Kornimate/medical-research-clean huggingface dataset:
a study investigating the safety, tolerability, drug levels and drug effect of bms-986278 in healthy adult participants (part 1) and japanese participants (part 2)

Conditions: Healthy Participants

Summary: the purpose of this study is to evaluate the safety, tolerability, drug levels and drug effect of bms-986278 in healthy adult participants and japanese participants.


Eligibility criteria:
inclusion criteria: * participants in the japanese cohort (part 2) must be first generation japanese (born in japan, not living outside of japan \> 10 years, both parents ethnically japanese). * body mass index (bmi) of 18.0 kilogram (kg)/meter (m)\^2 through 32.0 kg/m\^2, inclusive. bmi = weight (kg)/(height \[m\])\^2. * body weight ≥ 50 kg for males and ≥ 45 kg for females. exclusion criteria: * any significant acute or chronic medical illness. * any gastrointestinal (gi) disease or surgery (including cholecystectomy) or other procedures (for example, bariatric procedures) that could affect drug absorption, distribution, metabolism, and excretion. * any major surgery within 4 weeks of first study intervention administration. other protocol-defined inclusion/exclusion criteria apply.

Keywords: bms-986278 idiopathic pulmonary fibrosis (ipf) sildenafil
study to evaluate the safety, tolerability, and blood pressure effect of an oral dose of sumatriptan alone and in combination with mk-0974 (telcagepant) in migraine patients (0974-026)

Conditions: Migraine Disorders

Summary: study to understand the effects of migraine treatments on blood pressure in participants with migraine. the primary hypothesis is that the effect on semi-recumbent mean arterial pressure following the coadministration of telcagepant and sumatriptan is similar to that following administration of sumatriptan alone. that is, the true mean treatment difference (sumatriptan with telcagepant sumatriptan alone) in time-weighted mean arterial pressure for 2.5 hours following dosing is less than 5 mmhg.


Eligibility criteria:
inclusion criteria: * history of migraine for longer than 6 months. * free from migraine 24 hours before each dosing. * judged to be in good health. * nonsmoker exclusion criteria: * under age of legal consent. * legally or mentally incapacitated or has significant emotional problems. * taking any medications from about 2 weeks before the first dose of study medication. * has had surgery or donated blood or participated in another investigation study within 4 weeks prior to screening * currently a regular user of any illicit drugs or has a history of drug/alcohol abuse within about 2 years * consumes more than 6 caffeinated beverages per day
noninvasive preimplantation genetic testing for aneuploidy

Conditions: Preimplantation Genetic Testing (PGT); ICSI

Summary: the study is conducted to evaluate the sensitivity and specificity of non-invasive preimplantation genetic testing for aneuploidy (nipgt-a) using cell free dna into spent culture medium (scm).

our study is a diagnostic study, recruit 218 biopsied blastocysts from couples undergoing intracytoplasmic sperm injection (icsi) with preimplantation genetic testing for aneuploidy (pgt-a) or preimplantation genetic testing for structural rearrangements (pgt-sr) indication. oocyte retrieval, icsi and embryo culture are performed by routine protocol. on day 3, each embryo was washed and cultured in single droplets. te biopsy was conducted and 10μl scm of biopsied embryos are collected on day 5 or day 6. both sample types undergo whole-genome amplification (wga) using quanti flour one dsdna system and dna analysis by next-generation sequencing (ngs) using nextseq high output 150 cycles kit. comparison of ngs results from trophectoderm (te) biopsy and scm is done to identify the sensitivity and specificity of the test. a sample size of 218 day 5/day 6 embryos will be needed.

