Kornimate/medical-research-clean huggingface dataset:
study to evaluate met409 alone or in combination with empagliflozin in patients with type 2 diabetes and nash

Conditions: NASH; NASH - Nonalcoholic Steatohepatitis; Type 2 Diabetes; Diabetes Type 2; Diabetes; Fatty Liver; Fatty Liver, Nonalcoholic; NAFLD

Summary: a randomized, multi-center study evaluating met409 (50 mg) alone or in combination with empagliflozin (10 mg) for 12 weeks. assignment to met409 will be double-blind and placebo-controlled. empagliflozin will be incorporated into two of the treatment arms in an open-label manner.

subjects assigned to receive empagliflozin will be dosed at 10 mg per day for the duration of the study. approximately 30 subjects will be enrolled per treatment arm.

Eligibility criteria:
key inclusion criteria: * males and females 18 through 75 years of age. * diagnosis of nash based on nafld activity score (nas) ≥ 4 with at least 1 point in each of steatosis, inflammation, and ballooning; magnetic resonance elastography (mre) showing kpa ≥ 2.61 or a multiparametric mri (ie, livermultiscan) showing iron-corrected t1(ct1) \> 830 ms within 6 months of enrollment; or transient elastography (te, fibroscan) with liver stiffness ≥ 8.5 kpa and controlled attenuation parameter (cap) \> 300 db/m obtained within 3 months of enrollment. * liver fat content ≥ 8% measured by magnetic resonance imaging-proton density fat fraction (mri-pdff) during screening. * diagnosis of t2dm for ≤ 10 years, with hemoglobin a1c ≤ 10.0% during screening, stable and controlled with diet or treatment for at least 3 months. key exclusion criteria: * history of significant liver disease (eg, alcoholic liver disease, viral hepatitis, etc.) or liver transplant. * presence of cirrhosis on any prior liver biopsy (stage 4 fibrosis). * excessive consumption of alcohol. * use of any insulin (injectable or inhaled), sglt-2 inhibitor or glucagon-like peptide 1 (glp-1, injectable or oral) products for \> 7 days within 3 months of screening. * weight loss \> 10% in the 6 months prior to screening or \> 5% during screening. * use of drugs historically associated with causing nafld for more than 4 consecutive weeks within 12 months prior to screening. * concomitant use of drugs that are strong or moderate cyp3a4 inhibitors. * concomitant consumption of grapefruit juice with the study drug. * history of diabetic ketoacidosis (dka) within 1 month prior to the screening visit, or more than 2 episodes within 6 months prior to the screening visit. * history of \> 2 episodes of urosepsis or pyelonephritis within 5 years of screening.

Keywords: nash fxr fatty liver diabetes
to demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets

Conditions: Immunosuppression; Rheumatism

Summary: to demonstrate the relative bioavailability of hydroxychloroquine sulfate, 200 mg tablets.


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal finding on physical exam, medical history, or clinical laboratory results on screening. exclusion criteria: * positive test results for hiv or hepatitis b or c. * treatment for drug or alcohol dependence.

Keywords: immunosuppressant and antirheumatic
skin structure infections with suspected or proven methicillin-resistant staphylococcus aureus (mrsa)

Conditions: Skin/Soft Tissue Infections; Methicillin Resistant Staphylococcus Aureus (MRSA)

Summary: to determine if linezolid is superior to vancomycin in the treatment of complicated skin and soft tissue infections due to mrsa in adult subjects


Eligibility criteria:
inclusion criteria: * male and female subjects with signs or symptoms consistent with infection, and if available, laboratory findings consistent with staphylococcal infection (e.g., gram stain and culture results). * signs and symptoms consistent with infection * infection suspected to be due to methicillin resistant staphylococcus aureus exclusion criteria: * subjects who were treated with a previous antibiotic (systemic or topical) with mrsa activity (other than linezolid or vancomycin) for more than 24 hours and treatment extended into the 72 hour period prior to the first dose of study drug, unless documented to be a treatment failure (72 hours of treatment and not responding). * subjects with uncomplicated skin or superficial skin structure infection such as superficial/simple cellulitis, impetiginous lesion, furuncle, or simple abscess that only need surgical drainage for cure. * subjects excluded with necrotizing fasciitis, gas gangrene, osteomyelitis
natural procreative technology evaluation and surveillance of treatment for infertility and miscarriage

Conditions: Infertility and Miscarriage

Summary: this study involves research, and the purpose of this study is to evaluate live birth rates among couples who are treated by natural procreative technology, (npt) for infertility and miscarriage. comparisons will be made to those declining npt treatment, waiting for npt treatment, receiving other treatment, or stopping treatment. the investigator seeks to document specific pregnancy rates for different factors such as age and type of infertility diagnosis. investigators will also assess characteristics of environmental exposures that may be associated with infertility. couples will be followed for up to three years, regardless of when they begin npt treatment, or whether they continue treatment. data from all couples will be useful for this study, regardless of their individual circumstances or actual treatment.

