Kornimate/medical-research-clean huggingface dataset:
lopinavir/ritonavir in plwh with high-grade ain

Conditions: High-Grade Anal Intraepithelial Neoplasia

Summary: this study is being done to assess the safety of lopinavir/ritonavir in patients with plwh with ain. 30 participants will be recruited and can expect to be on active study for approximately 3 months and long term follow up for 40 weeks.

this is a phase i modified 3 + 3 design, in which the maximum tolerated dose (mtd) will be identified. the 3 + 3 dose escalation will consist of 6 dose levels (18 participants; planned escalation described in arms below) in combination with variation in dosing schedules of the drug lopinavir/ritonavir. this design also allows for some possible intermediate doses to be examined if dose-limiting toxicities (dlts) occur and de-escalation is needed. an expansion cohort of 12 participants will occur at the mtd. once the mtd is determined, then secondary outcomes will be evaluated. primary objective * to evaluate the safety and tolerability of intra-anal administration of lopinavir/ritonavir, administered via suppository with 3 different schedules, in plwh with high-grade anal intraepithelial neoplasia (hgain) (ain 2/3). secondary objectives * to measure the effect of intra-anal topical lopinavir/ritonavir administration * to evaluate clearance of human papillomavirus (hpv) * to elucidate the mechanism of action of protease inhibitors

Eligibility criteria:
inclusion criteria: * willing to provide informed consent * greater than or equal to 18 years of age * diagnosis of biopsy-confirmed hgain * human immunodeficiency virus (hiv)-positive with cd4 count greater than 200 cells/mm\^3 at screening and virologically suppressed on hiv-1 antiretroviral therapy (art) within last 12 months * willing to comply with all study procedures exclusion criteria: * diagnosis of low-grade anal dysplasia (ain, low-grade squamous intraepithelial lesion (lsil)) by hra. * cd4 count less than 200 cells/mm\^3 at the time of consideration for entry into the study * unable to provide informed consent * pregnant or breastfeeding female * currently receiving systemic chemotherapy or radiation therapy for another cancer. * have received topical therapy for anal dysplasia previously
patient-centered dementia care practice coaching intervention

Conditions: Dementia; Alzheimer Disease

Summary: the goal of this clinical trial is to compare staff outcomes in long-term care communities who participate in the intervention versus those who do not. the main questions it aims to answer are: 1. is employee satisfaction impacted by the intervention and 2. is dementia care confidence impacted by the intervention. participants will include monthly coaching visits for the intervention group and completion of surveys pre, immediately post and three-months post. researchers will compare the intervention group to the control group to see if the intervention impacted the outcomes.

over a six-month coaching program period, staff members from care communities work with a coach to assess their current level of adoption of dementia care practice recommendations (dcpr) (published recommendations by alzheimer's association) and prioritize areas of need /focus. teams meet with the coach virtually or in person for 1 hour each month during the six months. through an action planning and implementation process, care communities are guided to make organization-wide, measurable changes in the areas of (1) policies and procedures, (2) education and training, and/or (3) care practices to increase and maintain person-centered care practices as outlined in the dcpr. coaches provide ongoing support to the care community through telephone and email support between meetings. control group will not receive any coaching intervention but receive monthly email (e.g., newsletter about alzheimer's association but not related to outcomes) from coaches for check-in. alzheimer's association (aa) hires coaches in study areas based on their skills, experiences, interests and enthusiasm. each coach identifies and invites long-term care (i.e., nursing home and assisted living) communities using existing relationships between the aa chapter and those communities. in addition, aa staff will work with a national and/or state-wide networking group /association, as well as the association's dementia care provider round tables. the investigators will also pull the list of nursing homes in the study areas from publicly available data (e.g., definitive healthcare). once each care community is selected and has agreed to participate, dcpr coaches will request that the care community identify 4-6 staff members to serve on a care team. the consented care communities are randomly assigned to either a control or intervention group (1: 1 block randomization).

Eligibility criteria:
inclusion criteria: * licensed skilled nursing facilities * licensed assisted living facilities * located in the state of ohio exclusion criteria: * under the age of 18 * without documented endorsement for participation from facility leadership

Keywords: person-centered care dementia care practice recommendations coaching
arx788 in her2-positive, metastatic breast cancer subjects (ace-breast-03)

Conditions: HER2 Positive Metastatic Breast Cancer

Summary: a global, phase 2 study of arx788 in her2-positive metastatic breast cancer patients who were previously treated with t-dxd

a global, single arm, phase 2 study of arx788 in her2-positive metastatic breast cancer patients who were previously treated with t-dxd. the arx788 will be administered every 3 weeks (q3w) intravenous (iv) infusion.

