Kornimate/medical-research-clean huggingface dataset:
alleviant allay-hfref study

Conditions: Heart Failure

Summary: prospective, multicenter, randomized, sham-controlled, double blind (patient and observer), study designed to evaluate the safety and efficacy of a percutaneously created interatrial shunt using the alleviant alv1 system in patients with hfref.


Eligibility criteria:
inclusion criteria: * lvef ≤ 40% * nyha class ii, iii or ambulatory iv hf * receiving optimal, maximally tolerated, stable gdmt exclusion criteria: * advanced heart failure * life-expectancy \< 12 months * evidence of right heart dysfunction
neutrophil/lymphocyte ratio in acute pancreatitis

Conditions: Acute Pancreatitis

Summary: acute pancreatitis (ap) is a disease characterized by dysfunction of pancreatic acinar cells, improper activation of trypsin, and subsequent destruction of pancreatic self-defense mechanisms, further exacerbating injury and damage of pancreatic cells. it is a rapidly developing inflammatory process of the pancreas, and the most common reasons are alcohol and gallstones.

as one of the most common gastrointestinal diseases in hospitalized patients, the incidence of ap has gradually increased and is 4.9 to 73.4 cases per 100,000 people worldwide in the past few decades, imposing a heavy burden on the health system and leading to long-term hospitalization, most medical costs, and significant mortality. up to 10% to 20% of ap patients will develop sap, and the leading cause of poor prognosis in patients with ap is a vital organ (cardiovascular organs, lung, and kidney) failure and pancreatic necrosis . in clinical practice, varieties of scoring systems are available and have been gradually confirmed, such as the ranson score, glasgow score, acute physiology and chronic health evaluation (apache ii), bisap, and computed tomography severity index (ctsi) . these systems are cumbersome and take a long time to operate, requiring a lot of parameters that are not routinely collected in the early stages of the disease. for example, the bisap score is characterized by high specificity, but its sensitivity to sap is not satisfied. therefore, their early prediction power is not good. in ap, inflammation first activates a series of inflammatory cytokines, proteolytic enzymes, and anaerobic radioactive nucleic acids to destroy the tissue. the degree of neutrophils decrease is related to the improvement of prognosis of ap, while the degree of lymphocyte increase is related to the severity of the disease. the neutrophil-lymphocyte ratio (nlr) is a more comprehensive biomarker that used neutrophil and lymphocyte counts to respond rapidly to the extent of inflammatory progression and serves as a useful predictive marker to identify the severity of ap. it is well known that ap is a fast-onset inflammation of the pancreas, and an effective prediction of the severity of ap can guide ap patients to receive adequate treatment earlier, contributing to a better prognosis.

Eligibility criteria:
inclusion criteria: * patients with acute pancreatitis exclusion criteria: * patients with acute abdomen with diagnosis other than ap * patients with ap who are under age of 18 years old * patient's refusal
multicenter trial for the evaluation of a fixed dose combined tablet for the treatment of pulmonary tuberculosis

Conditions: Tuberculosis

Summary: the use of fixed-dose combined (fdc) drugs in the treatment of tuberculosis by national tuberculosis programmes has been recommended by both the international union against tuberculosis and lung disease (the union) and the world health organisation. the advantages of fdc drugs include preventing the emergence of drug resistance due to monotherapy, reducing the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding adherence and facilitating directly observed treatment. recent bioavailability studies of four-drug fdc tablets have demonstrated satisfactory results. in this study, we are testing the efficacy of this compound, when given in the initial intensive phase of treatment of patients with newly diagnosed smear positive pulmonary tuberculosis. this will be followed by four months treatment with a two-drug fdc of rifampicin and isoniazid.

