Kornimate/medical-research-clean huggingface dataset:
safety and effectiveness study of imiquimod creams for treatment of actinic keratoses (aks)

Conditions: Actinic Keratoses

Summary: the purpose of this study is to determine whether imiquimod creams are effective in treating actinic keratoses when applied to the face or balding scalp. actinic keratosis (ak) is a skin condition that shows up on skin routinely exposed to the sun, such as the face, scalp, shoulders, chest, back, arms, and hands. the active ingredient contained in the study cream for this study is the same as that of the approved product aldara, which has been shown to be safe and effective for the treatment of aks.

this was a randomized, double-blind, multicenter, placebo-controlled study that compared the efficacy and safety of 2.5% imiquimod cream and 3.75% imiquimod cream with that of placebo in the treatment of typical visible or palpable aks of the face or balding scalp. subjects were scheduled for a total of 9 visits (1 prestudy screening visit and 8 on-study visits). subjects determined to be eligible during the screening phase were randomized in a 1:1:1 ratio to 2.5% imiquimod cream, 3.75% imiquimod cream, or placebo cream. the creams were applied daily for 2 treatment cycles. the first treatment cycle consisted of 2 weeks of daily treatment followed by 2 weeks of no treatment, and the second treatment cycle consisted of an additional 2 weeks of daily treatment followed by 8 weeks of no treatment. the investigator selected the treatment area for the study (either the entire face or the entire balding scalp, but not both). subjects applied a thin layer of cream to the treatment area (up to 2 packets, or 500 mg of product, per application), avoiding the periocular areas, lips, and nares. study medication was applied prior to normal sleeping hours and removed approximately 8 hours later with mild soap and water. ears were excluded from both assessment and treatment. rest periods from daily treatment were instituted by the investigator as needed to manage local skin reactions (lsrs) or application site reactions, with resumption of treatment upon adequate resolution as determined by the investigator. the duration of each subject's study participation was approximately 18 weeks, including a 4-week maximum screening period and a 14-week study period.

Eligibility criteria:
inclusion criteria: * in good general health * have 5 to 20 aks on the face or balding scalp * negative urine pregnancy test (for women who are able to become pregnant) * willing to make frequent visits to the study center during treatment and follow-up periods. exclusion criteria: * women who are pregnant, lactating or planning to become pregnant during the study. * have had a medical event within 90 days of the first visit (such as; stroke, heart attack). * have any skin condition in the treatment area that may be made worse by treatment with imiquimod (e.g., rosacea, psoriasis, atopic dermatitis, eczema). * have received specific treatments/medications in the treatment area(s) within the designated time period prior to study treatment initiation.

Keywords: actinic keratosis skin disease
inhaled nitric oxide (ino) for congenital diaphragmatic hernia (cdh) - the "nono trial" - a multi-center, de-implementation, stepped-wedge, cluster-randomized trial within an established collaborative

Conditions: Congenital Diaphragmatic Hernia

Summary: the purpose of this study is to determine if deimplementation of ino in the post-natal resuscitation/stabilization phase affects the composite outcome of ecls use and/or mortality, as well as ecls use, mortality, and/or oxygenation in cdh newborns and to establish the cost-effectiveness of deimplementing ino as a therapy in the postnatal resuscitation/stabilization phase of cdh management, which will be assessed as the incremental health system costs (savings) per prevented ecls use and/or death.

in this multi-center study, centers will use ino per their usual protocol, and centers will then crossover to ino de-implementation (that is, at the time of crossover, centers will stop using ino in the initial resuscitation period). a stepped-wedge crossover study design will be used, and the timing of crossover will be cluster randomized at the level of the center.

Eligibility criteria:
inclusion criteria: * postnatal, live born neonates with cdh a. presence of associated or additional anomalies is acceptable for inclusion * bochdalek hernia location (right or left) * diagnosed prior to 1 month of life * born within or transferred to (within 1 week of life) a cdhsg member center participating in the trial exclusion criteria: * cdh diagnosis after 1 month of age * morgagni diaphragmatic hernia (central / anterior-medial diaphragmatic defect location) * transferred to a cdh study group (cdhsg) member center after 1 week of life * patients without potential access to ino

Keywords: cdh inhaled nitric oxide pulmonary hypertension
residual symptoms and the quality of life in individuals recovered from covid-19 infection: a survey from pakistan

Conditions: COVID-19 Pandemic; COVID-19 Respiratory Infection; COVID-19 Lower Respiratory Infection

Summary: there remains scarcity of literature regarding the patient's health status post-covid-19 infection. this study analyzes the prevalence of residual symptoms and quality of life (qol) after covid-19.

