Kornimate/medical-research-clean huggingface dataset:
pharmacogenetics of antifolate drugs in autoimmune diseases in taiwan

Conditions: Rheumatoid Arthritis

Summary: background. polymorphisms occur in several genes encoding key enzymes in the folate pathway may affect drug metabolism in patients with rheumatoid arthritis. whether these genetic variations contribute to differential responses to antifolate drug in patients with rheumatoid arthritis (ra) remains to be investigated in the taiwanese population. objective. the goal of the present study is to investigate the interactions between genetic variations in folate genes and the efficacy/side effects of anti-folate disease-modifying anti-rheumatic drug in taiwan. design. a cross-sectional study involving patients with ra were enrolled from tcvgh. disease activity, drug efficacy and associated side-effects were assessed. genotypes in folylpoly-gamma-glutamate synthetase and reduced folate carrier were determined by rflp or pyrosequencing.


Eligibility criteria:
inclusion criteria: * male/female age \>18 * ra diagnosed exclusion criteria: * must not be pregnant/breastfeeding * other conditions may lead to exclusion from the trial (e.g. diabetes mellitus, malignant melanoma, cardiac conduction disorders, hepatic/renal insufficiency.
evaluating the healing of diabetic foot ulcers with compounded anti-infective irrigation therapy

Conditions: Diabetic Foot Ulcer

Summary: diabetic foot ulcers (dfus) are a frequent clinical problem observed in diabetic patients. properly managed, most can be cured, but many patients needlessly undergo amputations because of improper diagnostic and therapeutic approaches. the purpose of this study is to evaluate the effectiveness of a compounded, anti-infective irrigation therapy to increase the healing rates of diabetic foot ulcers and thereby provide a new therapeutic option for health care providers treating high-risk patients with dfus regardless if secondary fungal infections are present. participants diagnosed with diabetes type 1 or 2 and with a documented open diabetic foot ulcer/wound with or without a secondary fungal infection will be included in this prospective, active intervention pilot study. healing rates will be evaluated every two weeks following the initiation of study therapy up to three months. participants with diabetic foot ulcers will be treated with a compounded, anti-infective irrigation therapy daily until closure of the ulcer or up to a maximum of 3 months. participants will be asked to return to clinic every two - four weeks for assessment of the ulcer and compliance with treatment. a sample size of approximately 100 patients is estimated to have 90% power to detect 15% improvement in ulcer healing rates to 45% and 35% compared to historical benchmarks of approximately 30% for ulcers of \<6 months duration and 20% for ulcers ≥6 months duration and/or prior treatment failure, respectively.


Eligibility criteria:
inclusion criteria: * type 1 or type 2 diabetes mellitus * an open dfu / wound of any size (including those requiring debridement in operation room or clinic setting) with or without a secondary fungal infection * ≥ 18 years of age * treatment naïve or treatment failure with oral antibiotics to current wound infection exclusion criteria: * patients who present with untreated or on active-treatment for osteomyelitis, exposed bone, or have a life-threatening need of immediate surgery. * patients who are allergic to any components of the investigated product. * patients who have ≥ 15 shoe size * patients who have received iv antibiotics within the past 30 days * patients with hgba1c \> 14 * patients on active cancer treatment * patients needing re-vascularization of the affected area but did not receive treatment. * patients diagnosed with hiv/aids * patients unable or unwilling to obtain and wear off-loading footwear
manual vs amigo smarttouch atrial fibrillation study

Conditions: Atrial Fibrillation

Summary: atrial fibrillation is a common form of heart rhythm disturbance that for some patients is treated by catheter ablation (making an ablation lesion or burn inside the heart using a fine wire (catheter)). a new system for manipulating the catheters has recently been introduced into clinical practice (the amigo remote catheter system (rcs)). this trial is designed to answer two primary questions: a) is the contact force (the force with which the catheter comes into contact with the heart) any different using the rcs to manual techniques,and b)are the resulting ablation lesions within the heart any different in terms of the volume and contiguity of the lesions produced. additionally the investigators aim to determine how the two techniques compare in success (the proportion of patients whose heart rhythm disturbance is corrected by the procedure).

the trial aims to recruit 50 patients, randomised into two groups, to have ablation for atrial fibrillation performed either using the rcs, or manually. contact force information will be collected during the procedure, but the operators will be blinded to this information. patients will have follow-up to include post-procedural cardiac magnetic resonance imaging and ambulatory electrocardiograms.

