Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the pharmacokinetics, safety, and antiviral activity of jnj-63623872 in combination with oseltamivir in adult, and elderly hospitalized participants with influenza a infection

Conditions: Influenza A Virus

Summary: the purpose of this study is to evaluate the pharmacokinetic parameters of jnj-63623872 in combination with oseltamivir in elderly participants (aged 65 to \<= 85 years) compared to adults (aged 18 to \<= 64 years) with influenza a infection.

this is a randomized (study medication assigned to participants by chance), double-blind (neither the researchers nor the participants know what treatment the participant is receiving), placebo-controlled, multicenter (when more than one hospital or medical school team work on a medical research study) study to evaluate the effect of jnj-63623872 in combination with oseltamivir in participants with influenza a infection. the study consists of 3 phases: screening visit (1 day), participants who meet all eligibility criteria will be randomized in a 2:1 ratio to receive study drug in double-blind treatment phase (7 days) and follow up phase (21 days). the duration of participation in the study for each participant is approximately 28 days. primarily pharmacokinetic parameters of jnj-63623872 will be measured. participants' safety will be monitored throughout the study.

Eligibility criteria:
inclusion criteria: * participant requires hospitalization to treat influenza infection and/or to treat complications of influenza infection * participant tested positive for influenza a infection within 1 day of signing of the informed consent form (icf)/assent form using a polymerase chain reaction (pcr)-based rapid molecular diagnostic assay * participants must be capable of swallowing study medication tablets and capsules * each participant (or their legally acceptable representative) must sign an icf indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study * participant must be willing and able to adhere to the prohibitions and restrictions specified in the protocol exclusion criteria: * participant received more than 3 doses of the influenza antiviral medication oseltamivir, zanamivir, or peramivir since the start of the influenza symptoms, or ribavirin within 6 months prior to screening * participant is unwilling to undergo regular nasal mid-turbinate (mt) swabs or has any physical abnormality which limits the ability to collect regular nasal specimens * participant is immunocompromised, whether due to underlying medical condition (example, malignancy) or medical therapy (example, medications, chemotherapy, radiation, post-transplant) * participant is undergoing peritoneal dialysis, hemodialysis, or hemofiltration * participant has an estimated glomerular filtration rate (egfr) less than or equal to (\<=)30 milliliter (ml)/minute (min)/1.73 meter\^2 (m\^2) according to the modification of diet in renal disease (mdrd) equation, assessed at screening or based on the most recent clinically relevant creatinine value if available

Keywords: influenza a virus jnj-63623872 oseltamivir
impact of artificial intelligence-based patient reinforcement on quality of colonoscopy

Conditions: Bowel Preparation

Summary: in order to improve bowel preparation for colonoscopy and consequently enhance detection rate of malignant and premalignant findings, a prospective, randomized and controlled three-arm study was developed. patients who undergo ambulatory colonoscopy are randomly assigned into a control group with standard preparation, a phone call supported preparation group or a group supported by an artificial intelligence based chatbot. primary endpoint is defined as quality of bowel preparation (boston bowel preparation score), secondary endpoints are patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation and the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support.

adequate bowel preparation is crucial for detection of adenoma and polyps of the colon, which can transform into malignant and premalignant lesions. in particular ambulatory performed colonoscopy is often insufficient due to inadequate preparation by patients at home. to focus this issue, a artificial intelligence based chatbot was developed to help patients who undergo bowel preparation by answering questions concerning bowel preparation. to compare the effect of this program, a three-arm randomized, controled multicentric clinical trial was developed. all patients who undergo ambulatory colonoscopy and meet the inclusion criteria (18 y.o., informed consent, whatsapp access) were randomized in a standard preparation group (medical briefing and preparation brochure), a group receiving phone calls with instructions for bowel preparation and a third group with access to the chat bot answering questions concerning bowel preparation and examination conduct. as the primary end point, the quality of bowel preparation measured as boston bowel preparation scale was defined. as secondary endpoints patients satisfaction, comprehensiveness of bowel preparation, sedation dose, rate of coecal intubation, the rate of adenoma and polyp detection, anxiety referred to colonoscopy and patients satisfaction with preparation support were measured.

