curcumin is a natural yellow product derived from the turmeric rhizome which has shown to be non-toxic and exhibits various bio¬logical activities such as anti-oxidant, anti-inflammatory, anti-carcinogenic, and anti-diabetic effects. curcumin is effective in reducing glycemic index and hyperlipidemia in rodent models and is relatively inexpensive and safe. most of the studies conducted on animal model, and just a few of them are on human model. the present study was planned to evaluate the effects of curcumin supplementation the effect of curcumin supplementation on anthropometric indices, insulin resistance and oxidative stress in patients with type 2 diabetes


Eligibility criteria:
insulin inclusion criteria: * a) tendency to participate b) age range of 40-65 c) suffering from diabetes type 2 ( between 1 to 10 yeares) d) bmi 18/5-30 e) patients with diabetes who administer oral hypoglycemic agents and do not use exclusion criteria: * a) patients with liver diseases b) patients with kidney diseases c) patients with inflammatory diseases d) patients with liver diseases e) administering herbal agents f) administering multivitamins and minerals in past 3 months
a randomized, double-blind, placebo-controlled study to evaluate sts101 in the acute treatment of migraine

Conditions: Migraine; Migraine With Aura; Migraine Without Aura

Summary: study sts101-002 is a randomized, double-blind, parallel group, placebo-controlled, multicenter study to evaluate the efficacy, safety, and tolerability of single doses of sts101 (dihydroergotamine nasal powder) in the acute treatment of migraine

the emerge trial is a multi-center, single-dose, randomized, double-blind, placebo-controlled, parallel group study in subjects with acute migraine (ages 18 to 65 years).

Eligibility criteria:
key inclusion criteria: * males or females, 18-65 years of age at the time of screening visit * subject has at least 1-year history of migraines (with or without aura), according to the international classification of headache disorder, 3rd edition (ichd3) exclusion criteria: * pregnant or breast-feeding women * women of child-bearing potential not using or not willing to use highly effective contraception. * diagnosis of headache conditions other than migraine with or without aura, including diagnosis of basilar or hemiplegic migraines or cluster headache. * history of coronary artery disease, coronary artery vasospasm (including printz-metals' angina), clinically significant arrhythmia or, peripheral vascular disease, ischemic disease (e.g. raynaud's syndrome, ischemic bowel syndrome, angina pectoris, myocardial infarction, or documented silent ischemia); percutaneous coronary intervention, or cardiac surgery. * history of cerebrovascular disease, including but not limited to stroke, transient ischemic attack, cerebral hemorrhage, subarachnoid hemorrhage. * diagnosis of major depression with current symptoms, psychosis, alcohol abuse or dependence, drug abuse or dependence, major psychiatric conditions (e.g. schizophrenia, psychosis or bipolar disorder), dementia. other significant neurological or psychiatric disorders (including other pain syndromes or risk of suicide) that in the opinion of the investigator might interfere with study participation and assessments or subject safety. * any clinically significant symptoms or conditions, including but not limited to central nervous system (e.g., seizures), cardiac, pulmonary, metabolic, renal, hepatic or gastrointestinal conditions or history of such conditions that, in the opinion of the investigator might interfere with study assessments or safety of participant.

Keywords: dihydroergotamine dihydroergotamine mesylate migraine
a study of pyrotinib plus vinorelbine in patients with brain metastases from her2-positive metastatic breast cancer

Conditions: Breast Cancer; Brain Metastases

Summary: pyrotinib is an oral tyrosine kinase inhibitor targeting both her1, her2 and her4 receptors. this study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from her2-positive metastatic breast cancer.


Eligibility criteria:
inclusion criteria: 1. age18-75 years. 2. ecog performance status ≤2. 3. histologically confirmed her2 positive advanced breast cancer. 4. prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). received ≤4 regimes in metastatic setting. prior to trastuzumab is allowed. 5. not received whole brain radiotherapy (wbrt) or recurrence after wbrt. 6. controlled cns symptoms (headache, dizziness, lethargy, nausea etc.). 7. patients with cns metastasis; at least one cns metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm; 8. signed the informed consent form prior to patient entry. exclusion criteria: 1. participated in other drug clinical trials within 4 weeks before the start of the study; 2. received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study; 3. received endocrine therapy within 7 days before the start of the study; 4. suitable for surgical resection; 5. accompanied by rapid progress of organ invasion; 6. factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.). 7. prior to pyrotinib or vinorelbine or anti-her2 tki drugs; 8. allergies to any compounds of experimental drugs; 9. cns disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia; 10. other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma. 11. any other situations judged by investigator as not suitable for participating in this study.

Keywords: breast cancer, brain metastases, pyrotinib, vinorelbine, her2