Kornimate/medical-research-clean huggingface dataset:
evaluation of using platelet-rich fibrin in adult pulpotomy

Conditions: Irreversible Pulpitis

Summary: the goal of this interventional randomized clinical trial is to evaluate the use of platelet rich fibrin in full pulpotomy in mature adult teeth. the main questions it aims to answer are: 1. does the use of platelet rich fibrin in complete pulpotomy in mature permanent teeth will raise the success rate of full pulpotomy of adult teeth? 2. does the use of cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs? participants will be asked to do the following: * receive the pulpotomy treatment of their target tooth. * record the pain score in the pain assessment chart. * attend the follow-up visits. they'll receive a full pulpotomy treatment of their target tooth. researchers will evaluate the usage of platelet rich fibrin in performing the pulpotomy procedure of adult teeth and if cone beam computed tomography scans will be more effective in early detection of apical periodontitis than periapical radiographs.


Eligibility criteria:
inclusion criteria: 1. patient age: 25-35 years 2. mature permanent premolar teeth with two separate roots. 3. clinical diagnosis of irreversible pulpitis. 4. patients without existing medical condition. exclusion criteria: 1. immature teeth. 2. non-restorable teeth. 3. non-vital teeth. 4. uncontrolled pulpal bleeding. 5. periodontally affected teeth.

Keywords: pulpotomy platelet rich fibrin
refralon versus amiodarone for cardioversion of paroxysmal fibrillation and atrial flutter

Conditions: Atrial Fibrillation Paroxysmal

Summary: patients hospitalized with paroxysmal atrial fibrillation and flutter to restore sinus rhythm will be randomized into two groups: one will be cardioversion with refralon and the other with amiodarone

atrial fibrillation (af) and flutter (afl) are the most common types of arrhythmia in clinical practice. both electrical and medical cardioversion can be used to restore sinus rhythm. currently, the most studied and commonly used drug for pharmacological cardioversion of paroxysms of af/afl is amiodarone, which belongs to class iii antiarrhythmic drugs. the highest recovery rates of sinus rhythm (sr) (\>90%) are achieved with intravenous administration of amiodarone at a dose of more than 1500 mg / day or up to a maximum of 3000 mg / day. however, most commonly, amiodarone is used at a standard dose of 5 mg/kg body weight, with an efficacy of 34-69%. in 2014, a new russian class iii antiarrhythmic drug, refralon, was registered. in 2020, the drug was included in the national clinical guidelines "atrial fibrillation and flutter", approved by the ministry of health of the russian federation. when using refralon in doses from 10 to 30 μg/kg, sr recovery was noted in 91.6% of patients with persistent af/afl in 50% of patients sr restored within 15 minutes from the start of the drug administration. randomized trials comparing the efficacy and safety of refralon with other antiarrhythmic drugs have not been conducted. it is extremely important to directly compare the efficacy and safety of these two drugs in patients with paroxysmal af in a prospective randomized study.

Eligibility criteria:
inclusion criteria: 1. paroxysmal form of af/afl; 2. indications for sr recovery exclusion criteria: 1. arrhythmogenic effect of refralon, amiodarone and other antiarrhythmic drugs in history; 2. chronic kidney disease with a decrease in glomerular filtration rate less than 30 ml / min / 1.73 m2; 3. chronic heart failure (functional class iv); 4. atrioventricular blockade of 2-3 degrees (with the exception of patients with an implanted pacemaker); 5. dysfunction of the sinoatrial node (with the exception of patients with an implanted pacemaker); 6. bradysystolic atrial fibrillation (heart rate \<50 beats/min); 7. duration of the qt interval \>440 ms; 8. hemodynamic instability requiring emergency cardioversion; 9. contraindications to anticoagulant therapy; 10. thyrotoxicosis or decompensated hypothyroidism; 11. uncorrected electrolyte disturbances at the time of cardioversion (potassium level less than 3.5 mmol/l); 12. pregnancy and breastfeeding period.

Keywords: atrial fibrillation and flutter paroxysmal atrial fibrillation and flutter cardioversion af amiodarone refralon niferidil new antiarrhythmic drug new russian antiarrhythmic drug refralon
the role of histamine in muscle protein synthesis following resistance training

Conditions: Histamine

Summary: blocking histamine h1/h2 receptors blunts chronic endurance training adaptations. the current study addresses the following research question: "what is the influence of histamine h1 signaling on training adaptations following ten weeks of resistance training in human skeletal muscle." results from this study will yield more insights into the molecular mechanisms of adaptations to exercise training.


