Kornimate/medical-research-clean huggingface dataset:
enhanced recovery after surgery protocols in total knee arthroplasty via midvastus approach

Conditions: ERAS; Knee Osteoarthritis

Summary: the study aimed to investigate the impact of enhanced recovery after surgery (eras) protocols on the clinical effect of total knee arthroplasty (tka) via the midvastus approach

in this study, a randomized controlled study was conducted to further investigate the impact of eras protocols in the clinical efficacy of tka with the midvastus approach. the eras protocols were adopted for the eras group and consisted of pure juice drinking 2 hours before the surgery, optimization of the preoperative anesthesia plan, phased use of tourniquets, and the use of tranexamic acid as well as a drug cocktail. the operative time, first postoperative walking time, first straight leg elevation time, postoperative hospitalization time, visual analogue scale score (vas score), new york hospital of special surgery knee score (hss score), knee society score (kss score), and knee range of motion were used to assess the clinical effects in the two groups. all the included patients were followed up for 12 months.

Eligibility criteria:
inclusion criteria: * unilateral primary knee osteoarthritis * varus, valgus, and flexion contracture deformity of the knee joint \< 10° * the range of motion of the knee joint was \> 80° * body mass index (bmi) \< 30 * no previous history of knee surgery on the affected side .agreed to participate in the trial. exclusion criteria: * rheumatoid arthritis * extra-knee deformity * simultaneous bilateral knee arthroplasty * severe dysfunction of the liver, kidney, and blood system * severe cardiovascular diseases * gastrointestinal ulcer .other medical conditions like nausea, vomiting, snoring, and allergy to related analgesic drugs.
mg1-magea3 with ad-magea3 and pembrolizumab in patients with previously treated metastatic melanoma or cutaneous squamous cell carcinoma

Conditions: Metastatic Melanoma; Squamous Cell Skin Carcinoma

Summary: this is a phase 1b open-label dose escalation trial of ad/mg1-magea3 and pembrolizumab in patients with metastatic melanoma or cutaneous squamous cell skin cancer that has failed prior standard of care treatments. upon determination of a maximum tolerated dose (mtd) or maximum feasible dose (mfd) the study will be expanded into up to 24 additional metastatic melanoma patients.

this is a phase 1b open-label dose escalation trial of ad/mg1-magea3 and pembrolizumab in patients with metastatic melanoma or cutaneous squamous cell skin cancer that has failed prior standard of care treatments. this study will consist of two arms where the dose will be increased independently until the maximum tolerated dose (mtd) / maximum feasible dose (mfd) is reached. arm 1 - low-dose cyclophosphamide, followed by an ad-magea3 intramuscular (im) prime, followed by intravenous (iv) administration of mg1-magea3 and iv pembrolizumab. arm 2 - ad-magea3 im injection as a prime, followed by iv administration of mg1-magea3, followed by intratumoral (it) injection of mg1-magea3 into tumors and iv pembrolizumab. in the phase 1b expansion for each arm, additional patients will be enrolled at the mtd/mdf as determined in phase 1 in order to more thoroughly explore immune response, pharmacokinetics/dynamics, and safety for malignant melanoma patients who have failed standard therapies.

Eligibility criteria:
inclusion criteria: * have histologically or cytologically confirmed diagnosis of locally advanced metastatic melanoma or cutaneous squamous cell carcinoma that has failed standard therapies * for patients treated intratumorally, must have a lesion suitable for direct injection of mg1-magea3 * have at least one tumor amenable to biopsy * have measurable disease via recist 1.1 criteria * adequate organ function and performance status * additional inclusion criteria present exclusion criteria: * prior treatment with any mage-a3 vaccine immunotherapy * prior systemic therapy for cancer within 4 weeks (8 weeks for lung radiation), and has recovered from chemo-related toxicities to grade 1 or less * intolerant to prior pd1/pd-l1 therapy * requires use of anti-platelet or anti-coagulant therapy that cannot be safely suspended for per protocol biopsies or intra-tumoral injections. * known active cns metastases and/or carcinomatous meningitis. * active autoimmune disease that has required systemic therapy in the past 2 years. * conditions likely to have resulted in splenic dysfunction. * known hiv/aids, active hbv or hcv infection. * additional exclusion criteria exist
the effect of ulistin on acute renal injury in patients undergoing opcab (off pump coronary artery bypass): a propensity score matched study

