Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study on the implantation of the tension-free vaginal tape (tvt-secur) under local anesthesia

Conditions: Urinary Stress Incontinence

Summary: the objective was to observe the satisfaction of local anesthesia during the implantation of the tvt-secur for the treatment of stress urinary incontinence, with the use of questionnaires completed by the patients, and to evaluate the short-term efficacy and safety of the sling, with a comparison of the two techniques of implantation: the 'u-method' and the 'hammock' technique.

stress urinary incontinence (sui) is a common problem, affecting women of all ages. treatment options for sui include physiotherapy and surgical interventions, such as retropubic operations and midurethral slings. conventional retropubic and transobturator tapes are the preferred choice for most surgeons, because of their wide applicability, technical simplicity and clinical efficacy. the retropubic tape has been effective for many years, but exposes the patients to serious complications, such as bladder perforations, principally because of the use of the retropubic space for the fixation of the tape. in an attempt to avoid the retropubic space, the second generation of slings, the transobturator tape, was introduced. however, prolonged postoperative groin pain as well as vascular injuries have been reported. the last generation of midurethral slings, the tension-free vaginal tape system (tvt-securtm, gynecare, ethicon, somerville, nj, usa), introduced in 2005, attempts to lower the number of complications, by involving only a small vaginal incision and no exit wound. this 8-cm long laser-cut polypropylene mesh can potentially be implanted under local anesthesia, because of a less-invasive technique using minimal vaginal dissection as well as avoidance of retropubic space and obturator fossa. in the case of conventional midurethral slings, even if their implantation under local anesthesia has been studied and proven relatively safe, this practice has not gained popularity. this was a prospective, clinical study with primary objective to observe the satisfaction of local anesthesia during the implantation of the tvt-secur, with the use of questionnaires completed by the patients. the secondary objective was to observe the short-term efficacy and safety of the sling. the final objective was to compare the two techniques of implantation: the 'u-method' and the 'hammock' technique.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of stress urinary incontinence or stress predominant mixed urinary incontinence * acceptance of local anesthesia

Keywords: suburethral slings urethra urinary incontinence urinary stress incontinence
effectiveness of selected physical therapy exercise program and transcutaneous electrical nerve stimulation on patients with pudendal neuralgia

Conditions: Pudendal Neuralgia

Summary: to study the efficacy of adding transcutaneous electrical nerve stimulation (tens) to selected physical therapy exercise program on pain in patients with pudendal neuralgia. fifty-two male participants with chronic pudendal neuralgia (30-50 years) shared in this study. methods: patients were assigned randomly into two groups equal in number; study and control groups with 26 patients in each. all patients were receiving the same physical therapy exercise program, in addition to the same prescribed analgesic medication. patients in the study group received additional tens therapy and those in the control group received sham tens. treatment was provided three sessions per week for twelve successive weeks. the participants underwent baseline and post treatment assessment for pain level as measured by three methods; serum cortisol level (scl), daily etodolac intake dose (deid), and numerical pain rating scale (nprs).


Eligibility criteria:
inclusion criteria: * nonsmoking male patients * diagnosed as having unilateral pudendal nerve entrapment resulting in pudendal neuralgia * ages ranged between 30 to 50 years * did not have any behavioral or cognitive impairments that could prevent them from following simple verbal commands or instructions during tests and training. exclusion criteria: * those who had history of skin malignancy * diabetes * sensory disorders * circulatory insufficiency * acute infection of the treatment area * renal failure * myocardial infarction * communication problems, or those with pace maker
two different ventilatory strategies in acute respiratory distress syndrome due to community-acquired pneumonia

Conditions: Community-acquired Pneumonia; Acute Respiratory Distress Syndrome

Summary: randomized controlled trial comparing two different ventilatory strategies in acute respiratory distress syndrome due to community-acquired pneumonia. the control strategy will be based on ardsnet approach. the intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.

there is no consensus on the optimal ventilatory management of patients with community-acquired pneumonia that require mechanical ventilation and have acute respiratory distress syndrome. the traditional ventilatory approach (ardsnet) is based on a fixed table for both end respiratory positive end-expiratory pressure according to inspired oxygen fraction. alternatively, a strategy that tailors positive end-expiratory pressure according to compliance and limits driving pressure may be beneficial, but evidence is lacking. we will perform an open label randomized controlled trial comparing both strategies.