Eligibility criteria:
inclusion criteria: * male * 18-45 years * not to medium physically active exclusion criteria: * smoking * chronic disease * high blood pressure * supplement or medication intake * seasonal allergies * vegetarian / vegan * resistance trained
insulin glulisine in type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: primary objective: to compare the pharmacodynamics of insulin glulisine and insulin lispro injected subcutaneously before three 500 kcal standard meals during a 12 hour day, in obese subjects with type 2 diabetes. secondary objectives: * to compare the pharmacokinetics of insulin glulisine and insulin lispro in obese subjects with type 2 diabetes, injected subcutaneously before three standard meals during a 12-hour day. * the safety of insulin glulisine, the relationship of the pharmacodynamics and pharmacokinetics with skin thickness and c-peptide, non-esterified fatty acid, triglyceride and β-hydroxybutyrate levels in these subjects will also be assessed.


Eligibility criteria:
inclusion criteria : * type 2 diabetes mellitus * body mass index (bmi) between 35 and 40 kg/m2 * hba1c ≤10% * plasma c-peptide levels ≥0.1 nmol/l. * female subjects have to either be postmenopausal, surgically sterilized, or not pregnant and using approved methods of contraception. exclusion criteria : * type 1 diabetes mellitus, as defined by the world health organization * subjects currently taking any insulin * history of hypoglycaemic unawareness * injection site skin thickness \< or = 8 mm * contra-indications from * the medical history and physical examination * laboratory tests (haematology, clinical chemistry, and urinalysis by dipstick) * blood pressure and pulse
early detection of cardiac toxicity in childhood cancer survivors

Conditions: Heart Failure; Cardiotoxicity

Summary: to evaluate cardiac mri and/or serum biomarkers for detecting cardiac cardiac toxicity in children who received anthracycline based chemotherapy (abc).

cardiac toxicity is a significant potential complication for patients receiving anthracycline chemotherapy. cells in the cardiovascular system have limited regenerative capability, making them susceptible to long term adverse effects from these chemotherapeutic agents. the ability to detect subclinical changes in cardiac function will allow clinicians to use proven treatments to prevent further progression in this vulnerable population. the current standard testing uses echocardiography, which is not as sensitive as cardiac mri or serum biomarkers.

Eligibility criteria:
inclusion criteria: * subjects that have received anthracycline based chemotherapy * age: 8 years old - 25 years old * subjects that do not require sedation for cardiac mri. * subjects must have completed treatment in the last 10 years exclusion criteria: * patients with significant congenital heart defects * patients with renal injury or renal failure, defined as an estimated glomerular filtration rate \[egfr\] \<30 ml/min/1.73 m2 body surface area), as previously calculated) * patients that require sedation for a cardiac mri * subjects that are pregnant or lactating * patients with contraindications to a cardiac mri: * cardiac pacemaker or implantable defibrillator * cerebral aneurysm clip * neural stimulator * metallic ocular foreign body * any implanted device (i.e. insulin pump, drug infusion device) * claustrophobia * metal shrapnel or bullet * investigator assessment of inability to comply with protocol * unable/unwilling to lie still throughout the research procedure * persons with cognitive impairment
avelox in complicated skin and skin structure infections

Conditions: Skin Diseases, Bacterial

Summary: this international, prospective, non-interventional, non-controlled observational study obtains data on efficacy, safety and tolerability of avelox treatment under daily-life treatment conditions. specifically investigated are the improvement of clinical symptoms and the duration until infection improvement and cure.any patient with a diagnosis of complicated skin and skin structure infection (csssi) treated with avelox can be documented. the observation period for each subject covers the treatment period with avelox. for each patient, the physician documents data at an initial visit and one or two follow-up visit(s) in line with routine practice.


Eligibility criteria:
inclusion criteria: * any patient with a diagnosis of complicated skin and skin structure infection (csssi) and for whom the decision was made by the attending physician to start treatment with avelox before inclusion into and independent of the study. exclusion criteria: * exclusion criteria are those specified in the local product information.

