Kornimate/medical-research-clean huggingface dataset:
study of difluprednate ophthalmic emulsion in the treatment of postoperative inflammation

Conditions: Inflammation

Summary: the purpose of this phase 2 study is to determine if difluprednate ophthalmic emulsion is effective in the treatment of postoperative inflammation.

the objective is to assess the efficacy and safety of 0.002% and 0.05% difluprednate ophthalmic emulsions in patients with postoperative inflammation after cataract surgery (implantation of intraocular lens). in addition, the evaluation system for a future dose-finding phase iii study of difluprednate ophthalmic emulsion will be established.

Eligibility criteria:
inclusion criteria: * patients with a mean postoperative (on the day of surgery or the day after surgery) flare intensity of 30 photon counts/msec * male and female patients aged 12 and \<75 years who were able to accurately express their own symptoms * patients providing written informed consent prior to the start of the study * inpatients (patients were allowed to be discharged from the hospital during the study period) exclusion criteria: * patients who did not meet any of the above inclusion criteria * patients receiving systemic administration, or topical application to the head or face (including instillation to the eyes) of any steroid, nonsteroidal anti-inflammatory drug, antiphlogistic enzyme, immunosuppressive drug or colchicine within 1 week prior to the start of the study treatment * patients with glaucoma or ocular hypertension (iop: 21 mmhg) * patients with corneal abrasion or ulcer * patients with any viral keratoconjunctival disease, tuberculosus eye disease, fungal eye disease or bacterial eye disease * patients with diabetes who met any of the following criteria * hba1c was 9.0% within 1 month prior to obtaining informed consent. * proliferative diabetic retinopathy was present. * rubeosis iridis was present. * patients with allergy to steroids * patients requiring the use of contact lens during the study period * women who were or might be pregnant * patients participating in another clinical study within 6 months prior to the start of the present study * patients sensitive to steroids (patients who previously experienced increased iop after instillation of a steroid) * patients with a grade 5 nuclear hardness as diagnosed according to emery-little classification * patients with fibrins or posterior rupture at baseline (f0)
kn046 (a humanized pd-l1/ctla4 bispecific single domain fc fusion protein antibody) in subjects with thymic carcinoma

Conditions: Thymic Carcinoma

Summary: this is a phase 2, open-label, multi-center, single arm study in subjects with advanced thymic carcinoma after failure of platinum-based combination chemotherapy. subjects should have documented progressive disease while on platinum-based combination chemotherapy. if subjects discontinued platinum-based therapy due to reasons other than progressive disease, subjects should have completed at least 2 cycles of platinum-based combination chemotherapy before the commencement of documented progressive disease. subjects will be treated with kn046 5 milligram per kilogram every 2 weeks.


Eligibility criteria:
inclusion criteria * male or female, ≥18 years * pathologically confirmed diagnosis of thymic carcinoma * inoperable or metastatic disease * had failed at least one regimen containing platinum-based combination chemotherapy for locally advanced unresectable or metastatic disease * baseline measurable disease exclusion criteria * thymomas, thymolipoma, germ cell tumors, teratomas, seminomas * leptomeningeal metastasis or untreated active cns (central nervous system) metastasis or leptomeningeal metastasis. * is currently participating and receiving an investigational drug or has participated in a study of an investigational drug within 4 weeks * has received other anti-tumor treatment within 4 weeks * major surgery for any reason, except diagnostic biopsy, within 4 weeks of the first administration of trial treatment * curative radiation within 3 months of the first dose of trial treatment. * subjects receiving immunosuppressive agents (such as steroids) for any reason should be tapered off these drugs before initiation of trial treatment
evaluation of wear experience with a weekly replacement soft contact lens in neophyte lens wearers with astigmatism

Conditions: Astigmatism Bilateral

Summary: this open-label study is of adults with astigmatism who have never worn contact lenses. subjects will be fit into a one week planned-replacement contact lenses and will wear lenses for approximately 3 weeks. subjects will return for vision and lens fit assessments and will complete surveys about their wear experience.


Eligibility criteria:
inclusion criteria: 1. subjects must be new to contact lenses and have astigmatism of -0.75 or greater (within the parameters available for the p7fa lenses) 2. subjects must have 20/20 or better best corrected visual acuity. 3. good general health (defined by medication use that has not changed within the last month and the absence of medical conditions or treatments that are deemed confounding to the data as determined by the pi) 4. ability to give informed consent 5. willing to spend time for the study. subjects will be required to attend three study visits and wear contact lenses on days between study visits. 6. willing and able to wear contact lenses for at least 8 hours per day for 5 days per week during the study as daily wear. 7. currently not using eye lubricating drops and willing to not use during study. 8. either gender and 18-40 years of age. 9. any racial or ethnic origin exclusion criteria: 1. any active ocular inflammation or infection. 2. has a systemic condition that in the opinion of the investigator may affect a study outcome variable. 3. are presbyopic and require or habitually uses reading glasses for near work 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable 5. history of refractive surgery 6. meets the diagnosis of dry eye disease with osdi screening score ≥13. 7. known history of allergy or sensitivity to contact lens solutions and/or sodium fluorescein 8. is pregnant or lactating or planning a pregnancy during enrollment in the study 9. is participating in another clinical research study that includes invasive ocular tests 10. an inability to perform contact lens application and removal after instruction.
clindamycin to reduce preterm birth in a low resource setting

