Kornimate/medical-research-clean huggingface dataset:
acellular porcine dermal matrix wound dressing in the management of diabetic foot ulcers

Conditions: Diabetic Foot Ulcers

Summary: have indolent diabetic ulcers completely healed by the acellular porcine dermal matrix (apm) in 12 weeks.

the primary objective of this study is time -to - healing with wound size determination at 12 weeks.

Eligibility criteria:
inclusion criteria: inclusion criteria and population: * male or female age 18 or older * informed consent must be obtained * patient's ulcer must be diabetic in origin and larger than 1cm2. debridement will be done prior to randomization. subject's informed consent for participating in this study, must be obtained prior to proceeding with sharp debridement. * patients with type 1 or type 2 diabetes (criteria for the diagnosis of diabetes mellitus per ada). * patient's ulcer must exhibit no clinical signs of infection. * patient is of legal consenting age. * patient is willing to provide informed consent and is willing to participate in all procedures and follow up evaluations necessary to complete the study. * patient has adequate circulation to the affected extremity, as demonstrated by one of the following within the past 60 days: * dorsum transcutaneous oxygen test (tcpo2) with results ≥30mmhg, or * abis with results of ≥0.7 and ≤1.2, or * doppler arterial waveforms,which are triphasicor biphasic at the ankle of affected leg exclusion criteria: * patients presenting with an ulcer probing to bone (ut grade iiia-d). a positive probe-to-bone will be confirmed when bone or joint can be felt with a sterile, ophthalmological probe. * patients whose index diabetic foot ulcers are greater than 25cm2. * patients considered not in reasonable metabolic control, confirmed by an hga1c greater than 12% within previous 90 days, * patients whose serum creatinine levels are 3.0mg/dl or greater. * patients with a known history of poor compliance with medical treatments. * patients who have been previously randomized into this study, or are presently participating in another clinical trial * patients who are currently receiving radiation therapy or chemotherapy. * patients with known or suspected local skin malignancy to the index diabetic ulcer. * patients on anticoagulant medication will as in any surgical procedure, be monitored according to the protocols employed at the enrolling center. * patients diagnosed with autoimmune connective tissues diseases. * nonrevascularable surgical sites * active infection at site * sensitivity to the following antibiotics: gentamicin, cefoxilin, linocmycin, polymyxin b, vancomycin * any pathology that would limit the blood supply and compromise healing; * patients that have received a biomedical or topical growth factor for their wound within the previous 30 days

Keywords: diabetic foot ulcers
evaluation of the efficacy of topical ophthalmic steroids in a modified conjunctival allergen challenge (cac) model

Conditions: Allergic Conjunctivitis

Summary: the purpose of this study is to evaluate the effectiveness of the modified conjunctival allergen challenge (cac) and observe how the produced allergic inflammation reacts to treatment with a proven ocular anti-inflammatory medication, prednisolone, assessed by the following measures: * ocular itching * conjunctival redness

prospective, single center, randomized, double-masked, placebo controlled study. subjects will be randomized to one of the following treatment arms to dose four times per day (qid) for 8 days between visits 4 and 5. * prednisolone phosphate * tears naturale ii ophthalmic solution (placebo) duration: approximately 19 days controls: artificial tears (tears naturale® ii)

Eligibility criteria:
inclusion criteria: * at least 18 years of age \& either sex, any race * willing and able to follow all instructions * positive history of ocular allergies * reproducible positive ocular allergic reaction induced by conjunctival allergen challenge exclusion criteria: * have planned surgery during trial period * female currently pregnant, planning a pregnancy or lactating * use of disallowed medications * have ocular infections, or ocular conditions that could affect study parameters * have moderate to severe dry eye * have used an investigational drug or device within 30 days of start of study * female that is currently pregnant, planning a pregnancy or lactating
spectroscopic profiling of extracellular vesicles by resonant gold nanostructures in the infrared

Conditions: Vesicle

Summary: extracellular vesicles, due to their ease of extraction and ability to represent the cells from which they originate, have high potential in the field of personalized medicine, especially in the identification of new early bio-markers of cancer, including hepatocellular carcinoma. nevertheless, the development of high-throughput diagnostic methods in this area is still in its infancy, and the design of new integrated technological solutions is of great interest and topicality. the main hypothesis of this study is that the development of a novel technology integrating resonant gold nanostructures in the mid-infrared can significantly contribute to the development of new approaches for the diagnosis of hepatocellular carcinoma.


