Kornimate/medical-research-clean huggingface dataset:
to evaluate the performance of total 30 (lehifilcon a) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.

Conditions: Eye Strain

Summary: to evaluate the performance of total 30® (lehfilcon a) contact lenses in patients using digital devices for greater than 8 hours per day 5 days per week based on subjective reported data.


Eligibility criteria:
inclusion criteria: * adult patients aged 18-40 of any sex and any race. * reports habitually using digital device usage (phone, ipad, computer, social media, video streaming) for 8 hours or more per day 5 days per week with plans to continue the habit throughout the study. * wearing contact lenses for at least 13 hours daily 5 days per week. * spherical refractive error between -11.00 d and +6.00d with \< -0.75 d of astigmatism. * willing to comply with the protocol instructions. * has read (or has had read to), understood, and signed an informed consent. * willing to not use any artificial tears, rewetting drops or dry eye treatments during the study. exclusion criteria: * active ocular infection or ocular inflammatory disease. * presbyopic or pre-presbyopic that have a measured add power for reading. * current total 30 contact lens wearer. * anterior basement membrane dystrophy or history of recurrent erosion syndrome or topographical abnormalities that might indicate ectasia or other corneal degenerative conditions. * current or previous diagnosis of dry eye disease; currently using a dry eye treatment including but not limited to artificial tears, rewetting drops or prescription treatments. * history of severe / serious ocular pathology or other medical conditions that could result in an inability to safely complete the study. * participation by the patient in any other investigational study within the past 30 days. * unlikely to comply with protocol instructions for any reason (confusion, substance abuse, etc.). the principal investigator or the medical monitor reserves the right to declare a patient ineligible based on medical evidence that indicates the patient is unsuitable for the study. * inability to utilize clear care cleaning solution. * pregnancy

Keywords: contact lenses digital devices eye comfort
efficacy evaluation and cutaneous acceptibility of a dermocosmetic product on subjects suffering of atopic dermatisis.

Conditions: Atopic Dermatitis; Eczema

Summary: atopic eczema is a chronic inflammatory skin disease, mainly affecting children, characterized by itching and flare-ups. it results from genetic and environmental factors, leading to immunological and cutaneous abnormalities. the aim of this study is to assess the efficacy of a product for atopic skin versus a placebo. primary objectives include assessing the number, the delay and severity of recurrences of atopic dermatitis (measured by the scorad score), and the evolution of symptoms such as dryness and pruritus. secondary objectives include quality of life and quality of sleep and skin acceptability. the study protocol is a multicenter, double-blind, randomized clinical trial, in which participants receive either the study product or a placebo, while continuing their topical corticosteroid treatment.


Eligibility criteria:
inclusion criteria: specific * sex: female and/or male; * age: from 3 months up to 12 years old; * phototype: i to iv; * 100% with atopic skin; * 100% with sensitive skin; * subject who had at least 3 eczema flares-up of atopic dermatitis during the last 6 months before start of the study, including the crisis observed on d-x. * subject presenting on the visit d-x a flare-up of eczema for which the dermatologist prescribed treatment with topical corticosteroids treatment; * subjects with scorad between 15 and 40 on d-x; * subject who do not require medical treatment anymore after using prescribed topical corticosteroids from d-x up to d0 and clinical signs of atopic dermatitis are resolved, to be defined on d0 visit (in case of insufficient healing of inflammatory lesions, the subject continues medical treatment as recommended by the investigator). general * healthy subject; * child whose at least one parent/legal guardian has given freely and expressly her/his informed consent; * child whose at least one parent/legal guardian is willing to adhere to the protocol and study procedures; * polish citizenship. exclusion criteria: * cutaneous pathology on the study zone other than atopic dermatitis; * use of topical or systemic treatment during the previous weeks liable to interfere with the assessment of the efficacy of the study products, including anti-histaminic treatment (except prescribed dermocorticoids on d-x and in case of flare-up during the study course); * subject having undergone a surgery under general anesthesia within the previous month; * excessive exposure to sunlight or uv-rays within the previous month; * subject enrolled in another clinical trial during the study period (concerns the studied zones); * subjects presenting oozing eczema lesions or any sign of infection on eczema lesions (e.g; pus).