Eligibility criteria:
key inclusion criteria: * age ≥ 18 years and older * life expectancy ≥ 6 months * unresectable or metastatic breast cancer subjects * presence of at least one measurable lesion per recist v 1.1 * subjects must have her2 positive breast cancer per asco-cap guidelines, documented in a clia lab pathology report * subjects must have had prior treatment with no more than 5 prior regimens of systemic treatment her-2 targeting therapy or chemotherapy in the metastatic setting. one of these prior treatments must have been treatment with t-dxd. * subjects with stable brain metastases * acute toxicities from any prior therapy, surgery, or radiotherapy must have resolved to grade ≤1 as per the nci-ctcae v 5.0, except alopecia, vitiligo, grade 2 peripheral neuropathy, or endocrine toxicities that are stable on hormone replacement. * adequate organ functions * willing and able to understand and sign an informed consent inform and to comply with all aspects of the protocol key exclusion criteria: any subject who meets any of the following criteria is excluded from the study: * history of allergic reactions to any component of arx788. * prior history of interstitial lung disease, pneumonitis, or other clinically significant lung disease. any requirement for supplemental oxygen. * any active ocular infections or chronic corneal disorders * history of congestive heart failure, unstable angina pectoris, unstable atrial fibrillation, cardiac arrhythmia, or myocardial infarction within 6 months prior to enrollment * grade 3 to 4 peripheral neuropathy (nci ctcae v 5.0). * history of unstable central nervous system (cns) metastases * radiotherapy outside of the brain administered \< 7 days prior to first dose of arx788 * current severe, uncontrolled systemic disease (eg, clinically significant cardiovascular, pulmonary, or metabolic diseases) * any uncontrollable intercurrent illness, infection (including subjects with active, symptomatic covid-19 infections), or other conditions that could limit study compliance or interfere with assessments * exposure to any other investigational or commercial anticancer agents or therapies administered with the intention to treat malignancy within 14 days before the first dose of arx788

Keywords: her2-postive breast cancer antibody drug metastatic arx788 her2
effects of transcutaneous acupoint electrical stimulation on intestinal obstruction after gastrointestinal surgery

Conditions: Postoperative Intestinal Obstruction

Summary: postoperative intestinal obstruction (poi) is one of the most common complications in the gastrointestinal surgery. compared with the conventional control group, transcutaneous acupoint electrical stimulation(teas) is possible to reduce the incidence of poi and accelerate the rapid recovery of the gastrointestinal tract.

participants will be randomly assigned, in a 1:1 ratio, to receive teas or blank treatment (acupoints selection are same with the experimental group, connect stimulator for patients, but not don't give stimulus). the randomization sequence will be computer-generated, and randomization will be performed in blocks and will be stratified according to participating center. teas will be performed in a series of time periods after operation. time of first fart and food-taking ,time of have normal diet after the transplantation will be recorded. the participation of each patient is scheduled for 30 days.

Eligibility criteria:
inclusion criteria: * all the patients signed the informed consent before treatment; * age ≥ 18 years old,american society of anesthesiologists(asa)grade are between i and iii; * plan to perform elective colon and rectal tumor resection under general anesthesia; * not involved in other clinical studies; * no cognitive impairment, mental disorders,communication disorders. exclusion criteria: * pregnancy, breast-feeding; * the history of intestinal surgery; * test point skin injury, infection, allergies to tape; * have undergone external enterostomy; * chief surgeon refuse to cooperate.

Keywords: postoperative intestinal obstruction;teas
effectiveness of short-foot exercises in water and on land in pes planus

Conditions: Pes Planus

Summary: pes planus is caused by the elongation of the intrinsic muscles in the medial arch of the foot, causing the arch to approach the ground or the sole of the foot to touch the ground completely.

for this purpose, in this project, the effectiveness of short foot exercises in water and on land will be compared in young adults with pes planus.

Eligibility criteria:
inclusion criteria: * between the ages of 18-25 * having bilateral pes planus * people with a score of 6 and above on the foot posture index score * individuals with more than 10 millimeters of pronation according to the navicular drop test were included. exclusion criteria: * rigid pes planus, hallux valgus, hallux rigidus, epin calcanei * lower extremity surgery * neurological or orthopedic problems and history of disease * regular exercise for the treatment of pes planus in the last three months
continuous glucose monitoring for screening for diabetes in pregnancy

Conditions: Gestational Diabetes

Summary: the purpose of this study is to evaluate whether continuous glucose monitoring (cgm) for diagnosis of gestational diabetes mellitus (gdm) improves maternal and neonatal outcomes related to gdm and to evaluate whether cgm for gdm diagnosis reduces the health system costs for mother-infant dyads compared to usual care


Eligibility criteria:
inclusion criteria: * 24-30 weeks gestation undergoing gdm screening exclusion criteria: * known diagnosis of type i and ii dm * history of bariatric surgery * major fetal anomalies * unwilling to use cgm for gdm screening * incarcerated subjects * history of allergic reaction to any of cgm metals or adhesives in contact with the skin
a study to investigate the intrapulmonary lung penetration of nacubactam in healthy participants