an anonymous online survey was administrated in pakistan from november 2020 to april 2021 in covid-19 survivors. the questionnaire used the 12-item short form health survey (sf-12) to assess mental and physical qol. multivariate linear regression was used to explore factors associated with mental and physical qol scores. a total of 331 covid-19 survivors participated in our survey. around 42.0% of the cohort reported within 1-3 months of diagnosis of covid-19. the common residual symptoms were body aches (39.9%), low mood (32.6%), and cough (30.2%). better physical qol was associated with being male (adjusted beta: 3.328) and having no residual symptoms (6.955). however, suffering from nausea/vomiting during initial covid-19 infection (-4.026), being admitted to the icu during covid-19 infection (-9.164), and suffering from residual body aches (-5.209) and low mood (-2.959) was associated with poorer qol. better mental qol was associated with being asymptomatic during initial covid-19 infection (6.149) and post-covid (6.685), while experiencing low mood post-covid was associated with poorer mental qol (-8.253 \[-10.914, -5.592\]). despite presumed "recovery" from covid-19, patients still face a wide range of residual symptoms months after initial infection, which contributes towards poorer qol. healthcare professionals must remain alert to the long-lasting effects of covid-19 infection and aim to address them appropriately to improve patients' qol.

Eligibility criteria:
inclusion criteria: * tested negative for covid-19 when enrolled in the study * covid-19 negative for at least 6 months exclusion criteria: * still positive for covid-19 tested one week ago * covid-19 negative for less than 6 months

Keywords: covid-19 residual symptoms quality of life
drug interaction study

Conditions: Antivirals/HIV

Summary: the purpose of this study is to evaluate the exposure of rifabutin (rib) when administered with atazanavir and ritonavir (atv/rtv)


Eligibility criteria:
inclusion criteria: * healthy male and female subjects between the ages of 18 to 50 years old with a body mass index (bmi) of 18 to 32 kg/m² * prior to enrollment, subjects must have physical and laboratory test findings within the normal limits, and women of childbearing potential (wocbp) must have a negative pregnancy test exclusion criteria: * any significant acute or chronic medical illness * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, electrocardiogram (ecg) or clinical laboratory determinations * use of any prescription drugs or over-the-counter acid controllers within 4 weeks prior to study drug administration * use of any other drugs, including over-the-counter medications of herbal preparations within 1 week prior to study drug administration
musculoskeletal pain of neck and shoulder area in female office workers: relations between muscle tone, stiffness, pain-pressure threshold, self-reported pain intensity and physical activity.

Conditions: Musculoskeletal Pain; Neck Pain; Shoulder Pain

Summary: the objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity in female office workers. 50-100 participants aged 20-60 are anticipated.

the objective of this study is to determine the differences between neck and shoulder region skeletal muscle tone, stifness, pain-pressure threshold, self-reported pain intensity and physical activity. participants: 50-100 subjects, all female, aged 20-60 are anticipated. methods: skeletal muscle tone and stiffness are measured using myotonometry. pain-pressure threshold is measured using algometry. prevalence of neck and shoulder area musculoskeletal pain is recorded using nordic questionnaire. self-reported pain intensity is measured using vas scale. self-reported physical activity is recorded using baecke physical activity questionnaire.

Eligibility criteria:
inclusion criteria: * office work (at least 4 day per week, 8 hours a day with over 50% working with a computer) exclusion criteria: * prior neck trauma, neurological or oncological conditions, recent use of muscle relaxants or painkillers, obesity (bmi of \>30)

Keywords: musculoskeletal pain muscle tone muscle stiffness pain-pressure threshold neck shoulder office work
unipolar or bipolar hemiarthroplasty in the treatment of displaced femoral neck fractures.

Conditions: Hip Fractures

Summary: hemiarthroplasty of the hip is standard treatment of femoral neck fractures (hip fractures). hemiarthroplasty means replacing the hip joint with a metal prosthesis. unipolar prostheses has a one-piece design where the hip movement occurs between the prosthesis and the acetabulum (hip socket). a bipolar prosthesis has an additional artificial joint between the two components of the prosthesis. both treatments are clinically proven and common around the world. no clinical trial has proven benefits of one or the other prosthesis design. the investigators want to measure the differences in acetabular wear using these two prostheses, using radiostereometric measurements.

patients 70 years or older presenting to our hospital with an acute femoral neck fracture are eligible for inclusion. 15 patients in each group will be recruited. one group receives a unipolar hemiarthroplasty and 15 receives a bipolar arthroplasty. tantalum markers are placed around the acetabulum during surgery. follow-up intervals are at 3, 12 and 24 months with radiostereometric evaluation (radiographs) and clinical evaluation.

