Kornimate/medical-research-clean huggingface dataset:
effect of drain care on infection rate and quality of life in implant-based breast reconstruction.

Conditions: Infections; Quality of Life

Summary: the goal of this clinical trial is to learn whether showering with surgical drain tubes in place after first stage breast reconstruction causes increased risk of infection. the main questions it aims to answer are: * is there an increased risk of infection/complications with showering 48 hours after drain tubes are in place * does showering after 48 hours with drain tubes in place affect quality of life.

ssi (soft tissue infection) is an aggravating risk specifically associated with implants. breast reconstruction quotes infection rates anywhere from 1-35% while cosmetic augmentations quote rates around 1.5%. usually, the causative organisms are skin flora like staph aureus and staph epidermidis. occasionally mycobacterium and other atypical bacterium are isolated more commonly in the immunocompromised. despite perioperative antibiotics, ssi is still a prevalent complication increasing total expenditure of patients and hospital systems upwards of $4000/patient in reoperation fees and hospital stay costs. skin prep and antibiotics in the preoperative phase is very important to the sterile technique and decreasing risk of infection by decreasing bacterial load at the time of incision and surgery. however, postoperative care and interventions are less strictly evaluated and defined. currently, there is no standard of care in regards to showering post operatively with jp (jackson-pratt) drains in place. timing of showering is ultimately based on surgeon preference. in practice, the investigators routinely have had patients wait to shower until the jp drains are removed. the investigators hypothesize that showering daily, even with drains in place, will not increase rates of infection in breast reconstruction and perhaps improve quality of life during first stage. this study is prospective with participants randomized to either shower daily after 48hrs or standard of care and shower after drains removed. the participants will be asked to fill out a quality of life survey 90 days after enrollment. the patients will also be monitored for signs of infection for 90 days.

Eligibility criteria:
inclusion criteria: * undergoing breast surgery with placement of tissue expander and drains, acceptance of protocol and procedures, age \> 18 exclusion criteria: * no existing wounds, previous infections related to implant device if delayed, refusal by patient
a clinical and biological research of combined chinese and western medicine in the treatment of pcos

Conditions: PCOS

Summary: this study evaluates the effects and biological mechanisms of dingkundan，diane-35 and the combination of dingkundan and diane-35 in the treatment of polycystic syndrome(pcos) in adults women. one third of participants will receive dingkundan capsules, one third of participants will receive diane-35 pills, and the another third will receive dingkundan capsules and diane-35 in combination.

dingkundan,diane-35 each ameliorate pcos, but they do so by different mechanisms. we generally treat pcos patients without immediate fertility requirement by short-acting contraceptives,diane-35 is one of the most commonly used drugs. dingkundan consists of multiple chinese herbs including ginseng,panax notoginseng,deer antlers,carthamus tinctorius l.,radix paeoniae alba,prepared radix rehmanniae,angelica etc., which gains widespread application in the treatment of gynecological diseases. based on the characteristics above, we try to explore its clinical application value in pcos and its biological mechanisms.

Eligibility criteria:
inclusion criteria: * subject is a female between the age of 18 and 40. * subject diagnosed as pcos by the 2003 rotterdam criteria. * subject provides written informed consent. exclusion criteria: * subject has other endocrine diseases,such as adrenal hyperplasias or tumor, androgen-secreting tumours, cushing's syndrome,thyroid diseases and hyperprolactinemia. * subject has received related medical or surgical treatment in the past 3 months. * subject suffered from substance abuse or dependence(such as alcohol or drugs); * subject is a heavy smoker(reaching or more than 20 cigarettes a day). * subject is pregnant or lactating or within 1 year after delivery. * subject has a severe systemic disease, such as cardiovascular system * subject has a history of malignancy or radiotherapy. * subject has an allergic history to the drugs used in the study. * subject has mental disorder incapable of elementary cooperations. * subject has participated in other clinical researches of medicine within 3 month prior to randomization.