Keywords: atopic dermatitis eczema dermocosmetic
pharmacist-led intervention on hemodialysis patients' therapy adherence

Conditions: Hemodialysis; End Stage Renal Disease Requiring Hemodialysis

Summary: a parallel-group, cluster-randomized, controlled trial designed to evaluate if hemodialysis patients benefit from bct. the study includes two groups: usual care and pharmacist-led intervention groups.


Eligibility criteria:
inclusion criteria: * adults (≥18 years of age), chronic kidney disease patients on standard in-center hemodialysis for at least three months, patients receiving 4 hours per session, moderate to poor adherence to their therapeutic regimen according to end stage renal disease adherence questionnaire (esrd-aq) at the time of inclusion exclusion criteria: * switching from hemodialysis to peritoneal dialysis, receiving transplantation during the research period, inability to communicate for any reason (cognitive impairment, hearing and visual loss, etc.), hemodialysis patients with viral hepatitis, and patient refusal to participate.

Keywords: adherences chronic kidney disease esrd behavioral intervention
ultrasound imaging and quantitative vibro-acoustic assessment of rickets under the age of ten

Conditions: Rickets

Summary: the goal of this study is to find out if the use of ultrasound pictures of bones can spot changes in the growth areas of children with rickets, a condition that affects how bones harden. researchers want to see if these ultrasound pictures can help tell the difference between children who have rickets and those who don't.

aims, purpose, or objectives: 1. to determine if ultrasound imaging of bone can identify the changes of impaired mineralization of the growth plates at the wrists and the knees, similar to those visible on plain radiographs. 2. to determine if quantitative vibro-acoustic measurements of the bone in subjects with rickets significantly differs from control subjects, matched for age, sex, and bmi. 3. to determine the relationship of ultrasound images and quantitative vibro-acoustic assessment with rickets severity score (rss), based on radiographs of the wrists and knees. 4. to determine if longitudinal changes in ultrasound images and quantitative vibro-acoustic assessment with treatment of rickets are related to changes in the rickets severity score.

Eligibility criteria:
inclusion criteria: * cases: prepubertal children less than 10 years of age with active nutritional or genetic rickets at enrollment (rss\>1.5 based on radiographs of the wrists and knees performed within 3 months prior to enrollment). cases will be recruited from the pediatric endocrinology bone clinic or from the mayo clinic outpatient or inpatient services in rochester, mn. cases who return for follow-up and demonstrate improvement in rss≥1.0 will be eligible for a single repeat ultrasound evaluation. * controls: healthy children empaneled in mayo clinic primary care (family medicine or community pediatrics) matched for age (±3 months), sex, and bmi (±0.5 kg/m2) exclusion criteria: * known fracture at imaging site * rickets of prematurity
diagnosis of structural sacroiliitis in patients with suspicion of spondyloarthritis (echospa)

Conditions: Structural Sacro-iliitis

Summary: the aims of this study are: 1° to assess the value of pelvic radiography and sacro-iliac joint (sij) mri compared to ct scan of sij for the diagnosis of structural sacro-iliitis and 2° to quantify structural elementary lesions on mri and for the first time on ct-scan according to a sparcc approach in a cohort of patients with a suspicion of spondyloarthritis (echospa).