Eligibility criteria:
inclusion criteria: * informed consent * smartphone with access to whatsapp * indication for ambulatory colonoscopy * asa i or ii exclusion criteria: * no informed consent given or possible * no access to a smartphone with whatsapp * \<18 years old * pregnancy/lactation * allergy to moviprep© * asa (american society of anesthesiologists) state \>ii * extended abdominal surgery in past history * no indication for ambulatory colonoscopy

Keywords: bowel preparation artificial intelligence polyp detection
experimental exposure to air pollutants and sympathetic nerve activity in human subjects

Conditions: Cardiovascular Morbidity

Summary: the primary hypothesis of the study is that in healthy elderly subjects experimental exposure to air pollutants increases sympathetic nervous system activity compared with sham (clean air) exposure. the secondary hypothesis of the study is that combined experimental exposure to air pollutants (particles + ozone) increases sympathetic nervous system activity to a greater extent than does the exposure to particles alone.

in a randomized, double-blind, and cross-over fashion, the participants will be exposed to clean air, ultrafine particles, or ultrafine particles and ozone in an exposure chamber. the investigators will determine blood pressure, heart rate, respiration as well as cardiac output and directly record sympathetic vasomotor tone using the microneurography technique. to elucidate the underlying mechanisms through which particles and ozone affect the autonomic nervous system, the investigators will assess the local and systemic inflammatory response as well as the changes in neurotrophic factors in sputum and blood. in addition, the activation of inflammatory cells in sputum and blood will be analyzed at different points in time after exposures. changes in sympathetic activity will be correlated with the degree of airway inflammation and oxidative stress assessed in induced sputum and blood. this study will provide important insight in the mechanisms through which air pollution, particularly ultrafine particle exposure, increases cardiovascular risk in human subjects and generate a human model for mechanistic and therapeutic studies.

Eligibility criteria:
inclusion criteria: * elderly man or postmenopausal woman older than 50 years of age. * signed written informed consent. exclusion criteria: * smoker. * cardiovascular and/or pulmonary disease. * medication with relevant impact on autonomic system function, e. g. norepinephrine reuptake inhibitors. stable medication with slight to moderate autonomic effects is tolerable. * subject is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol. * mental condition rendering the subject unable to understand the nature, scope, and possible consequences of the study. * subject unlikely to comply with protocol, e. g. uncooperative attitude or unlikelihood of completing the study. * known hypersensitivity to ozone. * history of drug or alcohol abuse. particles study - protocol version: october 19, 2012 14 * blood donation of more than 500 ml during the previous 3 months.

Keywords: air pollution ozone fine particle cytokine chemokine oxidative stress inflammation heart rate variability autonomic nervous system sympathetic nerve activity plasma catecholamine
effect of an experimental gel based on acmella oleracea extract associated or not with fluoride on dentin hypersensitivity

Conditions: Dentin Desensitizers; Non-carious Cervical Lesions; Dentin Hypersensitivity

Summary: this randomized, single-blind, placebo-controlled clinical trial aims to evaluate the effect of an experimental gel based on acmella oleracea (jambú) extract, associated or not with fluoride, in reducing dentin hypersensitivity (dh) in non-carious cervical lesions. the volunteers were randomized into 4 groups according to the treatments applied: ct (control), np (potassium nitrate), ao (acmella oleracea) and af (acmella oleracea associated with fluoride). prophylaxis with pumice stone and water was performed on the previously selected teeth and, subsequently, the gels were applied to the cervical region with a microbrush, rubbed for 10 seconds, and remained on the tooth surface for 10 minutes. three gel application sessions were performed, with 1-week interval between them. the dh evaluation was performed at four time points: baseline (before the first session), t1 (before the second session), t2 (before the third session) and t3, one week after the final application of the products.

