Kornimate/medical-research-clean huggingface dataset:
reducing blood loss during cesarean section by topical versus iv tranexamic acid

Conditions: Cesarean Section Complications

Summary: tranexamic (txa)acid is an inexpensive, antifibrinolytic drug long used to control bleeding due to surgery, menorrhagia, or trauma. additionally, tranexamic acid has been shown to reduce bleeding during cesarean delivery as well as the need for additional uterotonic agents, albeit to a minimal degree. however, previous studies have been performed only in women with a standard risk for postpartum hemorrhage( pph) and have not focused on assessing the effects of tranexamic acid in high-risk women. the aim of this study is to evaluate the efficacy of iv versus topical application of tranexamic acid in reducing blood loss during and after elective c.s. the research question is topical application of tranexamic acid effective in reducing blood loss during and after an elective caesarean section? the research hypothesis the txa could be able to reduce blood loss during and after elective caesarean section. the null hypothesis will, therefore, state that: there will be no difference between topical and iv txa and placebo in reducing blood loss during and after elective caesarean section.

patients were allocated to one of three groups after induction of general anesthesia and immediately prior to the operation and just before skin incision. they received 1-gram tranexamic acid (10 ml) in 100 ml saline infusion or placebo (110 normal saline) by slow intravenous injection at an approximate rate of 1 ml per min. throughout the operation, irrigation was done by 60 ml of (2g tranexamic acid (10 ml) diluted in 100 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.).at the end of operation, another dose of 60 ml of (1g tranexamic acid (10 ml) diluted in 50 ml of sodium chloride 0.9%) or placebo ( 60 ml of sodium chloride 0.9%.) was left intraabdominal

Eligibility criteria:
inclusion criteria: * all pregnant women with a single term fetus scheduled for elective cesarean section who will be at risk of postpartum hemorrhage exclusion criteria: * patients with a cardiac, hepatic, renal or thromboembolic disease. , * patients with the high possibility of the morbid adherent placenta, * known coagulopathy and * those presented with severe antepartum hemorrhage * refuse to participate

Keywords: cesarean section tranexamic acid postpartum hemorrhage
perfusion index in assessment of postoperative pain in children.

Conditions: Postoperative Pain

Summary: the aim of this study will be to examine the validity of perfusion index in predicting pain and evaluation of its severity in the postoperative period.

\* hypospadias repair is a common surgery that is accompanied with significant postoperative pain. the largest group of children usually undergo this type of surgery are infants and pre-verbal children who cannot verbally report pain, and their treatment depends typically on behavioral and observational tools. although these tools are valid and reliable measures in assessment of pediatric pain, they are still hindered by their subjectivity, which consequently could result in inadequate pain treatment that in early childhood may lead to negative behavioral and neurophysiological sequalae. that is why recent studies have focused on developing more objective measures to evaluate pain especially when self-report is not possible. \* changes in perfusion index(pi) caused by sympathetic stimulation refers to possible correlation between pain and pi which forms the basis of our study proposing that the pi is a non-invasive easy method that can be used in evaluating pain in infants

Eligibility criteria:
inclusion criteria: 1. patients aged \<3 years 2. sex:- both male and female. 3. asa i-ii 4. informed written consent obtained from parents or guardians of all patients. 5. undergoing hypospadias repair surgery exclusion criteria: 1. patients outside the selective age range 2. parents or guardians refusing to enroll their child in the study. 3. asa iii or vi 4. children with behavioral changes or physical developmental delay 5. children treated with sedatives or anticonvulsants.
effects of basic carbohydrate counting versus standard outpatient nutritional education in type 2 diabetes

Conditions: Type2 Diabetes; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders

Summary: the aim of the study is to examine the health benefits of adding a concept in basic carbohydrate counting (bcc) to the routine outpatient nutritional education for adult patients with type 2 diabetes. the study hypothesis is that training and education in the bcc concept will improve glycaemic control either by reducing hba1c or the average plasma glucose variability more than offering the routine dietary care as a stand-alone dietary treatment.

the trial has a parallel-group design with a study duration of 48 weeks for each participant (a 6-month intervention period and a 6-month follow-up period). a total of 226 patients will be enrolled in the trial. participants will be randomized to one of two arms: 1) standard medical and dietary care (control group) or 2) structured training and education in the bcc concept in addition to standard medical and dietary care. the primary objective is to evaluate the six months effect of structured training and education in the bcc concept compared to standard dietary care on glycaemic control as assessed by hba1c or mage (mean amplitude of glycaemic excursions).