among the 489 patients of the cohort, mri and ct examination of sij were performed simultaneously with pelvic radiographs in 173 patients. after harmonization, readers will be tested for inter-reader reproducibility for modified new york criteria, and scoring of each structural elementary lesion depicted on mri (erosions, fat metaplasia, backfill, sclerosis and ankylosis) and on ct-scan (erosion, joint space narrowing, sclerosis and ankylosis). when acceptable inter-reader reproducibility will be obtained, exams will be blindly and independently scored by 2 readers (rheumatologist and/or radiologist) in the following order: 1/ pelvic radiographs, 2/ mri, 3/ ct-scan. in case of discordance between readers for the diagnosis of sacroiliitis, an adjudicator will define the final diagnosis for each imaging method (senior rheumatologist or radiologist). severity of each structural lesion will be scored quantitatively according to structural sparcc approach. only lesions observed in the synovial part of the sij on 2 successive slices will be taken into account. sensibility, specificity and concordance for the diagnosis of structural sacroiliitis for radiograph and mri will be calculated with the ct-scan considered as the gold standard. quantitative mri and ct scores will be compared for each lesion: erosion, sclerosis and ankylosis. this quantitative approach will be used to explain cases of discordance or concordance for radiograph and mri.

Eligibility criteria:
inclusion criteria: * patients with suspected spondyloarthritis exclusion criteria: -
single and multiple ascending dose study of td-8236 by inhalation

Conditions: Asthma

Summary: this is a phase 1, randomized, double-blinded, placebo controlled study. the study consists of 3 parts: part a is a single ascending dose (sad) study in healthy subjects, part b is a multiple ascending dose (mad) study in subjects with stable, mild asthma, and part c (biomarker) is a multiple dose study in subjects with stable, moderate-to-severe asthma.


Eligibility criteria:
inclusion criteria: * male or female, 18 - 60 years old * willing and able to give informed consent and comply with the study * body mass index (bmi) 18 to 32 kg/m2 and weighs at least 50 kg * women of child bearing potential must have a negative pregnancy test and use a highly efficient birth control method * pre-bronchodilator fev ≥ 70% predicted for mad cohorts and \>40% predicted for biomarker cohorts * treatment with inhaled corticosteroids with or without long acting beta agonists * additional inclusion criteria apply exclusion criteria: * positive for hepatitis a, b or c, hiv or tuberculosis * clinically significant abnormalities of laboratory evaluations * have abnormal ecg measurements * any sign of respiratory tract infection within 6 weeks of screening * have a current bacterial, parasitic, fungal or viral infection * uses or have used tobacco or nicotine-containing products within 6 months prior to screening * additional exclusion criteria apply

Keywords: single ascending dose sad multiple ascending dose mad phase 1 first-in-human td-8236 asthma
effects of an alternative treatment for military sexual trauma on ptsd symptoms, neurosteroids and brain function

Conditions: Stress Disorders

Summary: our specific aims are: 1. to examine the efficacy of gift in improving mst-related clinical outcomes in women veterans 2. to examine the effects of gift on fronto-limbic brain function and 3. to examine the effects of gift on levels of neuroactive steroid associated with ptsd.

guided imagery is a complementary and alternative treatment (cam) modality. this directed meditation technique uses healing imagery to promote recovery in a variety of illnesses, including cancer, heart disease and, more recently, posttraumatic stress disorder (ptsd). ptsd is a severe and disabling anxiety disorder. it is among the most common mental disorders, affecting 10% of women in the united states during their lifetime. sexual assault is the most common cause of ptsd. similarly, military sexual trauma (mst) is disturbingly common among women in the armed forces. at least 20% of women veterans using va services report a history of sexual assault. unfortunately, high rates of mst-related ptsd are anticipated among women currently deployed to iraq and afghanistan. to address this issue, we will evaluate a guided imagery intervention for women veterans who have mst-related ptsd. we will evaluate the efficacy of guided imagery for trauma (gift) in decreasing ptsd symptoms. using brain-imaging techniques, this research will examine the effects of gift on brain function in the areas associated with ptsd. we will also examine the effects of gift on neurosteroids, which are candidate modulators of ptsd symptoms, and may also represent novel targets for therapeutic intervention.

