Kornimate/medical-research-clean huggingface dataset:
comparison of two treatment regimens (sitagliptin versus liraglutide) on participants who failed to achieve good glucose control on metformin alone (mk-0431-403)

Conditions: Diabetes Mellitus, Type 2

Summary: this study is being done to compare the effectiveness and safety of two treatment paradigms (oral sitagliptin with or without glimepiride versus liraglutide with or without increased dosing) for the treatment of participants with type 2 diabetes that is not adequately controlled with metformin alone. the primary hypothesis postulated that the mean change from baseline in hemoglobin a1c (a1c) in participants treated with a sitagliptin-based treatment is non-inferior to that of participants treated with a liraglutide-based treatment.


Eligibility criteria:
inclusion criteria * type 2 diabetes mellitus. * on stable dose of metformin monotherapy at a dose of at least 1500 mg per day for at least 12 weeks and a hemoglobin a1c ≥7.0% and ≤11.0%. * capable of using a liraglutide pen device. exclusion criteria * history of type 1 diabetes mellitus. * use of any oral antihyperglycemic agent (aha) besides metformin, within the prior 12 weeks of screening. * cardiovascular disorders within the past 3 months including acute coronary syndrome or new or worsening symptoms of coronary heart disease, coronary artery intervention, stroke, or transient ischemic neurological disorder. * impaired liver function. * impaired kidney function. * history of malignancy or clinically important hematological disorder that requires disease-specific treatment (chemotherapy, radiation therapy, surgery) or, in the opinion of the investigator, is likely to recur during the duration of the study. * history of leukemia, lymphoma, aplastic anemia, myeloproliferative or myelodysplastic diseases, thrombocytopenia, or malignant melanoma, regardless of the time since treatment. * pregnancy or breastfeeding, or intention to become pregnant or donate eggs within the projected duration of the study. * participation in another study with an investigational drug or device within 12 weeks prior to screening. * history of hypersensitivity or any contraindication to sitagliptin, liraglutide, glimepiride, or metformin based upon the labels of the country of the investigational site. * participation in a weight loss program and not yet in maintenance phase, or starting of a weight loss medication (such as orlistat or phentermine) within the prior 8 weeks. * surgery within the prior 4 weeks or major surgery planned during the study. * personal or family history of medullary thyroid carcinoma (mtc) or multiple endocrine neoplasia syndrome type 2 (men 2). * user of recreational or illicit drugs or recent history (within the last year) of drug abuse or increased alcohol consumption.
evaluation of heart failure treatment guided by n-terminal pro b-type natriuretic peptide (ntprobnp) vs clinical symptoms and signs alone

Conditions: Heart Failure; Ventricular Dysfunction, Left

Summary: the purpose is to study if hf treatment guided by ntprobnp in addition to clinical symptoms and signs is more effective than treatment guided by clinical symptoms and signs alone in patients with hf and left ventricular systolic dysfunction


Eligibility criteria:
inclusion criteria: * female/male, over 18 years with previously verified hf with left ventricular systolic dysfunction. * new york heart association(nyha) class ii-iv, * ntprobnp males\>800 ng/l, females \>1000 ng/l exclusion criteria: * planned cv hospitalisation, stroke or acute myocardial infarction (mi) last 3 months, * mitral/aortic stenosis, * patients already receiving optimal hf treatment, * severe reduction of kidney function

Keywords: heart failure ventricular dysfunction ntprobnp
food intake among women and men in fertility treatment

Conditions: Infertility

Summary: worldwide infertility is highly prevalent and lifestyle factors, such as food intake, could have an essential role in the success of a fertility treatment. the literature is not consistent and adequate for recommendations to the increasing number of women and men of reproductive age who ask for lifestyle guidance. therefore, the aims of the food \& fertility study will be to investigate the association between food intake and semen quality, pregnancy- and live birth rates in women and men undergoing assisted reproductive technology (art) treatment.

the food \& fertility study is a multicenter prospective cohort study which is planned to enroll a total of 4000 women and men between 2022 and 2024. the data collection will take place in four fertility clinics through a web-based food frequency questionnaire (ffq). data on sperm quality and pregnancy- and live birth rates will be obtained from medical records and national registers.