Conditions: Pregnancy; Prematurity; Preterm Birth; Bacterial Vaginosis

Summary: preterm birth has been linked to certain types of vaginal infections. the goal of this study is to determine if giving women pregnant between 13-20 weeks with an elavated vaginal ph(evidence of this type of infection)oral clindamycin(an antibiotic)will have a lower rate of preterm birth compared to women given a placebo(starch)

the primary study objective is to definitively test whether 300 mg oral clindamycin two times per day for 5-days administered at 13-20 weeks of gestation in women with a vaginal ph≥5 reduces the incidence of preterm delivery in karnataka, india by at least 30%. the national incidence of gestation \<37 weeks in india is 14.5%, was 18% in the study area in 2011 and was 20% among women with vaginal ph≥5 in the recently completed jawaharlal nehru medical collage (jnmc) hospital-based study of clindamycin to reduce preterm birth. using a two tailed test, α=0.05, 1-β=80%, a 17.5% rate of prematurity in women with vaginal ph≥5, a 2.5% refusal and a 7.5% loss to follow-up, assuming 86% of women presenting for antenatal care are 13-20 weeks gestation and 1% otherwise ineligible, and a multiple comparisons adjustment, 1,726 women, half in the clindamycin and half in the placebo group, need to be enrolled to test the primary hypothesis. the effects of clindamycin on spontaneous preterm birth, miscarriage, low birthweight (lbw), neonatal mortality (nmr), maternal and neonatal complications through 42 days postpartum, the utility of vaginal ph≥5 to identify women at risk for preterm delivery and the costs of preterm birth prevented by oral clindamycin treatment and compliance with the 5-day treatment regimen will also be assessed. this will be the first investigation to test whether oral clindamycin prevents preterm birth in a community-based, developing country setting, where most global newborn deaths occur.

Eligibility criteria:
inclusion criteria: * women with a singleton intrauterine pregnancy between 13-20 weeks * maternal age of 18 or older or if \< 18 assent of the women's parent/guardian * vaginal ph \> 5.0 exclusion criteria: * use of antibiotics within the 14 days prior to randomization * known sensitivity to antibiotics * uterine anomalies * major fetal anomalies * medical conditions that may result in iatrogenic prematurity(e.g.diabetes, lupus, hypertension)

Keywords: pregnancy prematurity preterm birth bacterial vaginosis
ultrasound assessment of gastric volume in high-risk pregnant women at term

Conditions: Pregnancy; Respiratory Aspiration of Gastric Content

Summary: the risk of pulmonary aspiration of gastric contents remains a significant risk during anesthesia, especially in pregnant women, as they may often require surgery without having observed appropriate fasting. a bedside ultrasound assessment of the status of the gastric content would be of great value for the clinician. this prospective observational study aimed to (1) qualitatively and quantitatively describe the sonographic appearance of the gastric antrum in fasted high-risk pregnant women during the third trimester and (2) evaluate the relationship between demographic and clinical variables and the gastric antral cross-sectional area (csa).

the aim of this prospective study is to provide a qualitative and quantitative description of the sonographic appearance of the gastric antrum in fasted high-risk pregnant women in the 3rd trimester. the investigators expect that the information obtained from the systematic ultrasonographic qualitative/quantitative assessment of the gastric content may help anesthesiologist to better assess aspiration risk and guide anesthetic and airway management, particularly in pregnant women scheduled for elective cesarean delivery after standard preoperative fasting guidelines.