Eligibility criteria:
inclusion criteria: * assisted reproductive treatment with icsi indication * having pgt-a or pgt-sr indication * having an agreement to be enrolled into nipgt-a study * having blastocyst to biopsy exclusion criteria: * in vitro maturation cycle

Keywords: nipgt-a cell free dna (cfdna) scm sensitivity
a study to assess safety and efficacy in participants age 40 to 55 with presbyopia (old eye) who receive agn-190584 in both eyes twice daily

Conditions: Presbyopia

Summary: currently available treatments for presbyopia (old eye) include nonsurgical options (spectacles or contact lenses) and surgical options, however, each has its own risks and limitations. the purpose of this study is to evaluate how effective agn-190584 is in treating presbyopia compared to vehicle (placebo). agn-190584 is an investigational drug being developed for the treatment of presbyopia. participants are placed in 1 of 2 groups, called treatment arms. each group receives a different treatment. there is a 1 in 2 chance that participants will be assigned to vehicle. around 200 participants age 40-55 years with a diagnosis of presbyopia will be enrolled in the study in approximately 20 sites in the united states. participants will receive agn-190584 or vehicle in each eye twice daily for 14 days. there may be additional procedures for participants in this trial compared to their standard of care. participants will attend regular visits during the study at a doctor's office. the effect of the treatment will be checked by medical assessments, vision/eye tests, checking for side effects and completing questionnaires.


Eligibility criteria:
inclusion criteria: - objective and subjective evidence of presbyopia. exclusion criteria: * corneal abnormalities (including keratoconus, corneal scar, fuchs' endothelial dystrophy, guttata, or edema) in either eye that are likely to interfere with visual acuity. * narrow iridocorneal angles (shaffer grade \<=2 or lower on gonioscopy examination), history of angle-closure glaucoma, or previous iridotomy. * diagnosis of any type of glaucoma or ocular hypertension. * history of cataract surgery, phakic intraocular lens surgery, corneal inlay surgery, radial keratotomy, or any intraocular surgery. * use of temporary or permanent punctal plugs or history of punctal cautery in one or both eyes.

Keywords: presbyopia agn-190584 pilocarpine hcl 1.25% old eye aged eye
postprandial blood glucose and insulin levels following consumption of lentil-containing food products

Conditions: Postprandial Glycemia in Healthy Adults

Summary: this study will recruit 20 healthy adults (male and female) to complete 9 study visits where they will consume different food products (chili, soup and muffin) with or without lentils incorporated into the them. blood samples will be obtained by finger prick before and for 2 hours after the meal and analyzed for glucose and insulin.

the purpose of the current study is to determine the effects of lentil-containing food products on postprandial blood glucose and insulin levels in healthy premenopausal women and men aged 18-40 years old.this study will use a randomized crossover design. participants will complete a series of 9 study visits during which participants will consume 9 study treatment meals consisting of muffins, soup and chilli, with and without lentils. participants will then have their blood sampled for the following 2 hours by finger prick. participants will remain seated during the test period. all study visits will occur at the human nutraceutical research unit and be separated by a washout period of 3-7 days. throughout the study, it will be asked that participants' lifestyle and physical activity remain unchanged. participants will be instructed to not start any new dietary approaches, and to not start any new natural health products (unless instructed by a physician).

Eligibility criteria:
inclusion criteria: * healthy men and women * age 18-40 years (aiming for equal distribution among 18-29, 30-40 years of age) * bmi 20-30 kg/m2 exclusion criteria: * diabetes (fasting blood glucose ≥7.0 mmol/l and/or 2hr blood glucose \>11.1 mmol/l post-75g ogtt) 1 * impaired glucose tolerance (igt) (fasting blood glucose 6.1-6.9 mmol/l and/or 2hr blood glucose 7.8-11.0 mmol/l post-75g ogtt) 1 * blood pressure \>140/90 mm hg * any major medical condition including a history of aids or hepatitis * medical or surgical event requiring hospitalization within 3 months of randomization * any medications except a stable dose (3 months) of oral contraceptives, blood pressure or statin medications * natural health products (nhps) used for glycemic control (all other nhps okay as long as table for 3 months) * tobacco use * probiotic supplement use * dietary fibre supplement use * pulse consumption \>4 servings per week * food allergy or non-food life threatening allergy * alcohol consumption \>14 drinks/week or \>4 drinks/sitting * recent or intended significant weight loss or gain (\>4 kg in previous 3 months) * elite athletes * shift workers

Keywords: diabetes lentils pulses postprandial glycemia
long-term follow-up of checkpoint inhibitors-induced ileo-colitis

Conditions: Immune Checkpoint Inhibitors-induced Colitis; Advanced Melanoma Skin Cancer, Non-small Cell Lung Carcinoma, Kidney Adenocarcinoma; Ileo-colitis; Immune Mediated-colitis