Eligibility criteria:
inclusion criteria: * aged 18-65 * status as a woman veteran * receives care at the durham vamc * history of mst * dsm-iv diagnosis of ptsd, confirmed by caps interview * able to participate in a research interview in english * regular telephone access exclusion criteria: * current diagnosis of organic or psychotic mental disorder * suicidality or parasuicidality * ongoing family violence * alcohol or drug dependence within previous 3 months * enrolled in cognitive-behavioral/exposure-based therapy during study period. * supportive therapy and psychiatric medications (if stabilized at least 3 months prior to enrollment) are acceptable. * an uncontrolled medical condition exclusion criteria for the fmri only: * foreign metallic objects or implanted devices in the body incompatible with mri * positive pregnancy test as determined by serum ß-hcg level * claustrophobia * cns neoplasms or neurological conditions such as parkinson's disease, huntington's chorea, demyelinating diseases, seizures, hydrocephalus, etc.

Keywords: guided imagery for trauma (gift) posttraumatic stress disorder (ptsd) military sexual trauma (mst) military sexual trauma - related ptsd
rosuvastatin to lower circulating tissue factor bearing microparticles in metastatic breast cancer

Conditions: Breast Cancer

Summary: research studies have shown a strong association between cancer and blood clots in the veins (also known as deep vein thrombosis). these blood clots can flow to the lungs (pulmonary embolism) which in severe cases may be life threatening. studies have demonstrated that increases in microparticles may contribute to the development of deep vein thrombosis in cancer patients. the purpose of this research study is to see if rosuvastatin lowers the number of tissue factor bearing microparticles in the blood (tfmp). tfmp are small particles that are generated from different types of blood cells in the body. in people who have cancer, tfmp are thought to be generated from cancer cells and may represent a risk factor for deep vein thrombosis.

* since no one knows which of the study options are best, participants will be "randomized" into the following study groups: group 1 (regular dose of rosuvastatin) or group 2 (higher dose of rosuvastatin). * participants will take 1 pill of rosuvastatin every day for 4 weeks. each 4 week period is called a cycle. * participants will have a physical exam at baseline, on day 1 of starting rosuvastatin, and 2 month visits. laboratory tests will be taken at baseline, on day 1 of starting rosuvastatin, 6 weeks and 2 months.

Eligibility criteria:
inclusion criteria: * metastatic adenocarcinoma of the breast (stage iv) * actively receiving endocrine therapy for at least 6 weeks (with or without her2 therapy) * minimum age 18 years * ecog performance status of 0, 1 or 2 * normal organ and marrow function as defined in the protocol exclusion criteria: * participants may not be receiving any other study agents * actively receiving chemotherapy (exclusive of hormonal or her2 therapy ) within last 5 weeks * any statin therapy within the last 3 weeks * asian decent (including filipino, chinese, japanese, korean, vietnamese or asian-indian origin) * concomitant use of the following drugs: cyclosporine, fibrates, niacin, gemfibrozil, ketaconazole, spironolactone, cimetidine, warfarin, erythromycin, or protease inhibitors * conditions predisposing to renal failure secondary to rhabdomyolysis * recent history of heavy alcohol use as judged by the treating physician * known to be pregnant (testing not required) or nursing * history of rhabdomyolysis on statin therapy * known history of hepatitis c or active hepatitis b infection (baseline testing not required) * uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Keywords: crestor tfbp rosuvastatin
open-label study of sofusbuvir+ribavirin with or without peginterferon alfa-2a in subjects with chronic hcv infection who participated in prior gilead hcv studies

Conditions: Chronic Hepatitis C

Summary: this study will evaluate the efficacy, safety, and tolerability of sofosbuvir (sof; gs-7977) in combination with ribavirin (rbv) with or without pegylated interferon (peg-ifn) in adults with chronic hepatitis c virus (hcv) infection who participated in a prior gilead hcv study and have not achieved sustained virologic response (svr).