Eligibility criteria:
inclusion criteria: 1. non-labouring pregnant women at 3rd trimester (≥ 28 weeks) 2. 18 years or older. 3. asa physical status i-iii 4. hospitilized in high risk pregnancy department 5. ability to understand the rationale of the study assessments and provide signed informed consent. 6. written informed consent exclusion criteria: 1. patients with american society of anesthesiology (asa) physical status class iv. 2. patient age \< 18 years 3. pregnant patients with upper gastrointestinal (gi) disease and pathology. 4. history of upper gi tract surgical procedures. 5. history of medications that affect gastrointestinal motility. 6. inability to understand the rationale of the study assessments and provide signed informed consent.
temporal interference for essential tremor

Conditions: Essential Tremor

Summary: this single-center prospective study aims to investigate the treatment efficacy of temporal interference (ti) in essential tremor patients aged 30-70.

temporal interference (ti) technology is a novel non-invasive method for deep brain stimulation (dbs). by generating an overlapping electric field from safe currents, ti creates focused stimulation in targeted deep brain areas. this approach allows for the exploration of deep brain nuclei functions and has the potential to serve as a non-invasive alternative to traditional invasive dbs for clinical treatments. this study aims to investigate the treatment efficacy of ti deep brain stimulation by including essential tremor patients aged 30-70. before and after ti stimulation, clinical data will be recorded. clinical and imaging data will be analyzed and processed to advance the treatment of essential tremor.

Eligibility criteria:
inclusion criteria: * aged 30-70 years old, regardless of gender. action tremor and postural tremor in both upper limbs, or action tremor and postural tremor in one limb; * no history of mental diseases; * informed consent signed. exclusion criteria: * presence of other neurological diseases affecting the study (such as epilepsy); * patients with moderate to severe cognitive impairment (montreal cognitive assessment ≤ 18 points); * orthopedic diseases that may affect motor symptoms; * patients taking antipsychotic or antidepressant medications; * presence of metal implants in the body (such as brain pacemakers or cardiac pacemakers); * history of electroconvulsive therapy; * presence of cardiovascular risk factors, etc.

Keywords: temporal interference essential tremor
acquired syphlis by non sexual contact

Conditions: Syphilis Acquired; Syphilis Infection

Summary: syphilis is classically described as a sexually transmitted disease. as this source of contagious has been described long ago -mainly though by observation- when children presents with acquired syphilis, child abuse is always considered and must be ruled out by specialists in a careful evaluation. however, muco-cutaneous lesions can be a contagious source for congenital syphilis; therefore the possibility of non-sexual transmission through intimate contact with infected people through humid lesions (such as in kisses, breastfeeding, food-handling) or contaminated fomites (towels, bed sheets, underwear, cups, pacifiers, cutlery) could be considered. experts worldwide have observed this non-sexual transmission, as described in many reports in literature. the investigators will study retrospectively patients from a cohort with non-sexual transmission. the diagnosis criteria used for acquired syphilis were as follows: age under 18 years with treponemic and nontreponemic positive tests, secondary-syphilis suspicious lesions and negative maternal syphilis serology. nonsexual contagious was defined as contacts without physical and psychosocial indicators of sexual abuse according to current guides. in this cohort, in every case a psychosocial evaluation was completed with a written report in order to evaluate sexual contact probability. the teamo will describe these patients clinical and laboratory findings, family and close acquaintances serologies and probable source of contagious.


Eligibility criteria:
inclusion criteria: - children with treponemic and non-treponemic positive tests with primary or secondary-syphilis suspicious lesions exclusion criteria: - children with diagnose criteria positive for congenital syphilis
study of cognitive behavioral therapy for insomnia (cbt-i) and acupuncture for insomnia and related distress among cancer caregivers

Conditions: Insomnia; Related Distress Among Cancer Caregivers

Summary: the other aim of this study is to determine which of those two treatments (acupuncture or cognitive behavioral therapy) works better for treating insomnia in informal caregivers of cancer patients.


Eligibility criteria:
inclusion criteria: * as per self report, age 18 and older * as per self report, identifying as an informal caregiver to mskcc patients of any site or stage of cancer * score greater than 7 on the insomnia severity index and meet the criteria for insomnia disorder as defined by the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5) (56) as assessed by the insomnia interview schedule * in the judgment of the investigators and/or consenting professional, able to read and comprehend english * in the judgment of the consenting professional cognitively able to provide informed consent exclusion criteria: * as per self report, participant has another sleep disorder provided that it is not adequately treated (e.g., sleep apnea without cpap treatment) * as per self report, participant has major depressive disorder, alcohol or drug dependence and * as per self report, heavy drinker (regularly having more than 14 alcoholic beverages per week) * as per self report, engaging in night shift work * to not obscure cortisol assessment, regular smokers per self report (daily use) will be excluded. * as per self report significant needle phobia as to prevent participation in acupuncture

Keywords: cognitive behavioral therapy acupuncture 17-001
analysis of mirna expression in endometrial cancer

Conditions: Endometrial Cancer

Summary: the tcga project identified four distinct prognostic groups of endometrial carcinoma (ec) based on molecular alterations: (i) the ultramutated subtype that encompasses pole mutated (pole) cases; (ii) the hypermutated subtype, characterized by mismatch repair deficiency (mmrd); (iii) the copy-number high subtype, with p53 abnormal/mutated features (p53abn); (iv) the copy-number low subtype, known as no specific molecular profile (nsmp). although the prognostic value of tcga molecular classification, nsmp carcinomas present a wide variability in molecular alterations and biological aggressiveness. given that the study aims to evaluate the mirna expression profile to identify novel potential biomarkers to better stratify the ec patients, taking into account the molecular status