Summary: this is a multicentric, observational study, including all european centres willing to take part. the multicentre nature is necessary for enhancing the generalisability of our results, and due to the rarity of this condition. the study is observational including both retrospective and newly diagnosed cases of cic with an endoscopically/histologically-proven diagnosis. detailed characteristics will be collected, with the aim of classifying the disorders from a clinical, endoscopic, and pathological point of view. age, sex, localisation, and histology of tumour, stage of tumour, oncological response to immune checkpoint inhibitors-induced colitis, colonoscopy, histology, inflammatory parameters, and clinical manifestations will be assessed for each patient, as well as therapy and outcome. the study will consist of 2 part: the first one will be retrospective, while the second one will be prospective al will include all incident patients diagnosed with cic during the enrolment period.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years; * patients able to provide informed consent or who have already given leave of use of their data for research in the retrospective part; waiving of the informed consent may be applied if national regulations allow to do so; * patients who have undergone at least one cycle of immune checkpoint inhibitors before the onset of intestinal symptoms; * patients with at least one colonoscopy showing macroscopical and/or histological colitis after commencement of immune checkpoint inhibitors therapy; for retrospective patients only, a follow-up of at least 12 months, unless death occurred before. exclusion criteria: * evidence of colitis/inflammatory bowel disease prior to checkpoint inhibitors administration

Keywords: immune checkpoint inhibitors
remote monitoring of patients with pacemaker or implantable cardioverter defibrillator

Conditions: Heart Failure

Summary: however, the current guidelines recommend the use of remote monitoring (rm) in patients with cardiac implantable electronic devices (cied) to reduce inappropriate shocks or early detection of atrial fibrillation, data is incomprehensive on the effectiveness of decreasing heart failure events or mortality in patients with heart failure and reduced ejection fraction (hfref). the only randomized trial, which proved the efficacy of rm on mortality was the in-time trial, which used a strict protocol for detection and intervention of the heart failure events. the primary aim of this study is to optimize the use of remote monitoring system in hfref patients already implanted an implantable cardiac defibrillator (icd) or a cardiac resynchronization therapy (crt). by creating a high-quality system with structured safety-net, which is able to use the data of remote monitoring messages and alerts of our patients, we can improve their outcome. the primary endpoint is the non-fatal heart failure event or all-cause mortality. secondary outcomes include all-cause mortality, cardiovascular mortality, heart failure hospitalization, cardiovascular hospitalization, unscheduled visits, af burden, stroke, inappropriate shocks, quality of life, nyha functional class. by using artificial intelligence-based methods, the optimal cut-off values of the previously, empirically used alert parameters will be validated or challenged. additionally, cost-effectiveness to reduce the hospitalizations will be calculated. due to this remote monitoring structured safety-net, these patients with severe heart failure can be treated more efficiently, safely and cost-effectively.


Eligibility criteria:
inclusion criteria: 1. crt-p/crt-d patients with a feasible device for home monitoring 2. icd (vvi/vdd/ddd) patients with a feasible device for home monitoring 3. sr/afib 4. transmission performance \>80% in the first 2 weeks with new device 5. informed consent exclusion criteria: 1. life expectancy\<1 year 2. unable to transmit data 3. patient is unable to visit the physician/clinic in 12 hours when it is indicated by the alerts 4. expected non-compliance 5. pregnancy 6. known drug, alcohol abuse 7. participation in other study or hm system concept

Keywords: remote monitoring home monitoring heart failure cardiac resynchronization therapy implantable cardioverter defibrillator
acute kidney dysfunction in covid-19 and non-covid-19 related ards

Conditions: COVID-19 Acute Respiratory Distress Syndrome; Acute Kidney Injury Due to COVID-19