Keywords: pcos dingkundan diane-35
surgery with implantable biodegradable carmustine (bcnu) wafer followed by chemo for patients with recurrent glioblastoma multiforme

Conditions: Glioblastoma Multiforme

Summary: the purpose of this research study is to try and identify a more effective treatment plan to improve survival rates for patients with a recurrent glioblastoma multiforme (gbm) brain tumor that can be removed by brain surgery. the study will record what effects (good and bad) the combination of surgery with chemotherapy wafers inserted in the spot where the patient's tumor was during your surgery and post-operative chemotherapy has on the patient and their survival rate over the next 12 months.


Eligibility criteria:
inclusion criteria: * histopathologically proven diagnosis of gbm in the past with mri findings compatible with disease recurrence. multifocal disease is permitted. * must have had prior treatment with standard doses of temodar * kps \>50; ecog \<3 * predicted life expectancy of \> 3 months * study entry must be within 5 weeks of surgical resection exclusion criteria: * prior exposure to vegf inhibitors or irinotecan * intracranial bleed as defined by ct or mri less than 6 months prior to entry * gi bleed less than 6 months prior to entry * uncontrolled concurrent illness that would limit compliance with study requirements
study to evaluate the efficacy and safety of moxifloxacin versus amoxicillin/clavulanate in the treatment of acute bacterial rhinosinusitis

Conditions: Sinusitis; Bacterial Infections

Summary: this is a clinical study organized to collect clinical data to better define the activity of some antimicrobials already marketed in italy and in the rest of the world for the treatment of acute bacterial rhinosinusitis


Eligibility criteria:
inclusion criteria: * age \>= 18 years * clinical diagnosis of acute rhinosinusitis with signs and symptoms present for \>/= 5-7 days but \< 28 days * clinical diagnosis will be confirmed by nasal endoscopic examination exclusion criteria: * history of chronic sinusitis defined as greater than four weeks of continuous symptoms (subject with history of sinus surgery may be included; subjects with recurrent acute sinusitis may be included) * any symptoms that suggest the subject's current illness is allergic rhinitis (e.g. repetitive sneezing, itchy nose or eyes, provocation by an allergen) and not acute bacterial sinusitis * known bacteremia, meningitis or infection infiltrating the tissues neighboring the sinuses * known immunodeficiency diseases including, but not limited to: neutropenia (neutrophil count \< 1000/mm3), human immunodeficiency virus (hiv) infection (cluster of differentiation 4 (cd4)+ t-cell count of \< 200/mm3). note: hiv testing is not required * received systemic antibacterial therapy likely to be effective in the treatment of acute bacterial sinusitis for more than 24 hours within 5/6 days of enrollment * requirement for concomitant systemic antibacterial therapy with agents other than those specified in this protocol * currently receiving topical nasal corticosteroids, unless they have been on a stable dose for \> 4 weeks prior to enrollment * requirement for concomitant therapy with systemic corticosteroids * pregnant or breast feeding * of childbearing potential in whom pregnancy cannot be excluded by a negative pregnancy test and who are not using reliable barrier method of contraception * received an investigational drug in the past 30 days * previously enrolled in this study * unable to take oral medication * history of allergy to quinolone antibiotics or related compounds and beta-lactams * history of tendinopathy associated with quinolones * known to have congenital or sporadic syndromes of qt interval corrected for rate (qtc) prolongation or receiving concomitant medication reported to increase the qtc interval (e.g. amiodarone, sotalol, disopyramide, quinidine, procainamide, terfenadine) * uncorrected hypokalemia * end stage liver cirrhosis (class child-pugh c) * severe renal impairment requiring dialysis * diagnosis of rapidly fatal illness with a life expectancy of less than 6 months

Keywords: treatment of acute bacterial rhinosinusitis
a phase ii open label study of bms-582664 in locally advanced or metastatic hepatocellular cancer

Conditions: Hepatocellular Carcinoma (HCC)

Summary: the purpose of this clinical research study is to learn if bms-582664 can shrink or slow the growth of advanced liver cancer. the safety of this treatment will also be studied.