this is a multiple country, multicenter study, using the parallel group open-label randomised trial design. the primary objective of this investigation is to assess the efficacy, acceptability and toxicity of a combined fdc regimen of chemotherapy in patients with newly diagnosed smear positive pulmonary tuberculosis in comparison with the standard regimen using separate drugs. patients will be allocated at random either : * an initial intensive phase of eight weeks of daily ethambutol, isoniazid, rifampicin and pyrazinamide, in a fixed dose combined tablet, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet three times a week (2comb/4(rh)3) or * the same drugs given in separate formulations in the initial intensive phase of eight weeks, followed by 18 weeks of rifampicin and isoniazid, in a fixed dose combined tablet, three times a week (2sepa/4(rh)3)

Eligibility criteria:
inclusion criteria: * patients with newly diagnosed pulmonary tuberculosis * two sputum specimens positive for acid-fast bacilli on direct smear microscopy * no previous anti-tuberculosis chemotherapy * aged 18 years and over * firm home address that is readily accessible for visiting for the duration of the trial (including follow up period) * agree to participate in the study and to give a sample of blood for hiv test exclusion criteria: * patients in a moribund state, * tb meningitis, * pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis, * pregnancy or breast feeding, * psychiatric illness * alcoholism * contraindication to any medications in the study regimens

Keywords: tuberculosis fixed dose combination dot shot-course chemotherapy
regulation of tissue lipolysis by insulin in type 2 diabetes

Conditions: Type 2 Diabetes

Summary: inadequate suppression of intramuscular and adipose tissue lipolysis, and consequent excessive delivery of fatty acids to ectopic tissues (e.g. muscle, pancreas and liver) could play an important role in the development and exacerbating of insulin resistance. therefore, the investigators propose to study the regulation of adipose tissue and skeletal muscle lipolysis, as well as further characterize the intracellular lipolytic pathways within these tissues, in obese normoglycaemic versus long-term diagnosed type 2 diabetic subjects.


Eligibility criteria:
inclusion criteria: * caucasian * normal blood pressure (sbp 100-140 mmhg, dbp 60-90 mmhg) * weight stable in last 3 months exclusion criteria: * smokers * people with intensive fitness training (e.g. athletes \> 3 times/week) * history of cardiovascular diseases * bleeding disorders * use of medication interfering with the study endpoints/hypotheses (e.g. beta-blockers) * not to be able to understand the study information * subjects on a special diet or vegetarian * blood donation 2 months prior to the study and during the study * participating in an other study
probiotics role in hpv cervico-vaginal infection clearance

Conditions: Vaginal Infection; HPV Infection

Summary: vaginal infections demonstrated to be implicated in the persistence of hpv, activating a vicious circle of vaginal microbial perturbations. hpv infection can destroy the biofilm barrier formed by the local vaginal immune microenvironment, leading to a condition called dysbiosis. contemporarily, the resulting local microecological imbalance in the vagina can subsequently upregulate the expression of the hpv protein, increasing hpv-related cytological alterations.

a total of 483 women affected by different vaginal infections and concomitant hpv-positivity were enrolled between 2018 and 2020 at department of gynecological, obstetrical and urological sciences, university "sapienza" of rome (rome, italy) and 2nd division of obstetrics and gynecology, azienda ospedaliera universitaria pisana, university of pisa (pisa, italy). women with positive swabs for infections were randomized in two groups, standard specific treatment (n=231) versus the standard treatment plus long-lasting (9 months) vaginal and oral probiotics implementation (n=252).

Eligibility criteria:
inclusion criteria * age \> 18 years * positive swabs for vaginal infections detected during colposcopy check * hpv test positivity exclusion criteria: * pregnancy or breastfeeding * concomitant malignancies * immunological diseases * severe comorbidities * prolonged corticosteroid treatment

Keywords: vaginal infections probiotics hpv
nigerian breast cancer risk-reduction study

Conditions: Risk Reduction Behavior; Breast Cancer; Health Behavior; Health Care Utilization; Health Knowledge, Attitudes, Practice