this is a prospective cohort observational study. couples presenting for possible treatment with npt will be recruited for participation in the study. no randomization will occur. if a couple agrees to participate, investigators will collect information in three ways: 1. questionnaires. (standard of care) these will be done at entry (soc) to the study, on an annual basis for up to three years (research related), for any pregnancy, or whenever a patient exits the study. questionnaires may be done by mail, email, or telephone. each questionnaire has a woman's and a man's version, except the pregnancy questionnaire, which only has a woman's version. each questionnaire will take approximately 30-45 minutes to complete. 2. the subject's own creighton model fertility charts. (standard of care) 3. information about npt treatment and pregnancies from the medical records of their npt physician(s). (standard of care)

Eligibility criteria:
inclusion criteria: * couple or women, seeking npt treatment or consultation to achieve pregnancy, to maintain pregnancy, or for fertility-related health issues. * couple or women who is seeking pregnancy within the coming year. exclusion criteria: * couple or women is not a candidate for npt for pregnancy (for example, couple or women is medically sterile or medically too high risk for pregnancy). * couple or women is not able to provide informed consent (for example, language barriers).
effectiveness of a handwashing programme in the prevention of school absenteeism due to respiratory infections

Conditions: Upper Respiratory Infections; Influenza; Common Cold

Summary: the aim of the study was to assess the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. students in intervention classrooms used hand sanitizers at schools and a programme educational on hand hygiene. the investigators hypothesize that the use de hand sanitizers in elementary school will reduce absenteeism due to upper respiratory infections.

school absenteeism due to respiratory infections is one of the greatest problems in schools. its high incidence and easy transmission among pupils have a great impact requiring a vast number of medical visits, hospitalisations, use of antibiotic and antipyretic treatments, symptomatic medication, etc. besides being a cause for school absenteeism and time off work for parents. hand- washing is the most important and effective measure to prevent the transmission of infections. the investigators evaluated the effectiveness of a hand-washing programme using hand sanitizer in the prevention of school absenteeism due to upper respiratory infections. a cluster randomised, controlled and open study of 2 cohorts of primary school children between the ages of 4 and 12, attending 5 public schools in a geographic area of the almería province (spain). this study was carried out throughout the 8 months of an academic year (october 2009 to may 2010). the experimental group washed their hands with soap and water, complemented with hand sanitizer, while the control group followed usual hand washing. the parents of both groups completed the survey on sociodemographic characteristics and questions about hand hygiene referred to when and how their children wash their hands progenitors of children who were absent from school collected upper respiratory infections symptoms and handed in the completed form to the teacher. one research assistant collected the absence sheets of the participating classes weekly, telephoned the parents of absent children to enquire about the cause of their absence, visited the classrooms and collaborated with the teachers in hand hygiene related activities.

Eligibility criteria:
inclusion criteria: * school children between the ages of 4 and 12 years old, enrolled in the above mentioned public schools, * the parents/tutors signed an agreement after being informed of its content. exclusion criteria: * children with absenteeism due to a different cause from upper respiratory infections * children with chronic illnesses that could affect their likelihood of contracting an infection or the duration of their period of absence from school * children whose parents did not authorise their participation in the study.

Keywords: handwashing hand sanitizer absenteeism school age children preschool children
sternectomy repair efficiency of a ceramic implant

Conditions: Bones, Tumors

Summary: for the replacement of the sternum, there is no consensus regarding the most appropriate and most effective physiologically material. the use of ceramic implant offers significant operational time saving and biocompatibility coupled with the strength of the material allow us to realize a more natural operation, limiting the risk of infection and rejection. main objective: to evaluate the efficiency of the replacement of the sternum by a ceramic implant on the respiratory capacity at 3 months post surgery.


Eligibility criteria:
inclusion criteria: * patient major * having a replacement indicating the sternum (or a part of the sternum) * with an expected life of over one year, estimated by the principal investigator * written consent of the patient exclusion criteria: * people under safeguard justice, * patient under guardianship, * patient pregnant or breastfeeding, * topic attending another search including a period of exclusion still going to run-in * contraindication to general anesthesia * of alumina allergy antecedent * recent infectious disease unsupported * bmi\> 40

Keywords: sternectomie ceramic implant bones tumors
tapioca starch stimutex as, aloe barbadensis, rose hip oil, allantoin comparing with topical 1% hydrocortisone cream