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) is a frequent complication after cardiac surgery. aki has been reported as 7-40% depending on the type of surgery, and is known to increase to about 50% when there are risk factors. cardiac surgery-associated aki (csa-aki) requires cardiac replacement therapy in 1-5% of patients and increases mortality to 1,4%, but the treatment is still unknown. therefore prevention of occurrence is very important. known factors related to the development of csa-aki include hemodynamic, inflammatory, metabolic, and nephrotoxic factors, and since there is a close connection between hypotension due to deterioration of cardiac function, preventive measures to prevent hypotension in juicing it is only possible. to date, strategies to protect kidneys with drugs are very limited. urinary trypsin inhibitor, ulistine, has anti-inflammatory and antioxidant effects, so it has been reported to protect against renal ischemia/reperfusion injury. various studies have been attempted to prevent csa-aki, but most of them are inflammatory reactions during surgery. it was performed only for surgery with extracorporeal circulation that causes severely. therefore, this study would like to verify the effectiveness of ulistine's medicine in the prevention of csa-aki in patients undergoing coronary artery bypass surgery without extracorporeal circulation.


Eligibility criteria:
inclusion criteria: * from january 2015 to june 2020, a retrospective study will be conducted on patients undergoing extracorporeal circulatory coronary artery bypass surgery at ajou university hospital. exclusion criteria: * patients who were undergoing renal replacement therapy prior to surgery due to end-stage renal failure are excluded from the study.
open label study of trx0014 in alzheimer's disease

Conditions: Alzheimer's Disease

Summary: this is an open label, dose-ranging study of two doses of trx0014 in patients with mild or moderate alzheimer's disease. the trial is made available to any patient ongoing on treatment in the clinical trial designated trx-014-001 at termination of that study. treatment for each individual patient will continue for as long as the treating physician feels there is benefit to the patient. this current protocol covers each patient for 12 months in the first instance.


Eligibility criteria:
inclusion criteria: * the patient may be of either sex and must be supervised by a carer who is competent to ensure compliance with the medication and who is willing to participate in completing the various assessments. the carer must provide written consent to his or her own participation in the study. * patients with capacity must give written informed consent to participate in this study. patients who lack capacity to consent must be in agreement with entering into the study and have a personal legal representative giving written informed consent to their participation. * the patient must have been ongoing in trx-014-001 at time of study termination. exclusion criteria: * there are no exclusion criteria. all patients taking medication at the termination of study trx-014-001 and who wish to participate are eligible for recruitment.
a pilot study of the bioavailability of nasal naloxone

Conditions: Drug Overdose

Summary: the overall is aim of this pilot study is to give a preliminary estimation of key parameters of the pharmacokinetics of a proper formulation of intranasal naloxone. these data will be used to design a well justified protocol for the final estimation of these parameters: * preliminary estimation of bioavailability of this intranasal naloxone in human, healthy volunteers * preliminary estimation of the maximum serum concentration (cmax) of this formulation * preliminary estimation of the time to maximum serum concentration (tmax) of this formulation * safety of the formulation


Eligibility criteria:
inclusion criteria: * healthy (adequate organ function is determined by electrocardiogram (ecg), liver and kidney clinical chemistry, and a standard clinical examination/interview. for safety reasons we may ask for urine sample for analysis of opioids) * informed consent exclusion criteria: * history of liver disease * taking any medications including herbal medicines the last week history of drug abuse * any local nasal disease or nasal surgery or recent cold for the last week * any history of drug allergies

Keywords: antidotes naloxone administration, intravenous administration, intranasal pharmacology
a study of zw191 in participants with solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to find out if zw191 is safe and can treat participants with advanced cancers, including ovarian, endometrial, and non-small cell lung cancers.

part 1 of the study will evaluate the safety and tolerability of zw191. part 2 of the study will further evaluate safety and explore the potential anti-tumor activity of zw191.

Eligibility criteria:
inclusion criteria: * pathologically or cytologically confirmed diagnosis of cancers with evidence of locally advanced (unresectable), recurrent and/or metastatic disease. * measurable disease per recist v1.1. * eastern cooperative oncology group (ecog) performance status score of 0 or 1. * adequate cardiac function: cardiac left ventricular function, as defined by left ventricular ejection fraction (lvef) ≥ 50% as determined by either echocardiogram (echo) or multigated acquisition scan (muga). * other adequate organ function. exclusion criteria: * known additional malignancy that is progressing or requires active treatment or may interfere with study endpoints. * has received prior topoisomerase i inhibitor(topo1i) antibody drug conjugate treatment, regardless of washout period. * acute or chronic uncontrolled renal disease, pancreatitis, or liver disease. * severe chronic or active infections (including known active sars-cov-2 infection) requiring systemic therapy, including antibacterial, antifungal, or antiviral therapy.