Keywords: skin diseases, bacterial product surveillance postmarketing
phase 1 study of alxn1840 on the metabolism of a cyp2c9 substrate in healthy participants.

Conditions: Wilson Disease

Summary: this was a phase 1, randomized, 2-period, 2-sequence, cross-over study designed to determine the effect of alxn1840 on the metabolism of celecoxib, a sensitive cytochrome p450 2c9 (cyp2c9) substrate, in healthy male and female participants. the safety and tolerability of alxn1840 were determined along with alxn1840 pharmacokinetics (pk) in plasma as measured via total molybdenum with the coadministration of celecoxib.

the study was conducted as a randomized, 2-period, 2-sequence, cross-over study to determine the effect of a single dose of alxn1840 (perpetrator) on the single-dose celecoxib (victim) kinetics in healthy male and female participants. the study had a screening period (day -28 to day -2), two 11-day study periods (day 1 to day 11) with a minimum of 14 days between doses of celecoxib, and an end of study visit (day 15 ± 2 days) after period 2 dosing. participants only reported to the clinical research unit (cru) on the day prior to the first dose because they were kept in the cru during the wash-out period due to coronavirus disease 2019. all participants received a single dose of celecoxib alone (treatment a) and celecoxib coadministered with alxn1840 (treatment b) during the study, 1 in each treatment period. based on randomization, participants were administered either treatments a-b or treatments b-a in each study period. the pk profile of alxn1840 and celecoxib was determined by blood sampling following single-dose administration. in addition to pk sampling, safety and tolerability were assessed by monitoring adverse events, vital signs, 12-lead electrocardiograms, physical examinations, and laboratory parameters.

Eligibility criteria:
inclusion criteria: * adequate venous access in the left or right arm to allow the collection of blood samples. * bodyweight ≥ 45 to ≤ 100 kilograms (kg) and body mass index within the range of 18 to \< 30 kg/meter squared. * willing and able to follow protocol-specified contraception requirements. * capable of giving signed informed consent. exclusion criteria: * history or presence of/significant medical history. * clinically significant multiple or severe allergies. * lymphoma, leukemia, or any malignancy within 5 years. * breast cancer within the past 10 years. * serum creatinine \> upper limit of normal (uln) of the reference range. * alanine aminotransferase, aspartate aminotransferase, or total bilirubin \> uln. * current or chronic history of liver disease or known hepatic or biliary abnormalities (with the exception of gilbert's syndrome or asymptomatic gallstones). * qtc \> 450 milliseconds (msec) for male participants or \> 470 msec for female participants.

Keywords: cytochrome p450 healthy alxn1840 celecoxib cyp2c9
comparative effectiveness and safety of tiotropium and olodaterol in comparison to triple therapy

Conditions: Pulmonary Disease, Chronic Obstructive

Summary: to assess the comparative effectiveness of combination tiotropium and olodaterol (tio+olo) (fdc) compared to combination lama/laba and ics (fixed or open), and to explore whether this varies across copd sub populations defined by exacerbation risk


Eligibility criteria:
inclusion criteria: * new users of tio+olo on the same date or of laba, lama and ics, either as a fixed-dose combination (laba/lama/ics) or free combination (laba/ics + lama, etc), on the same date between january 2013 and march 2019. * diagnosis of copd prior to first maintenance inhaler and age ≥ 40 years at index date exclusion criteria: * less than one year of medical history information prior to the date of combined treatment initiation (index date) * lung cancer, interstitial lung disease, or lung transplantation at any time prior to the index date * asthma diagnosis within one year prior to the index date
the effect of phacoemulsification on the macular changes in patients with neovascular age-related macular degeneration

Conditions: Neovascular (wet) Age-Related Macular Degeneration

Summary: the macula has a very high concentration of photoreceptor cells - the cells that detect light. they send signals to the brain, which interprets them as images. the rest of the retina processes our peripheral, or side vision to explore whether cataract surgery evokes development or relapse of choroidal neovascularization (cnv) in wet age-related macular degeneration (amd) patients followed for a 1-year postoperative period

age-related macular degeneration (amd) is a leading cause of vision loss in adults over the age of 50. amd causes damage to a small part of the retina responsible for central vision called the macula. when damage to the macula occurs, it typically causes loss of central, detailed vision which results in difficulty with tasks such as reading, driving, threading a needle, or recognizing faces. phacoemulsification is a modern-day cataract surgery that employs ultrasound energy to emulsify the nucleus, vacuum to catch the nuclear material, and irrigation and aspiration for cortex and viscoelastic removal. it is currently impossible to draw definitive conclusions whether phacoemulsification (phe) is safe for people with age-related macular degeneration (armd). it is not clear if phe causes the progression of armd and affects visual acuity (va). the purpose was to analyze the possible association of phe with armd progression in the early and late (up to 18 months after surgery) period.