Eligibility criteria:
inclusion criteria: * women and men undergoing fertility treatment: in vitro fertilization (ivf), intracytoplasmatic sperm injection (icsi), frozen-thawed embryo transfer (fet) or intrauterine insemination (iui). * availability of a semen sample analyzed 3 months before or after filling in the ffq. * read and understands danish. exclusion criteria: * treatment with double donation (both semen and oocyte donation)

Keywords: fertility assisted reproductive techniques food diet dietary supplements semen quality live birth
transseptal italian registry (title)

Conditions: Arrhythmia; Cardiac Disease

Summary: the goal of this observational study is to learn about the changing over the time of transseptal (tsp) catheterization for catheter ablation of arrhythmias in the left heart. this study aims to investigate if auxiliary tools for tsp catheterization improved the safety and efficacy.

data regarding transseptal catheterization in the centers involved will be retrospectively collected over the past 10 years. will be collected: 1) patients characteristics 1. type of procedure requiring transseptal catheterization 2. success rate 3. adverse events 4. use of tools for transseptal catheterization: * intracardiac echocardiography (ice) guidance * simplified transseptal puncture * "pig tail" catheter * "safe sept" guidewire * powered radiofrequency transseptal needle

Eligibility criteria:
inclusion criteria: * patients underwent transseptal catheterization of left side heart interventional procedures (catheter ablation) exclusion criteria: * patients with learning disabilities

Keywords: catheter ablation transseptal catheterization
tannin specific natural extract for covid-19 infection

Conditions: COVID-19; SARS-CoV 2; Coronavirus Infection

Summary: there is an urgent need to evaluate interventions that could be effective against the infection with sars-cov 2. tannins based wood extracts are an inexpensive and safe product with protective effect in both bacterial and viral infections likely due to its anti- inflammatory, anti-oxidative effects and their modulation of the intestinal microbiota. this randomized controlled trial seeks to evaluate the efficacy of the tannins based dietary supplement arbox in positive covid-19 patients.

the epidemic of 2019 novel coronavirus (causing the disease covid-19) has expanded from wuhan throughout china and is being exported to a growing number of countries, some of which have seen onward transmission. covid-19 caused clusters of severe respiratory illness and was associated with 2% mortality. there is currently no vaccine and no specific antiviral treatment recommended for covid-19. about 20% of the patients were severe and the mainstay of clinical management is largely symptomatic treatment, with organ support in intensive care for seriously ill patients. therefore, it is urgent to find a safe and effective therapeutic approach to covid-19. tannins have been shown to have antioxidant, anti-inflammatory, antimicrobial properties and a regulatory effect on the gastrointestinal metabolism. the investigators will realize a prospective, double-blind, randomized trial to assess the effect of treatment with a dietary supplement (arbox), a molecular complex of quebracho and chestnut tannins extract and vit b12, compared with placebo. 140 covid-19 patients will be recruited in a single center in buenos aires argentina. 70 patients will receive conventional treatment plus arbox (treated group) and 70 patients will receive conventional treatment plus placebo (control group). the effects will be evaluated during the 28 days follow up. the primary end point will be the time of discharge from the hospital. a panel of 27 cytokines level, intestinal microbiota composition and its metabolites will be assessed at day 1 and 14.

Eligibility criteria:
inclusion criteria: * over 18 years of age hospitalized in the general hospitalization room, who meet the definition of "confirmed case covid-19" (https://www.argentina.gob.ar/salud/coronavirus-covid-19/definicion -of-case) exclusion criteria: * pregnancy * lactancy * hypersensitivity to polyphenols * patients unable to receive oral medication (severe cognitive impairment, assisted ventilation, impaired state of consciousness) * lack of consent * participation in any other interventional clinical trial
time restricted feeding to reduce weight and cardiometabolic risk