Eligibility criteria:
inclusion criteria: * displaced femoral neck fracture * 70 years or older * ambulatory status: no walking aids * no mental illness or impaired cognitive function exclusion criteria: * pathological fracture (malignant disease) * ongoing systemic or local infection * radiologically presence of acetabular wear (osteoarthrosis)

Keywords: hip fracture femoral neck hemiarthroplasty bipolar unipolar displaced femoral neck fractures
efficacy, tolerability, and safety study of dfn-15

Conditions: Migraine Headache

Summary: efficacy, tolerability, and safety of dfn-15 in episodic migraine with or without aura, being conducted at multiple centers in the united states.


Eligibility criteria:
inclusion criteria: 1. a history of episodic migraine, who experience 2 to 8 migraine attacks per month for at least the past 12 months, with no more than 14 headache days per month, and with 48 hours of headache-free time between migraine attacks. 2. patients who have migraine with or without aura with onset before age 50 years 3. report usual migraine pain of 2 (moderate) or 3 (severe) on headache pain severity scale without treatment. 4. subjects who are willing and able to: 1. evaluate and record pain, migraine symptoms, and study drug effectiveness information in real-time using a subject ediary for the duration of the study; 2. record each instance of the use of study drug and rescue medication in real-time using a subject ediary for the duration of the study; 3. comply with all other study procedures and scheduling requirements. exclusion criteria: 1. minors, even if they are in the specified study age range 2. medication overuse: 1. opioids greater than or equal to 10 days during the 90 days prior to screening 2. combination medications (e.g., fiorinal®) greater than or equal to 10 days during the 90 days prior to screening (applies only if includes opioid and/or barbiturate) 3. nonsteroidal anti-inflammatory drugs or other simple medications greater than 14 days a month during the 90 days prior to screening 4. triptans or ergots greater than or equal to 10 days a month during the 90 days prior to screening 3. treated with onabotulinumtoxin a (botox®) for migraine within 4 months prior to screening. (if treated for cosmetic reasons, subjects may be included). 4. current treatment with antipsychotics or use of antipsychotics within 30 days prior to randomization. 5. patients who have received treatment with an investigational drug or device within 30 days of randomization, or participated in a central nervous system clinical trial within 2 months prior to randomization 6. patients with positive screening test for human immunodeficiency virus \[hiv\], positive hepatitis b surface antigen (hbsag), or positive hepatitis c virus \[hcv\] antibody 7. subjects who are employees or immediate relatives of the employees of the sponsor, any of its affiliates or partners, or of the clinical research study site.
imaging biomarkers of progression of mobility impairment in parkinson disease

Conditions: Parkinson's Disease

Summary: the purpose of this research is to evaluate changes in cholinergic brain activity over time in subjects with parkinson disease.

the project will apply positron emission tomography (pet) of acetylcholinesterase to study non-dopaminergic (i.e. cholinergic) brain changes over time in subjects with parkinson disease. acetylcholinesterase pet imaging was used to assess cholinergic changes over time in this study. acetylcholinesterase pet imaging is a diagnostic test as the investigator does not assign specific interventions to the subjects of the study based on the acetylcholinesterase pet. therefore, this is an observational study as defined as following: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Eligibility criteria:
inclusion criteria: * patients who meet the uk parkinson's disease society brain bank research center clinical diagnostic criteria for pd. * hoehn and yahr stages 1-2.5 at initial recruitment in baseline study. * absence of dementia confirmed by neuropsychological testing at initial recruitment in baseline study. exclusion criteria: * contra-indication for magnetic resonance study * pregnancy or breastfeeding

Keywords: pet acetylcholine
the validation and development of termination-of-resuscitation (tor) rules in ohca patients in asia countries

Conditions: Out-Of-Hospital Cardiac Arrest

Summary: objectives/hypotheses 1. prehospital termination-of-resuscitation (tor) rules were developed in north american and european sites. whether they remained valid in different geographic, ethnic, and cultural background areas is still under debate. 2. differences in characteristics of out-of-hospital cardiac arrests (ohcas) and configurations of emergency medical service (ems) between the western and asian countries, including relatively lower rate of presenting shockable rhythm (i.e. ventricular fibrillation / ventricular tachycardia; vf/vt), lower rates of bystander cpr, less advanced life support (als) implementation, and less public access defibrillators, might create potential threats to the prediction accuracy of tor rules. 3. we aim to conduct a study to validate the performance of ever published tor rules in asian ohca population, including non-traumatic, traumatic, and pediatric ohca patients. furthermore, assess the possible variables that may impact the performance of tor rules. 4. we also aim to develop new tor rules based on paros registry for asia population, focusing on non-traumatic, traumatic, and pediatric ohca patients, respectively.