Eligibility criteria:
inclusion criteria: * patients with community acquired pneumonia requiring invasive mechanical ventilation * bilateral pulmonary infiltrates on chest imaging not fully explained by fluid overload in the opinion of the attending physician * one of the criteria below: * oxygen inspired fraction above 50% with a positive end-expiratory pressure of at least 8 cmh2o to main peripheral oxygen saturation above 93%, or * arterial partial pressure of oxygen divided by inspired fraction of oxygen lower than 200 with peep values of at least 5 cmh2o exclusion criteria: * patients with inclusion criteria for more than 36 hours * refusal of the patient´s legal representative * acute neurologic disease (stroke, brain trauma, or any disease that may cause intracranial hypertension) * patients with current airway fistula or barotrauma * patients on chronic home use of oxygen due to underlying lung disease * patients younger than 18 years * patients not on full code status

Keywords: mechanical ventilation positive end-expiratory pressure community-acquired pneumonia
bioactive plant foods: effects on functional bioavailability and genomic stability

Conditions: Metabolic Syndrome

Summary: to achieve optimal health and to reduce the risk of age-related chronic diseases through an easily achievable dietary modification not achievable by the limited mixture of antioxidant supplements in older subjects, the investigators will focus their attention on the biological functions of bioactive plant food (angelica keiskei and/or glycine max) and its effect on genomic stability using noble assays. the investigators propose to study the ability of bioactive plant-based food (nutrition bar made from angelica keiskei and/or glycine max) to 1) exert biological functions: increase total antioxidant performance, decrease oxidative stress in vivo, and 2) affect genomic stability: decrease dna damage and modify dna methylation. the investigators hypothesize that bioactive plant food (green leafy vegetable power, and/or black bean power) will exert biological functions and affect genomic stability far more efficiently than the limited mixture of purified antioxidant supplements in the vulnerable population, older subjects (\> 50 years, men and postmenopausal women) with and without metabolic syndrome.


Eligibility criteria:
inclusion criteria: healthy control group (n=20) 1. age: over 50 years old 2. female subjects must be post-menopausal 3. bmi: 18.5 - 30, waist/hip ratio \< 0.9 for men, \< 0.85 for women 4. tg\<150 mg/dl (1.7 mmol/l) and no medication for tg 5. total cholesterol \< 200 mg /dl (5.18 mmol/l) and no medication for cholesterol 6. blood pressure: sbp \< 130 mmhg and dbp \< 85 mmhg and no hypertensive medication 7. plasma glucose: fasting blood glucose \< 100 mg/dl (5.6 mmol/l) and no diabetes medication inclusion criteria: metabolic syndrome (n=40) 1. age: over 50 years old 2. bmi: \> 30 or waist/hip ratio \> 0.9 for men, \> 0.85 for women 3. plus any two of the following four factors: * tg: 150-400 mg/dl (1.7 - 4.52 mmol/l) and/or medication for tg * hdl cholesterol: \<40 mg /dl (1.03 mmol/l) for men, \<50 mg/dl (1.29 mmol/l) for women and/or medication for cholesterol * blood pressure: sbp, 130-160 mmhg and/or dbp 85-95 mmhg and/or antihypertensive medication * plasma glucose: fasting blood glucose 100-125 mg/dl (5.55- 6.94 mmol/l) and no diabetes medication exclusion criteria: 1. study participants will be screened for normal hematologic parameters, normal serum albumin, normal liver function, normal kidney function, absence of fat malabsorption. 2. subjects with a history of kidney stones, active small bowel disease or resection, atrophic gastritis, insulin-requiring diabetes, alcoholism, pancreatic disease, or bleeding disorders will be excluded from the study. 3. exogenous hormone users will be excluded from the study. 4. moreover, subjects will be non-smokers and will not have taken vitamin or carotenoid supplements for at least 6 weeks prior to the study and throughout the study for both healthy subjects and subjects with metabolic syndrome.