Eligibility criteria:
inclusion criteria: * atrial fibrillation * scheduled for catheter ablation exclusion criteria: * contraindication to magnetic resonance imaging * pregnancy * life expectancy of less than six months * participation in another trial that would conflict with this trial

Keywords: remote catheter ablation atrial fibrillation
anti-androgens and cabazitaxel in defining complete response in prostatectomy (acdc trial)

Conditions: Prostate Cancer

Summary: this study evaluates the use of chemotherapy with cabazitaxel in addition to abiraterone acetate, prednisone, and leuprolide in neoadjuvant setting prior to radical prostatectomy in patients with high-risk prostate carcinoma. half of the participants will receive treatment with abiraterone acetate, prednisone, leuprolide, and cabazitaxel, while the other half will receive only abiraterone acetate, prednisone, and leuprolide.


Eligibility criteria:
inclusion criteria: * willing and able to provide informed consent; * histologically confirmed adenocarcinoma of the prostate without neuroendocrine differentiation or small cell features with a minimum of 3 cores positive for tumour; * tumour biopsy tissue accessible for downstream evaluation; * must be candidates for radical prostatectomy and considered surgically resectable by urologic evaluation; * high risk d'amico score defined as either psa \> 20, gleason score ≥ 8 as determined by the local pathologist; or t2c-3 based on dre, pathologic review +/- imaging; * eastern cooperative oncology group (ecog) performance status of 0 to 1; * no evidence of metastatic disease or nodal disease as determined by radionuclide bone scans and computed tomography (ct)/magnetic resonance imaging (mri); non-pathological lymph nodes must be less than 15 mm in the short (transverse) axis; * able to swallow the study drug(s) as prescribed and comply with study requirements; * required initial laboratory values: * absolute neutrophil count (anc) ≥ 1500/μl; * platelet count ≥ 100,000/μl; * hemoglobin ≥ 90 g/l; * creatinine ≤ 175 μmol/l; * bilirubin ≤ upper limit of institutional normal (uln); * ast/alt ≤ 1.5 × uln. exclusion criteria: * received an investigational agent within 4 weeks prior to screening; * stage t4 prostate cancer by clinical examination or radiologic evaluation; * hypogonadism or severe androgen deficiency as defined by screening serum testosterone below the normal range for the institution; * prior androgen deprivation, chemotherapy, surgery, or radiation for prostate cancer; * receiving concurrent androgens, estrogens, or progestational agents, or received any of these agents within the 6 months prior to randomization; * history of another malignancy within the previous 5 years other than curatively treated nonmelanomatous skin cancer and non-muscle invasive bladder cancer; * uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, cardiovascular disease, unstable angina pectoris, cardiac arrhythmia that is symptomatic or requires active therapy; deep venous thrombosis within 3 months prior to randomization; * previous use, or participation in a clinical trial, of an investigational agent that blocks androgen synthesis (e.g., abiraterone acetate, tak-700, tak-683, tak-448) or targets the androgen receptor (e.g., enzalutamide, bms 641988); * liver injury or disease (e.g., viral hepatitis, liver failure child-pugh class c).

Keywords: high risk
magnetic resonance lung function imaging study of pulmonary fibrosis combined with emphysema syndrome

Conditions: Using Functional Lung MRI to Explore Pulmonary Perfusion Changes in Patients With Pulmonary Fibrosis and Emphysema Syndrome

Summary: this study intends to use magnetic resonance pulmonary function imaging technology to explore imaging markers for early diagnosis of patients with cpfe. through baseline, 6-month and 12-month follow-up examinations, the changes in magnetic resonance pulmonary function in patients with cpfe and their correlation with disease progression were explored.