Keywords: advanced or metastatic cancers adc folate alpha receptor
safety and efficacy study of iv ganaxolone as adjuvant therapy for established status epilepticus (ese)

Conditions: Status Epilepticus

Summary: this study is designed to optimize the dosing regimen and evaluate the preliminary safety and efficacy of intravenous (iv) ganaxolone as adjuvant therapy for participants with ese receiving initial iv antiepileptic drug (aed) according to currently practiced standard of care (soc). the study will be composed of 2 phases: an initial, open-label, dose optimization phase followed by iv ganaxolone versus placebo double-blind phase.


Eligibility criteria:
inclusion criteria: 1. males or females at least 18 years of age at the time of the first ip bolus dose. 2. has received benzodiazepines before or after arrival to the ed for generalized convulsive seizures lasting more than 5 minutes. 3. has received the last dose of benzodiazepine more than 5 minutes prior to the first ip bolus initiation. 4. ongoing or recurrent convulsions, or evidence of electrographic se on rapid eeg immediately prior to the first ip bolus initiation. 5. the participant has not yet received a second-line iv aed for the treatment of the current episode of se or the first ip bolus can be initiated within 15 minutes before or 10 minutes after the administration of such iv aed(s). exclusion criteria: 1. the participant is intubated or the decision to proceed with intubation has been made. 2. the cause of se is acute anoxic brain injury, cardiac arrest, acute trauma, hyper- or hypo-glycemia, or eclampsia. 3. the participant is known or suspected to be pregnant. 4. the participant is incarcerated at the time of se occurrence. 5. participants who pre-emptively opted out of the study. 6. a known allergy or sensitivity to progesterone or allopregnanolone medications/ supplements. 7. receiving a concomitant iv product containing captisol®. 8. known estimated glomerular filtration rate (egfr) \<30 milliliters per minute (ml/min) and not receiving dialysis (may initiate first ip bolus prior to acute labs). 9. individual weighing or suspected to weigh \<40 kilograms (kg). 10. hypotension requiring 2 or more vasopressors. 11. an individual who, in the opinion of the investigator has a life expectancy of less than 24 hours. 12. use of an investigational product for which less than 30 days or 5 half-lives have elapsed from the final product administration. participation in a non-interventional clinical study does not exclude eligibility. 13. known or suspected history or evidence of a medical condition that, in the investigator's judgment, would expose participant to an undue risk of a significant adverse event or interfere with assessments of safety or efficacy during the study.

Keywords: established status epilepticus ganaxolone antiepileptic drug adjuvant therapy
cutibacterium acnes in deep tissues in primary spine and shoulder surgery

Conditions: Rotator Cuff Tear Arthropathy; Spine Degeneration

Summary: obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.

shoulder prosthetic surgery as well as interventional surgery on the spine are commonly contaminated by cutibacterium acnes. although the significance of this contamination is unknown, it represents a cause for concern since in some patients, contaminating cutibacterium acnes from surgery may develop long-term infection of the implant. unlike knee and hip surgeries, where the most common infection-causing germs are staphylococcus aureus, in shoulder and spine surgery, cutibacterium acnes represents one of the germs most frequently associated with infections. peri implant. skin preparation with chlorhexidine as well as antibiotic prophylaxis with cefazolin have been shown to be ineffective in eradicating cutibacterium acnes. recently, different studies support the use of benzoyl peroxide in topical application, to reduce the load of cutibacterium acnes on the skin. despite this, it has not been shown to reduce the rate of infection, nor to reduce the phylotypes of cutibacterium acnes associated with peri-implant infections (ia, ib and ii). obtain deep tissue samples from patients undergoing primary prosthetic surgery of the shoulder and patients undergoing primary instrumented surgery of the spine. patients will be randomized to receive benzoyl peroxide 3 days prior to surgery.

Eligibility criteria:
inclusion criteria: * patients \> 18 yrs. * primary prosthetic shoulder surgery. * instrumented primary surgery of the spine. exclusion criteria: * active infection. * previous surgeries. * interventionism prior to surgery in the last 6 months (infiltrations, arthro-ct, arthro-mri)
improving detection of fetuses at risk - who needs systematic training?

Conditions: Improving Obstetric Ultrasound Skills

Summary: detection of growth restricted fetuses relies primarily on abdominal ultrasound examinations during pregnancy. many clinicians, however, have not received systematic training and may therefore perform inadequately. we wish to examine, whether systematic, simulation-based training can improve diagnostic accuracy of estimated fetal weight by ultrasound at different levels of clinical experience.

participants are physicians working at obstetric departments. participant characteristics (age, experience in years and number of monthly scans) are recorded. participants perform two abdominal growth scans prior to randomization and estimated fetal weight is compared to birth weight. mean absolute percentage error is calculated as a measure of diagnostic accuracy. participants are then randomized to either control (no intervention) or intervention. the latter group receives training on the metaphor scantrainer trans abdominal ultrasound simulator until they pass a previously validated test. after completing the training the participants use a mannikin to practice systematic approach and 'knobology'. all participants then perform another two growth scans. diagnostic accuracy before and after the intervention or control period is compared. we wish to examine the effect of systematic training on the diagnostic accuracy of estimated fetal weight by ultrasound across different levels of clinical experience. if an effect can be found in the inexperienced participants, simulation-based training in obstetric ultrasound could be implemented as a part of basic obstetric training and/or as a means of maintaining skills.

