Kornimate/medical-research-clean huggingface dataset:
safety and efficacy of kpi-121 in subjects with inflammatory meibomian gland disease

Conditions: Blepharitis

Summary: the primary purpose of this study is to determine the efficacy and safety of kpi-121 ophthalmic suspension compared to vehicle (placebo) in subjects with signs and symptoms of inflammatory meibomian gland disease.

this is a phase ii, multicenter, double-masked, randomized, vehicle-controlled, parallel-group study designed to evaluate the efficacy and safety of kpi-121 ophthalmic suspension versus vehicle in subjects with signs and symptoms of inflammatory meibomian gland disease. the product will be studied over 28 days, with 1-2 drops instilled in each eye four times daily (qid).

Eligibility criteria:
inclusion criteria: have a documented clinical diagnosis of inflammatory meibomian gland disease in both eyes. exclusion criteria: * known hypersensitivity/contraindication to study product(s) or components. * be currently receiving treatment for glaucoma, have history of or current glaucoma, or an iop (intraocular pressure) over 21mmhg at visit 1 (screening) or visit 2 (randomization). * be unwilling to discontinue warm compress therapy, lid expression, or lid massage 14 days prior to day 1 and for the duration of the study. * diagnosis of: ongoing ocular infection; severe/serious ocular condition that in judgment of investigator could confound study assessments or limit compliance; severe/serious systemic disease or uncontrolled medical condition that in judgment of investigator could confound study assessments or limit compliance; or have been exposed to an investigational drug within the 30 days prior to screening. * have had ocular surgery in the past 90 days or require ocular surgery during the study. * in the opinion of investigator or study coordinator, be unwilling or unable to comply with study protocol or unable to successfully instill eye drops.

Keywords: pain corticosteroid meibomian gland disease blepharitis eyelid ocular discomfort
revlimid® capsules drug use-results surveillance (relapsed or refractory atll)

Conditions: Lymphoma

Summary: to understand the safety and efficacy of revlimid® capsules 2.5 mg and 5 mg (hereinafter referred to as revlimid) under actual conditions of use in patients with relapsed or refractory adult t-cell leukemia lymphoma (hereinafter referred to as relapsed or refractory adult t-cell leukemia lymphoma (atll)). 1. planned registration period 3 years 2. planned surveillance period 4 years and 6 months after a month after the approval for partial changes in the approved items is granted for relapsed or refractory atll


Eligibility criteria:
inclusion criteria: - relapsed or refractory adult t-cell leukemia lymphoma exclusion criteria: * n/a

Keywords: adult t-cell leukemia lymphoma teratogenicity myelosuppression haemorrhage infection thromboembolism hypersensitivity tumor lysis syndrome peripheral neuropathy ischaemic heart disease cardiac failure arrhythmia renal failure interstitial lung disease hepatic disorder hypothyroidism gastrointestinal perforation orthostatic hypotension convulsion somnolence confusion fatigue dizziness blurred vision second primary cancer cataract revlimid capsules
intestinal microbiome and extremes of atherosclerosis

Conditions: Gastrointestinal Microbiome, Atherosclerosis, Nutrients; Renal Function

Summary: patients attending stroke prevention clinics and a premature atherosclerosis clinic at university hospital in london, on, canada were recruited to the study. they completed a dietary questionnaire, provided stool samples and had blood drawn to measure plasma levels of metabolites produced by the intestinal bacteria.

patients were phenotyped by their residual score in linear multiple regression with measured carotid plaque burden as the dependent variable and coronary risk factors were predictors. the residual score essentially represents the distance off the regression line of predicted plaque. they were grouped into three categories: unexplained atherosclerosis (with more plaque than predicted by risk factors; residual score \>2); explained (the amount of plaque predicted by risk factors, residual score \>-2 and \<2); and protected (less plaque than predicted by risk factors, residual score \<-2). dna was extracted from stool samples in the lab of dr. allen-vercoe at university of guelph. rna makeup of the intestinal microbiome was assessed in the lab of dr. gregory gloor at western. plasma levels of trimethylamine n-oxide, p-cresylsulfate, hippuric acid, p-cresyl glucuronide, pheny acetyl glutamine and phenyl sulfate were measured by ultra-performance liquid chromatography coupled to quadrupole time-of-flight mass spectrometry in the lab of dr. bradley urquhart at western. nutrient intake over the past year was calculated at the harvard school of public health from the 131 item self-reported and semi-quantitative harvard food frequency questionnaire (ffq). estimated glomerular filtration rate was calculated from the chronic kidney disease epidemiological (ckd-epi) equations.