Eligibility criteria:
inclusion criteria: * (1) chest hrct shows emphysema mainly distributed in the upper lung field, manifesting as wallless or thin-walled (wall thickness \ 1 cm), and the emphysema area/total lung volume is ≥10%; (2) interstitial pulmonary fibrosis mainly distributed in the lower lung field and subpleura, manifesting as honeycomb shadow or grid shadow, and the lung structure is destroyed , may be accompanied by traction bronchiectasis, ground glass opacities and consolidation opacities. exclusion criteria: * (1) refusal to sign the informed consent form; (2) mri contraindications (implanted pacemaker/defibrillator, claustrophobia, or any clinical condition that prohibits longer mri examinations).
testing two models of prep delivery in obgyn clinics

Conditions: Hiv

Summary: the hiv center for clinical and behavioral studies, the albert einstein college of medicine and the alliance for positive change will test two healthcare models that integrate prep into obgyn services. model 1 is obgyn-prep with 4 parts: (1) prioritize prep; (2) train providers in prep and intervention; (3) identify prep-appropriate women through a risk screen; and (4) monitor progress and fidelity to protocol. model 2 is np-pc prep in which prep provider burden is shifted to a nurse practitioner (np) who will use a sex-positive approach to deliver prep services via telemedicine.

the albert einstein college of medicine (einstein), the hiv center for clinical and behavioral studies (hiv center), the montefiore medical center department of obstetrics and gynecology (obgyn, implementing partner) and the alliance for positive change (alliance, implementing and community partner) will compare two healthcare models that integrate prep into obgyn services. both models are acceptable standards of care and represent evidence-based approaches to the provision of care. this study is the first example of comparing these interventions in a head-to-head, comparative-effectiveness model. both groups will benefit from maintained access, enhanced assessment with the prep screening tool, and physicians will all receive an evidence-based prep education seminar with supporting materials and ongoing access to education and resources. model 1, obgyn-prep is based on pc4prep (r01mh107297) that has four steps: announce the policy that prep counseling is the responsibility of obgyn providers to address the "purview paradox"; train providers to manage patients on prep; use a screening tool to identify women appropriate for prep; and implementation coaching to monitor and encourage prep counseling. the goal is that prep be provided by a trusted provider with whom the patient has an ongoing relationship. in model 2, np-pc prep, all the same provisions and practices present in model 1 will be present however, a telehealth opportunity with a nurse practitioner (np) will be provided. a skilled and prep-trained np will deliver prep services via telemedicine visits

Eligibility criteria:
inclusion criteria: * ≥18 years of age female (biological female at birth) ability to speak and read english or spanish patient at montefiore medical center, eastchester professional center (epc). no gross evidence of cognitive impairment precluding consent and participation willing to have interview digitally recorded exclusion criteria: * \<18 years of age not a female (biological female at birth)- we have excluded transgender women because their sexual and reproductive health issues and prep use differ from those of biological females. does not speak english or spanish not a patient at montefiore medical center, eastchester professional center (epc). gross evidence of cognitive impairment precluding consent and participation not willing to have interview digitally recorded

Keywords: hiv prep
effect of prebiotic intake on adiposity, satiety and gut microbiota in overweight and obese children

Conditions: Overweight; Obesity

Summary: currently, over one third of canadian children and youth aged five to seventeen are overweight or obese. childhood obesity leads to increased risks of co-morbidities such as type 2 diabetes, fatty liver disease, cardiovascular disease and certain types of cancers. changes in the food supply have been linked to obesity and include a decrease in the intake of dietary fiber. prebiotic fibers are a group of non-digestible carbohydrates that modulate the composition and actions of the gut microbiota and have been shown to reduce body fat and energy intake in overweight and obese adults. the investigators hypothesis is that prebiotic fiber intake in overweight and obese children will similarly result in improvements in body composition and reduced energy intake.

obesity in the pediatric population is a primary public health concern given that overweight and obesity in childhood continues into adulthood. consumption of high-fat, calorie-dense diets do not provide individuals with the suggested daily intake of many important nutrients. this is especially true for dietary fiber which has positive health benefits such as roles in weight management. a form of dietary fiber with links to obesity treatment/prevention is prebiotic fiber. in the gut, there are many bacteria which have been shown to affect a person's health depending on the type and number of each type of bacteria. the role of prebiotic fiber is to increase the number of beneficial bacteria which in turn promotes health. studies in humans have shown that prebiotic fiber is effective at reducing body fat and food intake in overweight and obese adults. the aim of this study is to see if prebiotic fiber can provide the same benefits to overweight and obese children. since weight management becomes increasingly difficult as a person ages, treatments that promote weight maintenance at an early age are critically needed.