Eligibility criteria:
inclusion criteria:subjects included in this study aged above 50 and presented for routine check up after undergoing phacoemulsification: * above 50 years old * not diabetic individuals * wet armd exclusion criteria: * intraoperative complications * eyes with diseases predisposing them for postoperative macular edema, preexisting macular edema, and eyes that developed cystoid macular edema * active ocular inflammation or infection _glaucoma * a preoperatively worsened va regardless phe * ocular trauma * patients with central retinal ischemia * previous vitrectomy * dry amd
effects of m-tapa block on pulmonary functions

Conditions: Pulmonary Functions; Pain Management; Obesity, Morbid

Summary: adequate postoperative analgesia is difficult to achieve in patients undergoing laparoscopic sleeve gastrectomy (lsg). epidural anesthesia is technically difficult due to subcutaneous fat, which increases the risk of serious complications. moreover, patients in this condition often have comorbidities that require anticoagulation therapy. although ultrasound-guided transversus abdominis plane (tap) block may be useful, it is still controversial. recently, modified thoracoabdominal nerve block via perichondrial approach (m-tapa) has been reported as a new and promising technique that provides effective analgesia in the anterior and lateral thoracoabdominal wall. the most common reason for hospitalization after laparoscopic surgery is pain after nausea and vomiting. in addition, superficial and tachypneic breathing resulting from the patient's inability to breathe deeply with pain causes closure of small airways and increase in intrapulmonary shunts, resulting in hypoxia. postoperative pain management is important not only to prevent pain but also to reduce pulmonary complications that may occur due to changes in lung function and to reduce mortality and morbidity by controlling the stress response. in this study, the investigators investigated the effect of modified thoracoabdominal nerve block via perichondrial approach (m-tapa) on pulmonary function in patients undergoing laparoscopic bariatric surgery under general anesthesia.


Eligibility criteria:
inclusion criteria: * between 18-65 years old * asa i-ii-iii risk group * patients whose approval was obtained through an informed consent form * will undergo laparoscopic bariatric surgery * patients who will cooperate for the pft test exclusion criteria: * \ 65 years * asa ≥ iv * 50% below the expected value in sft * known diaphragmatic paralysis * having had a myocardial infarction within 1 month * dementia or confusion * lack of cooperation * those with respiratory disease * congestive heart failure * unstable hypertension * had thoracoabdominal surgery

Keywords: obesity pain management pulmonary functions respiratory function test
the impact of the human papilloma virus in pediatric chronic kidney disease, dialysis, and transplant patients

Conditions: Chronic Kidney Disease; Dialysis

Summary: the proposed study is a pilot study and a first step towards developing an optimized hpv vaccination strategy for girls who have ckd, or are on dialysis or have a kidney transplant.


Eligibility criteria:
inclusion criteria: * 9-18-year-old girls who have ckd stages 3 or 4 (glomerular filtration rates 15-59 ml/min/1.73m2). * 9-18-year-old girls who are on dialysis. * 9-18-year-old girls who have had a functioning kidney transplant for longer than 6 months and are on the same immunosuppression regimen. * healthy 9-18-year-old girls exclusion criteria: * pregnancy, fever, allergy to any vaccine component, any immune disorder and any blood product received in the previous 6 months.

Keywords: dose response relationship immunity
to assess safety, tolerability, pharmacokinetics/pharmacodynamics and the effect of fasting after single oral doses of azd5658 in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: the purpose of this study is to investigate the safety and tolerability of azd5658 following ascending single oral doses in type 2 diabetics. it will also estimate the maximum tolerated dose.

this is a randomized, single-blind, placebo-controlled, single-center, phase 1 study to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and the effect of fasting after single ascending oral doses of azd5658 in type 2 diabetes mellitus patients.