Summary: the study will be a randomized controlled trial. the aim of the study is to determine the breast cancer (bc) risk and to evaluate the effect of bc risk counseling on lifestyle changes and adherence to risk-reduction practices among first-degree female relatives of bc patients in south-west nigeria. this study's research questions are: * what are the nigeria breast cancer study (nbcs) and gail models estimates of the bc risk of first-degree female relatives of bc patients in south-west, nigeria? * what are the effects of bc risk assessment and counseling on adherence to breast screening recommendations among first-degree female relatives of bc patients in south-west, nigeria? * what are the effects of bc risk assessment and counseling on adherence to lifestyle risk reduction recommendations among first-degree female relatives of bc patients in south-west, nigeria? * what is the knowledge, attitudes, and perception of first-degree female relatives of bc patients in south-west nigeria towards genetic testing and bc etiology? * what factors predict breast screening among first-degree female relatives of bc patients in south-west nigeria? * what factors predict the time to first bc screening (post-intervention) among first-degree female relatives of bc patients in south-west nigeria? participants will be randomized into the control arm (standard care) and intervention arms of the study. the intervention arm of the study will have a bc risk assessment followed by individualized bc risk counseling. in addition, the intervention arm will receive bc awareness and mammacare® bse training. the control arm will receive only standard care comprising bc awareness and mammacare® bse training. both study arms will receive bc screening recommendations and lifestyle modification recommendations. we hope that the bc risk counseling will improve bc screening practices and modification of risk behaviors and this hypothesis will be tested.


Eligibility criteria:
inclusion criteria: 1. first-degree female relatives of histologically diagnosed bc patients in the study sites 2. women aged 20 to 75 years of age 3. willingness to be contacted after six months for follow-up exclusion criteria: 1. personal history of bc 2. previous exposure to breast cancer risk assessment and counselling 3. absence of intact breasts

Keywords: breast cancer first-degree relatives breast cancer prevention risk assessment risk counselling southwest nigeria
safety and performance study of the moderato system

Conditions: Hypertension Resistant to Conventional Therapy; Bradycardia; Atrioventricular Block

Summary: the purpose of the study is to evaluate the safety and performance of the moderato system by implanting the moderato pacemaker in patients who require a dual chamber pacemaker, and who also have hypertension, in order to reduce their blood pressure.


Eligibility criteria:
inclusion criteria: * subject is ≥ 18 years of age * subject is indicated for implantation or replacement of a dual chamber permanent pacemaker where no lead extraction is necessary. * subject has stable regimen of 2 or more maximally tolerated anti-hypertension medications, which is anticipated to be able to be maintained without changes for 3 months. * subject has office systolic blood pressure measurements \> 140 mmhg on two separate days within a one week period prior to enrollment, and the average of these two measurements is ≥150 mmhg exclusion criteria: * subject has known secondary cause of htn * subject has a history of atrial fibrillation * subject has ejection fraction \<50% * subject has symptoms of heart failure of nyha class ii or more * subject has hypertrophic cardiomyopathy, restrictive cardiomyopathy or interventricular septal thickness ≥15 mm * subject is on dialysis * subject has estimated glomerular filtration rate (gfr) \<30 ml/min/1.73m2 * subject has prior neurological events (stroke or tia) or carotid artery disease * subject has known autonomic dysfunction * subject has a history of clinically significant tachyarrhythmia * subject has had previous active device-based treatment for hypertension * subject has an existing implant, other than a pacemaker that needs replacing * subject with average systolic bp \>190 mmhg
pk papyrus covered coronary stent system

Conditions: Coronary Disease

Summary: the pk papyrus covered coronary stent system is a coronary stent being used at methodist dallas medical center for patients with coronary perforations.

the fda has approved the pk papyrus covered coronary stent system for use in patients being treated for acute perforations of native coronary arteries and coronary bypass grafts in vessels ranging from 2.5 to 5.0 mm in diameter, under a humanitarian device exemption (hde #h170004). methodist dallas medical center will use this device for treating the above-described patient population.