Eligibility criteria:
inclusion criteria: * out of hospital cardiac arrest (ohca) patients exclusion criteria: * age \<18 years * non-ems transport to the emergency department * obvious signs of death (e.g. decapitation, rigor mortis, lividity, and decapitation) or having do-not-resuscitate (dnr) orders * missing data despite meeting the inclusion criteria.

Keywords: out-of-hospital cardiac arrest ohca
comparative study of microrna changes in patients with reactive lymphoid hyperplasia and malignant lymphoma

Conditions: Lymphoma; Hyperplasia Lymphoid Reactive

Summary: the objectives are to: 1. validate a panel of tissue-specific mirnas that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma. 2. investigate the physiological range of the mirna panel in lymphoma and reactive hyperplasia subjects. 3. investigate the dysregulation of mirna panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia. the objectives are to: 1. validate a panel of tissue-specific mirnas that are differentially expressed in the tissue of patients with and without reactive hyperplasia and lymphoma. 2. investigate the physiological range of the mirna panel in lymphoma and reactive hyperplasia subjects. 3. investigate the dysregulation of mirna panel and their prognostic and predictive values in clinical outcomes to identifying patients with malignant lymphoma or reactive hyperplasia. this trial involves tissue samples diagnosed as lymphoma and reactive hyperplasia. the investigators will develop panels of mirnas that are specific biomarkers of lymphoma, and assist clinical outcomes with these mirnas.


Eligibility criteria:
inclusion criteria: * adults 18 years and above * has condition related to lymphoma or reactive lymphoid hyperplasia exclusion criteria: * age below 18 years * known pregnancy * lymph tissue cannot be accessed

Keywords: mirna biomarker
influence of the covid-19 pandemic on stress of occupational health workers

Conditions: Occupational Health

Summary: coronavirus has caused containment of more than half of the world's population and a major and rapid reorganization of clinical and support services. the spread of coronavirus (covid-19) has posed significant challenges for occupational health services. however, there is currently no data on the influence of this epidemic on the practice and feelings of dental surgeons and associates

this is an observational study by redcap questionnaire® via an internet link, which will be distributed to occupational health workers by any means the self-survey will assess stress, working conditions and changes in practices related to the coronavirus outbreak. this questionnaire includes 39 questions.

Eligibility criteria:
inclusion criteria: * all volunteers who are screened exclusion criteria: * none

Keywords: covid-19 occupational health stress
frequence of dressing change and bacterial colonization in pediatric intensive care unit

Conditions: Bacterial Infections

Summary: this study is non-inferiority trial design.the relationship between whether dressing change 24hrs after cvc (central venous catheter) catheterization and bacterial colonization of the skin.

central venous catheter (cvc) was punctured directly through jugular vein, subclavian vein and femoral vein, and its tip is located in superior vena cava or inferior vena cava. cvc is widely used in icu because of its kinds of advantages. however, cvc, as an invasive puncture method, may bring more complications. the incidence of central line associated bloodstream infection (clabsi) was 1.33-31.6/1000 catheterization day , and the death rate due to cvc associated bloodstream infection is 3-5% . therefore, various organizations have formulated guidelines for the prevention of clabsi and best evidence summary . from october 2019 to april 2020, taking the children's hospital of fudan university as the leading unit, picu of children's hospital affiliated to zhejiang university, anhui children's hospital, xiamen children's hospital, shenzhen children's hospital and guangzhou women's and children's medical center as the cooperation units, carried out children's central venous catheterization multi center research on best practices of management and maintenance. it was found that changing dressings 24 hours after catheterization may increase the incidence of marsi, and repeatedly exposing dressings may also increase the incidence of clabsi. the research team returned to the original evidence and consulted the guidelines. it was found that: under the premise of achieving the maximum aseptic catheterization, the guidelines issued by various institutions did not mention that the application should be replaced 24 hours after catheterization; however, the evidence was mentioned in the evidence summary, but there was no support from the relevant original literature. therefore, it is worth discussing whether children need to change dressings 24 hours after catheterization. this study is non-inferiority trial design.

Eligibility criteria:
inclusion criteria: * cvc catheter was placed in the research site (including the operating room and picu); * only one cvc catheter was placed during the research time exclusion criteria: * catheter was inserted from another hospital and in emergency; * the tip of cvc catheter was not in the upper and lower vena cava; * children had history of clabsi before the study

Keywords: central venous access device dressing bacterial colonization medical adhesive-related skin injury