Eligibility criteria:
inclusion criteria: * diagnosis of hepatocellular carcinoma (hcc) ≥ 2cm based on: * biopsy or * radiological evidence of hcc by contrast-enhanced ct scan or contrast-enhanced and * blood test positive for hepatitis b or c and * alpha fetoprotein above \> 400 mg/l * not appropriate for curative surgery * screening blood pressure \ 50% exclusion criteria: * heart attack within 12 months, uncontrolled chest pain within 6 months * ascites resistant to diuretic medication therapy * portal-systemic encephalopathy * portal hypertension with bleeding esophageal or gastric varices within the past 2 months * deficiency of sodium in the blood with sodium \< 125 meq/l * subjects with serious non-healing wounds, ulcers or bone fractures
clinical effect, safety and tolerability of gsk1070806 in atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: this study will evaluate efficacy and safety of gsk1070806 in moderate to severe atopic dermatitis (atd) participants.


Eligibility criteria:
inclusion criteria: * moderate to severe atd (confirmed by a dermatologist) according to the hannifin and rajka criteria or eichenfield revised criteria. * onset of atd symptoms occurring at least 6 months prior to screening, with stable disease for at least 1 month prior to screening. * eczema activity severity index greater than or equal to (\>=)16; investigator global assessment score \>=3. * group 1- biologic naïve: topical first line treatment: documented recent history (within 6 months before screening) of: a) either an inadequate response (ir) to out-patient treatment with at least one topical treatment (intermittent topical corticosteroid, topical calcineurin inhibitor), topical inhibitors or phosphodiesterase 4 inhibitor (crisaborole); b) or that topical treatments were otherwise not recommended. * group 2- dupilumab-inadequate responder: documented history of an ir to dupilumab: a) either following at least 16 weeks of treatment according to the investigator's judgement; b) or intolerant to dupilumab owing to adverse events. exclusion criteria: * other than atd, the presence of a significant skin morbidity that will influence the investigator's ability to assess the severity of the disease (e.g. psoriasis, confirmed or suspected cutaneous t-cell lymphoma, autoimmune bullous disease, fixed drug reaction and stevens johnson syndrome). * participants with any uncontrolled medical conditions, other than atd, that in the opinion of the investigator puts the participant at unacceptable risk or will likely interfere with study assessments or data integrity. other medical conditions should be stable at the time of screening and be expected to remain stable for the duration of the study. * treatment with biologic agents (investigational and marketed monoclonal antibodies) within 12 weeks or 5 pharmacokinetic half-lives (whichever is longer) prior dosing on day 1. * treatment with janus activated kinase inhibitors (e.g. baricitinib, upadacitinib) within 4 weeks or 5 half-lives (whichever is longer) prior to dosing on day 1. * mycophenolate mofetil, azathioprine, methotrexate, or calcineurin inhibitors within 4 weeks of screening.

Keywords: eczema activity severity index gsk1070806
effect of parcetamol in headach

Conditions: Headache

Summary: tension-type headache (tth) affects about 1 person in 5 worldwide. it is divided into infrequent episodic tth (fewer than one headache per month), frequent episodic tth (two to 14 headaches per month), and chronic tth (15 headache days a month or more). paracetamol (acetaminophen) is one of a number of analgesics suggested for acute treatment of headaches in frequent episodic tth.objectives to assess the efficacy and safety of paracetamol for the acute treatment of frequent episodic tth in adults.

headaches are a commonly reported problem in community-based surveys worldwide. the lifetime prevalence of headache is estimated to be greater than 90% , and the annual prevalence rate is estimated to be 46% in the general adult population . variations in reported prevalence may result from differences in study design, population, inclusion or exclusion of cases of infrequent episodic tth, overlap with probable migraine, cultural and environmental differences, or even genetic factors . tth is more common than migraine, a finding replicated across the work. the management of people with headaches is largely neglected , and may be fragmented by the involvement of clinicians from different medical specialities (neurology; ear, nose and throat; ophthalmology; psychiatry). because headache is rarely life-threatening and headache pain is generally mild to moderate in intensity, people often self medicate and do not seek formal care from health services . headache can be either primary (no underlying cause) or secondary (due to other systemic or local causes) . tth belongs to the group of primary headaches and is seen in nearly one-third of people experiencing headaches; the large number of people affected imposes a significant burden on the healthcare system. generally, episodes of tth are mild to moderate in intensity, and self limiting, but in a small group of people they may be more severe and disabling . people with longer lasting or more severe headaches may seek help in a clinical setting, but the majority of people do not do so, resulting often in inadequate and inappropriate management .