Eligibility criteria:
inclusion criteria: * proficiency in the danish language * no prior experience with obstetric ultrasound simulation * doctors who work within the field of gynecology and obstetrics exclusion criteria: * lack of proficiency in the danish language * prior experience with obstetric ultrasound simulation

Keywords: simulation-based training obstetric ultrasound intrauterine growth restriction ultrasound simulation
determining the sustained virologic response of declatasvir in egyptian patients with hepatitis c virus genotype 4

Conditions: Hepatitis C

Summary: this is a prospective, cohort study in faculty of medicine, zagazig university, egypt. from june to december, 2016, investigators will follow up patients with chronic hepatitis c virus genotype 4 receiving daclatasvir-sofosbuvir treatment regimen within the national program of egyptian ministry of health and population. the primary outcomes are safety of the treatment and the sustained virologic response 12 weeks after discontinuation of therapy. for the secondary outcomes, investigators will measure the change in health related quality of life and investigate the genetic sequence of viral rna of resistant patients.


Eligibility criteria:
inclusion criteria: * patients with hcv genotype 4 * age ≥ 18 years * hcv rna≥ 104 iu/ml * screening ecg without clinically significant abnormalities. exclusion criteria: * total serum bilirubin \> 3 mg/dl. * serum albumin \< 2.8 g/dl. * inr ≥ 1.7 * platelet count \< 50000/mm3. * hepatic cell carcinoma except four weeks after intervention aiming to cure with no evidence of activity by dynamic imaging (ct or mri). * extra hepatic malignancy except after two years of disease free interval * pregnancy or inability to use contraception. * inadequately controlled diabetes mellitus (hba1c \> 9%).

Keywords: hepatitis c virus genotype 4 antiviral virologic response
mrs probe study of alcohol

Conditions: Heavy Dose Drinkers

Summary: this protocol will investigate the neurobiological underpinnings of alcohol craving in recently detoxified alcoholic drinkers utilizing novel functional brain imaging. this clinical magnetic resonance spectroscopy (mrs) study will investigate whether glutamate and other brain metabolites correlate to measures of alcohol craving severity


Eligibility criteria:
inclusion criteria: (minimal or no alcohol group) 1. male or female age 21-70 2. consume less alcohol then what is described in this protocol as a "higher dose drinker", or consume no alcohol at all. 3. able to complete a 60 min. mrs brain scan. exclusion criteria: 1. inability to speak english 2. inability or unwillingness to provide written informed consent 3. diagnosis of active substance dependence other than nicotine (e.g. alcohol, cannabis, caffeine, prescription use of barbiturates, benzodiazepines, opiates, or stimulants) this will be determined using a prism (psychiatric research interview for substance and mental disorders) interview. 4. any unstable active medical or additional psychiatric condition as determined by the investigator 5. active suicidal ideation as determined by the phq-9 question 9 indicating response #2 or higher (several days; more than half the days; or nearly every day). 6. history of encephalopathy, hepatic failure, or hiv seropositivity 7. history of claustrophobia 8. history of major head trauma with loss of consciousness \>5 minutes or skull fracture 9. history of previous neurological event (e.g. epilepsy, stroke, transient ischemic attack) 10. implanted metal objects (e.g. pacemakers; aneurysm clips; metal prostheses, joints, rods, or plates) 11. contraindication to mri scanning 12. pregnancy or breast-feeding

Keywords: mrs heavy dose drinkers alcohol niaaa
coordinated access to care from hospital emergency departments

Conditions: Mental Health

Summary: the study will assess the effectiveness and cost-effectiveness of providing brief, intensive case management for frequent users of hospital emergency departments who have mental health and/or addictions problems. the goals of the intervention are to support patients' transition to community-based health and social services and supports - including primary and urgent psychiatric care, peer support and other community services and supports - so as to improve patient wellbeing and reduce avoidable ed visits and hospitalizations.


Eligibility criteria:
inclusion criteria: * legal adult status (age 18) * able to give informed consent * have made 5+ visits to participating hospital emergency department in the previous 12 months * one of these visits will have been for a mental health and/or addiction problem. exclusion criteria: -