initially, all volunteers will undergo prophylaxis with pumice and water and will receive an oral hygiene kit containing a soft-bristled toothbrush, dental floss, and their assigned toothpaste, along with oral hygiene instructions. relative isolation with cotton rolls will be performed in the region of the sensitive lesions, followed by the application of the gel corresponding to the participant's group (ct, np, ao, af). all gels will be applied in the same manner, using a microbrush applicator. after being rubbed for 20 seconds on each tooth, the gel will remain on the tooth surface for 10 minutes. at the end of this period, the gel will be removed using gauze and thoroughly rinsed. three clinical sessions will be conducted, with one-week intervals between them.

Eligibility criteria:
inclusion criteria: * presence of non-carious cervical lesions with sensitivity and up to 2 mm in depth * miller class i gingival recession * lesions located on the buccal surface of the teeth * score ≥ 4 on the visual analog scale (vas) after tactile and evaporative stimuli * healthy periodontal condition * no other conditions that could explain dentin hypersensitivity * good general physical health * no eating disorders or high-acid diets * occlusal stability exclusion criteria: * presence of restorations in the hypersensitive areas * presence of dental caries, pulpitis, or periodontal pockets * enamel cracks * systemic diseases * continuous use of antibiotics, anti-inflammatory drugs, analgesics, or corticosteroids * professional desensitizing treatment received within the three months prior to study recruitment * pregnancy or breastfeeding ongoing orthodontic treatment * dental prostheses that may interfere with the assessment of hypersensitivity

Keywords: acmella oleracea spilanthol dentin hypersensitivity
antibody production following h1n1 influenza vaccination after stem cell and heart transplantation

Conditions: H1N1 Influenza

Summary: stem cell and and heart transplant patients will receive pandemic h1n1 influenza vaccination according to the clinical guidelines. in these patients the investigators will measure the specific antibody production.

stem cell and and heart transplant patients will receive pandemic h1n1 influenza vaccination according to the clinical guidelines. two doses will be given, in 3-week interval. in these patients we will measure the specific antibody production. blood sample 5 ml will be drawn before the first vaccine, before the second, and 3-4 weeks after the 2nd dose.

Eligibility criteria:
inclusion criteria: * stem cell and and heart transplant patients who will receive pandemic h1n1 influenza vaccination according to the clinical guidelines. exclusion criteria: * patients with unstable grafts.

Keywords: stem cell and and heart transplant patients who will receive pandemic h1n1 influenza vaccinations
berries, bugs, and the blues

Conditions: Depressive Symptoms

Summary: this study aims to investigate the impact of daily freeze-dried blueberry powder consumption on the gut microbiota, fecal short chain fatty acids, and depressive symptom severity in 40older, sedentary adults with depressive symptoms.

this study is an ancillary project to a currently funded randomized, placebo-controlled 12-week intervention in older, sedentary adults with depressive symptoms (irb# pro00064749). this specific project proposes distinct aims to the trial by gathering preliminary data on the synergistic impact of dietary fiber and anthocyanins (via freeze-dried blueberry powder) on the gut-microbiota, gut-derived metabolites, and depressive symptoms in older adults. participants will then be randomized to consume either 48 g of freeze-dried blueberry powder (\~600 mg of anthocyanins and \~8 g of fiber) or 48 g of a nutritionally matched placebo powder (devoid of anthocyanins and fiber) each day for a total of 12 weeks. at baseline, participants will be undergo assessments for depressive symptom severity and provide a fecal sample for gut microbiota and short chain fatty acid measurement. after 4, 8, and 12 weeks of consuming the powder there will be study visits that assess depressive symptom severity. additionally, a final fecal sample will be taken after 12 weeks of the intervention.