Conditions: Obesity; Metabolic Syndrome; Pre Diabetes

Summary: the obesity rate in malaysia is higher than the average world obesity rate. central obesity is a component of metabolic syndrome (mets) which is also made up of dyslipidemia, impaired glucose tolerance, and hypertension. mets is a continuum in the risk of developing cardiometabolic complication. time restricted feeding (trf) involves an extended physiological overnight fast. researchers believe that the timing of meal intake that matches with the circadian rhythms is as important as the calories intake to prevent obesity and its complications. the investigators hypothesize that trf is effective in weight control and improvement of metabolic severity. subjects will be randomized into either the control group, which practices qqh dietary plan or intervention group, which practices trf as an adjunct to qqh dietary plan. subjects will be followed up at week 12 and week 24 to assess adherence, efficacy and safety of trf. this study intends to fill a few research gaps as follows: 1. longer study duration of 6 months. 2. this is the first study amongst the asian population. 3. adherence level to trf in real life setting is measured. this information can potentially predict the intensity level of trf that are feasible for practice in real life and also its association with the efficacy of trf. 4. trf is defined as eating within a≤12-hour period and fasting for at least 12 hours per day. this is the shortest fasting window studied so far.


Eligibility criteria:
inclusion criteria: 1. 20-59 years of age 2. bmi 27.5kg/m2 - 39.9kg/m2 3. smart phone users 4. willing to lose weight 5. capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form and in the protocol. exclusion criteria: 1. those with history of cardiovascular disease, cerebrovascular accidents, degenerative or inflammatory diseases of the nervous system; epilepsy, malignancy, gastrointestinal disorders, thyroid disorders, diabetes or medications which could have had metabolic effects. 2. women who are pregnant or breastfeeding. 3. those who are currently practicing any form of intermittent fasting or newly enrolled into a dietary or slimming program within the past 3 months. 4. subjects with any medical condition, which in the investigator's judgment may be associated with increased risk to the subject or may interfere with study assessments or outcomes. 5. those currently on medication for chronic illness. 6. permanent night shift worker 7. those who need to practise ramadan fasting during the period of this study.
novel regimens in covid-19 treatment

Conditions: COVID; Corona Virus Infection

Summary: nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus 2; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for coronavirus disease 2019.

nitazoxanide has been shown to have a clinical efficacy against severe acute respiratory syndrome coronavirus; ivermectin has also demonstrated a remarkable experimental efficacy with a potential to be used for coronavirus disease 2019. some studies demonstrated the efficacy of combined regimen of nitazoxanide and azithromycin or ivermectin and chloroquine.

Eligibility criteria:
inclusion criteria: * patients with covid-19 infection exclusion criteria: * allergy or contraindication to the drugs.
re-routing in treatment high anal fistula

Conditions: Anal Fistula

Summary: the aim of this study is to evaluate the role of rereouting in treatment of high anal fistula and evaluate the success rate, the recurrence and incontinence and see if rerouting of the track is a good choice in treatment of high anal fistula?

anal fistula is a very common perianal condition associated with considerable morbidity and inconvenience to the patient. it is hollow tract lined with granulation tissue that connects an in-depth primary opening inside the anal canal to a superficial secondary opening in the perianal skin. it is mostly nonspecific infection of an anal gland in the intersphincteric space as the initiating pathology different classifications have been put forward which categorize these fistula into low or high simple or complex, or according to their anatomy into intersphincteric, trans-sphincteric, and supra-sphincteric or extra-sphincteric surgical therapy is the main method used to treat anal fistula. the best treatment criterion is to eradicate the infected lesion, ensure sufficient drainage, and promote the closure of the fistula, while minimizing damage to the anal sphincter. high anal fistulas require more complex treatment when compared to low anal fistula because of their complexity. rerouting is a transposition technique for the management of high anal and anorectal fistulae is described by mann and clifton in 1985. the method involves re-routing the extrasphincteric portion of the track into an intersphincteric position with immediate repair of the external sphincter. the newly posi-tioned intersphincteric fistula is then dealt with at a later date when the external sphincter is soundly healed . the advantages of rerouting over other techniques in patients with high anal fistulae; patients had satisfactory results, decrease recurrence of fistulae or abscess formation. healing is rapid, short hospital stay and continence to flatus and faeces preserved