Eligibility criteria:
inclusion criteria: * both sex * 18 years old to 65 years * free ct brain exclusion criteria: * migrane * any brain pathology

Keywords: paracetamol
evaluation of the effectiveness of an intervention to reduce gaps in hypertension care in low-income medellin, colombia

Conditions: Hypertension

Summary: this study evaluates the effectiveness of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income communes of medellin, colombia, and assess the process and fidelity of the intervention's implementation.

a multi-component intervention was designed based on international guidelines, a cross-sectional population survey results, and consultation with the community and institutional stakeholders. three main components integrate activities related to (i) health services redesign, (ii) clinical staff training (iii) patient and community engagement. the effectiveness of the intervention will be evaluated in a controlled before-after quasi-experimental study, with two deprived communes of the city selected as intervention and control arms. two representative population-based surveys of adults aged 35 years or older will be undertaken in the intervention and the control communes two years apart, one before the intervention implementation and the other after. the surveys will include different adults. the main outcomes assessed will be the gaps in hypertension diagnosis, treatment, follow-up and control. effectiveness will be evaluated with "difference in difference" measures. generalized estimation equations models will be fitted considering the clustered nature of data and adjusting for potential confounding variables. the implementation process will be studied with mixed methods. finally, implementation fidelity will be documented to assess to which degree the components of the intervention were implemented as intended.

Eligibility criteria:
inclusion criteria: * 35 years or older * permanent inhabitant of the selected communes * must be able to provide written informed consent exclusion criteria: * mental disability * unable to answer the questionnaire

Keywords: heart disease risk factors primary health care controlled before-after studies latin america colombia
metabolomics profiling research of human cerebrospinal fluid in aging process

Conditions: Aging; Metabolites; Neurodegenerative Diseases

Summary: perform quantitative metabolomics on human cerebrospinal fluid (csf) samples and establish the first human csf metabolome database of aging process in taiwan.

metabolomics is new science based on metabolite profiles in biofluids and tissues, which under bioinformatics approaches and analyses could help to characterize metabolomic status of csf in aging process. in this prospective study, the investigators plan to enroll 200 health volunteers and 40 neurodegenerative diseases patients with received operation under spinal anesthesia. blood and csf samples will be analyzed using hydrogen-1 nuclear magnetic resonance (1h-nmr) and lipid chromatography-mass spectrometry (lc-ms).

Eligibility criteria:
inclusion criteria: aging groups: 1. . above 20 years. 2. . no history of central nerve system injury and neurologic illness 3. . asa≦ii 4. . written informed consent from the patient aged-related neurodegenerative diseases group: 1. . above 60 years of age 2. . medical record proved the history of parkinsonism or alzheimer disease 3. . asa≦iii 4. . written informed consent from the patient or guardian by statute. exclusion criteria: 1. patient refuses to sign informed consent 2. patients with coagulopathy, systemic infective disease and severe liver and renal function impairment 3. patients with spine or brain tumor and cns disease 4. the presence of severe and/or uncontrolled and/or unstable medical disease within 12 months prior to study (e.g. acute pancreatitis, stroke, liver cirrhosis, congestive heart failure, and systemic immune disorder etc 5. concurrent participation or planning to participate in another interventional clinical trial (concurrent participation in an observational trial allowed)