Keywords: angelica keiskei glycine max metabolic syndrome
effects of glp1-ra on ectopic fat deposition in chronic kidney disease

Conditions: Chronic Kidney Diseases

Summary: chronic kidney disease (ckd) is a burden of morbidity and mortality. increased protein breakdown in skeletal muscle (wasting) and ectopic fat deposition are important determinants of poor clinical outcome in patient with ckd. insulin resistance plays a critical role in skeletal muscle wasting and ectopic fat deposition. glucagon-like peptide-1 receptor agonists (glp-1ra) decrease ectopic fat deposition in patients with type 2 diabetes, prediabetes, obese and overweight subjects. the influence of glp-1ra on ectopic fat deposition in ckd patients in unknown. the investigators' will test the hypothesis that glp-1ra decreases intermuscular (ectopic) fat deposition in patients with stage 3-4 ckd. the investigators' will do so by addressing the following specific aims: specific aim 1: to test the hypothesis that glp-1ra decreases intermuscular fat deposition in patients with stage 3-4 ckd. specific aim 2: to test the hypothesis that glp-1ra improves skeletal muscle mitochondrial function in patients with stage 3-4 ckd. specific aim 3: to test the hypothesis that glp-1ra improves physical performance in patients with stage 3-4 ckd. specific aim 4: to test the safety and feasibility of 12 weeks of dulaglutide 1.5 mg/wk administration as an adjunct therapy to the standard care of patients with stage 3-4 ckd.


Eligibility criteria:
inclusion criteria: 1. patients with stage 3-4 ckd (egfr 15-59 ml/min/1/73 m2) 2. age ≥ 18 years and ≤75 years exclusion criteria: 1. patients with type 1 diabetes mellitus 2. patients with t2d who are on insulin therapy or who started a new antidiabetic medication within 1 month prior to study or who received incretin-based therapy within 3 months prior to study 3. bmi \ 40 kg/m2 4. hba1c\>8% measured within 1 month prior to study, or a history of hypoglycemic episode within 1 year prior to study, or a history of diabetic ketoacidosis 5. uncontrolled hypertension (\>200/100 mmhg) despite optimal antihypertensive therapy 6. arrythmia, heart failure (nyha class iii-iv), valve disease or heart diseases other than coronary artery disease 7. history of major gastrointestinal surgery, inflammatory bowel disease, pancreatitis or cholelithiasis 8. personal or family history of medullary thyroid cancer, or personal history of multiple endocrine neoplasia (men)-2 9. pregnancy, breast feeding or intention to become pregnant 10. previous renal transplantation 11. acute or chronic infectious diseases 12. cancer or chemotherapy within 3 years prior to study 13. treatment with systemic corticosteroids within 3 months prior to study 14. known or suspected allergy to dulaglutide 15. claustrophobia or other contraindications for magnetic resonance imaging

Keywords: chronic kidney disease intermuscular fat deposition glucagon-like peptide-1 agonist insulin resistance mitochondrial function
promoting adherence to treatment for latent tb infection through text messaging

Conditions: Latent Tuberculosis

Summary: the purpose of this pilot study is to determine whether regularly scheduled medication reminder text messages (sms) are effective in increasing latent tuberculosis infection (ltbi) treatment completion.

we aim to determine the feasibility and acceptability of text reminders for improving adherence in latent tb patients. specific objectives of the current study are to: 1) assess the feasibility of the intervention as indicated by participant recruitment and retention and; 2) evaluate the acceptability of the intervention, as indicated by intervention adherence, outcome measurement rates, and feedback from participants. data will be used to design a definitive trial which will test the hypothesis that the intervention will improve medication adherence, as measured through an increase in treatment completion rates, and result in higher self-reported medication adherence, fewer missed appointments and doses, and a shorter course of treatment.