Eligibility criteria:
inclusion criteria: * patients with acute perforations of native coronary arteries and coronary bypass grafts in vessels 2.5 to 5.0 mm in diameter exclusion criteria: * patients in whom antiplatelet agents or anticoagulation therapy is contraindicated. * patients with a known allergy or hypersensitivity to amorphous silicon carbide or any other compound of the system (siloxane-based polyurethane, l-605 cobalt chromium alloy including tungsten and nickel). * lesions that cannot be reached or treated with the system. * lesions with threatened or abrupt closure during attempted pre-dilation prior to stent implantation. * risk of treatment-related occlusion of vital coronary artery side branches. * uncorrected bleeding disorders. * allergy to contrast media.
combination of parasternal and serratus anterior plane block in coronary artery bypass graft surgery

Conditions: Parasternal Block; Serratus Anterior Plane Block; Acute Pain; Postoperative Analgesia; Cardiac Surgery

Summary: postoperative analgesia is a critical risk factor for the development of pulmonary and cardiovascular complications in coronary artery bypass graft (cabg) surgery. if patients with high pain levels cannot breathe effectively, it may lead to atelectasis, cardiac ischemia, and arrhythmias. this prolongs the time it takes for patients to be discharged and increases the frequency of postoperative pulmonary complications and postoperative morbidity. in addition to intravenous medications, various neuraxial and peripheral nerve blocks can be used in cardiac surgery. in recent years, neuraxial anesthesia has been avoided due to the use of intraoperative high-dose heparin. as an alternative, peripheral nerve blocks have recently gained popularity. parasternal block (psb) and serratus anterior plane block (sapb) are very superficial and easy to reach. recently, in the literature, the number of cases performed with these blocks under ultrasound guidance and the number of randomized controlled prospective studies have increased. with this study, it was aimed to observe the analgesic effects on both the sternum and the drain site by applying psb and sapb applications simultaneously in the postoperative analgesia of cabg patients.


Eligibility criteria:
inclusion criteria: * 18 to 80 years old * american society of anesthesiologists (asa) physical status i-ii-iii * bmi 18 to 30 kg/m2 * elective coronary artery bypass graft (cabg) surgery exclusion criteria: * patient refusing the procedure * emergency surgery * history of chronic opioid or analgesic used
blood flow rextriction training in upper extremity of elderly

Conditions: Exercise Training; Blood Flow Restriction Training; Geriatrics

Summary: our study aims to decrease independence by increasing upper extremity strength and performance by applying blood flow restrictive training, which has entered the literature as a new method, to the upper extremity in the elderly. the application will only be applied to the upper extremity and will last for 6 weeks.

people are living longer now than in the past. the experience of old age in modern societies has gained importance with the prolongation of life expectancy. over the years, the elderly lead to a decrease in physiological capacity and an increase in the risk of various diseases, resulting in a decrease in the functional capacity of the individual. many physiological changes occur in the organism with advancing age. muscle strength is an important determinant of healthy aging. it is known that the decrease in muscle mass and strength impairs body function and can have significant consequences for the individual, as well as increase economic costs. impairment in function initially results in difficulties performing common daily activities such as carrying household items; however, when body strength falls below a clinically relevant threshold, mobility restriction increases and may affect independence in activities of basic daily living. loss of independence requires support from caregivers; often leads to social withdrawal and adverse effects on well-being and quality of life. muscle strength, function and mobility are the biggest determinants of independence. handgrip strength is used in clinical practice, rehabilitation, and public health research to determine musculoskeletal function and assess frailty and disability. the aim of our study is to determine the effect of bfrt applied to the upper extremity for 6 weeks on general function, hand grip strength, upper extremity functional status, activities of daily living and functionality for elderly individuals between the ages of 65-75. our hypothesis is that bfr will increase upper extremity function and related activities of daily living and mobility by increasing hand grip strength in elderly individuals.

