Kornimate/medical-research-clean huggingface dataset:
phase 1 study for safety and tolerability of ebi-005 topically administered to eyes of healthy adult subjects

Conditions: Dry Eye

Summary: this is a first-in-human (fih) study to assess the safety and tolerability of ocular administration of ebi-005 in healthy volunteers. additionally, the pk and immunogenicity of ebi-005 will be assessed.

the planned dose levels are 5 mg/ml ebi-005 (group 1) and 20 mg/ml ebi-005 (group 2). a total of 8 subjects will be dosed in each group with subjects randomized in a ratio of 6:2, ebi-005:placebo. treatment administration in group 2 will proceed following a review of safety data from group 1. in both groups, subjects randomized to active treatment will receive ebi-005 in the right eye and placebo in the left eye. subjects randomized to placebo will receive placebo in each eye.

Eligibility criteria:
inclusion criteria: * healthy adult males and/or females between the ages of 18 and 65 years * medically healthy * best correction vision of greater than or equal to 20/40 in each eye * non-tobacco/nicotine-containing product users for a minimum of 6 months prior to dosing * tolerate topical administration to eye * signed and dated, institutional review board (irb) approved informed consent form (icf) prior to any protocol-specific screening procedures exclusion criteria: * history or presence of significant cardiovascular, pulmonary, hepatic, renal, hematological, gastrointestinal, endocrine, immunologic, dermatologic (including sensitive skin on the face), neurological, or psychiatric disease, or any other clinically significant disease not deemed acceptable by the pi * history of any primary malignancy, with the exception of basal cell or squamous cell carcinomas of the skin or cervical carcinoma in situ or other malignancies curatively treated and with no evidence of disease for at least 5 years * occurrence of active seasonal allergies including ocular allergies (e.g.; annual hay fever) * abnormalities following ophthalmological examination: abnormality of the cornea, evidence of ocular inflammation (dry eyes, blepharitis, allergic conjunctivitis, iritis, and uveitis), glaucoma, and optic neuropathy * subjects with a history of laser refractive surgery (laser assisted stromal in-situ keratomileusis \[lasik\], photorefractive keratectomy \[prk\]), radial keratotomy (rk), corneal transplantation, dry eyes, or radiotherapy to the eyes * use of contact lenses currently or within the past one year * positive urine drug/alcohol or cotinine testing

Keywords: healthy interleukin 1 receptor inhibitor dry eye
preschool based obesity prevention effectiveness trial

Conditions: Cardiovascular Diseases; Heart Diseases; Obesity

Summary: the purpose of this study is to compare changes in body mass index (bmi) among 3- to 5-year-old minority children randomized to a weight control intervention (wci) or a general health control intervention.

background: obesity is epidemic in the u.s. and is associated with increased risk for numerous medical problems. many obesity-related risk factors are strikingly apparent in minority populations. ethnic differences in obesity related risk factors begin as early as six to nine years of age. thus, the need for overweight prevention efforts as early as the preschool years is critical. this study builds upon the findings of the "hip-hop to health" program. the primary aim of hip-hop was to compare changes in body mass index (bmi \[kg/m2\]) in two groups of 3- to 5-year-old minority children randomized to a weight control intervention (wci) or a general health control intervention (ghi). results for the children at the year 1 and 2 follow-ups showed that children in the wci had significantly smaller relative changes in bmi compared to children in the ghi control group. the success was among the schools that served predominantly black children. hip-hop to health was an efficacy trial delivered by trained specialists in early childhood education, and the first efficacy trial to document change in bmi in preschool children. design narrative: this study will test a 14-week teacher-delivered weight control intervention (td-wci) to a 14-week teacher delivered general health control intervention (td-ghi) in a randomized community trial occurring in 16 preschools in the chicago school district. the study has the following aims: 1) to compare children in these two conditions on changes in bmi post intervention and at year 1 follow-up; 2) to compare children in these two conditions on changes in television viewing, physical activity, and fat, fiber, fruit and vegetable intake at post-intervention and year 1 follow-up; and 3) to compare classroom teachers in these two conditions on nutrition and exercise knowledge, nutrition attitudes, and support for healthy eating post-intervention and year 1 follow-up. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
inclusion criteria: * have received an annual physical * parent or guardian willing to give informed consent * parent or guardian willing to provide demographic and anthropometric data and agree to complete food intake and physical activity information for their child exclusion criteria: * requires a specialized diet outside of that served by the chicago public schools * has a chronic physical or behavioral disorder that requires participant to be under close medical psychological supervision and routinely absent from the study
impact of removable cast walker design on usability for patients with diabetic foot ulcers