Eligibility criteria:
inclusion criteria: * boys and girls between the ages of 7-12 years old * bmi percentiles \>85th percentile for their age and sex * tanner stage of ≤ 3, girls premenarche exclusion criteria: * tanner stage of \>3 or girls postmenarchal * use of antibiotics up to 3 months prior to study * regular prebiotic supplement and/or probiotic supplement use * subjects unable to provide consent (parental) or assent (child)

Keywords: pediatric overweight obesity gut microbiota adiposity prebiotic dietary fiber
efficacy of azithromycin plus doxycycline versus doxycycline plus placebo in patients with rocky mountain spotted fever

Conditions: Rocky Mountain Spotted Fever

Summary: the aim of this study is to impove the pharmacological treatment of rocky mountain spotted fever, since is a very ancient disease with an antibiotic therapy that have not changed much the mortality rates, being compared with the natural curse of the disease.

rocky mountain spotted fever is a potentially fatal infectious disease wich is transmitted trough vectors. this particular infection is caused by rickettsia rickettsii wich is a gramnegative intracellular bacilli. the pathophysiological mechanism and clinical manifestation is mainly due to the vascular affectation, since this pathogen has a tropism for endothelial cells. as it has been mentioned, this is an obligate intracellular pathogen, so the main choice with the antibiotic therapy is tetracyclines because of its action mechanism in the inhibition of the subunit 30s. the objective of the study is to prove new strategies of treatment to improve the pharmacological aproach by implementing azithromycin, wich is a macrolide that inhibits de 50s subunit of the bacteria. azithromycin has shown effectivity against other rickettsial diseases.

Eligibility criteria:
inclusion criteria: * any gender * over 18 years old * hospitalized in the internal medicine service, emergency department or intensive care unit of hospital general de mexicali (isesalud) or hospital general zona no. 30 (imss) with suspicion of rmsf that present fever and 2 or more of the next symptoms: headache, myalgia, rash, nausea, pharyngeal hyperemia, vomiting, abdominal pain, neurological disorders. * in addition to at least one of the next epidemiologycal fators: presence of vectors in areas of residence or endemic areas visited two weeks prior to the onset of symptoms, history of visiting or residing in areas with rmsf transmission in the last two weeks, existence of confirmed cases in the locality of origin, history of vector bite or contact with dogs in the two weeks. exclusion criteria: * other clinical suspicion rather than rmsf * history of allergy to doxycycline, azithromycin, bean starch or bovine gelatin. * not signing the informed consent * pregnancy.

Keywords: rocky mountain spotted fever azithromycin doxycycline
tactile imaging and electromyography

Conditions: Urinary Incontinence; Overactive Bladder

Summary: urinary incontinence (ui) and overactive bladder (oab) in women has high prevalence which is increasing with the age. in adults aged 40 and older in the us demonstrated prevalence rate of 27.2% among man and 43.1% among women, respectively. urine incontinence was reported to affect 15% of women ages 40 to 49, 25% ages 60 to 69, and 38% of women age 80 and older.

pelvic floor disorders result from neuro-urinary pathology as well as muscle functional impairment due to changes in bio-mechanical properties of soft tissues with the age. that is why pelvic floor characterization and diagnosis must include electomyographic (emg) and biomechanical measurements (pressure) or better if emg and tactile imaging with improved spatial resolution. the quantitative and objective imaging data for pelvic floor conditions could allow an effective treatment of oab and ui. in this research the investigators propose to develop a new device for accurate diagnosis of the diseased conditions by measuring the pelvic floor muscles strength and emg activity. the value to society is high given by the prevalence of oab and ui.