Eligibility criteria:
inclusion criteria: * men and women aged ≥65 years * self-reporting ≥ 8 hours of sitting per/day (e.g., sedentary behavior) * depressive symptoms (defined as ≥4 and \<16 points on the center for epidemiological studies depression-scale exclusion criteria: * unwilling to follow the study protocol * a median daily step count \>7,500 steps per day (as measured by the actigraph), or per discretion of the pi * cognitive impairment (defined as montreal cognitive assessment, moca \<22 points) * self-reporting a history of inflammatory bowel disease/syndrome, major depression, bipolar, schizophrenia, or other psychotic disorders, or per discretion of the pi * self-reporting type 1 or type 2 diabetes * allergic to intervention or control products * recent use (within the last 3 months) of antibiotics, or per discretion of the pi * recent use (within the last 3 months) of pro-biotics, or per discretion of the pi * current substance use disorder (drug abuse screening test, dast-10\>2 points) * current alcohol use disorder (alcohol use disorders identification test - consumption, audit-c≥4 points) * unstable anti-depressant use (e.g., change in medication within last 3-6 months), or per discretion of the pi * current homicidal or suicidal ideation (assessed via the p4 suicidality screener) * current psychosis (via the psychosis and hallucinations questionnaire, phq\>12 points) * manic symptoms (assessed by the mood disorder questionnaire, mdq \>5 points)

Keywords: anthocyanins fiber aging
bfpet for regional myocardial perfusion imaging

Conditions: Coronary Artery Disease

Summary: bfpet will be evaluated as a diagnostic pet agent for assessing myocardial perfusion in subjects with known or suspected coronary artery disease (cad) as compared to standard nuclear myocardial perfusion imaging (mpi). the safety of bfpet will be evaluated in known or suspected cad subjects.


Eligibility criteria:
inclusion criteria: * subjects must provide written informed consent prior to any study related procedures; * subjects must be ≥ 21 and ≤ 85 years of age; * subjects must have known or suspected cad documented by ≥2 segments of reversible perfusion abnormalities on a spect (mpi)study exclusion criteria * any clinically significant acute or unstable physical or psychological disease judged by the investigators based on medical history or screening physical examination; * blood pressure over 180/100mmhg * acute changes in comparison to most recent ecg; * recent (within 3 months) cardiac arrest, unstable angina, cerebro-vascular accident (cva), cabg or pci * any pacemaker or defibrillator implanted within the last three months; * inability to remain in camera for approximately 60 minutes * bronchospasm * serum creatinine \> 2 mg/dl; * cancer patients who have received chemotherapy or radiation therapy within the past 60 days. * any exposure to any investigational drug(s) or medical device(s) within four (4) weeks prior to imaging study; * any physical or psychological disease judged by the investigators to be incompatible with the study, based on medical history or screening physical examination. * nyha class iii or iv congestive heart failure; * subject has symptomatic hypotension * allergic or intolerant to aminophylline, nitroglycerin or metoprolol * allergic or intolerant to regadenoson or any of its excipients * prior participants in the study. * female subjects only: positive serum and/or urine pregnancy test or is lactating or the possibility of pregnancy cannot be ruled out prior to dosing. females not of child-bearing potential require confirmatory documentation in their medical records or must have a negative pregnancy test within 4 hours prior to receiving the test drug and agree to use an acceptable form of birth control for at least 30 days following bfpet administration.