Conditions: Gram-negative Bacterial Infections

Summary: the purpose of this study is to characterize the intrapulmonary penetration of nacubactam in healthy volunteers. nacubactam is a novel non-beta-lactam beta-lactamase inhibitor being developed as a combination therapy with the beta-lactam meropenem for the treatment of serious gram-negative bacterial infections. adult male and female healthy participants will receive a single intravenous infusion of nacubactam co-administered with meropenem and then undergo a bronchoalveolar lavage (bal) procedure to collect lung epithelial lining fluid (elf) for measurement of intrapulmonary concentrations of nacubactam and meropenem.


Eligibility criteria:
inclusion criteria: * 18 to 60 years of age, inclusive * healthy, as judged by the investigator and defined by the absence of evidence of any active or clinically significant chronic disease identified from a detailed medical and surgical history, physical examination including vital signs and 12-lead electrocardiogram (ecg), and laboratory safety test results * body mass index (bmi) within the range 18-30 kilogram per square meter (kg/m\^2),inclusive * non-smoker, or former smoker who has abstained from smoking for at least 6 months * negative pregnancy test and agreement to comply with measures to prevent pregnancy in women * refrain from sperm donation and agreement to comply with measures to prevent pregnancy in partner of childbearing potential for men exclusion criteria: * history of asthma or clinically significant lung disease * any condition which contraindicates a bal procedure * history of clinically significant gastrointestinal, renal, hepatic, broncho-pulmonary, neurological, psychiatric, cardiovascular, endocrinological, hematological, dermatological, immunological or allergic disease, metabolic disorder, cancer or cirrhosis * clinically significant change in health status, as judged by the investigator, or any major illness within the four weeks before screening, or clinically significant acute infection or febrile illness within the 14 days before screening * history of epilepsy (or known seizure disorder), brain lesions or other significant neurological disorders * participation in any other clinical study involving an investigational medicinal product or device within 3 months before screening * known history of clinically significant hypersensitivity or urticaria, or severe allergic reaction to any drug, in particular antibiotics * donation or loss of over 500 milliliter (ml) of blood within the three months before screening
environmental factors and the gut microbiome - endocannabinoid axis

Conditions: Food Habits; Energy Metabolism; Mental Health Wellness 1; Intestinal Disease

Summary: the general objective of this project is to investigate the interplay of the gut microbiome - endocannabinoid axis with host environmental factors and intestinal, metabolic and mental health status in free-living adults with various metabolic statuses and lifestyles.

the gut microbiome and the endocannabinoid system (ecs) could be interacting together and influence local enteric and peripheral metabolic functions and mental health. the association of some host environmental factors (e.g. age, metabolic status, dietary habits) with gut microbiota composition and function has been investigated but, to our knowledge, little is known about their influence on the ecs. there is also a need to better understand the influence of these factors and the interplay between the gut microbiota and the ecs and their relationship with intestinal, metabolic and mental health. the investigators therefore propose to fill this knowledge-gap in the general population of adults with various body composition, dietary habits and daily physical activity levels.

Eligibility criteria:
inclusion criteria: * computer and internet access * understanding of written french exclusion criteria: * intestinal pathologies * pregnancy or breast-feeding * recent significant weight variations * recent completion of antibiotic treatment * alcohol consumption over sex-specific recommendations

Keywords: gut microbiota endocannabinoide metabolic health gastrointestinal health mental wellbeing
vaginal innate immunity in normal and hiv-infected women

Conditions: HIV; Pregnancy

Summary: the innate immunity of the vaginal tract provides first-line defense from abnormal microorganisms or overgrowth of common organisms, such as candida species or gardnerella vaginalis. it is unclear from the current available literature whether the rate of vaginal infection increases or decreases in frequency during pregnancy when compared to the non-pregnant state, but this may be predicted by shifts in vaginal innate immunity. vaginal infections are important players in hiv disease, potentially increasing the risk of viral transmission. in addition, these infections may activate inflammatory markers in the reproductive tract and increase the risk of premature delivery or other negative pregnancy outcomes. the vaginal innate immune system has not been well characterized in pregnant women, or in women with hiv infection. the study of how this system changes in pregnancy and hiv infection will provide essential knowledge for further study of vaginal mucosal protection. the investigators study is an observational study designed to compare levels of vaginal innate immunity markers in women based on a) pregnancy status and b) hiv infection status. comparisons will be made between pregnant and non- pregnant women and between hiv positive and hiv negative women. the investigators hypothesize that there will be significant differences in levels of innate immunity between the groups.