Conditions: Diabetes Mellitus; Foot Ulcer

Summary: within their lifetime, over 30% of people living with diabetes will develop a diabetic foot ulcer (dfu), many of which will never heal and may require amputation. removable cast walkers (rcws) are commonly prescribed to offload (treat) dfus. while rcws are prescribed to be worn during all weight bearing activities, adherence to this prescription is low. this is a serious concern given that low adherence predicts poor dfu healing. this study will provide pilot/feasibility data to inform a larger clinical trial to evaluate the impact of existing rcw designs on adherence and dfu healing. we will also quantify the effect of rcw form on biomechanical and self-reported measures related to usability. our working hypothesis is that healing outcomes with a given rcw will be predicted by biomechanical and self-reported measures of rcw usability, with the predictive relationship partly explained by the effect of these measures on adherence.


Eligibility criteria:
inclusion criteria: * presence of a full thickness plantar (forefoot) diabetic foot ulcer ≥1cm2 that is being treated on an outpatient basis with a university of texas wound classification of 1a-c or 2 a-c; * self-reported ability to walk for at least two continuous minutes at a self-selected speed * confirmation of the presence of diabetic peripheral neuropathy as identified by failure to detect a 10 gram semmes weinstein monofilament on either foot at one of four sites tested (1st, 3rd, 5th metatarsal heads, and plantar surface of hallux) or a vibration perception threshold value of 25 or more at either hallux. exclusion criteria: * lower extremity amputation more proximal than transmetatarsal on either limb * chronic kidney disease stage 4 or higher (i.e., currently undergoing dialysis or egfr\<30 within last 60 days) * active charcot neuroarthropathy * severe peripheral arterial disease (non-palpable pulse at posterior tibia and dorsalis pedis arteries, and an ankle brachial index\<0.7) * gait/balance disturbance not attributable to diabetes (e.g. neuromuscular disease or cerebrovascular vascular accident) * current or previous (within past year) use of an ankle-high rcw or of a contralateral lift to offset an rcw-induced lld
a pilot study to explore the role of gut flora in colorectal cancer

Conditions: Colorectal Cancer; Colorectal Neoplasms; Colorectal Carcinoma; Colorectal Adenocarcinoma; Colorectal Cancer Metastatic; Colorectal Sarcoma

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding colorectal cancer.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding colorectal cancer.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female patients of any age (interest is given to children to compare with mothers). 3. diagnosis of colorectal cancer exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
machine learning-based anomaly recognition system

Conditions: Fetal Anomaly

Summary: mars is an artificial intelligence-powered system that aims at detecting common fetal anomalies during real-time obstetrics ultrasound. the current study comprises 2 stages: (1) the stage of model creation which will include retrospective collection of images from fetal anatomy scans with known diagnoses to train these model and test their diagnostic accuracy. (2) the stage of model validation through prospective application of this model to collected videos with known normal and abnormal diagnoses

routine second trimester anomaly scan has become a routine part of antenatal care. early detection of fetal anomalies permits patient counselling, consideration of termination if detected anomalies are considerable, and arrangement of delivery and immediate neonatal care if indicated. furthermore, with the expanding role of fetal interventions, early detection of fetal anomalies may expand management options, some of which may lead superior outcomes compared to postnatal interventions. however, fetal anatomy scan necessitates a particular level of training and expertise, either by sonographers or obstetricians. unfortunately, availability of experienced personals may be globally limited. furthermore, first trimester anatomy scan has been evolving rapidly as ultrasound machine continues to develop and clinical research yields more information on first trimester normal standards and abnormal ranges. accordingly, first trimester scan is anticipated to be a part of routine care in the near future. although this tool should provide substantial benefits to obstetric patients, this would require more providers with specific training, which is unlikely to be readily available. artificial intelligence has been incorporated in the medical field for more than 20 years. with the advancement of deep learning algorithms, deep learning has yielded exceptional accuracy in image recognition. in the last decade, deep learning exhibits high quality performance that may exceed human performance at times. one of the earliest and most prevalent applications of deep learning in medicine are radiology-related. in the current study, the investigators will create a series of deep learning models that appraise and identify common fetal anomalies in a series of frames including recorded videos or real time ultrasound. deep learning algorithms will be fed by labelled images of known normal and abnormal findings representing common fetal anomalies for both training and validation. these images will be collected retrospectively through medical records of contributing centers. their diagnostic performance will be tested on retrospectively collected videos including normal and abnormal findings. in the second stage of the study, these models will be applied to prospectively collected videos of fetal anatomy scan for further validation.