Eligibility criteria:
inclusion criteria:- patients with high anal fistula admitted at asuit university hospital at the period of study exclusion criteria:- any case with low anal fistula
the prevention of hypotension after epidural analgesia after major surgery

Conditions: Hypotension; Pain

Summary: epidural analgesia via continuous epidurally infused local anesthetic agent (la) is widely and very successfully used routinely for perioperative pain control in patients undergoing major orthopedic and abdominal surgery since 1928. the choice currently depends on the preference of the aps physician in charge of the case. a frequent unwanted side effect of epidural block is hypotension due to the epidurally injected la blocking the sympathetic nerves and thus the patient's response to hypotension, which is usually due to hypovolemia and/or an unopposed parasympathetic (via the vagus nerve) nervous system. the purpose of this research study is to see if adding epinephrine, to the epidural anesthetic will decrease possible side effects, such as low blood pressure, and lead to a better effect of the epidural anesthetic.

participants undergoing epidural analgesia to treat perioperative pain associated with major surgery will be approached for their willingness to participate in the study. participants undergoing major thoracic, abdominal, or orthopaedic surgery for whom thoracic or lumbar epidural block would be indicated and planned for intraoperative and postoperative analgesia as per the university of florida acute pain service (aps) usual and routine practice will be included in this study. all participants will receive a standardized continuous epidural block at the appropriate level for the planned surgery by the aps physicians in the block room that day. for the standardized continuous epidural block, placement will be confirmed with loss of resistance technique (lora), wave form analysis or nerve stimulation. participants will be randomly allocated by computer-generated randomization to one of four groups. this will be a quintuple blinded prospective study. the anesthesiologist managing the intraoperative anesthesia, the anesthesiologists (aps) placing the blocks and following the participants on the floors, the research nurse taking the measurement, the surgeons, nor the participants will be aware of what combination of drugs are used for the epidural block infusion. the three groups will consist of: 1. group a (ropivacaine 0.2% infusion; control group) 2. group b (ropivacaine 0.2% + 2 mcg/ml epinephrine) 3. group c (ropivacaine 0.2% + 5 mcg/ml epinephrine)

Eligibility criteria:
inclusion criteria: * undergoing epidural analgesia to treat perioperative pain associated with major surgery * undergoing major thoracic surgery * undergoing major abdominal surgery * undergoing major orthopaedic surgery exclusion criteria: * sepsis * acute trauma * coagulopathy * preoperative hemodynamic instability * symptomatic coronary artery disease * patients from the icu whose tracheas were intubated for any cause * allergies to medications in the protocol * primary or secondary block failure

Keywords: epidural analgesia
neoadjuvant adriamycin and ifosfamide plus high-dose ice in patients with soft tissue sarcoma (sts)

Conditions: Sarcoma, Soft Tissue

Summary: complete resection is still the only curative treatment option in patients with soft tissue sarcoma (sts). patients with a non-resectable sts have a dismal prognosis even without evidence of metastatic disease. the aim of this trial is to determine whether neoadjuvant dose-intensive chemo-radiotherapy is a feasible and effective approach in patients with non-resectable sts.


Eligibility criteria:
inclusion criteria: * histologically confirmed sts with locally advanced non-resectable disease * metastatic disease is allowed in case of solitary resectable metastases * grading according to coindre \> ii° * measurable tumor lesions * age \> 18 through 65 years * karnofsky status \> 70 % * written informed consent exclusion criteria: * prior chemotherapy * intercurrent disease interfering with the adequate administration of study medication including severe psychological disease * insufficient liver-, renal or bone marrow function * evidence of pregnancy * treatment within another clinical trial * uncontrolled viral infections (hiv,hbv, hcv) * other malignancies
treatment of primary menstrual pain with kanion capsule

Conditions: Primary Dysmenorrhea

Summary: the objectives of this clinical trial are: * to further study the safety of kanion capsule (gf) in primary dysmenorrhea subjects; * to further evaluate the efficacy of gf in treatment of primary dysmenorrhea.