Eligibility criteria:
inclusion * 18 years old with a diagnosis of liver cirrhosis of different etiology * 18 years old with a diagnosis of hepatocellular carcinoma exclusion * have not signed the informed consent * pregnant women

Keywords: microvescicles; cirrhosis; hcc; nanostructures.
a study to evaluate adverse events and change in disease state of oral upadacitinib in adolescent participants ages 12 to <18 years old diagnosed with atopic dermatitis (ad)

Conditions: Atopic Dermatitis

Summary: atopic dermatitis (ad; also known as atopic eczema) is an inflammatory skin disease. the safety and effectiveness of upadacitinib for ad has been well-documented in previous studies, however, these studies included a limited number of adolescent patients in japan. therefore, the purpose of this observational study is to evaluate safety and effectiveness of upadacitinib in adolescent ad participants age 12 to \<18 years old in japan in the real-world setting. upadacitinib is an approved drug being developed for the treatment of ad in adolescents in japan. around 170 participants age 12 to \<18 who are prescribed upadacitinib for the treatment of ad in routine clinical practice will be enrolled at multiple sites in japan. participants will receive oral upadacitinib as prescribed by their physician. data from these participants will be collected for approximately 2 years. there will be no additional burden for participants in this trial compared to their standard of care. participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.


Eligibility criteria:
inclusion criteria: * participants who are diagnosed with atopic dermatitis (ad). * history of topical anti-inflammatory agents such as topical steroids and topical tacrolimus for ad. * participants initiating upadacitinib for the treatment of ad in routine clinical practice. * body weight \>=30 kg at the start of dosing. exclusion criteria: * prior treatment with upadacitinib * currently participating in another registrational clinical research study * participants for whom upadacitinib is contraindicated

Keywords: atopic dermatitis atopic eczema upadacitinib rinvoq
efficacy and safety of hydrogen inhalation on bronchiectasis: a randomized, multi-center, double-blind study

Conditions: Bronchiectasis; Acute Exacerbation of Bronchiectasis; Oxidative Stress

Summary: this is a multi-center, randomized, double-blind, parallel-group trial. after a 2-week run-in period, eligible patients will be, based on the randomization codes kept in sealed envelopes, randomly assigned to receive usual care (mucolytics and/or chest physiotherapy) plus oxygen inahaltion (1 hr daily for 12 consecutive months) or hydrogen inhalation (1 hr daily for 12 consecutive months) provided by the sponsor. at 3 months after the end-of-treatment, a follow-up visit will be scheduled for all patients.

this is a multi-center, randomized, double-blind, parallel-group trial. after 2-week run-in period, eligible patients will be, based on the randomization codes kept in sealed envelopes, randomly assigned to two groups.on the basis of usual care \[ambroxool (30mg thrice daily), or n-acetylcysteine (0.2g thrice daily)/ serrapeptase (10mg thrice daily), or carbocisteine (500mg thrice daily) and/or chest physiotherapy (10 min, twice daily)\], patients were randomized to receive either hydrogen (66.7%, 3l/min, 1 hr twice daily) inhalation or oxygen inhalation (3l/min, 1 hr twice daily) via nasal canula for 12 months. a follow-up visit at month 3 following end-of-treatment was also scheduled. the primary endpoint was the annual frequency of bronchiectasis exacerbations. hospital visits were scheduled at baseline and months 1, 3, 6, 9, 12 and 15, respectively. at 3 months after the end-of-treatment, a follow-up visit will be scheduled for all patients.