Eligibility criteria:
inclusion criteria: * infection with hcv * must have participated in a prior gilead hcv study * use of highly effective contraception methods if female of childbearing potential or sexually active male * eligible patients include those in the following * received placebo or peg-ifn+rbv in a control arm * previously participated in a gilead-sponsored hcv study and did not attain sustained virologic response 24 weeks after discontinuation of therapy (svr24) on a regimen containing: * sofosbuvir+rbv * peg-ifn and/or rbv in combination with one or more gilead investigational direct-acting agents exclusion criteria: * pregnant or nursing female or male with pregnant female partner * current or prior history of clinical hepatic decompensation * infection with hepatitis b virus (hbv) or human immunodeficiency virus (hiv) * chronic use of systemically administered immunosuppressive agents * active drug abuse * use of any prohibited concomitant medications

Keywords: hcv genotype 2 (gt-2) hcv genotype 3 (gt-3) hcv sustained virologic response direct acting antiviral combination therapy gs-7977 ribavirin open label
individual patient expanded access for ab-pa01, an investigational anti-pseudomonas aeruginosa bacteriophage therapeutic


Summary: the purpose of the expanded access program is to allow physicians to provide treatment with investigational drug, ab-pa01, for patients with serious or immediately life-threatening pseudomonas aeruginosa infections, for which no alternative treatment(s) are currently available, and who meet the criteria for treatment under fda's expanded access regulations and criteria set forth by ampliphi biosciences corporation. to be considered for expanded access, the request should be submitted to ampliphi by a qualified and licensed physician with expertise and facilities appropriate for the administration of the investigational medicine. treating physicians should contact ampliphi by emailing expandedaccess@ampliphibio.com with "expanded access request" in the subject line, and include in the email the treating physicians name, organization/hospital/institution, physical address, email address, telephone number, and a brief description of the indication/condition. any approval of expanded access to investigational medicine must always comply with the applicable laws and regulations.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
french national observatory of aortic syndromes

Conditions: Acute Aortic Syndrome

Summary: the study examined the clinical characteristics and conditions of care for patients with acute aortic syndrome (aas) that will identify patients at risk for increased morbidity and mortality and provide a basis for the eventual achievement of specific studies on the optimal therapeutic management according to different risk profiles. the aim of the observatory is to provide a photograph "size" of practices in france at present, both in the larger centers than in smaller and optimize diagnostic and therapeutic currently available by the activation pathways of rational management.


Eligibility criteria:
inclusion criteria: * male or female age (e) over 18 years old * patients with a aas duly authenticated by further tests * patients who consented to participate in the study exclusion criteria: * refusal of consent for study participation and ancillary studies * aas occurring in the aftermath of a traumatic thoracic * diagnosis aas aside in favor of an alternative diagnosis

Keywords: acute aortic syndrome
safety and performance study of the ingevity lead

Conditions: Bradycardia; Sinus Node Dysfunction

Summary: the objective of this study is to gather data to establish the safety, performance and effectiveness of the ingevity pace/ sense leads.

the objective of this study is to gather data to establish the safety, performance and effectiveness of the ingevity pace/ sense leads

Eligibility criteria:
inclusion criteria: * subject is willing and capable of providing informed consent * subject has a class i or ii indication for implantation of a single(vvi (r) only) or dual chamber pacemaker or a crt-p system according to the acc/aha/hrs, or esc guidelines * subject is willing and capable of participating in all testing/ visits associated with this clinical study at an approved clinical study center and at the intervals defined by this protocol * subject is age 18 or above, or of legal age to give informed consent specific to state and national law exclusion criteria: * subject has or has had any pacing or icd system implants * subject has a sensitivity to dexamethasone acetate (dxa) * subject has a mechanical tricuspid heart valve * subject is enrolled in any other concurrent study, with the exception of local mandatory governmental registries and observational studies/registries * subjects with documented permanent or persistent af where the physician intends to implant dual chamber pulse generator (single chamber vvir pulse generators in these subjects is acceptable) * subject is currently on the active heart transplant list * subject has documented life expectancy of less than 12 months * women of childbearing potential who are or might be pregnant at the time of study enrollment or ingevity lead implant * subjects currently requiring dialysis

Keywords: bradycardia sinus node dysfunction