Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the product performance of a daily disposable contact lens

Conditions: Myopia; Contact Lenses

Summary: the objective of the study is to evaluate the product performance of visual acuity of the bausch + lomb investigational daily disposable contact lenses compared to the currently marketed johnson \& johnson acuvue moist contact lenses.


Eligibility criteria:
inclusion criteria: * subjects must be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers. * subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week. * subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logmar) or better (distance, high contrast) in each eye. * subjects must have clear central corneas that are free of any anterior segment disorders. * subjects must be myopic and require lens correction from -1.00 d to -6.00 diopters (d) in each eye. exclusion criteria: * subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months. * subjects with any systemic disease currently affecting ocular health or which in the investigator's opinion may have an affect on ocular health during the course of the study. * subjects using any systemic or topical medications that will, in the investigator's opinion, affect ocular physiology or lens performance. * subjects with an active ocular disease or who are using any ocular medication. * subjects who are not correctable to 32 letters (0.3 logmar) in each eye with soft spherical contact lenses. * subjects who currently wear monovision, multifocal, or toric contact lenses. * subjects with an ocular astigmatism of 1.00 d or greater in either eye. * subjects with anisometropia (spherical equivalent) of greater than 1.00 d. * subjects with any grade 2 or greater finding during the slit lamp examination (refer to appendix b for methods of clinical evaluation). * subjects with corneal infiltrates, of any grade, are not eligible. * subjects with any "present" finding during the slit lamp examination (refer to appendix b for methods of clinical evaluation) that, in the investigator's judgment, interferes with contact lens wear. * subjects with any scar or neovascularization within the central 4 mm of the cornea. subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the investigator's judgment, does not interfere with contact lens wear, are eligible for this study. * subjects who are aphakic. * subjects who are amblyopic. * subjects who have presbyopia. * subjects who have had any corneal surgery (eg, refractive surgery). * subjects who are allergic to any component in the study care products.
assessment of the effect of non-surgical periodontal treatment on endothelial function- a prospective study

Conditions: Endothelial Dysfunction; Periodontal Diseases

Summary: an association between periodontitis and endothelial dysfunction has been reported, suggesting that periodontitis presents an inflammatory burden to the cardiovascular system, that might lead to avd. the study aims aim to assess whether non-surgical periodontal therapy enhances endothelial function in periodontitis patients using a non-invasive diagnostic device to assess endothelial function through pwa and the assessment of levels of salivary endothelin-1, in a population of people in the uae.


Eligibility criteria:
inclusion criteria: * group 1: periodontally healthy subjects. * group 2: patients with periodontitis stage iii or iv and grades a,b or c. exclusion criteria: * medical conditions: diabetes,pregnancy,obesity,renal disease,patients with cardiovascular diseases including hypertension,recent myocardial infarction or unstable angina (within 3 months),congestive heart failure,valvular heart disease * heavy smokers(\>10 cigarettes per day), * regular administration of drugs resulting in gingival hyperplasia,root planning in the past 6 months * regular administration of drugs resulting in gingival hyperplasia (such as cyclosporine and phenytoin) * recent antibiotic use (in the past 3 months) * non-surgical periodontal therapy in the past 6 monthsp
long term vestibular impact of covid-19 vaccines among adolescence

Conditions: SARS CoV 2 Vaccination

Summary: long term impact of covid 19 vaccination on dizziness-related disability and balance in adolescence


Eligibility criteria:
inclusion criteria: * adolescence age range 10-17 * received a dose or more of an approved covid-19 vaccine at least one year before the study enrollment. the ability to complete all assessment measures independently. exclusion criteria: 1. vestibular or neurological disorders diagnosed before vaccination. 2. mixed covid-19 vaccine types. 3. a history of traumatic brain injury. 4. current use of medications that affect balance. 5. documented covid-19 infection within three months of assessment. 6. physical limitations that prevented them from completing balance testing.
development of a predictive algorithm for the risk of rehospitalization of patients with heart failure