Eligibility criteria:
inclusion criteria: * pregnant women between 18 and 45 years * available ultrasound image with clear findings * postnatal confirmation of diagnosis exclusion criteria: * absence of research authorization on medical records
a retrospective study on hospitalized patients with community-acquired pneumonia in china (cap-china)

Conditions: Community Acquired Pneumonia

Summary: the purpose of this study is to evaluate the disease burden of hospitalized patients with cap and healthcare-associated pneumonia (hcap) in real life of china .

in china, the data about current management of patients hospitalized with cap in the real-life setting is not available,type of pneumonia, selection of initial antibiotic, time to clinical stability, antibiotic choice anf modification,clinical outcomes and costs remain unclear. in this study, we will collect comprehensive information on cap and hcap management patterns to evaluate the disease burden of hospitalized patients with cap and hcap in real life of china .to analyze microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of patients with cap (\> and = 65 years, different comorbidities ,risk factors) ,to investigate microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of disease severity with cap ,to provide the difference on microbiological characteristics,clinical manifestations,antibiotic regimens ,and outcome between patients with cap and hcap ,to understand the current situation of antibiotic regimen ,to evaluate influence of different antibiotic regimens on prognosis.

Eligibility criteria:
inclusion criteria: * patients \> or = 14 years of age * patient meets the criteria of community acquired pneumonia * patient meets the criteria of healthcare-associated pneumonia exclusion criteria: * patients \<14 years of age * patient meets the criteria of hospital acquired pneumonia * known active tuberculosis or current treatment for tuberculosis * non-infectious pulmonary diseases * hiv positive

Keywords: community acquired pneumonia health care associated pneumonia
glucose monitoring during chemotherapy

Conditions: Breast Cancer; Hyperglycemia

Summary: this is a research study to look at blood sugar changes during chemotherapy using a continuous blood sugar monitoring device. the device uses patches that attach to the skin on the back of the arm to measure blood sugar changes for the duration of the chemotherapy course. each patch lasts for about 2-weeks. during chemotherapy visits, new patches will be placed and will be worn until the chemotherapy course is complete. participants will be in this study for 6 months. approximately 50 patients will be enrolled in this study.

this is a prospective observational cohort study monitoring trends in glucose in patients with early stage breast cancer treated with neoadjuvant or adjuvant chemotherapy. patients will wear a noninvasive glucose monitoring sensor, the freestyle libre pro for the duration of chemotherapy. the primary goal of this trial is to evaluate the prevalence of hyperglycemia in patients with early-stage breast cancer during neoadjuvant/adjuvant chemotherapy. fifty patients will be enrolled. during each chemotherapy encounter, subjects will have their glucose sensor scanned in order to download subjects' glucose data. if the sensor has become no longer adherent to the participant's skin, participants will bring the sensor with them to the chemotherapy infusion center to be scanned. during each chemotherapy encounter, the free style libre sensor will be replaced by the study team. participants who receive chemotherapy every three weeks will be asked to come in 10-14 days after their chemotherapy infusion to replace the sensor. the sensors will be worn through completion of chemotherapy (the duration will vary based on the individual's chemotherapy regimen). patients will have fructosamine, a glucose biomarker, and serum creatinine testing at baseline and every 3 weeks (weeks 3, 6, 9, 12, 15, 18, 21, 24) until week 24 (note: week 15, 18, and 21 are optional). patients will have additional glucose biomarker testing (hemoglobin a1c, glucose, and insulin \[fasting preferred\]) at baseline, week 12 and week 24. patients will also complete questionnaires assessing for symptoms of chemotherapy induced peripheral neuropathy, quality of life, and fatigue at baseline, week 12 and week 24. visits will be conducted within the below specified windows forbidding unexpected circumstances such as missed appointments or loss to follow-up.