Eligibility criteria:
inclusion criteria: * out-patients of either gender, ex- or never-smokers, aged between 18 and 75 years * clinically stable bronchiectasis, defined as respiratory symptoms and lung function parameters not exceeding normal daily variations and no acute upper respiratory tract infections for 4 consecutive weeks * patients with a history of 2 or more bronchiectasis exacerbations (bes) within the previous 2 years exclusion criteria: * other unstable concomitant systemic illnesses (i.e. coronary heart disease, recent cerebral stroke, severe uncontrolled hypertension, active gastric or duodenal ulcer, uncontrolled diabetes, malignancy, hepatic or renal dysfunction) * concomitant asthma, allergic bronchopulmonary aspergillosis, or active tuberculosis * concomitant chronic obstructive pulmonary disease as the predominant diagnosis * treatment with inhaled, oral or systemic antibiotics within 4 weeks * type 2 respiratory failure needing oxygen therapy or non-invasive mechanical ventilation * females during lactation or pregnancy * poor understanding or failure to properly operate the instrument * participation in other clinical trials within 3 months.

Keywords: hydrogen inhalation bronchiectasis
project power: an hiv risk reduction intervention for black men who have sex with men and women (bmsm/w)

Conditions: Unsafe Sex; Risk Reduction

Summary: the goal of this study is to develop and test a program to help black men who have sex with men and women reduce their chances of getting or giving hiv infection to their sex partners. the program is designed to be delivered via the internet so that it would be available to more men. men who agree to participate in the study will be assigned by chance to receive the power intervention or a similar program that is focused on general health called power-health. they will also complete a computer administered interview when they first enroll in the study, 2 weeks following the last session of the program and 3 months after that. participants will receive a small compensation for their time and effort.

the purpose of this study is to examine the preliminary efficacy, feasibility and acceptability of delivering a culturally and developmentally tailored hiv risk reduction intervention via the internet in real-time that promotes risk reduction among black men who have sex with men and women (bmsmw). during the developmental phase, our activities will consist of completing development (finalizing sessions, completing the manuals) of a theoretically grounded, culturally based, individual intervention, project power, to reduce risk of hiv acquisition and transmission among bmsmw. the investigators will then conduct a randomized controlled trial (rct) to test the preliminary efficacy, acceptability, and feasibility of power compared to health. using chain referral methods, the investigators will recruit 200 bmsmw (100 per arm) and assign them to 1 of 2 conditions (power or health). participants will complete an assessment battery delivered via acasi at baseline, immediate post intervention and at 3 months post intervention. the investigators will also measure uptake of hiv and sti testing. participants will also complete acceptability/feasibility assessments after the

Eligibility criteria:
inclusion criteria: * self identify as black or african descent * at least 18 years of age * resident of chicago msa * sexually active with men and women exclusion criteria: * previously participated in the study * identify as transgendered

Keywords: black msm/w hiv
deep brain stimulation of nucleus accumbens to treat severe anorexia nervosa

Conditions: Anorexia Nervosa

Summary: anorexia nervosa (an) is a complex and severe psychiatric disorder with high relapse rates under standard treatment.deep brain stimulation (dbs) may be a novel treatment in severe anorexia nervosa.


Eligibility criteria:
inclusion criteria: 1. age between 18 and 65 years of age, male or female patients. 2. diagnosis is anorexia nervosa(an) by the dsmiv(diagnostic and statistical manual of mental disorders fourth edition). 3. bmi\<16. 4. long-term pharmacotherapy resistance. 5. written informed consent. 6. normal intelligence and compliance exclusion criteria: 1. surgical contradiction（implanted artificial cochlea、cardiac pacemaker、cardiac defibrillator、stereotactic ablative surgery、dbs）or receive other surgery which may influence this time of surgery in half year, or other neurosurgical contradictions； history of brain trauma； 2. history of severe neuropsychiatric disease； 3. epilepsy； 4. severe liver、kidney、heart and lung disease, severe hypertension and severe orthostatic hypotension； 5. severe diabetes ,severe cardiovascular and cerebrovascular disease； 6. malignant tumor； 7. being using anticoagulant or showing clinical hemorrhagic tendency； pregnant female； 8. patients are taking part in other clinical trials in recent 3months； being deem as unfit for the trials by researcher

Keywords: anorexia nervosa deep brain stimulation nucleus accumbens
surgical management of placenta accreta

Conditions: To Publish Our Experience in the Surgical Management to Placenta Accreta Cases and the Maternal Outcome

Summary: purpose of this study was to report our experience for surgical management of suspected placenta accreta cases encountered in king hussein medical center

was a retrospective study of all patients who underwent planned deliveries for placenta accreta at king hussein medical centre (khmc) from august 2011 to october 2014.demographic characteristics were recorded. ultrasound (u/s) and magnetic resonance imaging (mri) were used for the diagnosis. surgery for all patients were performed by multidisciplinary teams. all information were obtained from patient's files.