Conditions: Heart Failure

Summary: heart failure is a chronic disease whose prevalence, due to the aging of the population, is increasing. in france, the prevalence of this pathology is 2.3% (it reaches 10% in the over 75 years) and affects nearly a million patients. the rehospitalization of patients with heart failure affects 25% of patients within 1-3 months of hospital discharge, and 66% at 1 year while 75% of hospitalizations are preventable. these readmissions result in decreased quality of life and increased mortality; from an economic point of view, hospitalization accounts for 70% of expenses related to the management of heart failure. avoiding rehospitalization is therefore a major public health issue. the current predictive scores remain perfectible, even though risk factors for readmission have already been the subject of numerous studies. the identification of patients at risk of rehospitalization is still an issue, especially for patients with preserved left ventricular ejection fraction. targeting patients requiring appropriate care remains an issue. the rise of innovative statistical techniques around big data in health opens new perspectives for the scientific exploitation of data available in electronic medical records, for example in the field of prediction. this study aims to explore the risk of rehospitalization in heart failure patients by analyzing routine data collected in medical records and by mobilizing artificial intelligence algorithms. a review of the literature confirms the innovative nature of such an approach: the majority of the studies identified implemented a prospective collection of data; only 20% of the studies mobilized the medical file; no french study used the new machine learning algorithms.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients with heart failure hospitalized in the cardiology department ath ghpsj between january 2015 to december 2018 exclusion criteria: * patient opposing the use of his data for this research * patient under tutorship or curatorship * patient deprived of liberty
the effect of a methylprednisolone taper on outcomes following total knee arthroplasty

Conditions: Arthritis Knee; Knee Osteoarthritis; Pain, Postoperative

Summary: pain control and early range of motion following total knee arthroplasty are essential for patient satisfaction. intraoperative steroids (dexamethasone) have been shown to have a significant effect in controlling acute pain following total knee arthroplasty. this study aims to evaluate the effect of a post-operative steroid (methylprednisolone) taper in improving functional and patient-reported outcomes following total knee arthroplasty. a taper means taking a high dose of a medication followed by taking lower doses and each following day until the medication is stopped.


Eligibility criteria:
inclusion criteria: * patients indicated for primary total knee arthroplasty. * access to computer or smartphone for completion of redcap surveys exclusion criteria: * patients less than 18 years of age, patients unable to consent, known diabetic patients and those with an hgba1c \>6.5 preoperatively, patients who are on chronic steroid treatments, patients with chronic pain on opioid management, patients with allergies to steroids, patients with a history of peptic ulcer disease, patients with a history of heart failure and patients with a history of renal and/or hepatic failure will be excluded. those that are immunosuppressed as well as pregnant and/or lactating will also be excluded.

Keywords: total knee arthroplasty knee osteoarthritis pain management
analgesic efficacy of duloxetine in patients undergoing lumbar discectomy

Conditions: Acute Pain

Summary: duloxetine is a serotonin-norepinephrine reuptake inhibitor primarily used for treatment of major depression and anxiety. duloxetine also has been used in the treatment of chronic pain conditions, such as osteoarthritis and musculoskeletal pain. there are few studies examining its effect for acute pain. the objective of this study is to evaluate the analgesic effect of duloxetine for patients undergoing lumbar discectomy.


Eligibility criteria:
inclusion criteria: * patients undergoing lumbar discectomy exclusion criteria: * patients on regular opioid therapy * uncontrolled hypertensive patients * patients with ischemic heart disease
a study of ibi3004 in subjects with unresectable, locally advanced or metastatic solid tumors

Conditions: Solid Tumor

Summary: this is an open-label, multicenter, dose escalation and expansion phase i /ii study of ibi3004 in subjects with unresectable, locally advanced or metastatic solid tumors. it includes a phase 1 dose escalation and expansion section to identify maximum tolerated dose (mtd)/recommended phase 2 dose (rp2d) of ibi3004. accelerated titration and the bayesian optimal interval (boin) design is used to find the mtd or rp2d, and the maximum sample size is 46. one or more dose levels will be selected for dose expansion, each dose group will be expanded to 30 subjects.