Eligibility criteria:
inclusion criteria: * participants aged 65 and over who are classified as advanced age according to the world health organization * volunteer basis exclusion criteria: * history of acute trauma to the hand or wrist * scrapped upper extremity * patients with symptoms of shoulder or elbow pain and rheumatoid arthritis, * those who have participated in upper extremity weight training training in the last 6 months, * those taking sedatives * upper extremity venous thrombosis, * being at high risk for cardiovascular conditions that interfere with exercise, unexplained chest pain or heart disease, fainting or dizziness during physical activity/exercise

Keywords: blood flow restriction training geriatrics performance muscle strength
comparison of the effects of metformin and pioglitazone on liver enzymes and ultrasound changes in non-diabetic non-alcoholic fatty liver

Conditions: NAFLD

Summary: background: non-alcoholic fatty liver disease (nafld) is a spectrum of hepatic disease ranging from fat accumulation in liver to fibrosis and cirrhosis. it affects 25% of the world population on average. objective of this study is to compare the effect of metformin (1000 milligrams daily) versus pioglitazone (30 milligrams daily) in improving liver transaminases and ultrasound changes in non-diabetic patients of nafld when given for six months. methods: a quasi-experimental study was conducted in mayo hospital lahore from october 2019 to november 2020.out of 96 half patients were assigned randomly to group-a (metformin) or group-b (pioglitazone). demographic history, abdominal ultrasound \& liver enzymes were recorded on proforma monthly till 6 months. data was put into and analyzed by spss version 26; t-test was used to compare the mean liver transaminases between the two groups. ultrasound findings were compared by chi square. the p value of less than 0.05 was counted as significant.


Eligibility criteria:
inclusion criteria: 1. gender: both male and female 2. age: 18-80 years 3. ultrasound evidence of fatty liver as per operational definition 4. liver enzymes as per operational definition exclusion criteria: 1. pregnancy 2. cirrhotic patients as per operational definition 3. chronic hepatitis b or chronic hepatitis c 4. patients taking long term steroids, highly active antiretroviral therapy, diltiazem, irinotecan, oxaliplatin and amiodarone 5. patients taking alcohol (based on history and ast to alt ratio) 6. patients with heart failure (nyha classification class iii or iv status: patients comfortable at rest but less than ordinary physical activity causes undue fatigue, dyspnea or palpitations) 7. patients with renal failure (serum creatinine ≥ 1.4 mg% or egfr \< 45 ml/min/1.73 m2)
the effect of peripheral nerve blocks on postoperative analgesia in elective cesarean section

Conditions: Anesthesia; Sexual; Analgesia

Summary: the goal of this prospective randomized study was to compare the efficacy of transversus abdominis plane block and transversalis fascia plane block for postoperative analgesia in patients undergoing elective cesarean section under spinal anesthesia. the main question\[s\] it aims to answer are: \[is transversalis fascia plane block more effective in postoperative analgesia? \] \[is there a difference between the duration of postoperative first analgesia requirement? \] since the pain scores after the block at the end of the operation will be evaluated during the postoperative 24 hours, the participants will be asked to give a value between 0 and 10 in certain time periods.

this prospective, randomized trial was conducted at başakşehir çam and sakura city hospital by the declaration of helsinki. after ethics committee approval (decision no: 2022-74, date: 09.03.2022) and written informed consent was obtained from all patients, the trial was conduct-ed according to consolidated standards of reporting trials (consort) guidelines.a total of 150 patients were divided into two groups: transversal fascia plane block (tfpb group) and transversus abdominis plane block (tapb group).vas values, time to first analgesic requirement, analgesic requirements, nausea \& vomiting and pruritus were evaluated for 24 hours postoperatively (6th hour (t2), 12th hour (t3), 24th hour .

Eligibility criteria:
inclusion criteria: * 20-50 years old pregnant woman * asaii-iii * patients accepting spinal anesthesia exclusion criteria: * morbid obesity(bmi \>40) * patients who are switched to general anesthesia in an unexpected perioperative situation * patients with placental anomaly * patients with bupivacaine allergy * fetal distress situations too urgent to wait for spinal anesthesia and patients who do not want spinal anesthesia

Keywords: anesthesia recovery period cesarean section obstetric anesthesia spinal anaesthesia postoperative analgesia