Eligibility criteria:
inclusion criteria: * age\>18yo * histological diagnosis of endometrial cancer * tumor resection * patient's informed consent exclusion criteria: * patients with other neoplasia within the last 5 years

Keywords: endometrial cancer mirna microrna tgca
mineral water rich in magnesium and perceived stress in healthy consumers

Conditions: Magnesium Deficiency; Stress, Psychological

Summary: the goal of clinical trial is to evaluate the effect of one month of consumption of mineral water rich in magnesium or not on perceived stress, duration and quality of sleep in healthy consumers having magnesium daily intakes below the recommended dietary allowance (rda).

this is a single-center, double-blind, controlled, randomized, 2 parallel-groups clinical trial. 256 healthy volunteers will be recruited for clinical trial if they meet the inclusion and no inclusion criteria. 50% of volunteers (mg+ group) will drink daily 1,5 l of mineral water rich in magnesium during 30 days 50% of volunteers (mg- group) will drink daily 1,5 l of water low in magnesium during 30 days volunteers in both groups will be equipped with a wristband-connected device allowing recording of duration and quality of sleep.

Eligibility criteria:
inclusion criteria: * a magnesium daily intakes lower than the recommended dietary allowance (rda) * a score at perceived stress scale (pps) greater than or equal to 25 * bmi \> 18 et \< 25 kg/m2 * describing himself as tired for reasons of stress or lack of sleep. * do not take any medication likely to act on stress and sleep as anxiolytics, hypnotics, antidepressants, etc. * knowing read and write french routinely, * possessing an internet connection at home, * possessing and knowing how to use a computer or tablet, * owning a smartphone, * affiliated with a social security scheme * not trust * having signed the informed consent letter exclusion criteria: * pregnant or breast-feeding or planning an early pregnancy during the study * severe chronic condition or type of acute disease: vascular cardio - pulmonary - renal - hematologic - liver - endocrine (thyroid) - allergic * inability to understand information about the protocol and / or to sign the informed consent

Keywords: magnesium deficiency stress psycological sleep duration and quality mineral water rich in magnesium
inspiring seniors towards exercise promotion to protect cognition

Conditions: Alzheimer Disease; Physical Activity

Summary: the goal of this clinical trial is to test the benefits of beat-accented music stimulation (bms) for behavioral changes of physical activity (pa) in older adults with subjective memory complaints. specific aims are to determine (1) whether bms beneficially influences pa behaviors and psychological responses to pa in older adults for 6 months, and (2) whether exercising with bms differently influences physical and cognitive functioning as well as quality of life in older adults.to test the effects of bms on pa, participants will be randomly assigned to an exercise intervention that either includes bms or does not include bms. participants will attend a supervised group strength training (st) (30 min/day) and and aerobic exercise (ae) (30-50 min/day) session for 3 days/week for the first 2 months, 1 day/week for the next 2 months (while encouraging participants to independently perform both ae and st on other days), and independently for the final 2 months (always with a goal of performing \>150min/week ae and 3 days/week of st for 30 min/day).


Eligibility criteria:
inclusion criteria: * adults at least 65 years old. * ambulatory/capable of walking for 6 minutes without pain or aid such as a walker/cane. * able to speak and read english. * healthy enough to exercise at moderate intensity with or without medical clearance by a primary care physician. * living in the community for the duration of the study (6 months). * having a reliable means of transportation. * having a safe place (at least 6 feet by 6 feet of open space) at home for unsupervised exercise training. * having self-perceived memory complaints. * having no symptoms of suicidal ideation and not meeting criteria for depressive disorder. * physically low-active by doing \< 60 min/week of moderate-intensity aerobic exercise and no strength training for the last 3 months. exclusion criteria: * diagnosis of neurological disorder or spinal cord disorder. * known exercise contraindications. * current cancer treatment. * stroke or neural impairment in the past 6 months. * hip/knee/spinal fracture or surgery in the past 6 month. * unable or unwilling to attend intervention classes 3x/week in months 1-2 and 1x/week in months 3-4. * currently participating in any other physical activity or fitness-related research study. * use of medication for alzheimer's disease. change in dosage of medications prescribed for anxiety or depression within the previous 6 months. * regularly drink \> 14 alcoholic beverages a week or current illicit drug use. * meet the threshold for cognitive impairment. * meet the threshold for clinical depression. * uncorrected hearing or visual impairments. * unable to understand the study procedures. * one of the household members is participating in this study.

Keywords: music aerobic exercise strength training cognition physical activity muscular strength memory complaint