Eligibility criteria:
inclusion criteria: 1. subjects have the ability to understand and give written informed consent for participation in this trial, including all evaluations and procedures as specified by this protocol; 2. male or female subjects ≥ 18 years old. for part 1, age ≥18 and ≤75 years old 3. eastern cooperative oncology group (ecog) performance status (ps) of 0 or 1; 4. anticipated life expectancy of ≥ 12 weeks; 5. adequate bone marrow and organ function exclusion criteria: 1. enrolled in any other interventional clinical research except unless only involved in an observational study (non-interventional) or in the follow-up phase of an interventional study; 2. received previous anti-tumor therapy: within 21 days of monoclonal antibodies or cytotoxic therapy prior to the first dose of the study drug, or within 14 days of small molecule targeted drugs prior to the first dose of the study drug. received palliative radiation therapy within 2 weeks prior to the first dose of the study drug, or received radical radiation therapy within 4 weeks prior to the first dose of the study drug; 3. received live vaccines within 4 weeks prior to first administration of the study drug or plan on receiving any live vaccine during the study; 4. has adverse reactions resulting from previous antitumor therapies, which have not resolved to grade 0 or 1 toxicity according to nci-common terminology criteria for adverse events (ctcae) v5.0 (except for alopecia, fatigue, pigmentation and other conditions with no safety risk according to investigator' discretion) or baseline prior to the first dose of the study drug; 5. undergone major surgery (craniotomy, thoracotomy or laparotomy, and other surgery according to investigator' discretion, excluding needle biopsy) within 4 weeks prior to the first dose of the study drug, or who are expected to undergo major surgery during the study period, or who have severe unhealed wounds, trauma, ulcers, etc.
revival of stem cells in addison's study

Conditions: Adrenal Failure

Summary: autoimmune addison's disease (aad) is a rare and debilitating disease in which an autoimmune attack progressively destroys the adrenal cortex. untreated it is universally fatal and treated people are absolutely dependent upon steroid medications lifelong, with a consequent excess in morbidity and mortality. a key feature of the adrenal cortex is that its cells are responsive to changes in circulating adrenocorticotrophic hormone (acth) concentration. this study aims to regenerate adrenocortical steroidogenic cell function in patients with established autoimmune addison's disease (aad) by stimulating proliferation and differentiation of their progenitor cells, the adrenocortical stem cells (acscs) (1,2). using daily subcutaneous acth, administered according to two different regimens over 20 weeks, we will investigate whether regeneration of adrenal steroidogenic function through revival of acsc activity is a realistic possibility.


Eligibility criteria:
inclusion criteria: * established autoimmune adrenal failure for \>1yr age 16 to 65 exclusion criteria: * significant cardio-respiratory, chronic renal or non-autoimmune liver disease; malignancy * asthma, current infectious disease, recent live vaccination, acute psychosis, peptic ulcer disease * pregnancy, breast feeding or plan for pregnancy within 9 months * known non-autoimmune cause for adrenal failure (haemorrhage, adrenoleukodystrophy etc.) * known hypersensitivity or allergy to synacthen
safety, pharmacokinetics and pharmacodynamics of velusetrag in healthy elderly subjects

Conditions: Alzheimer's Disease

Summary: this is a phase 1, randomized, placebo-controlled, double-blind, study of safety, pharmacokinetics and pharmacodynamics of velusetrag in healthy elderly subjects.