Eligibility criteria:
inclusion criteria: * all placenta previa accreta cases encountered in our institution over three year period exclusion criteria: -
maintenance boosted lopinavir monotherapy following salvage protease-inhibitor (pi) based regimen in hiv with non-nucleoside reverse transcriptase inhibitors (nnrti) based regimen failure

Conditions: HIV; AIDS; Lopinavir; Treatment Failure

Summary: the objective of this study is to determine efficacy of ritonavir-boosted lopinavir monotherapy as a maintenance regimen in hiv-1-infected patients who previously failed non-nucleoside reverse transcriptase inhibitors (nnrti) based regimens and currently received salvage protease-inhibitor (pi) based regimens.


Eligibility criteria:
inclusion criteria: * age 18-60 years * documented hiv infection * previously failed to nnrti-based regimens * no history of failing pi-based regimens * receiving ritonavir-boosted pi + obrs(such as nrits, etravirine, raltegravir) * having hiv-1 rna \<50 copies/ml for at least prior 6 months exclusion criteria: * pregnant or breastfeeding woman * hbv co-infection that had to treated with tdf, ftc or 3tc * had to received medications known to have potential significant drug interaction with lpv/r * life expectancy less than 6 months * serious systemic diseases such as liver cirrhosis child-pugh b/c, esrd, malignancy * hemoglobin \ 3 uln, estimated creatinine clearance \<50 ml/min

Keywords: hiv or aids lopinavir ritonavir anti-retroviral agents treatment failure treatment experienced nnrti failure monotherapy
acute liver injury in patients on dapagliflozin

Conditions: Acute Liver Injury

Summary: to compare, by insulin use at the index date, the incidence of hospitalization for acute liver injury (ali) among patients with type 2 diabetes mellitus who are new users of dapagliflozin with those who are new users of antidiabetic drugs (ads) in classes other than sodium-glucose cotransporter 2 (sglt2) inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylurea monotherapy.

the overall goal of this research study is to estimate the risk of hospitalization for acute liver injury in patients who are prescribed dapagliflozin compared to patients prescribed other specific oral antidiabetic drugs. dapagliflozin and other antidiabetic drugs are used to treat type 2 diabetes mellitus. because of the mechanism of action for dapagliflozin and results from small safety monitoring studies, there is interest in further evaluating the safety of dapagliflozin in large populations. the study will be implemented in three administrative health care data sources in two countries: in the united kingdom, the clinical practice research datalink (cprd); and in the united states, the centers for medicare and medicaid services (cms) medicare databases and the healthcore integrated research database (hirdsm). individuals in the databases will be included in the study if they meet the following age criteria; 18 years and older (cprd and hird), or 65 years or older (medicare); and if they did not have type 1 diabetes, are new users of one of the study drugs and meet the criteria of at least 180 days of electronic data before their first prescription of the study drug. the study period starts july 1, 2013 in cprd, january 1, 2014 in pharmo and january 9, 2014 in the united states data sources, and will end at the latest available data at each database at the time of analysis

Eligibility criteria:
inclusion criteria: 1. receive newly prescribed dapagliflozin (with or without other ads) or a newly prescribed ad (with or withoutother ads) in a class other than sglt2 inhibitors, insulin monotherapy, metformin monotherapy, or sulfonylureamonotherapy; 2. do not have evidence of type 1 diabetes; 3. are aged 18 years or older at the index date for cprdpatients, 18-64 years for hirdsm patients, or 65 years or older for medicare patients; and 4. have been enrolled in the data source for at least 180 days before the first prescription or dispensing for dapagliflozin or comparator ad. exclusion criteria: * previous diagnosis of ali; liver, biliary, or pancreatic disease; hepatobiliary or pancreatic neoplasm; or congestive heart failure
transanal irrigation to prevent major low anterior resection syndrome