Eligibility criteria:
inclusion criteria: * women above age of 21 with normal pelvic floor condition for the control * women with sui conditions as defined by international continence society guidelines * women with oab conditions as defined by american urological association and society of urodinamics, female pelvic medicine \& urogenital reconstruction. exclusion criteria: * any prior pelvic floor surgery related to sui, pop or oab conditions * active skin infection or ulceration within the vagina * presence of the vaginal septum * active cancer of the colon, rectum wall, cervix, vaginal, uterus or bladder * ongoing radiation therapy for pelvic cancer; impacted stool * surgically absent rectum or bladder * sever hemorrhoids * significant circulatory or cardiac conditions that could cause excessive risk * significant pre-existing pelvic pain including levator ani syndrome, severe vaginismus or vulvodynia.
magnetic resonance imaging and magnetic resonance spectroscopic imaging in evaluating patients who are undergoing treatment for gliomas

Conditions: Brain and Central Nervous System Tumors

Summary: rationale: diagnostic procedures, such as magnetic resonance imaging (mri) and magnetic resonance spectroscopic imaging (mrsi), (done before, during, and after treatment) may help doctors predict a patient's response to treatment and help plan the best treatment. purpose: this phase ii trial is studying how well mri and mrsi evaluate patients who are undergoing treatment for gliomas.

objectives: * determine the magnetic resonance spectroscopic imaging (mrsi) characteristics of patients who are undergoing treatment for supratentorial glioma. * determine the survival of patients who undergo magnetic resonance imaging and mrsi. * determine the clinical outcome of patients who undergo these imaging procedures. * correlate measures of metabolic tumor burden (i.e., cni, cccri, crni, and lli) with survival and clinical outcome in patients who undergo these imaging procedures. * determine the time to clinical progression in patients who undergo these imaging procedures. outline: patients are assigned to 1 of 2 treatment groups based on grade of disease. * group 1 (patients with grade ii glioma): patients undergo magnetic resonance imaging (mri) and magnetic resonance spectroscopic imaging (mrsi). patients then receive chemotherapy. patients undergo repeat mri/mrsi after courses 2 and 4 of chemotherapy. * group 2 (patients with grade iii-iv glioma): patients undergo mri/mrsi and then undergo surgical resection of the tumor. patients then receive chemoradiotherapy. patients undergo repeat mri/mrsi within 2 weeks and at 2 months after completion of radiotherapy. patients are followed for recurrence, disease progression, and survival. projected accrual: a total of 250 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed supratentorial glioma * grade ii-iv disease * previously untreated disease * eligible for surgical resection and/or chemotherapy with or without radiotherapy * tumor accessible by magnetic resonance spectroscopic imaging patient characteristics: * karnofsky performance status 60-100% * life expectancy ≥ 8 weeks * not pregnant * no contraindication for magnetic resonance examinations, including any of the following: * cardiac pacemaker or fibrillator * aneurysm clip * insulin or infusion pump * any implant held in place by a magnet * metal contamination anywhere in the body prior concurrent therapy: * no prior chemotherapy * no prior radiotherapy * no prior treatment for the malignancy

Keywords: adult anaplastic astrocytoma adult diffuse astrocytoma adult glioblastoma adult giant cell glioblastoma adult gliosarcoma adult pilocytic astrocytoma adult anaplastic ependymoma adult ependymoma adult myxopapillary ependymoma adult subependymoma adult anaplastic oligodendroglioma adult oligodendroglioma adult mixed glioma
new technique for laparoscopic appendicectomy

Conditions: Appendicitis Acute

Summary: introduction: appendectomy is one of the most frequent emergency surgical procedures, currently with a preference for laparoscopic management worldwide. objective: to report a new laparoscopic appendectomy technique and its results. material and methods: study of patients with a diagnosis of appendicitis who are managed laparoscopically. in a total 1063 patients, 148 were operated on with the zaragoza technique during the period from january 2002 to december 2018. the technique consists of making a window in the appendicular base between the meso and the appendicular wall, two prolene or silk sutures are placed, and the cecal appendix is cut between the two sutures, finally the mesoappendix is sectioned with a harmonic scalpel or bipolar clamp.

this is a retrospective study based on files

Eligibility criteria:
inclusion criteria: * patients with a diagnosis of appendicitis who are managed laparoscopically. exclusion criteria: * less than 18 year old