Keywords: aging cerebrospinal fluid metabolomics
dose of corticosteroids in copd

Conditions: COPD

Summary: copd (chronic obstructive pulmonary disease) is a long-lasting lung disease usually caused by long-term smoking. copd can get worse, making people sick enough to need hospitalization. corticosteroids are very effective and are almost always used, but nobody knows the right dose. high doses may work better but could cause more side effects than low doses. typical treatment lengths last at least one week. this study will be comparing two common regimens: either 40mg of corticosteroids daily (low dose), or 80mg of corticosteroids daily (high dose). it is unknown which regimen works better..

the goal of the study is to determine whether a high-dose corticosteroid regimen in patients admitted to the hospital with copd exacerbations is associated with better clinical outcomes and at acceptable risk of adverse effects compared to a low-dose corticosteroid regimen. our hypothesis is that high-dose corticosteroids is associated with a decreased rate of treatment failure, shorter length of hospital stay, and improved quality of life with similar risk of adverse effects. the study population includes patients ≥ 40 years-old with a ≥ 10 pack-years smoking history and a diagnosis of copd, emphysema, or chronic bronchitis who present to the emergency room with increased dyspnea, increased sputum, or increased cough that requires admission to the hospital. we will perform a prospective, randomized, double-blinded study to determine if a high-dose corticosteroid regimen, which is already in use in clinical practice, decreases treatment failure compared to a low-dose corticosteroid regimen that is based on national consensus guidelines.

Eligibility criteria:
inclusion criteria: i. patients with a diagnosis of copd, emphysema, or chronic bronchitis ii. age ≥ 40 years-old iii. smoking history ≥ 10 pack-years iv. presentation to the emergency room with increased dyspnea, increased sputum, or increased cough v. admission to the hospital exclusion criteria: i. alternative diagnosis for cause of dyspnea, increased sputum or cough ii. patients who requires intubation at time of recruitment iii. patients who are unable to give consent iv. patients who are pregnant or could be pregnant or are currently breast-feeding v. women of child-bearing age who cannot use methods of contraception as described in the consent, including condoms, female condoms, cervical caps, diaphragms, and intra uterine devices. vi. patients who were previously entered into the trial and are re-admitted to the hospital with a new copd exacerbation.

Keywords: chronic obstructive pulmonary disease copd chronic bronchitis emphysema corticosteroids
multiple dose escalation trial of pf-04603629 given to subjects with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Type 2

Summary: pf-04603629 is being investigated for the treatment of type 2 diabetes mellitus (t2dm). specifically, pf-04603629 is a protein that is a combination of exendin-4 (a glucagon-like peptide-1 (glp-1) mimetic currently marketed as byetta®) fused to human transferrin (a naturally occuring protein) in order to increase the concentration of exendin-4 in the blood. the purpose of this study is to characterize the safety, tolerability, pharmacokinetics, and pharmacodynamics of pf-04603629 following multiple escalating subcutaneous doses in adult subjects with t2dm.

b0571002 was terminated august 19 2008 due to the decision to discontinue development of pf-04603629 after observing (in both b0571001 and b0571002) a trend for a reversible increase in heart rate within the normal range, which occurred at efficacious doses. thus, the compound was primarily terminated due to safety concerns, although there was no immediate safety risk to any subject in the study.

Eligibility criteria:
inclusion criteria: * patients with type 2 diabetes mellitus who are not taking any treatment or are taking metformin (with no change in the treatment, including dose, over the past 2 months). subjects previously treated with a sulfonylurea in combination with metformin may be eligible if switched over to metformin only for a minimum of 4 weeks before dosing. * male and/or female subjects (females will be women of non-childbearing potential) between the ages of 18 and 70 years, inclusive. * body mass index (bmi) of approximately 22 to 40 kg/m2 * fasting c-peptide test result must be \>0.4 nmol/l. * hba1c ≥7% and ≤11%. if the subject requires to be washed off a sulfonylurea, the hba1c limits will be ≥7% and ≤9.5%. exclusion criteria: * screening fasting blood glucose, ≤60 or ≥270 mg/dl. one repeat screening fasting blood glucose will be allowed. * previous treatment with an approved or investigational glp-1 mimetic. * have a known allergy to yeast, yeast-derived or yeast containing products.

Keywords: long-acting glp-1 diabetes