Conditions: Low Anterior Resection Syndrome

Summary: bowel dysfunction after rectal cancer resection comprises a vast array of bowel symptoms and associated quality-of-life impairment, collectively termed as low anterior resection syndrome (lars). there are 40%-60% patients who suffer from major lars after sphincter-preserving surgery. no consensus exists for lars treatment or prevention. transanal irrigation (tai) was reported to play a helpful role in the management of major lars and fecal incontinence. however, the preventive effect and daily accessibility need further confirmation. in this randomized trial, tai compared with best support treatment, is used in patients who received curative low anterior resection for rectal cancer with diverting stoma, after completion of the stoma reversal. the primary outcome is the occurrence of major lars after 6 months of the treatment.


Eligibility criteria:
inclusion criteria: * age: 18-75 years old * curative low anterior resection for rectal cancer with diverting stoma * stoma closure within 1 month * preoperative radiotherapy or height of anastomosis less than 5 cm from anal verge * no evidence of anastomotic leakage or severe stenosis exclusion criteria: * tumor recurrence or distant metastasis * secondary operation with stoma * prior disease impairing bowel function except for rectal cancer * any contraindication for transanal irrigation * pregnant or nursing * serious cardiovascular disease, uncontrolled infections, or other serious uncontrolled concomitant disease * cognitive or psychological disorder

Keywords: low anterior resection syndrome transanal irrigation rectal cancer prevention
incidence of postoperative hypothermia and associated factors in adult patients undergoing surgery in siriraj hospital

Conditions: Hypothermia Following Anesthesia

Summary: inadvertent postanesthetic hypothermia is unintentional drop in core body temperature \<36c (96.8f) immediately following an operation, caused by multiple factors, and had lead to negative outcomes. in our institute, a study in 2011 reported an incidence of postoperative hypothermia in pacu of 45.4% (95% ci 39.61%- 51.23%). after that, various interventions aimed to prevent perioperative hypothermia were implemented. this study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at siriraj hospital.

inadvertent postanesthetic hypothermia is unintentional drop in core body temperature \<36c (96.8f) immediately following an operation, which is a common problem in post anesthesia care unit (pacu). it has been implicated in negative outcomes in surgical patients, including prolonged effects of intraoperative anesthetic medication, increased insulin resistance, postoperative morbidity, delayed surgical wound healing; and prolonged stay in the recovery room and hospital1-7. in the operating room (or), patients have to expose to a low ambient temperature with little or no clothing, evaporation from the surgical area, an irrigated fluid in surgical area; and an administration of intravenous fluids. moreover, many anesthetic agents have an influence on the autonomic thermoregulatory mechanism which causes vasodilatation. all these factors promote patients' unintentional loss of heat and cause hypothermia. even of a lot of efforts to keep patients warm intraoperatively and minimize hypothermia including optimizing ambient or temperature and using of various warming devices, the incidences of postoperative hypothermia in pacu are still high with the reported magnitude ranges from 50%- 90%7. in siriraj hospital, a study in 2011 reported an incidence of postoperative hypothermia in pacu of 45.4% (95% ci 39.61%- 51.23%)8. after that, various interventions aimed to prevent perioperative hypothermia were implemented such as maintaining the ambient room temperature of an or; warming intravenous fluids, blood products, and irrigants; heated, humidified anesthetic gases; and using warming blankets, forced-air warming, layering drapes and head wraps. this study is initiated to determine the incidence of postoperative hypothermia and associated factors of postoperative hypothermia in adult patients underwent surgery at siriraj hospital.

Eligibility criteria:
inclusion criteria: * all patients \>18 years undergoing surgery with anesthesia service * stay at postanesthetic care unit of syamindra building, fifth floor, siriraj hospital exclusion criteria: * procedure performed under local anesthesia * patients with missing data of temperature

Keywords: postoperative hypothermia patient warming inadvertent hypothermia