Eligibility criteria:
inclusion criteria: • is in reasonably good health as determined by the investigator based on a detailed medical history, full physical examination (pe), vital signs (vs) (including blood pressure and pulse rate measurement), 12-lead ecg, and clinical laboratory tests. * subjects with mild, chronic, stable disease (e.g., controlled hypertension, controlled hypercholesterolemia, non-insulin dependent diabetes, osteoarthritis) may be enrolled if well controlled and not anticipated to interfere with the objectives of the study. * mild deviations from normal limits in pe, vs, ecg parameters, lab tests are acceptable if associated with the stable condition or are age-related exclusion criteria: * has a condition, which in the opinion of the investigator, would confound or interfere with evaluation of safety and tolerability or pk or pd of the investigational drug, or prevent compliance with the protocol

Keywords: alzheimer's disease elderly
the rest study for cgm use in older adults with insulin-treated diabetes

Conditions: Diabetes Mellitus

Summary: to assess the efficacy of the rest model in facilitating adoption and sustained use of cgm, in older adults with type 1 diabetes (t1d) or type 2 diabetes (t2d) on complex insulin regimens. to examine barriers and enablers for the implementation feasibility of the rest intervention model using a mixed-methods approach. to assess the impact of rest model on economic factors and quality of life measures. the goal of this study is to facilitate the adoption of continuous glucose monitoring (cgm) in older adults (≥65 years) with diabetes mellitus (dm) on complex insulin regimens, and additionally, to build a framework for sustained cgm use over time using a novel patient-centered model - the rest model.

older adults with diabetes on multiple insulin injections are at greater risk of hypoglycemia and its poor outcomes. use of continuous glucose monitoring (cgm) has shown to improve glycemic control and reduce hypoglycemia in this age group. despite medicare coverage for cgm, uptake in this age group is still low. the goal of this study is to facilitate the adoption of continuous glucose monitoring (cgm) in older adults (≥65 years) with diabetes mellitus (dm) on complex insulin regimens, and additionally, to build a framework for sustained cgm use over time using a novel patient-centered model - the rest model. this model will assess readiness and barriers to cgm initiation and utilization, provide remote education, and implement a framework for sustainability of cgm technology adoption. the study will assess the impact of the rest model and its ability to increase cgm uptake and use in this age group, as well as its effectiveness on improving glycemic metrics. the study will also evaluate the impact of the rest model on economic and health-related quality-of-life measures.

Eligibility criteria:
inclusion criteria: * older adults age ≥65 years * t1d or t2d with duration longer than 1 year * insulin treatment includes: ≥3 insulin injections/day or on insulin pump therapy * cgm naïve and/or cgm users (dexcom g6) who are not meeting glycemic goals (per cgm metrics): * ≥4% hypoglycemia (sensor glucose ≤70 mg/dl) or * time in range (70-180 mg/dl) tir ≤40 % * willing to wear cgm dexcom at all times while in the study * willing to use/carry personal or loaned smart phone device to use as dexcom receiver for continual data upload to cloud exclusion criteria: * life expectancy \<1 year * end-stage renal disease (egfr\< 30ml/min) * on acetaminophen \>4 gr/day due to interference with dexcom g6 sensor readings * on hydroxyurea therapy due to interference with dexcom g6 sensor readings * impaired vision and hearing which would interfere with participation in remote video visits * use of hybrid closed-loop systems (this may require different and additional focused education and will not be addressed in this study).

Keywords: older adults cgm diabetes technology telehealth
mbi and breast tomosynthesis screening accuracies in patients with dense breast tissue

Conditions: Breast Neoplasms

Summary: primary: in women with heterogeneous or dense breast tissue (mammographic types 3 and 4), mbi (molecular breast imaging) will detect more breast cancers and have greater sensitivity in detecting breast cancer than breast tomosynthesis. secondary: 1. in women with heterogeneous or dense breast tissue, the specificity of mbi in correctly classifying subjects without breast cancer will be non-inferior to breast tomosynthesis. 2. in women with heterogeneous or dense breast tissue, the area under the receiver operating characteristic (roc) curve for mbi will be non-inferior or superior to breast tomosynthesis. 3. combining the use of mbi and breast tomosynthesis will provide performance superior to either technology alone, as manifest by a superior roc curve area.