Keywords: coronary artery disease myocardial ischemia coronary disease heart diseases cardiovascular diseases arteriosclerosis arterial occlusive diseases vascular diseases
impact of nasal high-flow vs venturi mask oxygen therapy on weaning outcome: a multicenter, randomized, controlled trial

Conditions: Weaning Failure; Acute Respiratory Failure

Summary: the purpose of this study is to determine whether, as compared with the venturi mask, a nasal, high-flow oxygenation device (optiflow) may reduce the extubation failure rate in patients needing oxygen therapy after extubation.

this study compares the effects of two devices for oxygen therapy, the nasal, high-flow (optiflow, intervention) and the venturi mask (control), on the outcome of extubation. available data suggest that optiflow can improve oxygenation and patient's comfort in critically ill patients after extubation. the study hypothesis is that optiflow may reduce the extubation failure rate in these patients. in the intervention group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive high-flow oxygen through nasal cannula (optiflow, fisher \& paykel healthcare ltd., new zealand) after extubation. the oxygen concentration (fio2) will be set to reach an oxygenation target similar to control patients (see below), while the gas flow rate will be set at 50 l/min. in the control group, patients fulfilling inclusion criteria and not presenting any of the exclusion criteria will receive oxygen through a standard venturi mask after extubation. the fio2 will be set to obtain a arterial oxygen saturation (spo2) between 92% and 98% (or between 88% and 95% in hypercapnic patients). further fio2 modifications will be performed by the attending physicians to meet the oxygenation target.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years 2. mechanical ventilation \> 24 hours 3. signed informed consent 4. successful spontaneous breathing trial 5. pao2/fio2 ratio ≤ 300 (or spo2/fio2 ratio ≤ 300 if spo2 is lower than 98%) within 30 min after extubation while breathing through a venturi mask with a delivered fio2 of 31% exclusion criteria: 1. pregnancy 2. presence of tracheostomy 3. need for immediate post-extubation non-invasive ventilation (\>3 consecutive failures of the spontaneous breathing trial and/or a paco2 \> 45 mmhg before the spontaneous breathing trial, with a respiratory rate ≥ 25/min)

Keywords: oxygen therapy extubation weaning reintubation acute respiratory failure
a study to evaluate the tolerance and pharmacokinetics of tqb3602 capsule

Conditions: Multiple Myeloma

Summary: this is a study to evaluate the tolerance, dose-limiting toxicity (dlt), phase ii recommended dose (rp2d), and maximum tolerated dose (mtd) of single and multiple oral doses of tqb3474 in patients with advanced malignant tumors.


Eligibility criteria:
inclusion criteria: * 1.understood and signed an informed consent form. 2.18 and 75 years old , male or female. 3. eastern cooperative oncology group (ecog) performance status score of 0 to 2. 4. life expectancy ≥12 weeks. 5. relapsed/refractory multiple myeloma had received at least two treatment methods. 6. male or female subjects should agree to use an adequate method of contraception starting with the first dose of study therapy through 6 months after the last dose of study (such as intrauterine devices , contraceptives or condoms) ；no pregnant or breastfeeding women, and a negative pregnancy test are received within 7 days before the randomization. exclusion criteria: * 1. hypersensitivity to tqb3602 or its excipient. 2. has peripheral nerve diseases ≥ grade 2. 3. has diarrhea grade \> 1 during screening period. 4. has received chemotherapy, radiotherapy, targeted therapy, immunotherapy, or other systemic antitumor therapies within 14 days before the first dose. 5. has received ixazomib and less than 5 half-life before the first dose. 6. has received allogeneic stem cell transplant. 7. pregnant or lactating women. 8. has participated in other clinical trials within 4 weeks before participating in this trial. 9. according to the judgement of the researchers, there are other factors that subjects are not suitable for the study.
ariscat and las vegus risk scores for predicting postoperative pulmonary complications after cardiac surgery

Conditions: Pulmonary Complication; Postoperative Complications; Postoperative Pulmonary Complications

Summary: the goal of this observational study is to compare the, ariscat and las vegus scales, for predicting postoperative pulmonary complications in patients undergoing cardiac surgery. the study aims to compare the diagnostic accuracies of the two risk prediction scores in predicting postoperative pulmonary complications.


Eligibility criteria:
inclusion criteria: * patients undergoing elective heart surgery exclusion criteria: * refusal to consent * patients undergoing emergency surgery