Eligibility criteria:
inclusion criteria: * consent to the study * own a mobile phone which operates on a telecom provider supported by our sms platform * initiating or actively receiving treatment for ltbi at the pima county tb clinic in tucson, az * prescribed self-administered therapy * report not having prior or current active tb disease * know how to and are able to receive sms messages * at least 18 years of age exclusion criteria: * do not meet inclusion criteria * do not consent to study

Keywords: tuberculosis latent tuberculosis texting adherence medication
a study of trastuzumab emtansine in combination with atezolizumab or placebo as a treatment for participants with human epidermal growth factor 2 (her2)-positive and programmed death-ligand 1 (pd-l1)-positive locally advanced (labc) or metastatic breast cancer (mbc)

Conditions: Metastatic Breast Cancer

Summary: this study will evaluate the efficacy, safety and patient-reported outcomes of trastuzumab emtansine plus atezolizumab compared with trastuzumab emtansine plus placebo in participants with her2-positive and pd-l1-positive labc or mbc.participants must have progressed either during or after prior trastuzumab- (+/- pertuzumab) and taxane-based therapy for labc/mbc; or during (or within 6 months after completing) trastuzumab- (+/-pertuzumab) and taxane-based therapy in the neoadjuvant and/or adjuvant setting.


Eligibility criteria:
inclusion criteria: * her2+ and pd-l1+ locally advanced (labc) or metastatic breast cancer (mbc) * progression must have occurred during most recent treatment for labc/mbc or during, or within 6 months after completing, neoadjuvant and/or adjuvant therapy * prior treatment with trastuzumab (+/- pertuzumab) and taxane in the neoadjuvant and/or adjuvant, locally advanced, or metastatic setting * no more than two prior lines of therapy in the metastatic setting * measurable disease per resist version 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * life expectancy \>= 6 months * adequate hematologic and end-organ function * for women of childbearing potential: agreement to remain abstinent or use contraception, and agreement to refrain from donating eggs * for men: agreement to remain abstinent or use contraceptive measures, and agreement to refrain from donating sperm exclusion criteria: * prior treatment with trastuzumab emtansine in metastatic setting * history of exposure to cumulative doses of anthracyclines * symptomatic or actively progressing central nervous system (cns) metastases; asymptomatic cns lesions ≤ 2cm without clinical requirement for local intervention or asymptomatic patients with treated cns lesions are eligible * current grade \>= 3 peripheral neuropathy * cardiopulmonary dysfunction * history of malignancy within 5 years prior to initiation of study treatment, with the exception of the cancer under investigation and malignancies with a negligible risk of metastasis or death * history of leptomeningeal disease * active or history of autoimmune disease or immune deficiency * active hepatitis b, hepatitis c and/or tuberculosis * prior allogeneic stem cell or solid organ transplantation * receipt of a live, attenuated vaccine within 4 weeks prior to initiation of study treatment, during treatment, or within 5 months following the last dose of study treatment * pregnancy or lactation
bli for the diagnosis of precancerous conditions