Eligibility criteria:
inclusion criteria: * women over 25 years of age with normal or increased risk of breast cancer. * women with type 3 or 4 breast density as determined by a breast imaging radiologist on a current unilateral (women with prior mastectomy) or bilateral mammography (within prior 6 weeks). * no contraindications to breast mbi or breast tomosynthesis. exclusion criteria: * women under the age of 25. * women who are or may be pregnant. * women who are currently lactating or have discontinued breast feeding \< 2 months prior to the study. * male patients are excluded as subjects. * those unable or unwilling to provide informed consent.
feasibility of translumenal endoscopic omental patch closure of perforated viscus

Conditions: Peptic Ulcer

Summary: this study is being done to see if a new approach to repair perforated ulcers in the stomach (holes in the stomach) or the first part of the intestine is possible. traditionally, either open operations (large single incision) or laparoscopic operations (multiple small camera-guided incisions) have been used to repair perforated ulcers. over the last ten years, some surgeons have used endoscopic equipment to assist them with performing the procedure. it is unknown if perforated ulcer repair can be done using an endoscope as the main instrument (a flexible tube with a video camera inserted into the stomach through your esophagus) to "patch" or plug the perforation. we will patch the perforation using a standard method which uses tissue from outside the stomach. a laparoscopic camera will also be used to assist our view. this study is intended to be a feasibility study to demonstrate the endoscopic technique can be safely performed hypothesis: the primary outcome is successful completion of the procedure.

perforation is the most dangerous complication of gastroduodenal ulcer disease. it accounts for more than 70% of deaths associated with peptic ulcer disease. in addition to age and concomitant disease, intervention related complications are statistically significant predictors of death after hospital stay. age, time to presentation and comorbidities are not factors that can be influenced. if it would be possible to reduce the impact of procedure related complications or the "second hit", that may lead to decreased morbidity and mortality. this will be a pilot clinical study to evaluate the safety and feasibility of endoscopic translumenal omental patch closure. patients with the clinical diagnosis of a perforated viscus who are scheduled to undergo surgical exploration will be recruited. endoscopic translumenal omental patch will be attempted first if the patient has no contraindication. should this prove unsuccessful, the surgical team will proceed with conversion to laparoscopic or open standard surgical therapy as indicated.

Eligibility criteria:
inclusion criteria: * patients presenting with clinical diagnosis of a perforated viscus who are scheduled to undergo surgical intervention * surgical candidate for endoscopic, laparoscopic, or open procedure * age \> 21 * informed written consent exclusion criteria: * prior gastric or duodenal surgery * prior total abdominal colectomy or transverse colectomy * prior omentectomy or omental flaps * known perforation site other than stomach or duodenum * patients with contra-indications for laparoscopy * patients with contraindications for endoscopy * upper gastrointestinal anatomy that would preclude endoscopic therapy * coagulopathy or thrombocytopenia * pregnant patients * patients \<21 years of age * prisoners * patients found at surgery to have disease processes other than perforated peptic ulcer disease will be asked for permission to record their data for comparison

Keywords: ulcer repair surgery transluminal omental patch
effects of transcranial direct current stimulation (tdcs) on neuropathic symptoms due to burn injury

Conditions: Pain; Burn Injury

Summary: the purpose of this study is to investigate the effects of transcranial direct current stimulation (tdcs) on the neuropathic symptoms (pain/itch) due to a burn injury. the investigators hypothesize that the active tdcs group will show a significant pain/itch reduction when compared to sham stimulation.


Eligibility criteria:
study eligibility criteria: 1. providing informed consent to participate in the study 2. 18 to 64 years old 3. any size closed wound from burn injury, occurring at least 3 weeks prior to enrollment in the study. - subjects with burns in scalp area will be excluded from the study as the electrode may cause irritation to the injuries 4. use of regular medications for pain and/or itching control at stable doses for at least 3 weeks prior to enrollment in the study 5. no contraindications to tdcs: * metallic implants in the head * implanted brain medical devices 6. subject is not pregnant at the time of enrollment 7. neuropathic pain or itching (rated at least 4 on the vas) within the burn scar or donor site, (pain can be described as burning, stabbing, piercing, pins and needles, tearing sensation) for at least 3 weeks. please note: if a patient reports pain and itching, we will enroll the patient based upon their most dominant symptom.

Keywords: transcranial direct current stimulation