Conditions: Intertrigo

Summary: a randomized controlled trial of efficiency and safety of liquid powder containing tapioca starch stimutex as, aloe barbadensis, rose hip oil and allantoin comparing with topical 1% hydrocortisone cream for the treatment of intertrigo

intertrigo is an inflammatory dermatosis involving body folds that develops through friction of skin to skin and is influenced by moist conditions. the prevalence of intertrigo was reported to be 2.5% for adults with an average age of 41.5 years. prevalence of intertrigo in the large skin folds varies from 6% in hospital patients to 17% in nursing home clients and 20% in home care patients. the inframammary fold was most often affected (9.9%), followed by the inguinal region (9.4%), axilla (0.5%) and abdominal region (0.5%). intertrigo may be mild and asymptomatic, but also may lead to intense erythema and desquamation. the affected skin may have a foul odor and may be macerated and ulcerated with copious or purulent discharge. the conventional therapy for simple intertrigo is minimizing moisture and friction. some suggest the use of absorptive powders, such as talc and cornstarch, or barrier creams. these topical treatments such as topical steroid, however, have little or no proven benefit and may cause irritation or facilitate yeast colonization. this study aims to evaluate the efficacy and safety of liquid powder containing tapioca starch stimutex as, aloe barbadensis, rose hip oil and allantoin comparing with topical 1% hydrocortisone cream of mild to moderate intertrigo patients.

Eligibility criteria:
inclusion criteria: 1. patients who had age more than 18 years 2. one intertrigo lesion at inframammary fold, inguinal region, interdigital, axilla or abdominal region with mild to moderate which only has erythema no epidermal loss 3. being diagnosed intertrigo by dermatologist. patients will be clinical and investigational with koh preparation and wood's lamp diagnosed with intertrigo by dermatologist. exclusion criteria: 1. patients receive topical steroids, topical anti-fungal drugs within 2 weeks prior the study 2. patients with skin conditions including fungal/bacterial infection, hailey-hailey disease, pemphigus, granuloma, psoriasis, acanthosis, or darier disease on intertriginous areas within 2 weeks prior to the study 3. patients with an allergic to tapioca starch และ stimutex as, aloe barbadensis, rosa hip oil และ allantoin, or topical hydrocortisone 4. pregnant or breastfeeding women 5. patients with severe intertrigo treated with high potent topical steroid or systemic corticosteroid

Keywords: intertrigo tapioca starch stimutex as aloe barbadensis rose hip oil allantoin
cardiac implantable electronic device lifelong antibiotic therapy vs stop and see

Conditions: Cardiac Implantable Electronic Device Infection

Summary: the goal of this non-randomized prospective study is to test whether 6-weeks antibiotic treatment can cure an cardiac implantable electronic device (cied) infection in patients where device extraction is not feasible. the main question it aims to answer: • is 6-weeks medical therapy effective in curing definite cied infection with device retention? participants will discontinue the antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total. after discontinuation of antibiotics, patients are closely observed for bacterial relapse. for patients who are not interested in participation and who do not have exclusion criteria, we will ask for consent into a registry as we wish to compare patients undergoing discontinuation of antibiotics with patients undergoing standard treatment.


Eligibility criteria:
inclusion criteria: * definite cied infection by the ehra criteria * deemed non-eligible for cied extraction exclusion criteria: * unavailable for follow-up (e.g., tourist)
spinal analgesia for colonic resection using an enhanced recovery after surgery (eras) program

Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Summary: this is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. the aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the enhanced recovery after surgery (eras) program. twenty patients will receive spinal analgesia and twenty patients will receive only patient control analgesia (pca).

this is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. the aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the eras program.

Eligibility criteria:
inclusion criteria: * patients scheduled to undergo laparoscopic colonic resection exclusion criteria: * patients who have trouble to understand, read or communicate either in french or in english * dementia * patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity * patients suffering from severe cardiac or respiratory disease (status asa iv) * patients suffering from metastatic carcinoma * patients who have a history of chemoradiation within the six months preceding surgery * morbid obesity * contraindication to spinal analgesia
mechanisms and treatment of intradialytic hypertension - sodium

Conditions: Hemodialysis; End-stage Renal Disease; Hypertension; Intradialytic Hypertension

Summary: the purpose of this study is to determine the role of dialysate exposure and fluid removal during hemodialysis in the pathophysiology of intradialytic hypertension.

specific aim #1 to determine in a crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether standard dialysis with ultrafiltration (dialysate na of 140), dialysis without ultrafiltration (dialysate na of 140), or ultrafiltration alone (no dialysate) is associated with the an increase in systolic blood pressure during hemodialysis specific aim #2 to determine in a crossover study of 15 maintenance hemodialysis with intradialytic hypertension whether standard dialysis with ultrafiltration, dialysis without ultrafiltration, or ultrafiltration alone is associated with change in either endothelin-1 or nitric oxide during hemodialysis substudy aims specific aim #1 to determine in a randomized 3-week, 2 period crossover study of 15 maintenance hemodialysis patients with intradialytic hypertension whether high vs low dialysate-to-serum na gradients impairs release of no, increases et-1 or causes an acute intradialytic increase in systolic bp,. specific aim #2 to determine in a randomized 16-week, 2-period crossover study of 30 hemodialysis patients with intradialytic hypertension the effects of 8 weeks of high dialysate-to-plasma na gradients to 8-weeks of low na gradients on ec function (fmd and adma) and 44 hour ambulatory bp.