Eligibility criteria:
inclusion criteria: * age ≥18 years * history of stage i-iii breast cancer * patient scheduled to receive adjuvant or neoadjuvant chemotherapy * signed informed consent exclusion criteria: * current treatment with insulin * current treatment with non-topical steroids, with the exception of steroid treatment as a supportive chemotherapy medication * inability to provide informed consent

Keywords: freestyle libre pro
pharmacological interaction of rifampicin on clindamycin in staphylococcic osteoarticular infections

Conditions: Staphylococcal Infections

Summary: clindamycin and rifampicin are authorized in osteoarticular infection treatment (idsa guidelines) but some interaction is observed. the objective of this study is to evaluate and quantify rifampicin interaction on clindamycin

it could suggest modification of recommended doses or incitement to antibiotic dosage. thus, theses antibiotics, if association is allowed, could limit fluoroquinolones prescription and avoid some antibiotic resistance.

Eligibility criteria:
inclusion criteria: * patients ≥18 years of age * osteoarticular infection * staphylococcus detected in bacteriological sampling * sensibility to rifampicin, erythromycin and clindamycin * active intravenous antibiotherapy against staphylococcus detected in bacteriological sampling exclusion criteria: * septic shock or severe initial sepsis * osteoarticular infection with other microorganism than staphylococcus * contraindication to clindamycin or rifampicin including case of hypersensibility to one of these two antibiotics * pre-existing renal insufficiency or severe renal insufficiency (creatinine clearance \<30 ml/min) * serious cognitive disorders * patient under guardianship, trusteeship or non affiliated to social security or cmu (beneficiary or assignee) * refusal to take part in the study and to sign the consent form * pregnancy * lactation * administration of clindamycin or rifampicin within the month before inclusion * treatment with enzymatic inductor or inhibitor within the month before inclusion * participation to another study modifying antibiotic treatment administration

Keywords: osteoarticular infection rifampicin clindamycin enzymatic induction antibiotherapy resistance
intralesional bevacizumab injection on primary pterygium

Conditions: Pterygium; Inflammation

Summary: the purpose of this study is to evaluate that intralesional injection of bevacizumab on primary pterygium can reduce the corneal pterygium area, inflammation, redness and other symptoms.

to evaluate the efficacy and safety of intralesional injection of bevacizumab on primary pterygium treatment

Eligibility criteria:
inclusion criteria: * primary pterygium exclusion criteria: * previous ocular surgery

Keywords: bevacizumab pterygium treatment elevation
quality of life after interventional thyroid treatment

Conditions: Thyroid; Deficiency; Quality of Life

Summary: in this study, patients are prospectively followed after radioiodine treatment to assess the relationship between thyroid status and their quality of life after thyroid ablative treatment. a third treatment arm after surgery has been stopped, as deemed currently not feasible to achieve its target.

patients are frequently dissatisfied with lt4 replacement treatment. the reasons for persisting patient complaints are poorly understood. conversion efficiency and impaired t3/t4 ratios in athyreotic patients may play a major role. we hypothesised that the extent of ablation either by surgery or radioiodine treatment may result in biochemical disequilibria between ft3, ft4 and tsh and those may be, in turn, associated with persisting symptomatology. the study follows patients after radioiodine therapy as well as a control group over half a year, assessing thyroid status, set points, conversion rates, thyroid volume, lt4 administration and dosing, demographic characteristics and quality of life measures. the treatment mode is not part of the study, and determined by criteria and procedures of best standard care. for that reason, a randomised or blinded design is not possible. changes and interrelationships between thyroid parameters and qol measures are analysed within-subjects and between treatment groups.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of a thyroid disease requiring radioiodine treatment * clinical diagnosis of a thyroid disease requiring follow-up but no ablative treatment (controls) * clinical diagnosis of a thyroid disease requiring surgery stopped recruiting exclusion criteria: * paediatric patients * interfering comorbidity * non-thyroidal illness * pregnancy * psychiatric disease * severe psychological disorder * lack of consent

Keywords: lt4 treatment qol