Eligibility criteria:
inclusion criteria: * type 2 diabetes * diabetes duration; from \>12 months * hba1c between 53 and 97 mmol/mol * diet or any glucose-lowering medication * provided voluntary written informed consent exclusion criteria: * practicing carbohydrate counting, as judged by the investigator * participated in a bcc group program within the last two years * low daily intake of carbohydrates (defined as below 25 e% or 100 g/day), as judged by the investigator * use of open cgm * use of a free libre device * use of an automated bolus calculator for carbohydrate counting, as judged by the investigator * gastroparesis * pregnancy or breastfeeding, or plans of pregnancy within the study period * uncontrolled medical issues, as judged by the investigator * concomitant participation in other clinical studies * unable to understand the informed consent and the study procedures

Keywords: carbohydrates basic carbohydrate counting diet type 2 diabetes
a study to compare the pharmacokinetic characteristics of cj-12420

Conditions: Erosive Esophagitis

Summary: to compare the pharmacokinetics after administration of different formulation of cj-12420

the purpose of this study is to compare the pharmacokinetics after a single dose administration of cj-12420 formulation 1 and formulation 2.

Eligibility criteria:
inclusion criteria: * healthy male aged 19 to 45 years at the screening * subject who is over 50kg with bmi between 19 kg/m2 to 28 kg/m2 (inclusive) * subject who fully understood after being informed detailed description of clinical trial, written informed consent voluntarily to observe the precautions. exclusion criteria: * subject who fall under the criteria below in laboratory test. * ast, alt, alp, ggt, total bilirubin, bun, creatinine \> unl x 1.5 * subject who with low blood pressure with clinical significance at screening test. * (systolic blood pressure is less than 90 mmhg or over 140 mmhg, and diastolic blood pressure is less than 50 mmhg or over 90 mmhg) * subject who has a medical history of symptomatic gerd, erosive esophagitis or duodenal ulcer, gastric ulcer, barrett's esophagus or zollinger-ellison syndrome.
reliability and validity of hhirs general quality of life questionnaire

Conditions: Musculoskeletal Pain; Neurological Disorder

Summary: quality of life is conceded by copious musculoskeletal and neurogenic conditions which are evaluated by manifold questionnaires. these questionnaires are obtainable in english and many other languages but in pakistan, these cannot be applied due to differences in languages, lifestyles, culture, and activities of daily living (adl's). in relation to the culture of pakistan, there are many accomplishments such as offer prayers and other domestic obligation which cannot be executed appropriately if any musculoskeletal and neurogenic disorders are existing. all these disorders can be assessed appropriately by questionnaires previously accessible but not in a single tool.

hhirs developed a general quality of life questionnaire in the urdu language for the expediency of patients. relation of the questionnaire with upper limb has been identified but there is no clear relation with other body regions. consequently, the purpose of this research is to evaluate the validity and reliability of the hhirs-general-qol questionnaire in the urdu speaking population of pakistan.