Eligibility criteria:
inclusion criteria: * on hemodialysis \> 30 days * male and female participants, aged 18 to 85 years old, of all races and ethnic origin * ability to provide informed consent * primary nephrologist deems patient is at target dry weight * kdoqi defined hypertension (predialysis sbp \>140 or postdialysis sbp\>130) and * pre to post hemodialysis sbp increase (\>10 mmhg) during 4/6 last hd session exclusion criteria: * patients with active cancer or active wounds * patient currently on antibiotics or on iv antibiotics within the last month * bp unable to be measured by routine mechanisms in the upper extremity * life expectancy \< 6 months * inability to provide informed consent * larger interdialytic weight gain (\>5 kg/treatment on average)

Keywords: hemodialysis end-stage renal disease hypertension
safety study to evaluate bms-767778 in healthy subjects and subjects with type 2 diabetes mellitus (t2dm)

Conditions: Type 2 Diabetes Mellitus

Summary: to assess the safety and tolerability and the pk/pd relationship of bms-767778 administered as single and multiple oral doses in healthy subjects, and in subjects with t2dm


Eligibility criteria:
parts a and part b of the study (maximum age 45 years): inclusion criteria: * healthy male and female subjects as determined by medical history, physical examination, 12-lead electrocardiogram (ecg), and clinical laboratory evaluations will be eligible to participate in the study. * men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) exclusion criteria: * evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ecg or clinical laboratory determinations part c of the study (maximum age 65 years): inclusion criteria: * drug naive patients with t2dm or patients who are on metformin-monotherapy (at current dose for ≥ 8 weeks) with inadequately controlled blood glucose levels (hba1c \>7 %and \<10 %) men and women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile) exclusion criteria: * poorly controlled diabetes with either new onset or worsening of symptoms of polyuria and polydipsia, weight loss, fatigue, abdominal pain, or other significant signs and symptoms * any of the following medical conditions: uncontrolled hypertension, unstable angina pectora, cushing's syndrome, addison's disease, uncontrolled hyperthyroidism or hypothyroidism, significant liver disease or renal failure, malignant diseases, or immunodeficiency (e.g., hiv/aids or organ-transplant), or history of myocardial infarction, congestive heart failure defined as new york heart association (nyha) stage ii and above, significant valvular disease, cardiac arrhythmia, or transient ischemic attack or cerebrovascular accidents (occurred within 6 months prior to entry into the study), or family history of long qt syndrome
effect of virtual reality spectacles on the management of pain and anxiety

Conditions: Cancer

Summary: to assess the contribution of the use of virtual reality glasses on the pain perceived by patients during the installation of an icp in the operating room under local anesthesia in the patient newly diagnosed with cancer

the insertion of an implantable catheter chamber (ich) is indicated in the case of prolonged or repeated infusions, particularly when the products injected are toxic to the venous walls, as is the case with cancer chemotherapy. the insertion of a ich is carried out in the operating theatre, usually under local anaesthesia. although this operation is potentially painful and stressful, the question of its perception by the patient has not yet been addressed, nor the relevance of using non-invasive devices to alleviate the pain felt by the patient. among the proposals, virtual reality glasses bliss solution would be likely to improve patient management when a ich is performed under local anaesthesia in the operating theatre. the evaluation will be made on the contribution of the use of the bliss solution virtual reality glasses in the management of pain during the installation of an ich under local anesthesia in the operating room.

Eligibility criteria:
inclusion criteria: * adult patient over 18 years of age * patient suffering from a cancerous pathology * patient taken care of for the installation of the ich exclusion criteria: * patient does not speak and understand french * patient who has had a previous ich installation * patient with cognitive impairment * patient with pain perception disorder

Keywords: virtual reality, pain, cancer
clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin.

Conditions: Multidrug-resistant Gram-negative Bacteria Infection

Summary: clinical usefulness of therapeutic drug monitoring of colistin in patients treated with colistin


Eligibility criteria:
inclusion criteria: * age over 18 years old. * those who receive colistin therapy for the treatment of multi-drug resistant gram negative bacteria infection. exclusion criteria: * those who received colistin therapy less than 48 hours * those who received colistin therapy through the bronchus