Eligibility criteria:
inclusion criteria: * patients attending stroke prevention clinics and a premature atherosclerosis clinic at university hospital, london, on, canada, * with measurements of carotid plaque burden and the risk factors used in the linear regression model. * willing to consent to the protocol approved by the ethics board exclusion criteria: * missing data on variables used in the regression model,

Keywords: intestinal microbiome atherosclerosis nutrients renal function
transcranial and rapid magnetic stimulation for gait apraxia due to normal pressure hydrocephalus and cerebral ischemia

Conditions: Walking; Cognitive Function

Summary: the investigator(neurologist) has published a study in international congress series, in the 15th international conference of biomagnetism vancouver proceedings 2006,and science direct website, of 15 patients with brain ischemia and dilated ventricles who improve when treated with transcranial monitoring or low ultrasound wave intensity (milliwatts) and with rapid magnetic stimulation which is also a diagnostic tool routinely used by many neurophysiologists. before, these patients will progress and may need a brain shunt called ventriculo-peritoneal shunt. he and collaborators now would like to do a double study as this appears to be a cheap and effective alternative treatment and help patients to walk again.

the transcranial monitoring intensity would be equivalent to the well known clotbust study (\<300mw/sq cm)for one hour, using two probes. all will be treated as an outpatient and there is no form of infusion or interventional treatment. the rapid magnetic stimulation is at about 50a/us, 15hz, 1000 pulses with 10 sec pause for ten days along the skull vault. informed consent will be obtained. 30 patients will be recruited and sham treatment would be just applying probe without power for transcranial and for magnetic stimulation coil will be angled away. data will be compiled by a separate blinded investigator and so with the statistics. vp shunt failure patients, which is common, will be included. barthel's daily living index and standard cognitive tests will be used to assess results.

Eligibility criteria:
inclusion criteria: * cerebral ischemia with our without hydrocephalus and gait apraxia exclusion criteria: * all other conditions which contribute to walking difficulty e.g. bad knees; or spondylosis; parkinson's or paralytic strokes

Keywords: transcranial sonolysis or monitoring rapid magnetic stimulation cerebral ischemia hydrocephalus barthel's index
effects of cardiovascular and pulmonary optimization on cerebral oxygenation in covid-19 patients with severe ards

Conditions: COVID-19; Respiratory Failure

Summary: the aim of the present study is to examine whether cerebral oxygenation could be a more useful parameter than peripheral oxygen saturation to guide clinical titration of permissive hypoxemia in covid-19 ards patients

mechanical ventilation is the cornerstone of supportive management for most ards patients to prevent life-threatening hypoxemia. arterial oxygenation can be improved via ventilator by increasing fractional inspired oxygen (fio2) and/or increasing mean airway pressure. when treating mechanically ventilated ards patients, the benefit of improved arterial oxygenation must be balanced against the potential risk of ventilator-induced lung injury (vili), oxygen toxicity occurring with high fio2 and development of right heart failure. arterial oxygen saturation target of 88-95 % and partial oxygen pressure (pao2) target of 7.3-10.6 are advocated in the management of patients with ards. surprisingly little randomized evidence exists to support these values and current recommendations are thus arbitrary and largely based on normal physiologic values. given the lack of evidence of strategies in oxygenating critically ill patients to an oxygen saturation and partial oxygen pressure that is generally accepted to be 'normal,' permissive hypoxemia may offer an alternative that has the potential to improve patient outcomes by avoiding unnecessary harm. permissive hypoxemia is a concept in which a lower level of arterial oxygenation than usual is accepted in order to avoid the potentially detrimental effects of high fractional inspired oxygen and invasive mechanical ventilation with high pressures, while maintaining adequate oxygen delivery by optimizing cardiac output. pulse oximetry is a simple, non-invasive and universally used method to monitor peripheral oxygen saturation of hemoglobin in a variety of clinical settings. pulse oximetry depends on pulsatile blood flow and only measures the oxyhemoglobin in arterial blood as it leaves the heart. however, this measure does not provide information regarding organ or tissue oxygenation, which reflects the important local balance between oxygen supply and demand. near-infrared spectroscopy (nirs) allows for continuous measurement of regional tissue oxygenation which reflects perfusion status and enables clinicians to directly monitor fluctuations in real time. nirs reflects the balance of oxygen that is delivered minus what is extracted at tissue level and is an indicator of the tissue oxygen uptake.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * verified covid-19 infection (throat swab or tracheal aspirate positive for sars-cov-2) * severe ards according to berlin definition * ventilator settings: controlled ippv, fio2 \> 0.70, peep \> 10 * norepinephrine infusion * svv \< 10% measured by lidco * rass - 5 exclusion criteria: * any of the following contraindications to lung recruitment: pneumothorax, patients on ventilator \> 1 week * patients with dark pigmented skin

Keywords: covid-19 ards nirs saturation
host immune response to novel rna covid-19 vaccination

Conditions: COVID-19 Vaccine; Cancer

Summary: to determine the antibody response level in patients with cancer to the covid-19 vaccination.