Eligibility criteria:
inclusion criteria: * participants able to read and write urdu * neurological disorders * musculoskeletal pain * systemic diseases exclusion criteria: * communication disorder * cognitive disorder

Keywords: reliability validity hhirs-general-qol questionnaire patient reported outcome measure
effects of oagb and djb-sg on 10-year and lifetime risks of mace

Conditions: Obesity

Summary: metabolic bariatric surgery (mbs) has demonstrated its efficacy in achieving sustainable weight loss and alleviating associated comorbidities. the primary objective of our investigation is to assess the long-term impact and sustainability of weight loss, the remission of t2d as well as risk prediction of cardiovascular events following mbs concerning one-anastomosis gastric bypass (oagb) and duodenojejunal bypass with sleeve gastrectomy (djb-sg).

metabolic bariatric surgery (mbs) offers enduring weight reduction and alleviation of obesity-related comorbidities, including dyslipidemia, type 2 diabetes (t2d), hypertension (htn), and major adverse cardiovascular events (mace). long-term data on one anastomosis gastric bypass (oagb) and duodenal-jejunal bypass with sleeve gastrectomy (djb-sg) is lacking, necessitating this investigation. in this multicenter prospectively-collected retrospective observational study, patients with complete follow-up data at various intervals up to 3 years after surgery were included in the final analysis. the study's primary focus was to evaluate the long-term safety, efficacy, and durability of oagb and djb-sg in promoting weight loss and t2d remission. additionally, changes in 10-year and lifetime risks of mace before and 3-year after surgery were assessed using the taiwan mace risk prediction model and the china-par project model based on taiwan national electronic health records and a large chinese participant dataset, respectively. hypothesis: this study contributes to providing valuable information in terms of the impacts of oagb and djb-sg on patients with obesity and associated diseases.

Eligibility criteria:
inclusion criteria: * patients whose bmi≧37.5 kg/m2 or patients whose bmi≧32.5 kg/m2 and have concurrent high-risk comorbidities, such as hypertension, obstructive sleep apnea, hba1c≧7.5% after anti-diabetic medication treatment, etc; * the patients have been treated with lifestyle intervention, including increase in physical activity and change in diet, for more than 6 months; * age between 20 and 65 years old; * patients without other endocrinological causes that result in morbid obesity; * patients without substance use, alcohol use and other psychiatric disorders; * the integrity of the patient's mental status is approved by the psychiatrist. exclusion criteria: * patients who did not complete 3-year follow-up * patients who are not eligible for surgery

Keywords: one-anastomosis gastric bypass duodenal-jejunal bypass with sleeve gastrectomy major adverse cardiovascular events type 2 diabetes mellitus obesity comorbidities
anti-inflammatory drug and endothelial function

Conditions: Cardiovascular Diseases; Endothelial Dysfunction; Sleep Apnea; Atherosclerosis; Coronary Artery Disease

Summary: in this randomized double-blinded clinical trial, 400mg of hydroxychloroquine will be given daily to people over the age of 65 years with moderate-severe obstructive sleep apnea for 8 weeks. the aim of this study is to test whether hydroxychloroquine can improve endothelial function.

sleep apnea and coronary artery disease are prevalent and relevant diseases due to their morbidity and mortality. the mechanism by which sleep apnea leads to coronary artery disease remains unclear. it is known that intermittent hypoxia, the main characteristic of sleep apnea, leads to inflammation and consequently may lead to endothelial dysfunction. endothelial dysfunction precedes the development of atherosclerotic disease and the occurrence of cardiovascular events. agents that potentially act to improve endothelial function may assist in the prevention of cardiovascular events. patients using immunomodulators due to rheumatic diseases have a lower prevalence of cardiovascular diseases. however, the cardioprotective effect of these drugs in patients without autoimmune diseases is not known. hydroxychloroquine (hcq) is an immunomodulator used in the treatment of rheumatoid arthritis and systemic lupus erythematosus. in addition to its anti-inflammatory properties, hcq reduces cholesterol and glycemia levels and has antithrombotic effects. the drug is inexpensive and widely available. the adverse effects of hcq are rare and occur more frequently when using high doses.

Eligibility criteria:
inclusion criteria: * apnea-hypopnea index of 15 events/hour or higher exclusion criteria: * contraindication for hydroxychloroquine (retinopathy, chronic liver disease, chronic renal disease) * rheumatologic disease
comparative effects of two conservative treatments in teres major in handball athletes with shoulder pain

Conditions: Shoulder Pain; Dry Needling; Diacutaneous Fibrolysis; Athletic Injuries

Summary: the aim of the study is to investigate the effects of the dry needling technique and diacutaneous fibrolysis technique in teres major muscles on pain, range of motion, strength extensibility and muscular properties of the soft tissues of the shoulder in athletes with shoulder pain.