Eligibility criteria:
inclusion criteria: * female * age 18 - 40 years * able to provide informed consent exclusion criteria: * women with the following conditions will be excluded: * currently active syphilis or herpes simplex infection * other (non-hiv) comorbid conditions causing acute or chronic inflammatory states or immunosuppression (i.e., transplant recipients, active systemic lupus) * current use of hormonal birth control or with iud in place * history of hysterectomy or bilateral oophorectomy women with the following conditions will require rescheduling of the study visit: * use of hot tub or pool, vaginal creams, douches, vaginal medications, or vaginal intercourse within 48 hours * current vaginal bleeding * recent treatment for vaginal infection will require 4 - 6 week delay in enrollment pregnant women with the following conditions at the time of examination will be excluded: * active labor or other conditions of duress * signs or symptoms of preterm labor * vaginal bleeding * placenta previa * history of prior preterm birth * ruptured amniotic membranes * multifetal gestation * stillbirth or intrauterine fetal demise (iufd)

Keywords: innate immunity hiv pregnancy vaginal immunity
influencing factors of acute achilles tendinopathy in runners

Conditions: Achilles Tendinopathy

Summary: achilles tendinopathy is highly prevalent in runners, but its evolution is not easily predictable. the aim of this study is to evaluate the impact of clinical and social factors on the prognosis of acute (less than 3 months) achilles tendinopathy in runners. runners will be evaluated in person twice. at their first visit, data related to their training (frequency, intensity, ...), their running pattern (cadence, foot contact angle) and shoes (minimalist index) will be collected. moreover, an ultrasound evaluation of achilles tendon will be performed. at one, two and three months after their initial evaluation, participants will receive a link to complete an online survey about their pain. three months after their initial evaluation, a second ultrasound of achilles tendon will be performed.

at their first visit, participants will read and sign the consent form. they will then fill self-report questionnaires about their pain (using the victorian institute of sport assessment for achilles tendinopathy score and visual analog scale) and its impact on their activities, and they will be questioned on their training habits. then, participants will be asked to run on a treadmill for five minutes at a comfortable speed. during the run, video will be recorded to evaluate to cadence and the foot contact angle. finally, an ultrasound of achilles tendon will be performed to evaluate thickness, area, echogenicity and inflammation of the tendon. all the images will be revised by a physician qualified in diagnostic ultrasound and the tendinopathy will be graded according to matthew and al. model. one, two and three months after their initial visit, participants will receive a questionnaire by email to quantify their pain. moreover, three months after their initial visit, participants will come back in person to the laboratory. information about their pain, training and treatment will be collected and a second ultrasound analysis will be performed. statistical analysis: baseline data will be compared using independent t-test or a mann-whitney u test. significant variables in the univariate analysis will be considered as potential predictor variables. logistic analysis regression will then be performed to identify predictive factors for pain chronicity.

Eligibility criteria:
inclusion criteria: * have achilles tendon pain for less than three months * run at least five kilometers per week * have a score on the victorian institute of sports assessment of achilles tendinopathy of 80 or less * consent to the study exclusion criteria: * history of achilles tendon surgery or rupture

Keywords: runners acute prognosis
24-hour blood pressure measurements and ischemic conditioning

Conditions: Blood Pressure

Summary: to determine if 24-hr ambulatory blood pressure monitoring effects endothelial function, we will measure flow-mediated dilation before and after the blood pressure monitoring (ischemia conditioning).

reestablishing blood flow (reperfusion) to organs that had their blood supply restricted (ischemia) can cause damage to the vasculature via injury and tissue death resulting in endothelial dysfunction. this ischemia-reperfusion (blood flow occlusion and resupply) triggered injury can be reduced or prevented by preceding brief periods of ischemia called preconditioning. properly-performed preconditioning can exert a powerful protection against a subsequent sustained period of ischemia in a variety of organs in the body including the heart, kidney, and skeletal muscle. preconditioning protocol involves repeated brief inflation and deflation of a blood pressure cuff. in many of human cardiovascular research studies, it is common to measure endothelial function and ambulatory (24-hour) blood pressure. the ambulatory blood pressure device takes repeated blood pressure readings every 15-30 minutes during the daytime and 30-60 minutes at night. it is possible that repeated bouts of inflation/deflation of the blood pressure cuff could induce preconditioning effects and influence endothelial function. therefore, in the proposed study we aim to address this hypothesis.

Eligibility criteria:
inclusion criteria: adults aged between 30 to 60 years old. exclusion criteria: exclusion from the study may be due to: i) pregnancy (by asking the subjects when the last time she had menstruation; we do have simple testing kits available if a subject is unsure about her status); ii) a recent illness, recent surgery, or any medical intervention in the 48 hours before any of the study days; iii) personal history of diabetes (fasting blood glucose \> 126 mg/dl), heart disease, or other cardiovascular problems.