Eligibility criteria:
inclusion criteria: 1. age 18 years or older 2. must be eligible to receive the covid19 vaccination by standard and current cdc guidelines. this includes all rna vaccinations grant eua status by the fda 3. diagnosed with any malignancy within the last 5 years, with the exception of early-stage squamous cell skin cancer, early-stage basal cell skin carcinoma and noninvasive pathology such as dcis (ductal carcinoma in-situ) 4. able to provide informed consent 5. patients can be on any form of treatment (including clinical trials) and at any stage (including remission) in their cancer therapy plan - including chemotherapy, immunotherapy, targeted therapy, hormonal therapy, radiation, palliative care or observation. exclusion criteria: 1. previously documented covid infection 2. previously enrolled in a vaccination trial and either still blinded or known to receive the vaccination. (those patients on a trial but known to receive a placebo dose are eligible to enroll) 3. contraindication to the vaccination based on current cdc guideline such as know allergic reactions that increase risk of having an allergic reaction to a covid rna vaccination. this includes but is not limited to: * severe allergic reaction (e.g., anaphylaxis) after a previous dose of an mrna covid-19 vaccine or any of its components * immediate allergic reaction of any severity to a previous dose of an mrna covid-19 vaccine or any of its components (including polyethylene glycol \[peg\]) * immediate allergic reaction of any severity to polysorbate (due to potential cross-reactive hypersensitivity with the vaccine ingredient peg) 4. pregnant or breastfeeding 5. unable to comply with study related procedures as determined by the study team.
testing decision aids about early stage prostate cancer

Conditions: Prostatic Neoplasms

Summary: this is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. the purpose of this study is to compare patient-physician communication between patients who receive a dvd that models patient communication strategies vs. those who do not receive a dvd. all patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. the investigators hypothesize that the dvd will: * increase patients' perceptions of the importance of their preferences to their decision making * increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists * increase patients' actual engagement with their physician during the clinical encounter * increase the concordance between patient decision making preferences and actual decision making outcomes * increase long term satisfaction with decision on type of treatment selected * increase patient satisfaction with their decision and the decision making process * influence patient perception of his physician (e.g., trust) and of the diagnosis visit


Eligibility criteria:
inclusion criteria: * men aged 18 years and older * scheduled for a prostate biopsy to test for prostate cancer * ability to read and answer survey questions in english exclusion criteria: * previous diagnosis of prostate cancer

Keywords: patient-physician communication decision support techniques health communication physician-patient relationship decision making
comparative study of rohto dry-aid® and systane® ultra in patients with dry eye

Conditions: Dry Eye Syndromes; Dry Eye

Summary: the objective of this study is to evaluate the efficacy of rohto dry-aid® in comparison to systane® ultra on visual function and tear film stability in patients diagnosed with dry eye.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age * provide written informed consent * have a reported history of dry eye * have a history of use of eye drops for dry eye symptoms * ocular discomfort * conjunctival redness * tear film break up time * corneal and conjunctival staining exclusion criteria: * have any clinically significant slit lamp findings at entry visit * be diagnosed with an ongoing ocular infection * have any planned ocular and/or lid surgeries over the study period * have an uncontrolled systemic disease * be a woman who is pregnant, nursing or planning a pregnancy * be a woman of childbearing potential who is not using an acceptable means of birth control * have a known allergy and/or sensitivity to the test article or its components * have a condition or be in a situation which the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study
resistance training in intradialysis patients

Conditions: Dialysis; End Stage Renal Disease

Summary: dialysis patients usually have peripheral muscle weakness due to metabolic disturbances (increased protein catabolism) and fatigue. this muscle weakness may decrease functional capacity and quality of life. it also serves to increase cardiovascular risk factors in these end stage renal disease patients. peripheral muscle strength training shall combat physical inactivity during dialysis. in the investigators trial, the investigators hypothesis that peripheral muscle training might regulate protein catabolic rate,renal functions, cardiovascular risk factors, improve functional capacity and quality of life in endstage renal disease patients undergoing dialysis.

end stage renal failure patients undergoing dialysis have profound muscle wasting, reduced functional capacity and quality of life due to uremia, steroids, frequent dialysis and fatigue. during dialysis, physical inactivity further deteriorates the patient's functional capacity. aerobic or strength training may combat this physical inactivity. it may also improve the functional capacity and quality of life. recent studies have claimed the benefits of resistance exercises in improving functional capacity. but they have not documented effects on kidney function (electrolyte and urea kinetics) and muscle wasting (protein catabolic rate). in our trial, we attempt to study the effects of resistance training in improvement of renal function and muscle wasting apart from functional capacity and quality of life in dialysis patients