Eligibility criteria:
inclusion criteria: * athletes with shoulder pain * glenohumeral internal rotation deficit * presence of active mtrp in the teres major muscle exclusion criteria: * previous surgery in the upper limb * previous physiotherapy treatments in the shoulder * dry needling contraindications * previous dry needling experience to mantain the blinding
gastric bypass stent small-sample-size study for nonalcoholic fatty liver disease

Conditions: Nonalcoholic Fatty Liver Disease

Summary: evaluate the preliminary effectiveness and safety of the gastric bypass stent system in treating nonalcoholic fatty liver disease.

the gastric bypass stent system is intended to be used in patients with diagnosis of nonalcoholic fatty liver disease， proton density fat fraction measured by magnetic resonance imaging (mri-pdff) ≥8%. in this pivotal, prospective, single-arm clinical investigation the sponsor seeks to demonstrate the safety and performance of the gastric bypass stent system in treatment of patients with nonalcoholic fatty liver disease

Eligibility criteria:
inclusion criteria: （ - ） males or females with age between 18 and 65 years old; （ - ） diagnosis of nonalcoholic fatty liver disease; （ - ） proton density fat fraction measured by magnetic resonance imaging (mri-pdff) ≥8%; （ - ） bmi≥24; patients who understand the objective of the study; voluntarily participate in the study and have signed the informed consent form; and are able and willing to comply with all requirements, including follow up and evaluations. exclusion criteria: （ - ） history of excessive alcohol consumption (alcohol consumption equivalent to ethanol \> 30 g/d for males and \> 20 g/d for females); （ - ） end-stage liver disease (e.g. hepatic cirrhosis or hepatic cancer) or other conditions which may lead to fatty liver; （ - ） unable to cooperate to complete mr examination; （ - ） subjects who have used any nonsteroidal anti-inflammatory drug or corticosteroid in the past month; （ - ） patients with iron deficiency or iron deficiency anemia; （ - ） alt or ast increased to 8 × upper limit of normal (uln), and bilirubin increased to 2×uln; （ - ） patients with coagulation disorder or haemorrhagic diathesis (platelets \<100×109/l); （ - ） patients with duodenal ulcer, or previous or existing pancreatitis; （ - ） history of liver abscess; （ - ） history of gallstones (symptomatic or presenting of any stone with a diameter greater than 20mm); （ - ） patients with gastrointestinal hemorrhage or potential hemorrhage; （ - ） gastrointestinal tract anomalies, such as gastrointestinal tract atresia or any or other conditions that would result in failed placement in the gastrointestinal tract; （ - ） patients with history of intestinal obstruction or related disease in the past year; （ - ） drug abusers or patients with uncontrollable psychiatric disorders; （ - ） patients with any contraindication to endoscopy based on the investigator's judgment; （ - ） pregnancy or lactating women; （ - ） patients who are participating in any other drug or medical device clinical study; （ - ） patients with any other conditions evaluated by the investigators as unsuitable for participating in the trial;
a close examination of patient experiences in bipolar disorder clinical trials

Conditions: Bipolar Disorder

Summary: participation in clinical trials usually favors a particular demographic group. but there is limited research available to explain what study attributes affect the completion of these specific demographic groups. this study will investigate the safety and efficacy of bipolar disorder treatments. the focus will be on tracking the rates of completion and withdrawal among these individuals. it will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future bipolar disorder study.