Eligibility criteria:
inclusion criteria: * patients must be of non-childbearing potential. * body mass index between greater than or equal to 19 and less than or equal to 40 kg/m2 * patients with confirmed type 2 diabetes diagnosis for at least 1 year and treated with metformin exclusion criteria: * clinically significant illness or clinically relevant trauma within 2 weeks before the first administration of the ip * participation in another clinical study during the last 30 days prior to enrollment * significant cardiovascular event within the last 6 months prior to enrollment

Keywords: first in man study evaluating azd5658 in type 2 diabetics. effect of fasting safety tolerability
effect of sodium glucose co-transporter 2 inhibitors on left atrial remodeling

Conditions: Atrial Fibrillation

Summary: investigators are going to assess direct effect of sglt2 inhibitors on left atrial remodeling in participants with nonvalvular paroxysmal atrial fibrillation regardless of diabetes status.


Eligibility criteria:
inclusion criteria: 1. with non-valvular paroxysmal atrial fibrillation (af that terminates spontaneously or with intervention within seven days of onset). 2. patient age 18-60 years. 3. patients with glomerular filtration rate (gfr) \>45 ml/min/1.73m2 (cockcroft-gault equation). 4. patient with normal left atrium or dilated (diameter \<5 cm) exclusion criteria: 1. patients \< 18 yrs old. 2. patients with valvular heart diseases (moderate to severe ms, severe as, prosthetic heart valves). 3. patients with left atrium \> 5cm. 4. patients with glomerular filtration rate (gfr) \<45 ml/min/1.73m2 (cockcroft-gault equation). 5. patient with ischemic heart disease (previous mi, ua, pci or cabg). 6. patient with previous ischemic stroke.
effect of gastrogenic microbiota in fd

Conditions: Dyspepsia; Dysbiosis

Summary: single-center prospective interventional study aimed at demonstrating the effect of gastric-origin probiotics on dyspeptic symptoms, tryptophan metabolism, and microbiome parameters in fd patients without helicobacter pylori infection, compared to a placebo group

prospective randomized placebo-controlled study in 2 parallel fd cohorts (8 weeks) : cohort 1fd : receiving 8 weeks of gastrogenic microbiota cohort 2fd : receiving 8 weeks of placebo clinical outcomes and tryptophan metabolism, microbiome parameters will be assessed at the beginning and end of each treatment period (week 0, 8).

Eligibility criteria:
inclusion criteria: * adults aged ≥18 and ≤70 years, with symptoms such as upper abdominal pain or burning sensation, postprandial bloating, early satiety, etc., and who meet the diagnostic criteria for functional dyspepsia (fd) according to the rome iv criteria. * negative result on the c13 urea breath test, and no organic changes observed on gastroscopy. exclusion criteria: * use of acid-suppressing drugs, prokinetic agents, antibiotic or anxiolytics within 4 weeks prior to enrollment. * history of abdominal surgery, abdominal or inflammatory bowel disease, diabetes, active psychiatric disorders, or severe diseases of vital organs such as the heart, lungs, liver, or kidneys. * pregnant or breastfeeding participants, or those currently involved in other clinical research studies.
special drug use surveillance on long-term use of sodium risedronate tablets (benet 75 mg tablets) (12-month treatment survey)

Conditions: Osteoporosis

Summary: the purpose of this study is to evaluate the safety and efficacy of sodium risedronate tablets (benet 75 mg tablets) in osteoporosis patients in daily medical practice, as well as to examine "the status of treatment compliance" - i.e., whether sodium risedronate tablets are taken properly in accordance with the prescribed once-monthly regimen

this surveillance was designed to evaluate the safety and efficacy of sodium risedronate tablets (benet 75 mg tablets) as well as to evaluate the status of treatment compliance in osteoporosis patients in daily medical practice. the usual dosage for adult is 75 mg of sodium risedronate administered orally with a sufficient volume (approximately 180 ml) of water once monthly after waking. for at least 30 minutes after administration, patients should avoid lying in a supine position and should avoid taking food, drink (except for water) or other oral drugs. for more details, see the "precautions related to dosage and administration" section of the package insert.

Eligibility criteria:
inclusion criteria: * osteoporosis patients exclusion criteria: * none

Keywords: pharmacological therapy