Summary: in addition to respiratory involvement, sars-cov 2, the virus responsible for coronavirus 2019 or covid-19, appears to be responsible for renal involvement such as acute renal failure or proteinuria, so the mechanisms are not known at this time. the consequences of covid-19 on renal function in the short and long term are not known. it is important to be able to better document these renal impairments to understand the mechanisms of this disease. the main objective of this study is to describe the prevalence of covid-19-related renal damage (acute renal failure, proteinuria, microalbuminuria, hematuria) in a large cohort of patients in intensive care for sars-cov 2 infection with severe respiratory impairment. the other objectives will be to evaluate in this cohort the impact of these renal impairments on the severity of the covid-19 disease, and to compare them to the renal impairments of patients in intensive care for acute respiratory distress syndrome (ards) due to other respiratory diseases. blood and urine samples will be taken at the time of intubation in all critically ill patients with respiratory distress requiring mechanical ventilation for covid-19 or other cause of respiratory distress with pao2/fio2 ratio \< 300. patients will be followed for the duration of their icu and hospital stay. data will be collected prospectively in three icus in the university hospitals of marseille.


Eligibility criteria:
inclusion criteria: * • displaying acute respiratory distress needing invasive mechanical ventilation * with pao2/fio2 ratio \< 300 after orotracheal intubation exclusion criteria: * patients in icu following thoracic surgery or lung transplantation * patients with cardiogenic pulmonary oedema * patients with end stage kidney disease * moribund patients
carotid artery implant for trapping upstream emboli for preventing stroke in atrial fibrillation patients

Conditions: Atrial Fibrillation

Summary: vine™ is a permanent carotid filter designed to provide protection against embolic stroke in people with atrial fibrillation. it is implanted bilaterally in the common carotid arteries from a thin needle under ultrasound guidance. the procedure is performed without general anesthesia and takes minutes. the safety, feasibility and tolerability of vine™ will be evaluated. patients who are eligible will receive vine™ and will be followed-up for a year after device implantation.

capture is a prospective, single-arm, multicenter trial, designed to evaluate the safety, feasibility and tolerability of the vine™ permanent carotid filter. the trial will enroll up to 30 patients, and will be conducted in up to five sites worldwide. all enrolled patients will be invited for non-invasive follow-up tests and clinical evaluations according to the study protocol.

Eligibility criteria:
inclusion criteria: 1. atrial fibrillation (af): documented persistent or permanent 2. cha2ds2-vasc score ≥ 4 3. age \> 50 4. unsuitable for oral anticoagulation therapy (oac), defined as contraindicated for oac, patient refusing oac, or physician is reluctant to prescribe oac 5. maximal (systolic) cca diameter range: ≥ 5.3mm and ≤ 9.8mm 6. cca accessibility: up to 60mm from skin to cca center, safe approach 7. patient is willing to provide informed consent 8. patient is willing to complete all scheduled follow-up exclusion criteria: 1. evidence of carotid stenosis \> 30% \[cca, internal carotid artery (ica), or external carotid artery (eca) 2. evidence of any atherosclerotic disease in cca above the clavicles 3. evidence of carotid dissection 4. pre-existing stent(s) in cca 5. contraindicated or allergic to antiplatelet therapy, or any medication required during the study 6. recent stroke, tia, or myocardial infarction (mi) within two months prior to index procedure 7. female who is pregnant or who is planning to become pregnant during the course of the study 8. life expectancy of less than 1 year 9. active systemic infection 10. known sensitivity to nickel or titanium metals, or their alloys 11. known hereditary or acquired coagulation disorders 12. any planned surgical or endovascular procedure within 14 days prior to or 30 days after the index procedure 13. a co-morbid disease or condition that could confound the neurological and functional evaluations or compromise survival or ability to complete follow-up assessments 14. current use or a recent history of illicit drug(s) use or alcohol abuse (defined as regular or daily consumption of more than four alcoholic drinks per day) 15. active participation in another investigational drug or device treatment study 16. any other condition that in the opinion of the investigator may adversely affect the safety of the subject or would limit the subject's ability to complete the study

Keywords: af
challenging the gold standard: pilot study comparing continuous glucose monitoring system (cgms), capillary glucose monitors and 3 hour glucose tolerance test (gtt) to diagnose gestational diabetes mellitus (gdm)

Conditions: Diabetes, Gestational

Summary: the purpose of this research study is to compare 3 methods of measuring blood glucose (blood sugar) levels to see if the finger-stick method or the continuous glucose monitoring system is better than or as good as the 3 hour glucose tolerance test (gtt) for the diagnosis of gestational diabetes.