Conditions: Gastric Cancer; Preneoplastic Condition; Early Gastric Cancer

Summary: introduction: traditionally, white light endoscopy (wle), enhanced by biopsies following the updated sydney system guidelines, has been the benchmark for diagnosing and classifying gastric preneoplastic conditions. nevertheless, the pronounced interobserver variability and the often weak correlation between endoscopic observations and histopathological results have driven the increasing adoption of virtual chromoendoscopy (vce). vce technologies have demonstrated greater effectiveness in identifying these conditions compared to wle, with narrow band imaging (nbi) being particularly notable. significantly, nbi has played a key role in validating the endoscopic grading of gastric intestinal metaplasia (eggim) system. however, data on the effectiveness of other vce technologies in this domain is relatively sparse in europe, specifically with blue light imaging (bli), despite the promising diagnostic performance demonstrated with this technology. primary aim: to assess the diagnostic accuracy of bli and to externally validate the applicability of eggim classification for staging gim. material and methods: a multicentric cohort study will be performed involving centres from two european countries (portugal, italy). consecutive patients performing upper gastrointestinal endoscopy will be evaluated by wle and bli. random biopsies or targeted plus random biopsies will be performed in order to determine de accuracy of bli system to detect and stage gim. expected results: we anticipate that bli would enable us to assess the extension of gim without the need for biopsies. if observed, this would overall improve the upper gi endoscopy accuracy.


Eligibility criteria:
inclusion criteria: * individuals older than 18 years. * indication to submit diagnostic or surveillance upper gi endoscopy. exclusion criteria: * history of previous gastric surgery. * history of previous gastric cancer. * contraindications to biopsies. * individuals unable to give informed consent
a study of real-world experience of psoriasis patients treated with apremilast in clinical dermatology practice

Conditions: Psoriasis

Summary: this is a retrospective, multi-center observational cohort study. this study will be implemented first in germany (approximately 50 sites), the united kingdom (approximately 20 sites) and sweden (approximately 25 sites), followed by a selected number of countries in europe, depending on apremilast local availability. the design of this apremilast retrospective study aims to provide clinical information regarding the treatment initiation and outcomes in psoriasis patients when prescribed apremilast in real world settings. in addition, this study is aiming at capturing physicians' and patients' treatment goals when initiating apremilast and whether these goals are achieved following apremilast use. this study is primarily descriptive in nature, and no a priori hypotheses are specified. patients must voluntarily sign an informed consent form, be 18 or over, have been diagnosed with plaque psoriasis and have been treated with apremilast during the previous 5-7 months to participate in this study. they must not be involved in any other clinical study involving apremilast.


Eligibility criteria:
inclusion criteria: 1. must have understood and voluntarily signed the informed consent form (icf). 2. age ≥ 18 years at the time of signing the icf. 3. diagnosed with plaque psoriasis. 4. initiated treatment with apremilast 6 months (+/- 1 month) previously (patients may or may not have completed 6 months of apremilast treatment) exclusion criteria: 1. refusal to participate in this study or current participation in the treatment phase of an interventional clinical trial. 2. started apremilast as part of a clinical trial.

Keywords: psoriasis apremilast appreciate dermatology retrospective observational
cardioinsight 3 - lbbb

Conditions: Heart Failure

Summary: background cardiac resynchronization therapy (crt) is proven to improve survival and heart function of patient with certain electrical conduction abnormality and heart failure. however, in patient with certain electrical conduction abnormality, being nonresponder is observed in up to 40% in patient receiving crt. conventionally the surgical approach of crt is to implant one pacing lead in the right heart and one in the left heart to resynchronize the contraction and the pacing lead in the left heart is usually placed in the posterior or lateral portion of the left heart. however, this single approach may not be optimal, especially for those patients with conduction abnormality known to have no response to crt. purpose of the clinical investigation the purpose of the activation pattern and acute hemodynamics of his and left bundle pacing is to study the acute effect on the heart function and conduction abnormality of his and left bundle pacing in conventional crt candidate. during crt implantation, hisbundle lead and left bundle pacing lead will be placed and the acute effect on heart function will be studied by a wire placed in the left ventricle of the heart and the activation pattern will be studied by a noninvasive global mapping system. the pacing approach that optimally corrects conduction abnormality and improvement on the heart function acutely will be determined


Eligibility criteria:
inclusion criteria: * adult (aged 18 or above) of both sexes * candidate for crt therapy according to international guidelines.7 * informed consent by the patient * already received stable dose of guideline directed medical therapy for at least 3 months exclusion criteria: * pregnant * participating in another study