Eligibility criteria:
inclusion criteria: * must have end stage renal disease (diagnosed and the stage graded by nephrologist or the intensivist concerned) for more than 6 months and dialysis for at least 3 months (the impact of exercise training can be easily assessed) * must be between the ages of 30 - 60 years of age/ both genders. * must be able to understand the purpose of exercise testing and resistance training. exclusion criteria: * those with acute nephritic syndrome and hematuria \< 2 months. * those with profound anemia and blood transfusion \< 2 months * those underwent renal transplantation \< 6 months. * those receiving/ received cytotoxic drugs - amiloride, azathioprine/ aspirin (antiplatelets)\< 2 months * those with coagulation disorders or under anticoagulants \< 4 months. * those underwent recent cardiac surgeries and with recent unstable cardiac failures * those with recent cerebrovascular accidents \< 6 months * those have recent urinary tract infections, renal and bladder carcinomas \< 2 months * those with absolute contraindications for resistance exercise training (as per american college of sports medicine.

Keywords: intradialysis resistance training protein catabolic rate urea kinetics quality of life vo2 max
chromosomal and morphological structure of mature and immature male germ cells and recognition of il-18 in testicular tissue of azoospermic men

Conditions: Infertility

Summary: to develop a biotechnological assay which will be able to recognize germ cells of the spermatogenic lineand and to identify the chromosomal and morphological structure of mature and immature male germ cells, in cases of of sperm production disorders(azoospermic patients). to recognize il-18 in testicular tissue of azoospermic men compared to control group as it has been suggested that this cytokine may serve as a paracrine defense factor in the male gonad associated to spermatogenesis.

a new biotechnological assay was developed by adapting an existing computerized system which scans cell morphology and chromosomal ploidy in the same cell of hematologic line using digital technology, to recognize germ cells of the testis by their morphology and cytogenetics. testicular tissues which obtained from 15 men were enzymatically digested and the cells received were fixed on slides. the cells were stained by giemsa may grinwald staining and scanned automatically in a bright field for cell morphology. fluorescence in situ hybridization (fish) using centromeric probes for chromosomes x, y and 18 was performed on the same slide after destaining. the cells were automatically scanned and classified according to the ploidy of the chromosome signals. the presence of il-18 in the same men's testis was examined parallelly, by immunohistochimical staining using specific antibody for human il-18.

Eligibility criteria:
inclusion criteria: * non-obstructive azoospermic patients exclusion criteria: * obstructive azoospermia

Keywords: azoospermia fish il-18 testicular biopsy
endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer

Conditions: Colorectal Cancer; Indocyanine Green

Summary: prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer

to observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer, and analyze the relevant factors, so as to guide the submucosal injection of preoperative indocyanine green better. this study is prospective and observational. in order to analyze the related factors that affect the imaging effect, we enrolled patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical resection for colorectal cancer.

Eligibility criteria:
inclusion criteria: * patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer. exclusion criteria: * have simultaneously other cancer * have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases * have gastrointestinal surgery * indocyanine green or iodine allergy * the period is too late or the tumor is too large to carry on a laparoscopic surgery.
safety, tolerability and relative bioavailability study of bms-986195 in healthy subjects

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to evaluate the safety profile, tolerability, pharmacokinetics, and pharmacodynamics following single and multiple ascending oral doses of bms-986195 in healthy subjects, and to assess the relative bioavailability of two formulations of bms-986195 with or without food.


Eligibility criteria:
for more information regarding bristol-myers squibb clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * body mass index(bmi) of 18 to 32 kilograms/meter\^2 * healthy male and female, first generation japanese with confirmed paternal and maternal japanese ancestry, 18-55 years old, whose residency outside of japan does not exceed 10 years with a bmi of 18-30 kilograms/meter\^2 inclusive. * women must not be pregnant or breastfeeding * women of childbearing potential (wocbp) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required. * males who are sexually active with wocbp must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug plus 14 days or longer if required. exclusion criteria: * any significant acute or chronic medical illness * known or suspected autoimmune disorder, including but not limited to rheumatoid arthritis, fibromyalgia, systemic lupus erythematosis, polymyalgia rheumatica, giant cell arteritis, behcet's disease, dermatomyositis, multiple sclerosis, moderate to severe asthma, any autoimmune vasculitis, autoimmune hepatitis, or any other active autoimmune disease for which a subject requires medical follow-up or medical treatment * any history of known or suspected congenital or acquired immunodeficiency state or condition that would compromise the subject's immune status (example: history of splenectomy) * presence of any factors that would predispose the subject to develop infection e.g., rectal fissures, poor dentition, open skin lesions, and presence of preexisting skin conditions that increase risks for injection site complications e.g. behcet's disease, psoriasis, pustular dermatoses * any history or risk for tuberculosis (tb) other protocol defined inclusion/exclusion criteria could apply