Eligibility criteria:
inclusion criteria: * patient is at least 18 years of age * diagnosis of bipolar disorder * ability to understand a written informed consent document, and the willingness to sign it. exclusion criteria: * women of childbearing potential without a negative pregnancy test; or women who are lactating. * has a serious medical or psychiatric illness likely to interfere with participation in this clinical study. * inability to perform regular electronic reporting

Keywords: bipolar disorder
nationwide utilization of danish government electronic letter system for increasing influenza vaccine uptake among adults with chronic disease

Conditions: Influenza; Behavior and Behavior Mechanisms

Summary: in randomized clinical trials and observational studies, influenza vaccination has been shown to be effective in reducing influenza-related illness, hospitalizations, cardiovascular events, and mortality in select populations. however, the real-world effectiveness of influenza vaccination is limited by its uptake. this study will investigate whether digital behavioral nudges delivered via the official, mandatory danish electronic letter system can increase influenza vaccine uptake among adults aged 18-64 years with chronic diseases.

the study is a prospective, randomized, open-label implementation trial. the study population will consist of persons aged 18-64 years identified as eligible for free-of-charge influenza vaccination due to a chronic condition. subjects will be identified through danish nationwide health registries using codes from the international classification of diseases, 10th revision (icd-10). individuals will be randomized to 1 of 7 arms (1 usual care arm and 6 intervention arms) with each testing different nudging strategies employing various behavioural economic principles. the interventions will be delivered through the official, mandatory danish electronic letter system. all subject data will be retrieved from the danish nationwide registries with the exception of information on intervention allocation. endpoints will be retrieved at prespecified dates using prespecified search algorithms.

Eligibility criteria:
inclusion criteria: 1. age 18-64 years 2. must be registered in the danish nationwide registries as meeting at least one of the following eligibility criteria for free-of-charge influenza vaccination in the danish public health system: 1. chronic lung disease 2. chronic cardiovascular disease other than hypertension 3. type 1 or type 2 diabetes mellitus 4. congenital or acquired immunodeficiency 5. impaired breathing due to muscular weakness 6. chronic renal or hepatic insufficiency 7. other chronic conditions with an increased risk of severe influenza as determined by the treating physician 3. access to the official, mandatory danish electronic mailbox system exclusion criteria: none

Keywords: influenza vaccination nudging behavioral science
ventricular tachycardia ablation through radiation therapy consortium: concept description of an observational retrospective multicentric trial

Conditions: Ventricular Tachycardia (VT)

Summary: recurrent ventricular tachycardia (vt) is a potentially life-threatening arrhythmia in patients with structural heart disease. despite the use of antiarrhythmic drugs, implantable cardioverter-defibrillators (icds), and radiofrequency catheter ablation, vt recurrence rates remain high-reaching up to 66% in some series. for patients with refractory vt who are not candidates for further ablation or surgical interventions, there is a significant unmet need for novel, effective, and non-invasive treatment options. stereotactic body radiation therapy (sbrt) has recently emerged as a promising approach for treating ventricular arrhythmias through a technique known as stereotactic arrhythmia radioablation (star). preliminary studies, including a phase i/ii clinical trial, have demonstrated a substantial reduction in vt burden-up to 99.9%-following treatment, with an acceptable safety profile. reported adverse events have included manageable pericardial effusion, radiation-induced pericarditis, and pneumonitis. the growing body of evidence supports star as a feasible and effective alternative for selected patients with treatment-resistant vt. the objective of this study is to evaluate the efficacy and safety of stereotactic radiotherapy as a non-invasive ablation technique for the treatment of ventricular tachycardia (vt) in patients with refractory arrhythmias in whom conventional therapies have failed. this is a retrospective observational study aimed at comparing outcomes between patients who received stereotactic radioablation and those who did not. a matched-pair analysis will be used to adjust for baseline clinical characteristics and ensure comparability between groups.


Eligibility criteria:
inclusion criteria: * diagnosis of refractory ventricular tachycardia (vt), as previously defined * age greater than 18 years * presence of an implantable cardioverter-defibrillator (icd) for follow-up * not eligible for heart transplantation * estimated life expectancy of at least 1 year * ability to provide autonomous, informed consent to participate in the study exclusion criteria: * icd interrogation demonstrating polymorphic vt * patients with intermacs class more than 4 * patients with lvads * patients with active neoplastic disease under oncological treatment

Keywords: ventricular tachycardia radioablation