the rate of gestational diabetes and fetal macrosomia is increasing. moreover, it appears that many macrosomic infants are born to non-diabetic mothers. however, this presents the question of whether our current accepted means of diagnosis is reflecting the true prevalence of gdm. the 3-hour gtt measures glycemic control over a limited period of time. a more prolonged period of monitoring makes more physiologic sense, as it would paint a picture of a patient's overall trend before a diagnosis can be confirmed or excluded. given the ability of the cgms and capillary glucose monitor to follow glycemic trends over an extended time period, these methods may prove more effective at identifying patients with abnormal glucose tolerance. as these modalities test the patients in their native environments, the effect of dietary changes prior to the testing period may be minimized, potentially providing an more accurate assessment of abnormal glucose utilization. furthermore, both modalities should be more cost-effective than the 3- hour gtt.

Eligibility criteria:
inclusion criteria: * pregnant patients seen in the center for women's health at university hospital in cincinnati, ohio between 24-28 weeks gestation * one hour 50-g glucose challenge test (gct) value greater than 130 mg/dl. exclusion criteria: * patients with known diabetes mellitus * patients receiving steroids or oral terbutaline therapy * patients entering prenatal care later than 20 weeks gestation

Keywords: gdm gestational diabetes gtt cgms
comparison of minimal versus conventional extracorporeal circulation in coronary surgery

Conditions: Coronary Artery Bypass

Summary: the aim of this study is to assess the effect of minimal (miecc) versus conventional (cecc) extracorporeal circulation on perfusion characteristics and remote end-organ protection (lungs, brain, kidneys, liver, stomach, intestine), after elective coronary bypass grafting (cabg).

the aim of this study is to investigate whether coronary surgery with minimal invasive extracorporeal circulation (miecc) offers advantage over conventional cpb (cecc). in order to draw an evidence-based conclusion, the investigators aim to evaluate perfusion characteristics during coronary surgery with mecc and associated remote end-organ function. improved end-organ protection translates into improved clinical outcome which greatly affects quality of life. this is the first study in the literature adequately powered to analyse organ pathophysiology during surgery with mecc and at the same time correlating common clinical variables with a detailed quality of life evaluation. superiority of mecc could provide firm evidence towards widespread use of mecc in coronary surgery as standard of care.

Eligibility criteria:
inclusion criteria: * all patients scheduled for elective coronary artery bypass grafting exclusion criteria: * history of psychiatric disorder * inability to undergo neuropsychological assessment * history of transient ischemic attack or stroke * carotid artery stenosis \> 60% assessed by duplex ultrasonography

Keywords: coronary artery disease coronary artery bypass grafting cardiopulmonary bypass minimal extracorporeal circulation
pharmacokinetic study of bramitob® administered for inhalation by pari eflow® vs pari lc® plus nebulizer

Conditions: Cystic Fibrosis

Summary: the purpose of this study is to assess pharmacokinetic and safety comparability of bramitob® when administered for inhalation by using pari eflow® rapid electronic nebulizer vs pari lc® plus nebulizer in cystic fibrosis patients infected with pseudomonas aeruginosa


Eligibility criteria:
main inclusion criteria: * patients of either sex aged ≥ 18 years; * clinical diagnosis of cystic fibrosis (patients registered in the national registry of cystic fibrosis or other documents, if applicable, depending on country legislation); * positive response (sweat chloride concentration ≥ 60 mmol/l) in the standard sweat test documented in the clinical records or sweat chloride concentration ≥ 40 mmol/l and at least two gene mutations consistent with cf documented in the clinical records; * chronic colonization of pseudomonas aeruginosa * fev1 ≥ 35% of the predicted normal value calculated according to the recommendation of the official statement of the european respiratory society and american thoracic society main exclusion criteria: * evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl); * evidence of impaired auditory function (auditory threshold in either ear above 20 db at frequencies between 250 and 8000hz); * sputum culture containing burkholderia cepacia; * received loop diuretics within 7 days before study drug administration;

Keywords: cystic fibrosis, tobramycin,nebulizer, pk