Eligibility criteria:
inclusion criteria: * primary dysmenorrhea exclusion criteria: * secondary dysmenorrhea

Keywords: primary dysmenorrhea herbal remedy
fall risk assessment and speech intelligibility enhancement using in-ear device

Conditions: Hearing Loss; Dizziness; Vertigo; Fall Related Injury Risk; Fall Prevention; Imbalance; Speech Intelligibility

Summary: the purpose of this study is to develop and validate methods to use hearing aids equipped with embedded sensors and artificial intelligence to assist in the assessment of fall risk and in the implementation of interventions aimed at reducing the risk of falling, as well as to improve speech intelligibility in quiet and in background noise, track physical activity, and social engagement. the investigators hope is that the knowledge that is generated through this study will ultimately translate to the clinical setting and will help reduce the likelihood that individuals experience a fall, and improve the quality of hearing in individuals who wear hearing aids.


Eligibility criteria:
inclusion criteria: * age 55 years or older * bilateral hearing aid user * able to consent in english * having access to a phone capable of running the mobile app required for the study * screen for fall risk ("yes" to any question: feels unsteady when standing or walking? worries about falling? has fallen in past year? if the participant has fallen: how many times? were they injured/hurt?) * ambulatory without need for a wheelchair exclusion criteria: * people with mobility restrictions (e.g., wheelchair bound) that would prevent the performance of the functional assessments. * people with severe movement (e.g., advanced parkinson's disease) or cognitive (e.g., advanced dementia) disorders that would prevent the individual from either performing the functional assessments, or would lead to restricted activities that would prevent motion data from being collected according to the goal of the study. * inability to understand, consent, and complete requirements including verbal instructions and non-ambulatory/wheelchair-dependent.

Keywords: fall risk hearing loss
assessment of the effect of periodontal disease prediction system on oral hygiene motivation

Conditions: Motivational Interviewing; Computer-Aided Design; Periodontal Diseases

Summary: the aim of this trial is to evaluate the effect of patient specific periodontal disease prediction (pdp) system, a part of motivational interview, (mi) on probing depth (pd), rustogi modified navy plaque index (rmnpi), and papillary bleeding index (pbi) scores in patients with periodontitis following non-surgical periodontal therapy.

a total of 120 participants included in our study and were then randomly assigned to three groups: a) conventional method (cm) (n=40), b) three-dimensional animation (3da) (n=40), and c) periodontal disease prediction (pdp) interaction (n=40). pd, pbi, and rmnpi values were recorded before periodontal therapy (t0). following periodontal treatment, individuals in the cm group were instructed on oral hygiene via a model and brochure. individuals in the 3da group were informed using 3d video visuals. participants in the pdp group were informed in a computer-based three-dimensional manner, providing projections of their current status and potential future gingival recessions after viewing the first and second parts of the 3d animation. clinical periodontal measurements were repeated at 3, 6, and 12 months post-treatment. data obtained after the study were analyzed using appropriate statistical methods. it was concluded that the proposed approach in this project could enhance periodontitis individuals' awareness about periodontal disease and personal oral hygiene especially for interdental cleaning over a long period. by this way, this pdp system can lead clinical benefits in reducing the recurrence of periodontal disease. it was hypothesized that patients in the pdp group could achieve significantly better plaque control and have lower bleeding scores compared to patients in the control groups, which include traditional oral hygiene motivation and three-dimensional video education.

Eligibility criteria:
inclusion criteria: * patients aged 30 to 60 years. * no prior periodontal treatment or oral hygiene education. * simplified oral hygiene index (ohi-s) greater than 3 (indicating poor oral hygiene). * diagnosed with 'stage iii' 'grade b' periodontitis. * at least 20 natural teeth present (excluding third molars). * minimum of 12 years of education. * not a dentist or dental student. * no systemic diseases affecting memory or cognitive function. * no physical disabilities that could hinder the performance of oral hygiene procedures. exclusion criteria: * presence of diffuse dentinal hypersensitivity. * acute infections. * faulty restorations. * root caries complicating oral hygiene. * full-mouth fixed or removable dentures. * ongoing orthodontic treatment.

Keywords: oral hygiene motivation computer-aided design periodontal disease motivational interview